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ASPI system - as of the 31st July 2017, till item 81/2017 of the Collection of Laws and 25/2017 of the Collection of International Treaties - RA1071
372/2011 Coll. - the Health Services Act - the final version of the text does not become effective until the 1st September 2017

372/2011 Coll. 

ACT

of the 6th November 2011 

on health services and on conditions of their provision 

(the Health Services Act) 

As amended by: 167/2012 Coll. 
As amended by: 437/2012 Coll. 
As amended by: 66/2013 Coll. 
As amended by: 303/2013 Coll. 
As amended by: 60/2014 Coll. 
As amended by: 205/2015 Coll. 
As amended by: 126/2016 Coll. 
As amended by: 47/2016 Coll., 147/2016 Coll. 
As amended by: 189/2016 Coll. 
As amended by: 298/2016 Coll. 
As amended by: 192/2016 Coll., 264/2016 Coll. 
As amended by: 65/2017 Coll. 
As amended by: 183/2017 Coll. 
As amended by: 206/2017 Coll. 
As amended by: 193/2017 Coll. 
 
	The Parliament has passed the following Act of the Czech Republic: 

PART ONE 

INTRODUCTORY PROVISIONS 

Section 1 [Practical commentary] [DZ] 

	This Act regulates the health services and the conditions for their provision and the related performance of state administration, different types and forms of health care, the rights and the obligations of the patients and of their relatives, of the providers of health services, healthcare professionals1), 2), other professionals2) and other persons in connection with the provision of health services, the requisite conditions for the evaluation of the quality and the safety of the health services, including other activities that are related to the provision of health services and it also incorporates the relevant European Union regulations3). 
 
Section 2 [Practical commentary] [DZ] 

	(1) The provider of health services is understood as being a natural person or a legal entity who is authorised to provide health services in a manner pursuant to this Act. 
 
	(2) Understood as health services will be  
 
a) the provision of health care by healthcare professionals1), 2) pursuant to this Act, and the activities of other professionals2), whereby such activities are carried out in direct connection with the provision of health care, 
 
b) consultation services for the purpose of assessing an individual treatment regimen, or of a proposal for modifying or supplementing it, together with other consultations supporting patient’s decision-making in regard to the provision of health services by another provider (hereinafter referred to as the "provider") or by the healthcare professional whom the patient has chosen, 
 
c) dealing with the deceased body to the extent stipulated by this Act, including the transfer of the body for a pathological-anatomical autopsy or a medical autopsy and, from the place where the pathological-anatomical autopsy or the medical autopsy has been performed by the Provider in accordance with the Act on Funeral Services4), 
 
d) the medical rescue service5), 
 
e) the medical transportation service, the purpose of which is 
1. the transportation of the patients between the individual providers or to the provider and back to the patient’s own social environment, if this is necessary for ensuring the provision of the requisite health services, 
2. the rapid transportation of healthcare professionals to provide urgent care at the provider’s premises, 
3. the transportation of persons, including the patient who has deceased, in connection with transplantation, the urgent transportation of tissues and cells that are intended for human use, the transportation of medicinal products, blood or its components, and of the medical devices that are necessary for providing urgent care or the transportation of other biological materials, 
 
f) the transportation of urgent care patients, which is understood as their transportation between the providers solely under the condition of continuous urgent care being provided throughout the transportation, 
 
g) health services within the scope of activities of collection establishments or tissue establishments in accordance with other legislation governing the procedures for ensuring the quality and safety of human organs, tissues and cells6), 
 
h) healthcare services that are within the scope of the operation of a blood establishment or a blood bank pursuant to the legislation governing the production, storage and dispensation of the transfusion products7), 
 
i) anti-alcohol and anti-drug sobering-up service52) (hereinafter referred to as "sobering-up service"). 
 
	(3) Also understood as health services are specific services that are pursuant to the Act on Specific Health Services, Health Services under the Transplantation Act or the Act on the Induced Termination of Pregnancy8). 
 
	(4) Understood as health care is 
 
a) a series of activities and other measures that are carried out on behalf of the natural person for the purposes of: 
1. the prevention, detection and eradication of illness, defects or health conditions (hereinafter referred to as the "illness"), 
2. maintaining, restoring or improving health and fitness conditions, 
3. supporting and prolonging life and also alleviating suffering, 
4. assistance with reproduction and childbirth, 
5. health assessment, 
 
b) preventive, diagnostic, medical, rehabilitative, nursing or other medical procedures that are provided by healthcare professionals (hereinafter referred to as "medical procedures") for the purpose referred to in Point a); 
 
c) specialist medical examination in accordance with Act on Health Protection from the Harmful Effects of Drugs53). 
 
Section 3 [Practical commentary] [DZ] 

	(1) Understood as the patient is a natural person, to whom health services are provided. 
 
	(2) Understood as an attending healthcare professional is a healthcare professional who proposes, coordinates, provides and evaluates the individual medical treatment process of a specific patient and coordinates the provision of other necessary health services. 
 
	(3) Understood as an individual medical treatment is the provision of health services, including individual healthcare, in a logical and temporal sequence to a specific patient, including their possible options and methods. The individual medical treatment process in particular includes diagnostic discretion, proposal of treatment, including rehabilitation care and recommendations for further treatment in the course of providing health services. An individual treatment process also includes a treatment regimen, understood as which is a set of measures that support treatment and minimise its possible risks, including the recommendations for lifestyle adjustments. 
 
	(4) Hospitalisation refers to a period generally longer than 24 hours during which inpatient care is provided to a patient admitted to a bed in the inpatient provider’s health care facility. 
 
	(5) The registrar provider refers to a provider of outpatient care in the field of general medical practice, in the field of practical medicine for children and adolescents, in the field of dentistry or in the field of gynaecology and obstetrics, who has accepted the patient into care for the purpose of providing primary outpatient care; upon receipt of the patient into care the registrar provider is obliged to fill in the registration sheet, which the patient signs. In the event that several physicians provide health services at the provider’s premises referred to in the first sentence, the patient is registered with a specific physician. 
 
Section 4 [Practical commentary] 

	(1) Understood as healthcare facilities are the premises intended for the provision of health services. 
 
	(2) Understood as health visiting service is the provision of health care in the patient’s own social environment, especially in cases where the patient cannot attend the provider’s healthcare facility due to his/her health condition and the provision of health care in this way is feasible in terms of its nature. 
 
	(3) For the purposes of this Act, the patient's own social environment means the patient's home environment or the environment replacing the patient's home environment, such as social services facilities9), facilities for children requiring immediate help, school facilities for institutional care or protective education or school facilities for preventive-remedial care or other similar facilities, prisons for custody and imprisonment, detention facilities, detention facilities for foreigners10) and asylum facilities11). 
 
	(4) For the purposes of this Act the field of healthcare refers to 
 
a) dentistry, pharmacy, specialist training fields or fields of certified courses of physicians, dentists or pharmacists pursuant to another legal regulation1); 
 
b) the expertise of paramedical staff or specialised education fields or the fields of certified courses of paramedical staff pursuant to another legal regulation2). 
 
	(5) Understood as an appropriate professional level is the provision of health services in accordance with the rules of science and accepted medical practices, while respecting the patient’s individuality and taking into account the specific conditions and the objective possibilities. 
 
PART TWO 

HEALTH SERVICES AND HEALTH CARE 

CHAPTER I 

TYPES AND FORMS OF HEALTH CARE 

Section 5 [Practical commentary] [DZ] 

Types of health care 

	(1) Types of health care in accordance with the timeliness of its provision comprise 
 
a) urgent care, the purpose of which is to prevent or reduce the formation of acute conditions that are imminently life-threatening or that could lead to sudden death or to a serious threat to the health, or that are causing a sudden and intense pain or sudden changes in the patient’s behaviour who is endangering himself/herself or others. 
 
a) acute care that is aimed at averting a serious deterioration of the health  condition or at reducing the risk of a serious deterioration of the health  condition in such a manner as to timely identify the facts that are necessary to establish or alter an individual treatment or to prevent the patient from condition in which s/he could endanger himself/herself or others, 
 
c) necessary care that is medically required by the health condition of the patient who is a foreign insured person, taking into account the nature of the benefits and the length of his/her stay in the Czech Republic; in the case of foreign insured persons from a Member State of the European Union, the European Economic Area or the Swiss Confederation, health care must be provided to such an extent that a foreign insured person does not need to travel to the country of insurance before s/he originally intended, 
 
d) planned care which is not the health care referred to in points a), b) nor c) 
 
	.

	(2) Types of health care in accordance with the purpose of its provision comprise 
 
a) preventive care aimed at the early identification of factors that are causally related to the onset of the disease or the deterioration of the health condition, and the implementation of measures that are aimed at eliminating or minimising the effects of these factors and preventing their occurrence, 
 
b) diagnostic care, the purpose of which is to determine the patient's health condition and the circumstances affecting the patient's health condition, the information necessary to identify the disease, its condition and severity, other information necessary to establish a diagnosis, individual treatment and information about the effect of the treatment, 
 
c) dispensary care, the purpose of which is the active and long-term monitoring of the health condition of a patient who is at risk of or suffering from a disease or of a deterioration of the health condition, where due to the development of the disease a change in his/her health condition may reasonably be anticipated, while its early diagnosis may substantially influence further treatment and the development of the disease, 
 
d) medical care aimed at achieving a favourable effect on the health condition by virtue of the implementation of an individual treatment procedure with the aim of curing or mitigating the consequences of the illness and preventing the occurrence of handicap or disability or mitigating their extent, 
 
a) assessment care to determine whether 
1. the patient's stabilised health condition will not be adversely affected by the demands placed on him/her in connection with work, service, occupation or other activities in specific conditions, or 
2. the patient's health condition is in accordance with the assumptions or requirements set forth in regard to the performance of work, service, occupation, other activities or other purposes, 
 
f) therapeutic rehabilitation care, the purpose of which is to restore the physical, cognitive, speech, sensory and psychological functions of the patient, by eliminating the occurring functional disorders or by replacing certain functions of his/her organism, or by slowing down or stopping the disease and stabilising his/her health condition; if natural healing resources or climatic conditions favourable for treatment in accordance with the Spa Act12) are utilised in its provision, it is a spa treatment rehabilitation care, 
 
g) nursing care with the purpose of maintaining, supporting and restoring health and satisfying biological, psychological and social needs altered or arising in the context of a disorder of individuals or groups or in connection with pregnancy and childbirth, and additionally also developing, preserving or restoring self-sufficiency; it also includes the care of incurable patients, alleviating their suffering and ensuring peaceful dying and dignified natural death, 
 
h) palliative care, the purpose of which is to alleviate suffering and maintain the quality of life of a patient suffering from an incurable disease, 
 
i) pharmacy care and clinical-pharmaceutical care (hereinafter referred to as "pharmacy care"), the purpose of which is to provide, prepare, modify, store, control and dispense of drugs, with the exception of transfusion products and raw materials for the production of blood derivatives pursuant to the Pharmaceuticals Act, laboratory chemicals, testing agents, disinfectants, and the provision, storage, distribution and sale of medical devices pursuant to the Medical Devices Act 13), provision, storage, dispensation and sale of food for special medical purposes; also provided as part of this care are advisory, counselling and other services in the field of prevention and early detection of disease, health promotion and assessment and control of the efficient, safe and cost-effective use of medicinal products and associated procedures. 
 
	(3) The implementing legal regulation specifies a) the types, content and intervals of preventive examinations, groups of persons to whom the various kinds of preventive examinations are provided and groups of providers who carry out preventive examinations, b) diseases in regard to which dispensary care is provided, the intervals of the examinations carried out and the groups of providers who carry out dispensary care. 
 
Section 6 [Practical commentary] [DZ] 

Forms of Health Care 

	The forms of health care comprise outpatient care, one-day care, inpatient care and health care provided in the patient's own social environment. 
 
Section 7 [Practical commentary] 

Outpatient Care 

	(1) Outpatient care is a health care that does not require hospitalisation of the patient nor the admission of the patient to a bed in a one-day care provider's health care facility. 
 
	(2) Outpatient care is provided as 
 
a) primary outpatient care the purpose of which is to provide preventive, diagnostic, therapeutic and assessment care and consultations, and also coordination and follow-up of the health services provided by other providers; this healthcare is provided to the patient by a registrar provider, 
 
b) specialised outpatient care that is provided within the specific healthcare sectors pursuant to Section 4, Paragraph 4, 
 
c) stationary care, the purpose of which is the provision of healthcare to patients whose health condition requires repeated daily provision of outpatient care. 
 
	(3) Primary outpatient care provided by registrar providers in the field of general practical medicine and practical medicine for children and adolescents always comprises a visiting service. 
 
Section 8 [Practical commentary] 

One-Day Care 

	One-day care is healthcare, which requires a patient to stay on a bed for a period of less than 24 hours, taking into account the nature and length of the healthcare provided. When providing one-day care, continuous access to acute intensive inpatient care should be ensured. 
 
Section 9 [Practical commentary] 

Inpatient Care 

	(1) Inpatient care is a healthcare which can not be provided in an outpatient manner and the patient’s hospitalisation is requisite for its provision. Inpatient care must be provided in a non-stop operation. 
 
	(2) Inpatient care is 
 
a) acute intensive inpatient care that is provided to a patient in cases of sudden failure or imminent threat to essential life functions, or when those conditions can reasonably be expected, 
 
b) acute standard inpatient care that is provided to the patient 
1. with a sudden illness or a sudden deterioration of a chronic disease which seriously endanger his/her health but which do not directly lead to a failure of his or her vital functions; or 
2. for the purpose of carrying out medical procedures which cannot be carried out in an outpatient manner; early rehabilitation is also provided within the framework of acute inpatient care, 
 
c) inpatient after-care that is provided to a patient whose primary diagnosis has been established and his or her health condition has been stabilised, whose sudden illness or a sudden deterioration in chronic illness has been managed, and whose health condition requires the provision of medical treatment or rehabilitation care in particular; intensive after-care may also be provided as part of this inpatient care to patients who are partially or completely dependent on the support of their basic life functions, 
 
d) long-term inpatient care provided to a patient whose health condition cannot be substantially improved by health care and which worsens without systematic provision of nursing care; intensive nursing care for patients with essential function disorders may also be provided within this type of inpatient care. 
 
Section 10 [Practical commentary] 

Health care provided in the patient's own social environment 

	(1) Health care provided in the patient's own social environment includes 
 
a) visiting service, 
 
b) home care consisting of nursing care, therapeutic and rehabilitation care or palliative care. 
 
	(2) In addition to the health care provided pursuant to Paragraph 1, artificial ventilation and dialysis may also be provided in the patient's own social environment. 
 
	(3) Within the framework of the health care provided pursuant to Paragraph 1, only such medical procedures may be carried out, the provision of which is not subject to the technical and material equipment necessary for their implementation in the healthcare facility. 
 
CHAPTER II 

GENERAL CONDITIONS FOR THE PROVISION OF HEALTH SERVICES 

Section 11 [Practical commentary] [DZ] 

Provision of Health Services 

	(1) The provider may provide only the health services specified in the licence for the provision of health services. 
 
	(2) Without obtaining the licence for the provision of health services, it is possible to 
 
a) provide professional first aid, 
 
b) provide health services in social service facilities pursuant to the Act on Social Services, 
 
c) ensure the transport of the person whose health condition requires it, from abroad to the Czech Republic or from the Czech Republic abroad by an entity authorised to do so pursuant to the legal regulations of another state from whose territory or on whose territory the transport is taking place and if it is a temporary activity in the territory of the Czech Republic, 
 
d) provide health services in accordance with Section 20. 
 
	(3) Health services may be provided only by persons authorised to exercise the health profession or to carry out activities related to the provision of health services. 
 
	(4) Personnel provision of health services shall correspond to the fields, type and form of healthcare and medical services provided in accordance with Section 2, Paragraph 2d) to f) and i). Requirements for minimal personnel provision of health services related to the professional, specialised or special professional competence of health professionals and other professional staff and their number shall be stipulated by the implementing legal regulation. 
 
	(5) Health services may be provided only in health care facilities at the places specified in the licence for the provision of health services; this shall not apply in the case of health care provided in the patient’s own social environment, urgent care patient transportation, pre-hospital urgent care provided in the context of a medical rescue service, health services provided in mobile medical facilities of the armed forces in emergency situations and if it is the transfer of the deceased's body to an autopsy and from an autopsy pursuant to the Act on Funeral Services. If the provider provides home care only, it must have a contact point. 
 
	(6) Healthcare facility must be technically and materially equipped for the provision of health services. The technical and physical equipment of healthcare facilities must correspond to the fields, type and form of healthcare and medical services provided in accordance with Section 2, Paragraph 2d) to f) and i). Requirements for the minimum technical and physical equipment of healthcare facilities related to the technical, functional design and layout of premises and their equipping by selected medical devices and other devices, for the equipment of the contact point, and in the case of pharmacy care provided in the separated department of drug dispensing also for the place of provision of care, shall be stipulated by the implementing legal regulation. This shall not prejudice the requirements for healthcare facilities pursuant to other legislation. 
 
	(7) The medical rescue service provider, the medical transport service provider and the urgent medical care transport provider shall be equipped with appropriate means of transport for the implementation of the provided medical service. Requirements for the provider’s equipping by the means of transport and the requirements for the technical and material equipment of these means of transport and their marking and colours shall be stipulated by the implementing legal regulation. This shall not prejudice the requirements for means of transport pursuant to other legislation. 
 
	(8) Prior to the commencement of the provision of health services in social service facilities pursuant to Paragraph 2, Point b), the social service provider is obliged to notify the regional authority competent in accordance with the place of their provision. When providing health services, the social service provider is required to comply with the obligations set forth for the provider in Section 45, Paragraph 1,  Paragraph 2, Point n), Section 51, Paragraph 1 and Section 53, Paragraph 1. 
 
Provision of preventive care outside healthcare facilities 

Section 11a 

	(1) Preventive care may be provided outside the healthcare facility focused on prevention and early diagnosis of the disease on the basis of a permit granted by the regional authority. 
 
	(2) The permit shall be granted to a provider who is authorised to provide health services under which the healthcare provided pursuant to Paragraph 1 shall be provided outside the healthcare facility. Only preventive medical care may be provided outside the healthcare facility, the provision of which is not conditional upon the technical and material equipment necessary to carry them out in the healthcare facility. 
 
	(3) The permit shall be granted for a maximum period of one year. The granting of the permit is decided by the regional authority, in whose administrative district medical procedures will be provided outside the healthcare facility. 
 
	(4) The permit may be granted only on the basis of a positive binding opinion of the regional public health authority in whose administrative district health services will be provided outside the healthcare facility. The provider's request to issue a binding opinion shall contain the particulars referred to in Paragraph 5. The request must additionally include hygienic and anti-epidemic measures to prevent the occurrence and spread of infectious diseases during the activities referred to in the first sentence. 
 
	(5) In addition to the requirements set forth by the Administrative Code, the request for issuing the permit,  shall include 
 
(A) identification information of the provider to the extent specified in the decision to grant authorisation to provide health services, 
 
b) the definition of activities to be provided outside the healthcare facility, 
 
c) the place where healthcare will be provided outside the healthcare facility, 
 
d) the period for which the permit is to be granted, determined by the specific date. 
 
	(6)  With its request for issuing the permit the applicant shall submit 
 
a) a copy of the decision to grant authorisation to provide health services, unless the decision was issued by the regional authority responsible for granting the authorisation, 
 
b) a binding opinion of the Regional Public Health Authority. 
 
	(7) In addition to the requirements set forth by the Administrative Code, the decision concerning issuing the permit includes the information referred to in Paragraph 5. The Regional Authority shall send a copy of the final decision to the Regional Public Health Authority, which issued a binding opinion pursuant to Paragraph 4. 
 
	(8) In the provision of preventive healthcare services outside the healthcare facility pursuant to Paragraph 1, the provider is not obliged to maintain medical records. 
 
Section 11b 

	(1) The permit shall expire 
 
a) by the termination of authorisation to provide health services, 
 
b) upon expiry of the period for which it was granted, or 
 
c) by withdrawing the permit via the decision of the Regional Authority which issued the permit. 
 
	(2) The Regional Authority shall withdraw the permit if the provider 
 
a) ceased to fulfil any of the conditions pursuant to Section 11a, 
 
b) seriously or repeatedly breached any obligation related to healthcare provided outside the healthcare facility stipulated by this Act or by other legal regulation, or 
 
c) provided medical procedures outside the healthcare facility in conflict with the permit. 
 
	(3) The Regional Authority shall send a copy of its decision to withdraw the authorisation to the Regional Public Health Authority, which issued a binding opinion pursuant to Section 11a, Paragraph 4. 
 
	(4) The appeal against the decision on the withdrawal of the authorisation shall not have any suspensory effect. 
 
Section 12 [Practical commentary] [DZ] 

Qualification for the independent performance of the medical profession 

	(1) For the purposes of this Act, qualification for the independent performance of the medical profession means the capability to pursue the profession of a physician, a dentist or a pharmacist independently or to practice as a health professional in a paramedical profession without direct guidance and professional supervision under other legal regulations1),2). 
 
	(2) The provider that is a natural person must be capable of the independent performance of the medical profession in accordance with Paragraph 3 or it is required to appoint a professional representative of that capacity; the provision of a professional representative is not permitted in the event of the provision of health services under the authorisation referred to in Section 16, Paragraph 2. The provider that is a legal entity, is always obliged to appoint a professional representative with the qualification to  independently perform the medical profession in accordance with Paragraph 3. 
 
	(3) When health services are provided 
 
(a) in the fields of specialist training of physicians, the qualification is required to independently pursue the profession of physician in at least one of those fields, 
 
(b) in the fields of dentist or of specialist training of dentists, the qualification is required to independently pursue the profession of dentist in at least one of those fields, 
 
(c) in the fields of pharmacist or of specialist training of pharmacist, the qualification is required to independently pursue the profession of pharmacist in at least one of those fields, 
 
(d) only in the fields of training of paramedics or other professionals, the qualification is required to independently pursue a medical profession in at least one of these fields; the professional representative may also be a physician, a dentist or a pharmacist if s/he is qualified to pursue direct guidance or professional supervision of these employees in at least one of these disciplines pursuant to another legal regulation. 
 
Section 13 [Practical commentary] 

Integrity

	(1) for the purposes of this Act, a person of integrity is a person who has not been legally convicted 
 
a) for an intentional criminal offense with unconditional imprisonment for a period of at least one year, or 
 
b) for an offense committed during the provision of health services, 
or who is looked upon as if s/he were not convicted. 
 
	(2) Integrity shall be evidenced by an excerpt from the Criminal Record and by a document proving the fulfilment of the condition of integrity issued by the state of which the natural person is a citizen and the documents issued by the states in which the person  has resided in the last 3 years continuously for more than 6 months; these documents must not be older than 3 months. The recognition of documents of integrity issued by the competent authority of another Member State of the European Union, the European Economic Area or the Swiss Confederation shall be governed by the Act on the Recognition of Professional Qualifications14). If the State referred to in the first sentence does not issue the excerpt from the criminal record or an equivalent document or if it cannot be obtained, the natural person shall submit a declaration of integrity made in front of a notary or another competent authority of that State. 
 
	(3) If a declaration of integrity is required for the purposes of proceedings under this Act by means of an excerpt from the Register of Criminal Records, a request for issuing an excerpt shall be made by the administrative body competent to grant the authorisation to provide health services; the request for issuing an excerpt from the Register of Criminal Records and the actual excerpt from the Register of Criminal Records shall be transmitted in an electronic form in a manner enabling remote access. 
 
Section 14 [Practical commentary] [DZ] 

Professional representative 

	(1) The professional representative professionally manages the provision of health services. Appointed as the professional representative may be a natural person who is 
 
a) qualified for the independent pursuit of the medical profession pursuant to Section 12 and is a member of the Czech Medical Chamber, the Czech Dental Chamber or the Czech Chamber of Pharmacists (hereinafter referred to as "the Chamber"), if the membership in a Chamber represents a condition for the exercise of that profession, 
 
b) fully sui juris, 
 
c) a person of integrity, 
 
d) a bearer of a residence permit in the territory of the Czech Republic, if s/he is obliged to have such a permit. Appointed as the professional representative may not be a natural person who is subject to some of the obstacles to the granting of authorisation listed in Section 17. 
 
	(2) The function of a professional representative must be exercised in a labour-law or a similar relationship with the provider. This condition shall not apply if the professional representative is a statutory body or a member of the statutory body of the provider or if the professional representative is the spouse or the registered partner of the provider; even in this instance, however, the professional representative must be in the contractual relationship with the provider. 
 
	(3) The professional representative shall perform his/her duties to the extent necessary for proper professional management of the health services provided. The same person cannot act as a professional representative for more than 2 providers. 
 
	(4) The professional representative shall be obliged to notify in writing the provider of any changes to the data indicated in the decision on the granting of the authorisation for the provision of health services, in the application for the granting of this authorisation and in the documents submitted with this application, and of any changes and amendments of data concerning the conditions for the exercise of the office of the professional representative and to provide evidence of them. Any changes to the data pursuant to the first sentence must be notified by the professional representative within 10 days of the date on which they occurred. 
 
	(5) If the professional representative ceases to perform his/her duties or ceases to fulfil the conditions for performing this function, the provider is obliged to appoint a new professional representative at the latest 10 days from the day when it learned of some of these facts. 
 
PART THREE 

AUTHORISATION FOR PROVIDING HEALTH SERVICES 

Section 15 [Practical commentary] [DZ] 

The competence of the administrative authorities 

	(1) Deciding on the granting of authorisation to provide health services belongs to 
 
a) a regional authority in whose administrative district is the healthcare facility located, in which the health services will be provided, 
 
b) the Ministry of Defense or the Ministry of Justice in the case of medical services provided in healthcare facilities established by these Ministries, with the exception of the authorisation pursuant to Section 16, Paragraph 2, or 
 
(C) the Ministry of Interior, in the case of medical services provided in healthcare facilities established by that Ministry or in healthcare facilities established by the Office for Foreign Relations and Information or by the Security Information Service, with the exception of the authorisation pursuant to Section 16, Paragraph 2, 
	(hereinafter referred to as the “Competent Administrative Body”) 
 
	(2) The authorisation to provide pharmacy care may be granted only on the basis of a positive binding opinion of the State Institute for Drug Control concerning the technical and material equipment of the healthcare facility in which such care will be provided. The State Institute for Drug Control will issue a binding opinion on the basis of a written request within 30 days of the date of its receipt. The request for issuing a binding opinion shall contain the particulars referred to in Section 18, Paragraph 1. 
 
Section 16 [Practical commentary] [DZ] 

Conditions for the granting of authorisation to provide health services 

	(1) A natural person shall be granted authorisation to provide health services upon his/her written request, if 
 
a) s/he reached the age of 18 years, 
 
b)  s/he is fully sui juris, 
 
c)  s/he is a person of integrity, 
 
d)  s/he is a bearer of a residence permit in the territory of the Czech Republic, if s/he is obliged to have such a permit. 
 
a)  s/he is qualified for the independent pursuit of the medical profession in the field of healthcare, which s/he will provide as a health service and is a member of a Chamber, if the membership in a Chamber represents a condition for the exercise of that profession, or if s/he appointed a professional representative, 
 
f) s/he is entitled to use a medical facility for the provision of health services which meets the requirements for technical and physical equipment, 
 
g) the requirements for staffing of provided health services are met, 
 
h) The State Institute for Drug Control has issued a positive binding opinion pursuant to Section 15, Paragraph 2, in the case of the provision of pharmacy care, 
 
i) the Public Health Protection Authority has approved the Operating Regulations of the Health Facility pursuant to the Act on Public Health Protection16), 
 
j) the Ministry of Health (hereinafter referred to as "the Ministry") has issued its consent to the provision of a spa treatment and rehabilitation care in the case of providing such care, 
 
k) there are not any obstacles to the granting of the authorisation listed in Section 17. 
 
	(2) A natural person who will provide health services only in a health facility operated by another provider, shall be granted an authorisation to provide health services upon his/her written request, if 
 
a)  s/he is qualified for the independent pursuit of the medical profession in the field of healthcare, which s/he will provide as a health service and is a member of a Chamber, if the membership in a Chamber represents a condition for the exercise of that profession, and s/he meets the conditions set forth in Paragraph 1, Points a) to d) and k), 
 
b) s/he is entitled to use for the provision of health services a medical facility utilised by another provider which meets the requirements for technical and physical equipment, 
 
c) the conditions are met referred to in Paragraph 1, Points g) to j). 
	Authorisation under the first sentence cannot be granted for the provision of health care in the field of general practical medicine, practical medicine for children and adolescents, dentistry and gynaecology and obstetrics in the case of performance of the activity of the registrar provider. 
 
	(3) A legal entity person shall be granted authorisation to provide health services upon its written request, if 
 
a) the statutory body of a legal entity or its members or the head of the organisational unit of the state or of the organisational unit of a territorial self-governing unit, if the provision of health services is provided by this organisational unit, are persons of integrity, 
 
b) it appointed a professional representative who meets the conditions defined in Section 14, Paragraph 1 to 3, 
 
c) the conditions are met referred to in Paragraph 1, Points f) to j). 
 
d) there are not any obstacles to the granting of the authorisation listed in Section 17, Points b) to e). 
 
e) it was established by the Regional Authority as a subsidiary organisation pursuant to the Medical Emergency Service Act and is entitled to use the National Emergency Number Line 155 in the case of the provision of medical emergency services. 
 
	(4) The authorisation to provide health services cannot be transferred to nor it passes on to another entity. Another person may only provide health services on the basis of the authorisation, if it continues to provide health services pursuant to Section 27. 
 
Section 17 [Practical commentary] [DZ] 

Obstacles to the granting of authorisation to provide health services 

	Authorisation to provide health services cannot be granted 
 
a) to a natural person who has been charged by a court or by an administrative body with a prohibition on the provision of health services, for the duration of that prohibition, 
 
b) to a natural person or a legal entity whose authorisation has been revoked pursuant to Section 24, Paragraph 2, Point b), Paragraph 3, Points a), b), c) or d) or  Paragraph 4, Points a), b), c), d) or e) for a period of 3 years from the date on which the decision to revoke the authorisation has become final, 
 
c) to a natural person or a legal entity for a period of 3 years from the effective date of the decision rejecting the insolvency petition, because the debtor's assets are insufficient to cover the costs of the insolvency proceedings or for a period of 3 years from the effective date of the decision to cancel the bankruptcy because the debtor’s assets are totally  insufficient to satisfy the creditors, 
 
d) to a natural person or a legal entity, if the court in the insolvency proceedings has ordered an injunction whereby the person whose bankruptcy or imminent bankruptcy has been addressed in this proceeding has been limited in his/her disposal of the property and the preliminary insolvency trustee has not given his/her written consent to that person's actions related to the establishment of the authorisation, or 
 
e) a natural person or a legal entity in the course of insolvency proceedings whose assets have been declared bankrupt and the insolvency trustee has not given his/her written consent to that person’s acts related to the establishment of the authorisation. 
 
Section 18 [Practical commentary] [DZ] 

The request for granting the authorisation to provide health services 

	(1) In addition to the requirements set forth by the Administrative Code, the request for issuing the authorisation to provide health services,  shall include 
 
a) where the applicant is a natural person 
1. name(s), surname, birth name, nationality, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the date and the place of birth of the applicant, 
2. personal identification number17) (hereinafter referred to as the "identification number"), if it was assigned, 
3. name(s), surname, birth name, nationality, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the date and the place of birth of the professional representative, if s/he must be appointed, 
4. the form of healthcare, the fields of healthcare, or the kind of healthcare in accordance with Section 5, Paragraph 2, Points f) to i) or the name of the health service pursuant to Section 2, Paragraph 2, Points d) to f) and i), for each individual place of provision of health services, 
5. the address of the place(s) where health services are provided; in the case of medical transport services or transport of emergency care patients the address of the place of individual workplaces and in the case of the provision of home care the address of the contact point, 
6. the date on which the applicant intends to commence the provision of health services, 
7. the period for which the applicant intends to provide health services when applying for a fixed term permit, 
 
b) where the applicant is a legal entity 
1. business name, registered office; in the case of a legal entity established outside the territory of the Czech Republic, also the place of establishment or an organisational unit of a legal entity in the territory of the Czech Republic, 
2. should the provision of health services be provided by the organisational unit of the state or the organisational unit of the territorial self-governing unit, its name, registered address and identification number and the name of its founder, as well as the name(s), surname, birth name, nationality, address of permanent residence in the territory of the Czech Republic or in the case of a person without permanent residence in the territory of the Czech Republic, the address of the residence outside the territory of the Czech Republic and, if applicable, the address of the place of the reported residence in the territory of the Czech Republic and the date of birth of the head of the organisational unit of the state; information concerning the head of the organisational unit of the state are not mentioned in the case of the Security Information Service and the Office for Foreign Relations and Information, 
3. the information referred to in point (a) (3) concerning the professional representative and the persons who represent the statutory body of the applicant or its members or who act on behalf of a legal entity registered in the Commercial Register or a similar register before its establishment, 
4. the address of the place(s) where health services are provided; in the case of medical rescue services, medical transport services or transport of emergency care patients the address of the place of individual workplaces and in the case of the provision of home care the address of the contact point, 
5. information referred to in Points a) 2), 4), 6) and 7). 
 
	(2) With the application for authorisation to provide health services the applicant shall submit: 
 
a) where the applicant is a natural person referred to in Section 16, Paragraph 1 
1. evidence of the qualification for the independent performance of the medical profession, if s/he has such a qualification, 
2. a proof of integrity, 
3. in the event of appointing a professional representative, evidence of the qualification of the professional representative for the independent performance of the medical profession, a proof of integrity and a declaration of the professional representative that s/he agrees to the appointment as a professional representative and that there are not any of the reasons referred to in Section 14, Paragraphs 1 and 3, for which s/he could not act as a professional representative, 
4. a list of healthcare professionals and other professionals who will perform the medical profession in a labour-law or similar relationship with the applicant, to the extent of the requirements for minimal personnel provision of health services. For physicians, dentists and pharmacists who are qualified for the independent performance of the medical profession, the name(s), surname, field in which they are qualified to independently perform the medical profession and their weekly working hours shall be listed; for senior staff their job title shall also be indicated. For other healthcare professionals and other professionals, only their number classified in accordance with their professional qualification shall be indicated in the list. The list is broken down in accordance with the classification of the staff based on individual form of healthcare, the fields of healthcare, or the kind of healthcare in accordance with Section 5, Paragraph 2, Points f) to i) or the name of the health service pursuant to Section 2, Paragraph 2, Points d) to f) and i); in the case of more places of provision of health services, the list is also broken down in accordance with these places, 
5. Declaration that the healthcare facility is technically and materially equipped for the provision of health services pursuant to this Act. 
6.  In the case of the provision of pharmacy care, a positive binding opinion of the State Institute for Drug Control concerning the technical and material equipment of the healthcare facility, 
7. Consent of the Ministry of Health to the provision of a spa treatment and rehabilitation care, in the case of providing such care, 
8. Decision of the Public Health Protection Authority concerning the approval of the Operating Regulations of the Health Facility together with the actual copy of the Operating Regulations, 
9. A document proving the applicant's right to use the premises for the provision of health services, 
10. a document proving the  residence permit of the applicant and its professional representative, if established, in the territory of the Czech Republic, if they are obliged to have such a permit, 
11. Declaration that there are not any obstacles to the granting of the authorisations listed in Section 17, Points a) to c) and the written consent of the preliminary insolvency trustee or the insolvency trustee in the event that the issuance of such consent would not constitute an obstacle to the granting of the authorisation referred to in  Section 17, Point d) or e), 
 
a) where the applicant is a natural person referred to in Section 16, Paragraph 2 
1. Evidence of the qualification for the independent performance of the medical profession and the documents referred to in Points (a) (2), (10) and (11), 
2. A contract with a provider that operates a healthcare facility in which the applicant will provide health services, authorising the applicant to use the technical and material equipment of the healthcare facility and personnel provision of the health services of that provider for the provision of health services; if the contract does not secure it or if it does not imply the fulfilment of all the requirements for the technical and material equipment of the healthcare facility and the personnel provision of the health services that the applicant intends to provide, the applicant shall be obliged to prove the fulfilment of the requirements that are not secured by the contract by means of the documents referred to in Points (a) ( 4) to (8), 
 
c) where the applicant is a legal entity 
1. A proof that a legal entity has been established, unless it is entered in a commercial or similar register or if the registration has not yet been completed; if the applicant is a legal entity established outside the Czech Republic, an excerpt from a commercial or similar register maintained in the state of residence and a proof that a legal entity or a branch or an organisational unit of a legal entity in the Czech Republic has been entered in the Commercial Register, if the entry has already been made; a proof of entry in the commercial or equivalent register or the excerpt from such registers shall not be older than 3 months; the documents referred to in this point do not need to be submitted with the application if it is a legal entity established in the territory of the Czech Republic or if health services will be provided by the organisational unit of the state or of the territorial self-governing unit, 
2. A proof of integrity of persons who represent the statutory body of the applicant or its members, 
3. A proof of integrity of the head of the organisational unit of the state or of the organisational unit of a territorial self-governing unit, if the provision of health services is provided by this organisational unit, 
4. Documents referred to in Points (a) (3) to (10). 
5. In the case of the provision of medical emergency services, a proof that the applicant was established by the Regional Authority as a subsidiary organisation pursuant to the Medical Emergency Service Act and a document from which the applicant's authorisation to use the National Emergency Number 155 is evident,6. Declaration that there are not any obstacles to the granting of the authorisations listed in Section 17, Points b) and c) and the written consent of the preliminary insolvency trustee or the insolvency trustee in the event that the issuance of such consent would not constitute an obstacle to the granting of the authorisation referred to in  Section 17, Point d) or e), 
 
	(3) If the applicant for the granting of authorisation for the provision of health services is the person who is the acquirer of the property rights related to the provision of health services by the former provider, s/he should also attach the documents proving the transfer of the property rights to the applicant to the application. Submission of the document referred to in Paragraph 2, Point (a) (4) may be replaced by a declaration of the applicant that there has been no change in the information provided by the previous provider in those documents; in this case the document referred to in Paragraph 2, Point a) (6) also does not need to be presented. If the applicant for the authorisation to provide health services is a person who continues to provide health services pursuant to Section 27, the first and the second sentences shall be valid for the submission of the documents similarly. 
 
	(4) In the case of provision of long-term inpatient care only by healthcare professionals of a paramedical profession, the applicant shall submit a contract with the provider of outpatient care in the field of general practical medicine or in the field of practical medicine for children and adolescents concerning  the provision of acute health care to patients together with the application for the authorisation for the provision of health services. 
 
Section 19 [Practical commentary] [DZ] 

The decision on granting the authorisation to provide health services 

	(1) In addition to the requirements set forth by the Administrative Code, the decision on granting the authorisation to provide health services,  shall include 
 
a) name(s), surname of the provider and its professional representative, if s/he must be appointed, and the address of their permanent residence in the Czech Republic or, in the case of a natural person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic, the provider’s identification number, and the date of their birth, 
 
b) the form of healthcare, the fields of healthcare, or the kind of healthcare in accordance with Section 5, Paragraph 2, Points f) to i) or the name of the health service pursuant to Section 2, Paragraph 2, Points d) to f) and i), for each individual place of provision of health services, 
 
c) the address of the place(s) where health services are provided; in the case of medical rescue services, medical transport services or transport of emergency care patients the address of individual workplaces and in the case of the provision of home care the address of the contact point, 
 
d) the period for which the authorisation is granted when applying for a fixed term permit, 
 
e) date of the commencement of the provision of health services. 
 
	(2) In addition to the requirements set forth by the Administrative Code, the decision on granting the authorisation to provide health services to a legal entity,  shall include 
 
a) provider’s business name, registered office; in the case of a legal entity established outside the territory of the Czech Republic, also the place of establishment or an organisational unit of a legal entity in the territory of the Czech Republic, and the identification number, if assigned, 
 
b) name(s), surname, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the date of birth of persons who represent the provider’s statutory body or its members 
 
c) name(s), surname, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and the address of the place of residence declared in the territory of the Czech Republic and the date of birth of the professional representative, 
 
d) the particulars referred to in Paragraph 1, Point b) to e). 
 
	(3) In addition to the particulars stipulated by the Administrative Code, the decision on the granting of authorisaton for the provision of health services, if the provision of health services is provided by the organisational unit of the state or by the organisational unit of the territorial self-governing unit, contains 
 
a) name, registered address of the organisational unit of the state or of the organisational unit of the territorial self-governing unit and the identification number, if assigned, 
 
b) name of the founder of the organisational unit of the state or of the organisational unit of the territorial self-governing unit, 
 
c) name(s), surname, address of permanent residence in the territory of the Czech Republic or in the case of a person without permanent residence in the territory of the Czech Republic, the address of the residence outside the territory of the Czech Republic and, if applicable, the address of the place of the reported residence in the territory of the Czech Republic and the date of birth of the head of the organisational unit of the state; information concerning the head of the organisational unit of the state are not mentioned in the case of the Security Information Service and the Office for Foreign Relations and Information, 
 
d) name(s), surname, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and the address of the place of residence declared in the territory of the Czech Republic and the date of birth of the professional representative, 
 
e) the particulars referred to in Paragraph 1, Points b) to e). 
 
	(4) The competent administrative body shall send a copy of the written decision on the granting of authorisation for the provision of health services within 15 days of the effective date of the decision to the relevant tax authority administering the income tax, to the relevant district social security administration and to the relevant Chamber; in the case of authorisation to provide pharmacy care, it will also send a copy of the decision to the State Institute for Drug Control. The competent administrative body shall record the granting of authorisation for the provision of health services within 15 days of the effective date of the decision to the National Register of Health Service Providers (hereinafter referred to as the "National Register of Providers") and via that register it shall record the relevant reference data or changes to relevant reference data in the Basic Register of Legal Entities, Entrepreneurs and Public Authorities18) (hereinafter referred to as the "Register of Persons"). 
 
	(5) Should a decision on the granting of authorisation to provide health services be issued for a legal entity, which has been founded on the day of registration in a commercial or another register designated by the law, prior to registration, this legal entity shall be entitled to provide health services on the date of its entry in the register. Should a decision on the granting of authorisation to provide health services be issued for a legal entity, which is entered in the Commercial Register and established outside the territory of the Czech Republic, prior to registration, this legal entity shall be entitled to provide health services on the date of its entry in the Commercial Register. Should the legal entity referred to in the first or the second sentence fail to submit the application for registration within 90 days of the effective date of the decision on the granting of the authorisation or should the registration has not been filed within 90 days from the date of filing the application for registration the authorisation shall expire upon the expiry of this period. The legal entity is obliged to send to the relevant administrative body a document proving the filing of the application for registration within 15 days from the date of filing the application, in addition to the proof that the legal entity was registered, within 15 days from the date of registration. 
 
Section 20 [Practical commentary] [DZ] 

Provision of health services by persons/entities established in another Member State of the European Union, the European Economic Area or the Swiss Confederation 

	(1) Authorisation to provide health services is not required from 
 
a) a natural person who is established in another Member State of the European Union, the European Economic Area or the Swiss Confederation if s/he provides a visiting service or home care as a visiting person under another legislation and is authorised under the law of his/her state of establishment to provide health services as part of which the visiting service or home care are provided, 
 
b) a legal entity who has its registered office in another Member State of the European Union, the European Economic Area or the Swiss Confederation and it is in accordance with the law of its state of establishment authorised to provide health services as part of which the visiting service or home care are provided and persons, through which the visiting service or home care are provided, meet the conditions set forth for visiting persons under another legal regulation.  
 
	(2) The person referred to in Paragraph 1 shall be obliged to notify in writing his/her intention to provide a visiting service or home care to the regional authority in whose administrative district s/he will provide such services no later than 7 days prior to the date of commencement of their provision. The notification should include a document proving the authorisation to provide the relevant health services in another state of the European Union, the European Economic Area or the Swiss Confederation where the natural person is established or where the legal entity has its registered office, and its officially certified translation into the Czech language unless it is a document in the Slovak language. 
 
	(3) The person providing visiting service or home care pursuant to Paragraph 1 shall be subject to the obligations referred to in Section 45, Paragraph 1, Section 51, Paragraph 1 and Section 53, Paragraph 1. Should the person referred to in Paragraph 1, in accordance with the laws of his/her state of establishment, cease to be authorised to provide health services as part of which a visiting service or home care is provided, s/he shall immediately notify the regional authority in whose administrative district s/he has provided such services. 
 
	(4) Should the regional authority find a serious breach of the obligations under this Act by the person referred to in Paragraph 1, it shall notify about this fact the Ministry which informs the relevant Member State of the European Union, the European Economic Area or the Swiss Confederation. 
 
	(5) Should the regional authority find a serious breach of the obligations under this or another Act by the person referred to in Paragraph 1, it can issue a decision prohibiting this person from providing health services in the territory of the Czech Republic for a maximum period of 3 years. The appeal against the decision shall not have any suspensory effect. The regional authority shall send a written copy of the decision within 15 days from the effective date of the decision to the Ministry, which shall inform the relevant Member State of the European Union, the European Economic Area or the Swiss Confederation about the prohibition of the provision of health services. 
 
Section 21 [Practical commentary] [DZ] 

Notification of changes by the provider 

	(1) The provider shall be obliged to notify in writing the relevant administrative body of any changes to the data indicated in the decision on the granting of the authorisation for the provision of health services and of any changes to the data in the documents submitted together with the application for the authorisation and to submit documents concerning these changes if they may be the reason for the suspension, change, cancellation or termination of the authorisation. The provider is additionally obliged to notify in writing the relevant administrative body that issued a consent, permit or any other decision or binding opinion as a basis for the decision on the granting of the authorisation for the provision of health services of any changes related to these decisions or to the binding opinion if they may be the reason for the their change, termination or withdrawal. In the case of changes to the information referred to in Section 18, Paragraph 2, Point a)(4), only changes related to senior staff shall be communicated. The administrative body which has granted consent, permission or any other decision or binding opinion as the basis for the decision on the granting of the authorisation for the provision of  health services shall immediately notify the competent administrative body of their change, withdrawal or termination. 
 
	(2) The provider shall be obliged to notify the changes pursuant to Paragraph 1 within 15 days from the date on which it became aware of them. 
 
	(3) Where a change concerns the information that is not listed in the decision on the granting of the authorisation for the provision of health services and if the conditions for the provision of health services are still met, the competent administrative body shall make a record of this change in the file. In other cases, the competent administrative body shall decide, as appropriate, on the modification, suspension or withdrawal of the authorisation for the provision of health services. 
 
Section 22 [Practical commentary] [DZ] 

Cessation of the authorisation for the provision of health services 

	The authorisation for the provision of health services shall cease to exist 
 
a) by the death of the provider, unless it is pursued in accordance with Section 27, 
 
b) by the termination of the provider, 
 
c) by the deletion of the organisational unit of a legal entity established outside the territory of the Czech Republic from the Commercial Register, 
 
d) by the cancellation of the organisational unit of the state or of the organisational unit of the territorial self-governing unit, if the provision of health services was secured by this organisational unit, 
 
e) upon the expiration of the period if the authorisation was granted for a fixed period of time, 
 
f) by the decision of the competent administrative body to withdraw the authorization, or 
 
g) in other cases stipulated by this Act. 
 
Withdrawal, Suspension and Change of the Authorisation 

Section 23 [Practical commentary] 

	(1) The competent administrative body shall withdraw the authorisation to provide health services if: 
 
a) the provider ceased to fulfil any of the conditions referred to in Section 16, Paragraph 1, Point b) or c) or Paragraph 2, Point a), 
 
b) there was an obstacle to the provision of health services pursuant to Section 17, Point a) or c), or 
 
c) based on the provider’s request. 
 
	(2) The competent administrative body shall withdraw the authorisation to provide health services pursuant to Paragraph 1, Point c) based on the provider’s written request. An application for the withdrawal of the authorisation for the provision of health services must be submitted no later than 60 days prior to the date on which the provider requests the authorisation to be withdrawn; this deadline shall not apply if the provider requests the withdrawal of the authorisation on the grounds for which the authorisation is withdrawn ex officio. In the event of the failure to meet the deadline for submitting an application, the competent administrative body shall withdraw the authorisation for the provision of health services no later than 60 days after the date of filing the request. 
 
	(3) The provider who requests the withdrawal of the authorisation for the provision of health services and intends to transfer the property rights related to the provision of health services to another person shall notify the relevant administrative body upon filing the application for withdrawal of the authorisation. Where the acquirer of property rights related to the provision of health services intends to commence the provision of health services on the date of withdrawal of the authorisation from the previous provider, it shall state this fact in the application for the authorisation for the provision of health services. If the application for the authorisation for the provision of health services is filed at the latest on the date of submission of the request for withdrawal of the authorisation by the previous provider and the conditions for granting the authorisation are met, the competent administrative body shall decide on the withdrawal of the authorisation and the granting of the authorisation on the same day; the appeal against the decision shall not have any suspensory effect. 
 
Section 24 [Practical commentary] 

	(1) The competent administrative body shall change, suspend or withdraw the authorisation for the provision of health services, if 
 
a) the provider ceased to fulfil any of the conditions referred to in Section 16, Paragraph 1, Point f) or g) and Paragraph 2, Point b), or 
 
b) if the consent, authorisation or any other decision or binding opinion which represented the basis for the decision on granting the authorisation has been withdrawn. 
 
	(2) The competent administrative body shall change, suspend or withdraw the authorisation for the provision of health services, if the provider 
 
a) ceased to fulfil any of the conditions referred to in Section 16, Paragraph 1, Point d) or e) or Paragraph 3, Point a) or b), or 
 
b) if it is not insured against liability for damage caused in connection with the provision of health services. 
 
	(3) The competent administrative body may suspend or withdraw the authorisation for the provision of health services, if 
 
a) the provider seriously or repeatedly breached its obligation established for the provision of health services by this Act or by any other legal regulation, 
 
b) the provider failed to comply with the obligation to remedy the deficiencies found within the deadline set, 
 
c) the provider does not maintain the medical records or maintains it in violation of this Act or of other legal regulation; or 
 
d) the provider does not fulfil its obligation to pay social security contributions and contributions to the state employment policy. 
 
	(4) The competent administrative body may withdraw the authorisation for the provision of health services, if 
 
a) the provider has provided health services under the influence of alcohol or any other addictive substances, 
 
b) the provider has repeatedly provided health services through a person who was under the influence of alcohol or any other addictive substance and did not take remedial action, 
 
b) the provider has repeatedly provided health services through a person who was under the influence of alcohol or any other addictive substance and did not take remedial action, 
 
d) the provider seriously or repeatedly breached its obligations resulting for it from the Act on Public Health Insurance, 
 
e) the provider has repeatedly requested patients to reimburse medical services in contravention of the Act on Public Health Insurance, or 
 
f) health services are not provided for a period of more than one year. 
 
	(5) Prior to the commencement of proceeding for the change or withdrawal of the authorisation for the provision of provide health services pursuant to Paragraphs 1, 2 or 3, Points a), c) or d), the competent administrative body shall provide the provider with a reasonable period of time for remedying the deficiencies, in the case that these can be remedied. 
 
	(6) In its decision to suspend the authorisation for the provision of health services, the competent administrative body shall define the period of suspension of the authorisation and shall determine those health services which cannot be provided during this period. The period of suspension of the authorisation for the provision of health services may not exceed 1 year. 
 
Section 25 [Practical commentary] [DZ] 

Notification of change, termination and suspension of the authorisation for the provision of health services 

	(1) The competent administrative body shall send a copy of the written decision on the change, withdrawal or suspension of the authorisation for the provision of health services within 15 days of the effective date of the decision to the entities referred to in Section 19, Paragraph 4 and to health insurance companies with which the provider has entered into contracts pursuant to the Act on Public Health Insurance as of the effective date of the decision. 
 
	(2) The competent administrative body shall send a copy of the written decision on the change, withdrawal or suspension of the authorisation for the provision of health services pursuant to Section 16, Paragraph 1, Point b) or c) or Paragraph 2, Point a) or pursuant to Paragraph 17, Point a)within 15 days of the effective date of the decision to the recognition body for the recognition of professional qualifications and other competencies for the exercise of the medical profession, pursuant to another legal regulation. 
 
	(3) The competent administrative body shall notify the bodies referred to in Section 19, Paragraph 4 and the health insurance companies with which the provider has concluded contracts under the Act on Public Health Insurance concerning the termination of the authorisation for the provision of health services granted for a fixed period of time within 30 days of the date when the authorisation expired; in other cases of the expiration of the authorisation that are not covered by Paragraph 1, it shall do so within 30 days of the date on which it learned about the termination of the authorisation. 
 
	(4) The competent administrative body shall record the change, withdrawal or suspension of the authorisation for the provision of health services within 15 days of the effective date of the decision in the National Register of Providers and also in the Register of Persons. The competent administrative body shall record the termination of the authorisation for the provision of health services granted for a fixed period of time within 15 days from the date of the termination of the authorisation in the National Register of Providers and through this register it shall also record the relevant reference data or changes to the relevant reference data in the Register of Persons; in other cases of the expiration of the authorisation that are not covered by the first sentence, it shall do so within 15 days of the date on which it learned about the termination of the authorisation. 
 
Section 26 [Practical commentary] [DZ] 

Interruption of the provision of health services 

	(1) The provider may interrupt the provision of health services for a maximum period of 1 year. Interruption means the non-provision of health services continuously for a period of more than 1 month. 
 
	(2) The provider is obliged to notify in writing the interruption of the provision of health services not later than 60 days prior to the date on which it intends to interrupt the provision of health services to the relevant administrative body, which will record this fact in the file, in the National Register of Providers and through this register records the relevant reference data or changes in the Register of Persons, and also to the health insurance companies with which it has concluded contracts pursuant to the Act on Public Health Insurance; at the same time, the provider is obliged to disclose the information concerning the interruption of the provision of health services in a manner to enable its accessibility by patients. If the reason for the interruption of the provision of health services does not enable the provider to fulfil its obligations stated in the first sentence within the specified deadline, it is obliged to do so without undue delay. 
 
	(3) During the period of the interruption of the provision of health services, the provider is obliged to ensure that, in the case of a patient to whom it provided health services and who chooses at the time of the interruption another provider of health services, or of it is necessary to ensure the continuity of health services for that patient, a copy of the patient's medical records or an extract from the medical record is provided to the health care provider providing or taking care of the patient. 
 
	(4) The provider shall be obliged to notify in writing continuation of the provision of health services after their interruption to the competent administrative body which will record this fact in the file, to the National Register of Providers and to through this register will record the relevant reference data or changes to the relevant reference data in the Register of Persons, and also to health insurance companies with which it has concluded contracts pursuant to the Act on Public Health Insurance, no later than 15 days prior to the date on which it intends to continue to provide health services. 
 
	(5) The provision of health services may be repeatedly interrupted after the expiration of 5 years from the date stated in the notice on the continuation of the provision of health services after the previous interruption of their provision. 
 
	(6) The competent administrative body of the interruption and continuation of the provision of health services shall notify the local district social welfare office within 15 days from the date of notification of this fact by the provider. 
 
Section 27 [Practical commentary] [DZ] 

Continuation of the provision of health services 

	(1) If the provider dies and if it is not a person referred to in Section 16, Paragraph 2, another natural person or legal entity may continue to provide health services on the basis of his/her authorisation for the provision of health services, if 
 
a) he/she/it is entitled to use the healthcare facility where the deceased provider provided the health services, 
 
b) the conditions are met set forth in Section 16, Paragraph 1, in the case of a natural person, or the conditions set forth in Section 16, Paragraph 3, Points a) to d) in the case of a legal entity, 
 
c) within 15 days of the date of the provider’s death he/she/it notifies the competent administrative body in writing of the intention to continue to provide the health services. 
The person/entity who continues to provide health services bears the rights and obligations of the provider. 
 
	(2) The person referred to in Paragraph 1 is also obliged to notify the intention to continue the provision of health services in writing, within 15 days from the date of the provider’s death, to the health insurance companies with which the deceased provider had concluded contracts pursuant to the Act on Public Health Insurance as of the date of his/her death. If more than one person notifies concerning his/her intention to continue to provide health services, the provision of health services may continue with those agreed upon in writing; signatures on the agreement must be officially verified. The competent administrative body shall invite those persons who have indicated their intention to continue in the provision of health services to the conclusion of the agreement; this body shall at the same time set the deadline for the agreement to be submitted to it. 
 
	(3) The provision of health services must be restarted no later than 60 days from the date of the provider's death. The person referred to in Paragraph 1 shall be obliged to notify the competent administrative body in writing of the date from which s/he will continue in the provision of health services not later than 10 days after that date. The notification shall include the documents proving the compliance with the conditions set forth in Section 16, Paragraph 1, Points a) to e), in the case of a natural person or in Section 16, Paragraph 3, Points a) and b), in the case of a legal entity, and also a declaration that the notifier is entitled to use the healthcare facility for the provision of health services in which the health services were provided by the deceased provider, a declaration of compliance with the condition referred to in Section 16, Paragraph 1, Point k), in the case of a natural person, or in Section 16, Paragraph 3, Point d), in the case of a legal entity, and a declaration that the conditions referred to in Section 16, Paragraph 1, Points f) to j) continue to be met. In the event of a change in the technical or physical equipment of the healthcare facility or the change of personnel provision of health services, it shall also include the documents proving the fulfilment of the conditions specified in Section 16, Paragraph 1, Points f) and g). Where there has been a change in the conditions under which the binding opinion referred to in Section 16, Paragraph 1, Point h or the operating rules referred to in Section 16, Paragraph 1, Point i were approved, the new documents referred to in Section 18, Paragraph 2, Point (a) (6) or (8) shall also comprise a part of the notification. 
 
	(4) If the conditions for continuing of the provision of health services are met, the competent administrative body shall, on the basis of the notification referred to in Paragraph 3, provide the notifier with a certificate of compliance with these conditions. The competent administrative authority shall send a written copy of the certificate within 10 days from the date of its issuance to the health insurance companies referred to in Paragraph 2 and to the entities referred to in Section 19, Paragraph 4 and made record concerning the issuance of a certificate to the National Register of Providers and through this register it shall record the relevant reference data or changes to the relevant reference data in the Register of Persons. If the conditions for the procedure under the first sentence are not met, the competent administrative body shall decide that the notifier has failed to meet the conditions for continuing to provide health services. The appeal against this decision shall not have any suspensory effect. 
 
	(5) The right to continue the provision of health services shall also expire on the date of termination of the authorisation for the provision of health services of the deceased provider; then the provider may provide health services in a healthcare facility where the health services were provided by the deceased provider only on the basis of its own authorisation to provide health services. The deceased provider’s authorisation to provide health services shall expire upon the vain expiration of the deadline for notifying the intention to continue to provide health services pursuant to Paragraph (1) (c) the vain expiration of the deadline for submitting an agreement to the competent administrative body pursuant to Paragraph 2, the vain expiration of the deadline for the continued provision of health services pursuant to Paragraph 3 or on the effective date of the decision that the conditions for continuing the provision of health services have not been met. The deceased provider’s authorisation to provide health services shall also expire 90 days from the date of the continuation of provision of health services referred to in the notification pursuant to Paragraph 3; however, if a person continuing to provide health services asks for the authorisation to provide health services within 90 days from the date of continuation of the provision of health services, the deceased provider’s authorisation to provide health services ceases to exist on the effective date of the decision on the application. 
 
PART FOUR 

THE POSITION OF THE PATIENT AND OF OTHER PERSONS IN RELATION TO THE PROVISION OF HEALTH SERVICES 

CHAPTER I 

RIGHTS AND OBLIGATIONS OF THE PATIENT AND OF OTHER PERSONS 

The patient’s rights 

Section 28 [Practical commentary] [DZ] 

	(1) Health services may be provided to the patient only with his/her free and informed consent, unless otherwise provided in this Act. 
 
	(2) The patient shall be entitled to the provision of health services at the appropriate professional level. 
 
	(3) During the provision of health services the patient is also entitled 
 
(a) to respect, to be treated with dignity, to courtesy and respect for privacy in the provision of health services in accordance with the nature of health services, 
 
(b) to choose a provider authorised to provide health services that meet the patient's health needs, and a health facility, unless otherwise provided in this Act or in other legislation, 
 
(c) to request consultancy services from a different provider or a healthcare professional than the current health service provider; this shall not apply in the case of urgent care or in the case of custody, imprisonment or detention, 
 
d) to be acquainted with the internal rules of the inpatient or one-day care healthcare facility (hereinafter referred to as the "Internal Rules"), 
 
e) to 
1. the continuous presence of a legal guardian or a person appointed by a legal guardian, a foster parent or another person to whom the patient has been entrusted, by decision of the court or of another body, if s/he is a minor, 
2. the continuous presence of a caregiver or a person appointed by a caregiver, if s/he is a person whose legal capacity is limited so that s/he is not competent to assess the provision of health services, or the consequences of their provision (hereinafter referred to as "the patient with a limited legal capacity"), 
3. the presence of a close relative or a person designated by the patient, 
in accordance with other legislation and internal rules, and provided that the presence of such persons does not impair the provision of health services; this shall not apply to persons in custody, imprisonment or security detention; this provision, however, does not affect Section 47, Paragraph 1, Point b), 
 
f) to be informed in advance of the price of the health services provided, which are not paid for or partially covered by the public health insurance and of the manner of their payment, if his/her health condition enables it, 
 
g) to know the name(s) and surnames of healthcare professionals and other professionals directly involved in the provision of health services and of persons training to perform the healthcare profession who are present during the provision of health services or carry out the activities that are part of the training, 
 
h) to refuse the presence of persons who are not directly involved in the provision of health services and of persons training for the occupation of a healthcare professional, 
 
(i) to receive visits in the inpatient or one-day care healthcare facility, with regard to his/her health condition and in accordance with the internal rules and in a manner that does not violate the rights of other patients, unless otherwise provided in this Act or other legislation, 
 
j) to receive spiritual care and spiritual support in the inpatient or one-day care healthcare facility from spiritual leaders of churches and religious societies registered in the Czech Republic or from persons authorised to perform spiritual activities (hereinafter referred to as "clergy") in accordance with the internal rules and in a manner that does not violate rights of other patients, and with regard to his/her health condition, unless otherwise provided by other legislation; a spiritual visit cannot be denied to the patient in cases of danger to his/her life or serious damage to health, unless otherwise provided by other legislation, 
 
(k) to provide health services in the least restrictive environments while ensure the quality and safety of health services provided. 
 
	(4) A patient with limited legal personality or who is a minor may require that the person referred to in Paragraph, Point e) is not present during the provision of health services, if s/he is stating that s/he is a person who abuses or neglects him/her. In this instance it shall be proceeded pursuant to Section 35, Paragraph 5. 
 
	(5) The patient's rights referred to in Paragraph 3, Points c), e), i) and j) cannot be applied by the patient who is provided with a sobering-up service or who is required to undergo a medical examination in accordance with the Act on Health Protection from the Harmful Effects of Addictive Substances. While exercising his/her right pursuant to Paragraph 3, Point h), such patient may also not refuse the presence of a member of the Police of the Czech Republic, a member of the Military Police, a Municipal Police officer or a member of the Prison Service of the Czech Republic (hereinafter referred to as the "Prison Service"), who at the request of the provider cooperates in the provision of the sobering-up service or in the examination under the first sentence. 
 
Section 29 [Practical commentary] 

	(1) The choice of the provider and of the healthcare facility in the case of minor patients 
 
a) who are based in children's homes for children under 3 years of age, in school facilities for institutional or protective care, in social facilities providing residential services, where a court has ordered an institute or a protective care, or children entrusted to the care of facilities for children requiring immediate help on the basis of a court decision belongs to the statutory body of this facility, 
 
b) entrusted to foster care or to the care of other persons, belongs to a foster parent or another person to whom the patient has been entrusted by a court or by another authority (hereinafter referred to as "the foster parent or another caregiver"). 
 
	(2) The choice of the provider and of the healthcare facility shall not apply to 
 
(a) the medical rescue service and to the provider to whom the medical rescue service provider brings the patient, 
 
(b) occupational health services, 
 
(c) ordered isolation, quarantine or protective treatment, 
 
d) persons placed in Police cells established at the departments of the Police of the Czech Republic; these persons may invite, at their own expense, the selected healthcare provider to attend the provision of health services, 
 
(e) persons in custody, imprisonment, detention, detention facilities for foreigners or reception centers, 
 
(f) persons whose health condition is assessed for the purposes of employment services19) and for social security purposes20), 
 
g) active soldiers and soldiers in the active reserve under the conditions stipulated by the Act on Professional Soldiers, 
 
h) cases where another legislation provides for the assessment provider, or where the provider is designated by a person authorised to do so by another legislation, 
 
i) sobering-up service. 
 
Section 30 [Practical commentary] 

	(1) A patient with a sensory disorder or with severe communication problems caused by health reasons shall be entitled in a communication related to the provision of health services to communicate in a manner that is understandable to him/her by means of communication that s/he has chosen, including methods based on interpretation by another person. In the case of persons in custody, imprisonment or security detention, an interpreter shall be appointed by the Prison Service. 
 
	(2) The second sentence of Paragraph 1 shall apply mutatis mutandis in the case of foreign language interpreters, with the exception of Slovak language. 
 
	(3) A patient with a sensory or physical disability who uses a specially trained dog shall be entitled, with regard to his/her current state of health, to a company and a presence of the dog in a health care facility, in the manner prescribed by the internal rules so as not to violate the rights of other patients, unless otherwise provided by other legislation; this does not apply if the persons are in custody, imprisonment or security detention. Considered a specially trained dog for the purposes of the first sentence is a guide dog or an assistant dog. 
 
Information concerning the patient's health and the proposed health services 

Section 31 [Practical commentary] [DZ] 

	(1) The provider is obliged to 
 
(a) ensure that the patient is adequately informed of his or her health condition and of the proposed individual treatment process and any changes thereto (hereinafter referred to as "health information") in a clear and comprehensible manner, 
 
(b) enable the patient or a person designated by the patient to ask additional questions related to his/her health condition and proposed health services, which must be clearly answered. 
 
	(2) The health information referred to in Paragraph 1 comprises data on 
 
(a) the cause and origin of the disease, if known, its stage and foreseeable development, 
 
(b) the purpose, nature, expected benefits, possible consequences and risks of the proposed health services, including individual medical procedures, 
 
(c) other options for the provision of health services, their suitability, benefits and risks to the patient, 
 
(d) other necessary treatment, 
 
(e) limitations and recommendations on lifestyle with regard to his/her health condition and 
 
f) the possibility 
1. to waive the provision of health information pursuant to Section 32 and 
2. to designate persons pursuant to Sections 32 and 33 or to issue a ban on health information pursuant to Section 33. 
Health information is communicated to the patient when admitted to care and then always whenever it is expedient to do so with regard to the health services provided or the patient's health condition. 
 
	(3) Health information shall be provided by the attending healthcare professional who is competent to provide health services to which the information relates; the attending healthcare professional shall make a record of the information provided in the medical records. 
 
	(4) Health information shall not be provided to a patient who, due to his or her health condition, is unable to perceive the information provided. 
 
	(5) In the case of a minor patient or a patient with a limited legal capacity, the right to health information and the right to ask questions belongs to the patient’s legal guardian or his/her caregiver and to the patient if s/he is  reasonably advanced in terms of his/her intellect and volition. 
 
	(6) If the patient’s health condition or the nature of his/her illness requires, the provider is entitled to disclose to the persons who will personally take care of the patient the information necessary to provide such care or to protect their health. 
 
Section 32 [Practical commentary] 

	(1) The patient may waive the right to the provision of information on his or her medical condition, or determine to whom is to be provided. A record of waiving his/her right to the provision of health information and determining the person to whom health information shall be provided constitutes a part of the patient's medical record; the record shall be signed by the patient and the healthcare professional. A waiver of health information is disregarded if it is information that the patient is suffering from an infectious disease or from other illness in relation to which he or she may endanger the health or the lives of others. 
 
	(2) Information on the unfavourable diagnosis or prognosis of the patient's health condition may be withhold to the necessary extent and for the period necessary, if it can be reasonably assumed that its provision to the patient could cause serious harm to the patient. It is not possible to proceed in accordance with the first sentence, if 
 
a) the information on a specific disease or predisposition to it represents the only way to enable the patient to take precautionary measures or to undergo early treatment, 
 
b) the patient's health poses a risk to his/her surroundings, 
 
c) the patient specifically asks for accurate and truthful information to be able to arrange for personal matters. 
 
	(3) To the extent necessary, the provider may withhold information about the health condition of the minor patient to his or her legal guardian, foster parent or another caregiver in the event of suspected involvement of that person in the abuse or maltreatment or endangering the healthy development of that minor patient, if it is possible to assume that the provision of this information could endanger the patient. A similar procedure should be applied in the case of a patient with a limited legal capacity. 
 
Section 33 [Practical commentary] 

	(1) When admitted to care, the patient may identify persons who may be informed of his or her health condition and s/he may also determine whether or not such persons may view his/her medical records or other records related to his/her health condition, make excerpts from or copies of these documents, and may, in the cases pursuant to Section 34, Paragraph 7, express their consent or dissent with the provision of health services. The patient may designate persons or declare a ban on providing health information to any person at any time and s/he can also cancel the designation of a person or a ban on the provision of health information at any time. The record of the patient's statement constitutes a part of his/her medical record; the record shall be signed by the patient and by the healthcare professional. The record shall also include the patient's communication of how information about his or her health condition may be communicated. 
 
	(2) A ban on the provision of health information communicated by the patient shall not apply to the provision of information or to the communication of data which may be communicated without the patient's consent under this Act or other legislation. 
 
	(3) In the case of a patient who, in respect of his or her health condition, is unable to designate the persons referred to in Paragraph 1, close relatives shall be entitled to the provision of information on his/her current health condition and to making excerpt from and copies of medical records kept on the patient's behalf. If the patient has previously expressed a ban on the communication of information about his or her health condition to certain close relatives, this information may be provided to such persons only if this is  necessary to protect their health or the health of others. 
 
	(4) Persons close to the deceased patient, or other persons designated by the patient, shall be entitled to the provision of information on the health condition of the patient who has died and of information on the outcome of the autopsy if done, including the right to inspect the medical records kept on his/her behalf or other records relating to his/her health condition and to make excerpts therefrom or copies thereof. If the deceased patient has previously, during his/her life, expressed a ban on the communication of information about his or her health condition to certain close relatives, this information may be provided to such persons only if this is necessary to protect their health or the health of others and and only to the extent necessary. 
 
	(5) The right to information on the patient's health condition, to the extent necessary only, also includes the persons who have come into contact with the patient and this information is crucial for the protection of their health. 
 
Provision of health information with consent 

Section 34 [Practical commentary] [DZ] 

	(1) Consent to the provision of health services (hereinafter referred to as "consent") is deemed to be 
 
a) free, if provided without any coercion, 
 
b) informed if prior to the expression of his/her consent the  patient is informed pursuant to Section 31; consent is also deemed to be informed if the patient waived his/her right to the provision of the information pursuant to Section 32, Paragraph 1. 
 
	(2) A written form of consent is required if it is stipulated by another legal regulation21) or if the provider determines this with regard to the character of the health services provided. Consent with hospitalisation must always be provided in a written form. At his/her request the patient will be provided with a copy of the written consent form. 
 
	(3) The patient to whom information was provided concerning his/her health condition or who waived his/her right to the provision of information pursuant to Section 32, Paragraph 1 and who refuses to express his/her consent to the provision of health services, unless the health services are provided without consent, is repeatedly provided information on his/her health condition to the extent and in a manner from which it is evident that the non-provision of health services can seriously damage his/her health or endanger his/her life. If the patient continues to refuse the provision of his/her consent, s/he will make a written statement about it. 
 
	(4) The patient may withdraw his/her consent to the provision of health services. The withdrawal of consent shall not be effective if the medical procedure has already begun, the interruption of which may cause serious harm to the patient or endanger his/her life. 
 
	(5) The written consent, the written withdrawal of the consent, or a record of the withdrawal of the consent, if the patient has withdrawn his/her consent without a written statement, a written statement about disagreement with the provision of health services, or a record of this disagreement, if the patient refuses to make a written statement, constitute a part of the medical records kept on behalf of the patient; they are signed by the patient and by the healthcare professional. If the patient refuses to sign the record pursuant to the first sentence, the healthcare professional shall add this fact to the record; the record then will be signed by the health professional and a witness. 
 
	(6) If the patient's medical condition does not allow for the expression of consent, withdrawal of consent or disagreement with the provision of health services in the required manner, the healthcare professional shall record the patient's unambiguous manifestation of his/her volition to the patient's medical records, indicating the manner in which the patient has manifested his/her volition and health reasons that prevent the patient to express himself/herself in a desired manner; the record shall be signed by the healthcare professional and a witness. 
 
	(7) If due to his/her health condition the patient cannot express his/her consent to the provision of health services, and if the health services cannot be provided without consent, the consent of the person designated by the patient pursuant to Section 33, Paragraph  1 is required, if there is not such a person or if it is not available, a spouse or a registered partner, , if there is not such a person or if it is not available, the consent of the parent, , if there is not such a person or if it is not available, required is a consent of another close relative, if s/he is known. 
 
Section 35 [Practical commentary] 

	(1) In the provision of health services to a minor patient, it is necessary to find out his/her opinion concerning the provision of the intended health services if this is reasonable to his/her intellectual and volitional maturity of his/her age. (5) In the case of a minor patient or a patient with a limited legal capacity, the right to health information and the right to ask questions belongs to the patient’s legal representative or guardian and to the patient if he or she is  reasonably advanced in terms of his/her intellect and volition. In regard to obtaining the consent to the provision of health services from a minor patient, the legislation governing the legal personality of natural persons49) shall be applied, with the proviso that the intended health services can be provided to the minor patient based on his/her consent, if such an act is appropriate to his or her intellectual and volitional maturity corresponding to his or her age. This shall not affect the possibility of providing health services without consent. 
 
	(2) The provision of health services based on the consent of a minor patient shall not prevent the attending healthcare professional from providing the legal representative with information about the health services provided or the health condition of the minor patient. 
 
	(3) In the case of health services which consist of providing 
 
a) urgent care that is not a care pursuant to Section 38, Paragraph 4, or 
 
b) acute care, and 
	the consent of a legal guardian cannot be obtained without undue delay, the attending healthcare professional shall decide on their provision. This shall not apply if health services can be provided under Paragraph 1 on the basis of the consent of a minor patient. 
 
	(4) In the case of a patient with a limited legal capacity, Paragraphs 1 to 3 shall apply mutatis mutandis, with the age of the patient being disregarded. 
 
	(5) In the case of a patient referred to in Section 28, Paragraph 4, the provider shall exclude if it suspects that the patient is being abused or that his/her healthy development is endangered by the presence of the persons referred to in  Section 28, Paragraph 3, Point e) to the provision of health services in regard to examinations to exclude the signs of those facts. 
 
Section 36 [Practical commentary] [DZ] 

Previously expressed wish 

	(1) For the case that s/he becomes unable to consent or disagree with the provision of health services and the manner of their provision, the patient may provide his/her consent or disagreement in advance (hereinafter referred to as the "previously expressed wish"). 
 
	(2) The provider shall take into account the previously expressed wish of the patient, if available, provided that at the time of the provision of the health services a foreseeable situation has occurred to which the previously expressed wish relates and the patient is in such a health condition when s/he is unable to express a new consent or disagreement. Only such previously expressed wish will be respected that was made on the basis of a written instruction provided to the patient concerning the consequences of his/her decision by by a general practitioner with whom the patient is registered or by another healthcare practitioner in regard to the previously expressed wish. 
 
	(3) The previously expressed wishes must be made in a written form and must be provided with the patient’s notarised signature. The previously expressed wish shall include a written instruction pursuant to Paragraph 2. 
 
	(4) The patient may also make a previously expressed wish when accepted for care by the provider or at any time during his/her hospitalisation, in regard to the provision of health services provided by that provider. The wish expressed in this manner will be recorded in the patient's medical records; the record shall be signed by the patient, the healthcare professional and a witness; in this instance it is not proceeded in accordance with Paragraph 3. 
 
	(5) Previously expressed wish 
 
a) does not need to be respected if from the time of making it such developments occurred in regard to the health services provided to which this wish relates,  that it is possible to reasonably expect that the patient would express his/her consent to their provision; a decision to disregard the patient's previously expressed wish and the reasons which led to it shall be recorded in the patient's medical records, 
 
b) cannot be respected if it requires such practices the result of which is an active cause of death, 
 
b) cannot be respected if its fulfilment could endanger other persons, 
 
b) cannot be respected if such medical procedures were initiated at the time when the provider had not have available a previously expressed wish, the interruption of which would lead to an active cause of death. 
 
	(6) The previously expressed wishes cannot be applied in regard to minor patients or patients with a limited legal capacity. 
 
Section 37 [Practical commentary] [DZ] 

Confidential childbirth 

	(1) A woman with her permanent residence in the territory of the Czech Republic, unless it is a woman whose husband has a presumption of fatherhood22), shall be entitled to confidentiality of her person in connection with childbirth. 
 
	(2) The woman referred to in Paragraph 1, if she intends to conceal her identity in the context of childbirth, shall submit a written request to the provider providing the relevant health services in regard to the confidentiality of her identity during childbirth (hereinafter referred to as "confidential childbirth"); the request shall comprise a statement by a woman that she is not going to take care of the child. 
 
	(3) Understood as the implementation of the  confidential births are the procedures during the provision of health services to a woman referred to in Paragraph 1 in connection with pregnancy and childbirth which preserve her anonymity, with the exception of the procedures necessary to ensure the payment of health services from public health insurance and the provision of information for the National Health Information System. 
 
Hospitalisation of the patient and the provision of health services without consent and use of restraints 

Section 38 [Practical commentary] [DZ] 

	(1) The patient may be hospitalised without his/her consent 
 
a) if 
1. s/he was ordered a protective treatment in the form of inpatient care by the final decision of the court, 
2. an isolation, a quarantine a treatment was ordered to him/her pursuant to the Act on Public Health Protection, 
3. his/her medical examination has been ordered pursuant to the Code of Criminal Procedure or the Act on special judicial proceedings, 
 
b) s/he endangers himself or herself or others  in the imminent and serious manner and shows signs of mental disorder or suffers from it, or is under the influence of an addictive substance unless the threat to the patient or to others can be avoided otherwise, or 
 
c) his/her health condition requires the provision of urgent care and at the same time it does not allow him/her to provide a consent. 
 
	(2) In the case of a minor patient or a patient with a limited legal capacity, the hospitalisation can also be effected without the consent of a legal guardian or a caregiver if there is a suspicion of abuse or neglect. 
 
	(3) The patient may only be provided urgent care without his/her consent, in the case 
 
a) where the health condition does not allow the patient to provide this consent; this shall not affect the previously expressed wish pursuant to Section 36, or 
 
b) of a treatment of serious mental disorder if, in the absence of treatment, it is likely to cause serious damage to the patient’s health. 
 
	(4) The minor patient or the patient with a limited legal capacity may be provided urgent care without his/her consent, in the case 
 
a) as provided for in Paragraph 3, Point b), or 
 
b) of health services necessary to save or prevent serious damage to health. 
 
	(5) The minor patient or the patient with a limited legal capacity may be provided urgent care without the consent of his/her legal guardian, if there is a suspicion of abuse or neglect. 
 
	(6) The provider shall be obliged to inform the person designated pursuant to Section 33 about the hospitalisation in accordance with Paragraph 1, Point b) or c), if such person is not a close relative, or a cohabitee, or a legal guardian of the patient, provided that these persons are known to the provider. If no person pursuant to the first sentence is known to the provider or if s/he cannot be reached, the provider shall inform the Police of the Czech Republic. 
 
	(7) Other health services may be provided without consent, if provided by the Act on the Protection of Public Health, and also the sobering-up service. 
 
Section 39 [Practical commentary] 

	(1) Utilised for the restriction of the patient’s free movement during the provision of health services may be 
 
(a) holding the patient by healthcare professionals or by other persons designated by the provider, 
 
(b) restraining the patient in the movement by means of protective belts, 
 
c) placing the patient in the net bed; this does not apply in the case of the provision of a sobering-up service, 
 
d) placing the patient in a room intended for safe movement, 
 
e) a protective jacket or waistcoat preventing the patient to move his/her upper limbs 
 
(f) psychopharmaceuticals or other medicinal products administered parenterally which are suitable to restrict the free movement of a patient during the provision of health services, unless it is a treatment at the request of the patient or a systematic treatment of a psychiatric disorder, or 
 
g) the combination of means referred to in Points a) to f), 
	(hereinafter referred to as  "restraints") 
 
	(2) Restraints may be used 
 
a) only if the purpose of their use is to prevent the imminent threat to the life, health or safety of the patient or of other persons, 
 
b) only for as long as the reasons for their use under Point a) remain and 
 
c) after a more lenient procedure was used than the use of restraints, with the exception where the use of a more lenient procedure would clearly not have led to the attainment of the purpose referred to in Point a), with the least restrictive means being chosen for the purpose of its use. 
 
	(3) The provider is obliged to ensure that 
 
a) the patient in which the means of restraint has been used is clearly informed about the reasons for the use of the restraint with regard to his/her health condition, 
 
b) the patient's legal guardian or caregiver has been informed without undue delay about the use of the means of restraint referred to in Paragraph 1, Points b), c), d) or e); communication with the patient's legal guardian shall be recorded in the patient's medical records, the record shall be signed by the health professional and the legal guardian or caregiver, 
 
c) the patient is during the use of the means of restraint under the supervision of healthcare professionals; supervision must be consistent with the severity of the patient's health condition and, at the same time, measures must be taken to prevent damage to the patient's health, 
 
d) the use of a means of restraint is always indicated by a physician; in exceptional cases requiring urgent solutions, the use of restrictive means may also be indicated by another paramedical professional who is present; the physician must be informed of such use of the means of restraint and must confirm the justification for the restriction, 
 
e) any use of the means of restraint, including the reason for its use, is recorded in the patient’s medical records. 
 
	(4) The provider is obliged to maintain a central register of the use of restrictive means, which contains summary data concerning the number of cases of use of means of restraint per calendar year, for each restrictive means separately; the identification data of the patient in regard to whom the means of restraint has been used are not recorded in the central register. The use of the means of restraint shall be recorded in the central register within 60 days of its use. 
 
Section 40 [Practical commentary] 

	(1) The provider shall notify the court within 24 hours 
 
a) about the hospitalisation of a patient pursuant to Section 38, Paragraph 1, Point b) and c); similarly it hall be proceeded, if the patient, the patient’s legal guardian or his/her caregiver has withdrawn his/her consent, and the reasons to be hospitalised without consent remain, 
 
b) additional restrictions in free movement or in regard to the contact with the outside world on the patient who has been hospitalised based on his/her consent pursuant to Section 39, Paragraph 1, Points b) to g) that were applied during the treatment. 
 
	(2) The patient’s hospitalisation and additional restriction shall not be notified to the court if the consent has been additionally made within 24 hours in a demonstrable manner. 
 
Obligations of the patient and of other persons 

Section 41 [Practical commentary] [DZ] 

	(1) During the provision of health services the patient is obliged 
 
a) to adhere to the proposed individual medical treatment if s/he has provided his/her consent to the provision of health services, 
 
b) to comply with the internal rules, 
 
c) to reimburse the provider for the cost of the health services provided that are not paid or are only partially covered by public health insurance or other sources provided to him/her with his/her consent, 
 
d) to inform the attending healthcare professional truthfully about his/her current health condition, including information on infectious diseases16), on health services provided by other providers, on the use of medicinal products including the use of addictive substances and other facts essential for the provision of health services, 
 
(e) not to drink alcohol or take other addictive substances during his/her hospitalisation and, based on a decision by the attending physician, to undergo, in justified cases, an examination to determine whether or not s/he is under the influence of alcohol or other addictive substances. 
 
	(2) The obligations under Paragraph 1, Points c) and d) belong to the patient’s legal guardian or caregiver. The patient’s legal guardian or caregiver shall be obliged to create the conditions for the fulfilment of obligations by the patient pursuant to Paragraph 1, Points a), b) and e). The obligations under Paragraph 1, Points a) and d), if the patient is hospitalised, shall be used proportionately for the patient's legal guardian; the obligations under Paragraph 1, Points b), c) and e) shall also apply to the legal guardian. 
 
	(3) The patient, his/her legal guardian or caregiver, a person designated by the patient, a person close to the patient or his/her cohabitee shall be required to prove their identity by an identity card if the provider or healthcare professional through whom the provider provides the patient with health services asks for it. The obligation to prove with an identity card shall apply also to a person who exercises, under this Act or other legal regulation, the right to information on the patient’s health condition, and the person who intends to visit the hospitalised patient and s/he is not the person pursuant to the first sentence. In the case of a foreigner, the identity shall be proved by a travel document or any other identity card. If the healthcare professional has a doubt as to whether a person is relative, such person shall certify this fact by an affidavit stating his/her contact details and the identity card number; an affidavit constitutes a part of the patient's medical records. 
 
	(4) If the patient, his/her legal guardian or caregiver refuses to provide a proof of identity in accordance with Paragraph 3, the provider or healthcare professional may refuse to provide a health service, if s/he is not a patient who needs urgent care. If another person referred to in Paragraph 3 refuses to prove his/her identity, the provider or healthcare professional may refuse to provide the requested co-operation or to not allow him/her to visit the hospitalised patient. This shall not apply if the patient acknowledges the person's identity. The healthcare provider or the healthcare professional shall  inform the hospitalised patient immediately or as soon as the communication of this information is possible based on the patient’s health condition concerning the refusal of visit. 
 
Section 42 [Practical commentary] [DZ] 

	Rights and obligations of the legal representative pursuant to 
 
a) Section 31, Paragraph 5, 
 
b) in the case of provision of health services with the consent of the legal guardian, where there is a risk of delay and the opinion of the legal guardian cannot be obtained without undue delay; the reasons for which the consent of the legal guardian has not been obtained shall be recorded in the patient's medical records, 
 
c) Section 38, Paragraphs 2, 5 and 6, 
 
d) Section 39, Paragraph 3, Point b), 
 
e) Section 41, Paragraphs 2 and 3, 
 
f) Section 47, Paragraph 1, Point b) and 
 
g) Section 93, Paragraph 1 
	also belongs to a foster or another caregiver, a statutory body or an authorised person of a child care homes for children under 3 years of age, a school facility for the exercise of institutional or protective education, or facilities for social services providing residential services, where a court ordered institutional or protective education, or facilities for children requiring urgent help in the case of the children entrusted to the care of such facility on the basis of a court decision. 
 
CHAPTER II 

HEALTH SERVICES AND PROVISIONS PROVIDED IN CHILD CARE HOUSES FOR CHILDREN UNDER 3 YEARS OF AGE 

Section 43 [Practical commentary] [DZ] 

	(1) In child care homes for children under 3 years of age health services and care are usually provided for children of up to 3 years of age, who cannot grow up in a family environment, especially children who are abused, neglected and endangered in their development by inappropriate social environment or children with disabilities. Understood as provision is catering, accommodation, clothing and educational activities. 
 
	(2) Child care homes for children under 3 years of age may also provide accommodation for women during pregnancy if their health is endangered due to an unfavorable life situation. 
 
Section 44 [Practical commentary] 

	(1) Persons who are obliged to provide sustenance are obliged to contribute to the provider for the child who is placed in a child care home for children under 3 years of age and, if necessary, also for his/her guardian. If the persons obliged to provide sustenance do not live in a common household, the person to whom the child is entrusted is obliged to pay the contribution. 
 
	(2) The contribution for the payment of the child's sustenance shall be reduced to the difference between the proven income and the sum of the subsistence level of the obligated person and the persons jointly assessed with that person, and the sums needed to cover the normative housing costs23), if the obligated persons submit to the provider documents by which they prove that their income after the payment of the contribution to the child's sustenance would have fallen below the subsistence level of the household and the normative housing costs. The subsistence minimum of a child placed in a child care home for children under 3 years of age is not included in the subsistence minimum of a household. Contribution to the payment of child’s sustenance is not required if it is less than CZK 100 per month. 
 
	(3) If the amount of the household income changes, the obligated persons who pay the contribution to the payment of the child's sustenance shall be obliged to notify the provider of the change within 15 days from the date of the change. 
 
	(4) When determining the amount of the contribution to cover the child's sustenance, his/her age shall be taken into account, including his/her specific needs and the related complexity of the provision. The implementing legal regulation determines the amount of the contribution to cover the sustenance of the child and its guardian and also the method of payment. 
 
	(5) If a provider who provided health services in a child care home for children under 3 years of age dies or ceases to exist, and if the provision of health services and the provision of sustenance for children placed in these health facilities is not ensured, the provision of health services and the provision of sustenance shall in another child care home for children under 3 years of age shall be ensured for these children by the regional authority in the area of which the health services were provided. 
 
PART FIVE 

POSITION OF THE PROVIDER, HEALTHCARE PROFESSIONALS AND OTHER PROFESSIONALS IN RELATION TO THE PROVISION OF HEALTH SERVICES 

Rights and obligations of the provider 

Section 45 [Practical commentary] [DZ] 

	(1) The provider shall be obliged to provide health services at the appropriate professional level, to create conditions and measures to ensure the implementation of the rights and obligations of patients and other authorised persons, healthcare professionals and other professionals in the provision of health services. 
 
	(2) The provider is obliged 
 
a) to inform the patient about the price of health services provided, which are not covered or are only partially covered by public health insurance, before such services are provided, and to issue a bill for the paid up health services, unless stipulated otherwise by another regulation, 
 
b) to prepare a list of prices of health services provided, which are not covered or are only partially covered by public health insurance, and display it in such a manner that the list is available to patients; this shall not apply to the providers of pharmacy care.  
 
c) to define the operating and surgery hours and to place the information about them in such a manner that it is accessible by patients, 
 
d) to provide the health facility with a visible identification which must include the business name, name(s) and surname of the provider, and the identification number, if assigned, 
 
e) in the absence or temporary interruption of the provision of health services, to make available to patients information on the provision of urgent care by another provider within the limits of his{her surgery hours, 
 
f) to provide a report on the health services provided to the registrar provider in the field of general practitioner or in the field of practical medicine for children and adolescents if it is aware of it, and, on request, also to the medical rescue service provider or to the patient; a registrar provider in the field of dentistry or a gynaecology and obstetrics shall be required to report only when the provision of health services has been indicated by the registrar in the field of general practitioner or in the field of practical medicine for children and adolescents, 
 
g) pass on to other providers of health services or social services the necessary information concerning the patient's health condition that are necessary to ensure the continuity of other health and social services provided to the patient, 
 
h) process a list of health services the provision of which require written consent; this shall not apply to the providers of medical rescue service, medical transportation services, transport of urgent patient care, sobering-up services and pharmacy care, 
 
i) inform the patient that healthcare professionals may be involved in the provision of health services, including the viewing of medical records, who are acquiring the competence to pursue the profession of healthcare professional or another professional, and that the patient may prohibit the presence of such persons during the provision of health services and the viewing of medical records, 
 
j) accept the patient for 
1. an isolation, a quarantine, a treatment treatment or medical supervision provided for under the Act on Public Health Protection , if it is entitled to provide the required health services, 
2. a protective treatment ordered by a court in the case of a provider providing this service pursuant to the Act on Specific Health Services, 
 
k) to provide health services indicated by a physician of the Prison Service to a person charged with or convicted or placed in an institution for the exercise of security detention on a date agreed in advance with the Prison Service; this does not apply in case of urgent care, 
 
l) upon the request of the regional authority, by which it was granted the authorisation to participate in the provision of medical emergency services, pharmacy emergency services and dental emergency services; this does not apply if it is a Prison Service, 
 
m) to transmit data to the National Health Information System, 
 
(n) to conclude an insurance contract for the insurance of its liability for damage caused in connection with the provision of health services, to the extent to which it can reasonably be assumed that such liability could be attributed to it; this insurance must be maintained throughout the entire duration of the provision of health services; a copy of the insurance policy shall be forwarded by the provider to the competent administrative body no later than 15 days from the date of commencement of the provision of health services, 
 
o) to provide information to the National Focal Point upon its request pursuant to the Act on Public Health Insurance50). 
 
	(3) The provider is also obliged 
 
a) to hand over to the patient a medical opinion or a certificate for the Labour Office of the Czech Republic - a regional branch and at the territory of the capital city of Prague for a branch office for the Capital City of Prague, if the patient is not able to fulfil his/her obligation to cooperate with the Regional Branch of the Labour Office or with a branch for the capital city of Prague in mediation of employment24), 
 
b) to enable the entrance of persons authorised by the competent administrative body, the public health authority, the State Institute for Drug Control, the health insurance company, the Chamber, the authorised medical experts of the district social security administration, the employees of the district social security authorities who are responsible for the inspection, the Ombudsman and the staff members of the Office of the Ombudsman in order to identify the necessary supporting documents for the performance of tasks pursuant to this Act or other legislation regulating the activities and tasks of the said entities and to provide them with the necessary cooperation and also with the documents necessary for carrying out the inspection and performing their tasks; the presence of authorised persons must not impair the provision of health services, 
 
c) to enable the entrance of physicians and employees of the service bodies responsible for inspection pursuant to the Sickness Insurance Act25) and bodies of the Ministry of Defence, the Ministry of the Interior or the Ministry of Justice pursuant to the Act on the Organisation and Implementation of Social Security26) for the purpose of identifying the supporting documents necessary for carrying out tasks under this Act, the Sickness Insurance Act or Act on the Organisation and Implementation of Social Security in connection with the performance of tasks in regard to the retirement insurance; the presence of these persons must not impair the provision of health services, 
 
(d) to provide the competent administrative body, the Ministry and the State Institute for Drug Control, at its request, with the supporting documents and data necessary for the preparation for the handling of emergencies and crisis situations, 
 
e) to ensure the cooperation of members of international bodies in the performance of their tasks, should this obligation result from the international treaties binding on the Czech Republic, 
 
f) to ensure compliance with the obligation of notification and communication of data pursuant to the law governing the social and legal protection of children, 
 
g) at the request of the patient to whom an after-care or long-term inpatient care is provided for the same illness or lasting injury, including after-care or long-term care provided by previous providers, for a continuous period of more than 60 days, to issue a written confirmation of this fact, for the purpose of proceedings concerning the contribution for care pursuant to the Social Services Act, 
 
h) to enable the social workers of the Czech Labour Office - regional branches and the branches for the Capital City of Prague and social workers of the Ministry of Labour and Social Affairs to carry out a social investigation for the purposes of proceedings concerning the care allowance pursuant to the Social Services Act and to communicate to those workers the information necessary for this investigation; this must not interfere with the provision of health services. 
 
	(4) The provider is obliged to inform 
 
a) a person designated by the patient as referred to in Section 33, Paragraph 1, in the absence of such a person or, if unavailable, a spouse or registered partner, in the absence of such a person or, if unavailable, parents,  in the absence of such a person or, if unavailable,  another legally competent relative, if it known him/her, that the patient arbitrarily left the inpatient healthcare facility, and 
 
b) the Police of the Czech Republic, 
	in cases where any interruption of the provision of health services seriously jeopardises the health or life of the patient or of third parties. 
 
Section 46 [Practical commentary] 

	(1) The provider is obliged 
 
a) to familiarise the patient with his/her rights and obligations in the provision of health services and with internal rules; the internal rules must not interfere with the rights of the patient beyond what is strictly necessary for the proper functioning of the healthcare facility and for respecting the rights of other patients, 
 
b) to establish, coordinate and implement the individual healing process and to ensure the completeness, continuity and coordination of the health services provided, 
 
c) to inform the patient about other health services and other possible social services that may improve his/her health condition, in particular about the possibilities of social, work and pedagogical rehabilitation, 
 
d) to enable the access to information in the patient's medical records concerning his/her health condition to another provider or another healthcare professional whom the patient has been consulting and which is indispensable for the provision of consultation services, 
 
e) upon the invitation of the emergency medical service provider, to cooperate without delay in the provision of health services in the event of emergencies, mass accidents or poisoning, industrial accidents or natural disasters, including the provision of immediate follow-up inpatient care; this shall not apply in the case of a Prison Service, 
 
f) at the request or based on the action taken by the competent public health protection body, to provide without delay the involvement of healthcare professionals in the provision of health services in the event of, or at risk of, epidemics; this shall not apply in the case of a Prison Service, 
 
g) to ensure that health services are provided to persons in custody, imprisonment or detention in the presence of a Prison Service officer, only by sight, out of reach of his/her ears, with the exception in cases of danger to the life, health or safety of a health professional or another professional or property, whereby the officer is also entitled to be present to the provision of health services within earshot. 
 
	(2) The provider is additionally obliged to ensure that persons who are preparing for the medical profession, during their clinical, practical and professional training that takes place at its workplaces, perform only activities, including health care, which are part of teaching or practice, under the direct guidance of a healthcare professional who is competent to carry out the medical profession independently and is in a labour-law or similar relationship with the provider. Where clinical, practical and professional training takes place in the presence of a healthcare professional who is not in the labour-law or similar relationship with the provider referred to in the first sentence and who is 
 
a) a practical or professional training teacher in the healthcare disciplines of education27), or 
 
b) an academic who is a teacher of a healthcare discipline28), 
	the provider is obliged to ensure that the healthcare professional does not provide health services at its workplace and works in cooperation with the healthcare professional referred to in the first sentence. 
 
Section 47 [Practical commentary] 

	(1) The provider of one-day care or inpatient care is obliged 
 
a) to ensure hospitalisation 
1. of minor patients separately from adult patients, at least in separate rooms, as of the day they reach the age of 15, 
2. women separately from men in separate rooms, with the exception of providing acute intensive inpatient care, 
 
b) to allow the presence of a legal guardian or a person appointed by him/her together with a hospitalised minor patient or a patient with a limited legal capacity, provided that the set-up of the healthcare facility enables it and the provision of health services will not be impaired or such a presence is not excluded by another legal regulation; this shall not apply in the case of the provision of sobering-up services, 
 
c) to inform the patient's legal guardian concerning his/her discharge from day-care or inpatient care, 
 
d) to prepare a traumatology plan in which it established the set of measures applicable to mass disasters and update it at least once every two years; to submit one copy of the plan to the competent administrative body within 30 days of the date of its processing or update; its processing is based on local conditions and possibilities and the results of its discussion pursuant to point e); a traumatology plan is not processed in regard to the provision of sobering-up services, 
 
e) to discuss the draft traumatology plan in accordance with letter d) and the proposal for its updating with the relevant administrative body, if it is a teaching hospital, with the Ministry; details of the contents of the traumatology plan and the procedure for its processing and discussion with the relevant administrative body or the Ministry shall be laid down by an implementing legal regulation, 
 
f) upon the patient’s discharge to provide him/her with the medicinal products and medical devices for 3 days or, in duly justified cases, for the additional necessary period of time; this shall not apply in the case of the provision of sobering-up services. 
 
	(2) If because of his/her health condition the patient is not able to cope without another person’s assistance, s/he can be discharged from one-day or inpatient care only after the previous timely informing of the person expected to provide this assistance. If a patient for whom no further care is ensured is to be discharged from hospital, the provider should inform in a timely manner the municipal authorities at the patient’s permanent residence and if the patient’s permanent residence is in Prague, the Prague City Hall should be informed;  similar rule applies to minor patients whose social situation in the families is serious. 
 
	(3) As part of ensuring the quality and safety of the health services provided the Provider is also obliged  
 
a) to justify in medical records the cases where healthcare services deviate from a recognised medical practice, 
 
b) to establish an internal system of quality and safety assessment of health services provided; the minimum requirements for the implementation of an internal assessment system are published by the Ministry in the Bulletin of the Ministry of Health and on its website, 
 
c) to ensure that antibiotics are used in a particular patient in order to reduce the risk of the increase in antibiotic resistance. 
 
	(4) Within the framework of the prevention and control of infections, the provider of inpatient care is obliged to prepare a programme for the prevention and control of healthcare associated infections and to ensure its operability. The focus of this program must be in line with the nature of the healthcare provided and must be based on the assessment of the risk of healthcare associated infections in the specific conditions of the provider. 
 
	(5) The registrar provider or other provider who accepted  has taken care of the patient is obliged, if required by the patient’s health condition, to provide him/her with a written recommendation for a relevant specialised outpatient care,one-day care or inpatient care. The recommendation shall comprise a written justification and important information regarding the patient's health condition, including the results of the examinations carried out and information on the treatment to date. 
 
Section 48 [Practical commentary] [DZ] 

	(1) The provider whom the patient chose may refuse to take care of the patient if: 
 
a) by admitting the patient it would exceed the acceptable workload or his/her acceptance is prevented by operational reasons, staffing or technical and material equipment of the specific healthcare facility; understood as exceeding the workload is a condition whereby the provision of healthcare services to this patient would reduce the level of quality and safety of healthcare provided to patients already admitted, 
 
b) the distance of the patient's place of residence would not allow in the case of the provision of healthcare services in the field of general practical medicine and practical medicine for children and adolescents the provision of visiting service, or 
 
c) the patient is not the insured person of a health insurance company with which the provider has concluded a contract under the Public Health Insurance Act; this right shall not apply to insured persons from other Member States of the European Union, the European Economic Area, the Swiss Confederation, or from the countries with which the Czech Republic has concluded a social security agreement covering, to a substantial extent, the right to healthcare. 
 
	(2) The provider may terminate the patient’s care if 
 
a) it demonstrably passes the patient, with his/her consent, to the care of another provider, 
 
b) the reasons for the provision of health services are no longer met; this shall not apply in the case of the registrar provider; the provisions of Section 47, Paragraph 2 shall not be affected, 
 
c) the patient disagrees with the provision of all health services, 
 
d) the patient severely restricts the rights of other patients, deliberately and consistently fails to comply with the proposed individual treatment plan if s/he has provided his/her consent to the provision of health services or does not comply with the internal rules and his/her behaviour is not caused by his/her health condition, 
 
e) the patient ceased to provide the necessary cooperation for the further delivery of health services; this is not the case if the failure to provide cooperation is related to the patient's health condition; 
	termination of care must not result in an imminent threat to life or serious injury to the patient. 
 
	(3) The provider must not refuse to take care of the patient pursuant to Paragraph 1 or terminate his/her care pursuant to Paragraph 2, Point d) or e) in the case of a patient who needs to be provided urgent treatment, if it is the case of childbirth or in the event of health services that are necessary for the protection of public or occupational health, in the case of emergency situation or the exercise of a protective treatment ordered by a court, unless provided otherwise by other legislation. 
 
	(4) The provider additionally may not refuse to admit the patient under Paragraph 1 in the case of a patient 
 
a) where the provision of healthcare by the Prison Service was interrupted as a result of the termination or interruption of the custody, imprisonment or placement in the institution for execution of security detention, in the event of the provision of continuity of health services commenced during the custody or imprisonment or placement in a security detention facility; the Prison Service in whose healthcare facility the patient was provided with health services, if the provider is not known to take care of the patient, shall provide the patient with the information pursuant to Section 45, Paragraph 2, Point g), 
 
b) in the custody, imprisonment or placed in the institution for execution of security detention, in the case of health services, which the Prison Service does not provide, upon prior agreement with the Prison Service; this shall not apply in the case of reasons of provision of health services pursuant to Paragraph 3. 
 
	(5) The reasons for refusing to take care of a patient pursuant to Paragraph 1 or termination of care in accordance with Paragraph 2 shall be assessed by the provider. The provider shall provide the patient with a written report concerning the refusal to admit him/her to care pursuant to Paragraph 1 or concerning the termination of healthcare pursuant to Paragraph 2 d) and e), or concerning the refusal to provide health services pursuant to Section 50, Paragraph 2,  stating the reason for refusal or termination. 
 
Section 49 [Practical commentary] [DZ] 

Obligations of the healthcare professional 

	(1) The healthcare professional is obliged 
 
(a) to provide health services for which s/he has acquired professional or specialised competence pursuant to other legislation, to the extent appropriate to his or her competence and the patient's health condition, at the appropriate professional level, and to comply with ethical principles, 
 
b) to provide immediate first-aid to any person if without such aid his/her life would be endangered or his/her health seriously threatened and if this aid is not available in a timely manner in the usual way and to provide him /her with health services, as necessary. 
 
c) to carry out other obligations pursuant to this Act or other legislation. 
 
	(2) Obligations pursuant to Paragraph 1 
 
a) Points a) and c) also apply to other professionals who are involved in the provision of health services, 
 
b) Point c) also apply to other professionals carrying out activities directly related to the provision of health services. 
 
Section 50 [Practical commentary] [DZ] 

Rights of the healthcare professional 

	(1) The healthcare professional shall be entitled 
 
a) to obtain information from the patient that the patient to whom s/he is providing the health services is the carrier of an infectious disease under the Public Health Protection Act and other relevant facts related to the patient's health condition, 
 
b) not to provide health services in the event of a life threatening situation or serious threat to his/her health in the case of provision of these services. 
 
	(2) A healthcare professional may refuse to provide healthcare services to a patient if their provision is contrary to his or her conscience or religion. S/he is obliged to immediately inform the provider about this fact who will provide the patient with another healthcare professional. If the provider cannot provide another healthcare professional, s/he will provide the patient with another provider who will provide him/her with the healthcare service if the patient does not refuse the provision of another provider. A record of refusing the provision of another healthcare professional or provider shall constitute a part of the medical records; the record is signed by the patient and by the healthcare professional. A healthcare professional may not refuse to provide a patient with healthcare services for the reason stated in the first sentence if the patient's life is threatened or his or her health is seriously endangered and the provider is unable to provide the health services by another healthcare professional. The first to the fourth sentences shall apply mutatis mutandis if the provider refuses to provide the health services. 
 
	(3) The provisions of Paragraphs 1 and 2 shall apply mutatis mutandis to other professionals engaged in activities directly related to the provision of health services. 
 
Section 51 [Practical commentary] [DZ] 

Maintaining confidentiality in connection with health services 

	(1) The provider is obliged to maintain confidentiality about all the facts that ite has learned in connection with the provision of health services. 
 
	(2) Not considered as a violation of the mandatory confidentiality shall be 
 
a) the transmission of information necessary to ensure the continuity of the health services provided, 
 
b) the communication of data or other facts where the provider is exempt by the patient or the patient’s legal representative of confidentiality, and if it communicates the data or the facts to the extent of the exemption, 
 
c) communicating or reporting data or other facts pursuant to this Act or other legal regulations, if this Act or other legal regulations imply that the data or facts can be communicated without the consent of the patient, 
 
d) communicating data or other facts for the purposes of criminal proceedings in the manner stipulated by the law governing criminal proceedings; the disclosure of data or other facts in connection with the fulfilment of the statutory obligation to prevent or notify the commission of a criminal offence shall also not be considered to be a breach of the obligation of confidentiality. 
 
	(3) Additionally not considered to be a breach of confidentiality is the disclosure of data or other facts by the provider to the extent requisite for the protection of its rights in criminal proceedings, civil proceedings, arbitration and administrative proceedings or communication of facts to a court or other authority, if a dispute between the provider, or its employee, and the patient or another person who claims damages or protection of personality in connection with the provision of health services represents a subject of proceedings before the court or other body; in that context, the provider shall be entitled to transfer to a court, an expert, an expert body, a Chamber a copy of the patient's medical records for the purpose of drawing up an expert opinion requested by the defence or by a party to civil proceedings. This shall apply mutatis mutandis to a disclosure of data or other facts to the person referred to in Section 64, Paragraph 1. 
 
	(4) Disclosure of data or of other facts by a healthcare professional who is a member of the Chamber to the extent necessary for the purposes of the proceedings conducted by the bodies of the Chamber is also not considered to be a breach of confidentiality. 
 
	(5) The mandatory confidentiality referred to in Paragraph 1 shall also apply to 
 
a) healthcare professionals and other professionals in connection with the pursuit of their occupation, 
 
b) health professionals or other professionals who no longer pursue their occupation and who obtained information in connection with their former pursuit of the profession of healthcare professional or other professional or occupation associated with the provision of health services, 
 
c) persons acquiring competence to pursue the occupation of a health professional or another professional, 
 
d) persons referred to in Section 65, Paragraph 2 who, without the consent of the patient, view his/her medical records, 
 
e) members of expert committees under the Act on Specific Health Services, 
 
f) persons referred to in Section 46, Paragraph 1, Point g), 
 
g) other persons who learn the information about the patient's health condition or related information in connection with their activities under other legislation. 
 
PART SIX 

MEDICAL RECORDS AND THE NATIONAL HEALTH INFORMATION SYSTEM 

CHAPTER I 

PROCESSING OF PERSONAL DATA 

Section 52 [Practical commentary] [DZ] 

	When processing personal data the patient's personal identification number can be used  
 
a) in the patient’s medical records, 
 
(b) in the National Health Information System, if the collection or processing of data and/or its storage relates to a particular patient. 
 
CHAPTER II 

MEDICAL RECORDS 

Medical records management 

Section 53 [Practical commentary] [DZ] 

	(1) The provider is obliged to keep and maintain medical records and deal with it pursuant to this Act and other legal regulations. The medical records represent a set of information referred to in Paragraph 2 related to the specific patient. 
 
	(2) In accordance with their purpose the medical records comprise 
 
a) the patient’s identification information, which includes name(s), surname, date of birth, personal ID number, if assigned, the number of the insured person of the public health insurance, if this number is not the patient’s personal ID number, the address of the place of permanent residence in the territory of the Czech Republic, in the case of the foreigner the place of the reported residence in the Czech Republic and in the case of the person without permanent residence in the territory of the Czech Republic the address of residence outside the territory of the Czech Republic, 
 
b) the patient’s gender, 
 
c) the provider’s identification information, which comprises name(s), surname of the provider and the address of the place of the provision of healthcare services in the case of a natural person, the provider's company name, the address of the registered office or the address of the place of business in the case of a legal person, identification number, if assigned, name of the department or a similar section if the healthcare facility is divided in this manner, 
 
d) information about the patient's health condition, on the course and the outcome of the health services provided and on other relevant circumstances related to the patient's health condition and to the procedures related to the provision of health services, 
 
e) information obtained from the patient’s family, personal and occupational history and, if justified, also from social history, 
 
f) data related to the patient’s death, 
 
g) other information pursuant to this Act or other legislation governing health services or healthcare provision. 
 
Section 54 [Practical commentary] 

	(1) Under the conditions stipulated by this Act the medical records may be kept in a written or an electronic form or in combination of both of these forms. In the electronic form, medical records are procured, processed, stored and mediated in digital form, using information technology. 
 
	(2) The medical records, including their independent components, must be kept in a conclusive, true, legible and continuous manner. Entries shall be made without undue delay. In the case of acute inpatient care, an entry concerning the patient's current health condition shall be made at least once a day. 
 
	(3) Any entry into medical records kept 
 
a) in a paper form, must be provided with 
1. the date of its implementation, 
2. the signature of a healthcare professional or other professional who made the entry and with a stamp bearing a name or a legible transcription of his or her name(s) and surname; this does not apply in the case of a provider who provides health services on his/her behalf, 
 
(b) in electronic form it shall be provided with the entry identifier; the entry itself shall contain the unchangeable, undisputable and verifiable data that comprise 
1. the date of the entry, 
2. the identification data of the healthcare professional or other professional who made the entry. 
 
	(4) The corrections of entries in the medical records shall be made by a new entry. The entry shall be provided with the date of the correction and the other particulars pursuant to Paragraph 3. The original entry must remain legible. Addition or correction of the entry in the medical records at the patient request shall indicate the date and time of the entry and the note that it is a correction or addition made at the patient’s request; the entry shall be signed by the patient and by the healthcare professional who made it. 
 
Section 55 [Practical commentary] 

	Medical records can be conducted in an electronic form only, subject to meeting the following conditions: 
 
a) the technical means utilised to store the records in electronic form ensure that the data in the recordings made cannot be retrofitted; the technical means include organisational and technical measures, information systems, technical equipment and selected working procedures, 
 
b) the information system, in which the medical records are kept in an electronic form, records the list of record identifiers in the electronic records of patients kept by the provider and enables its provision by remote access, 
 
c) safety copies of the data files are made at least once per working day, 
 
d) prior to the expiration of the life of the record on the technical data carrier, transmission to another technical data carrier is ensured, 
 
e) the storing of copies for long-term preservation must be made in a way that prevents to additionally interfere with these copies; these copies are created at least once per calendar year, 
 
f) when retaining copies for the long-term preservation on a technical data medium, access to such data is granted only to authorised persons and their readability is ensured for at least the period stipulated for the retention of medical records 
 
g) documents in paper form which constitute a part of the medical records and require the signature of a person who is not a health professional or another professional must be converted into an electronic form and in this form supplemented by a confirmation of conversion signed by the certified electronic signature of the person who carried out the conversion; the document in the paper form shall be kept, 
 
h) the outputs from the medical records can be converted into paper form by means of an authorised conversion of documents29), 
 
i) the information system in which the medical records are kept must enable the creation of a special copy of the medical records stored in a format readable and processable in another information system. 
 
Section 56 [Practical commentary] [DZ] 

Medical records management in the case of confidential childbirth 

	(1) The medical records concerning the confidential childbirth pursuant to Section 37 is maintained within the scope of health services related to pregnancy and confidential childbirth. Separately from the medical documentation is kept the woman's name(s) and surname, to whom health services are provided in connection with the pregnancy and the confidential childbirth, the application for confidentiality of the childbirth, the date of the birth of the woman and the date of the childbirth. 
 
	(2) Upon termination of the hospitalisation of a woman who has given confidential childbirth, the provider shall complete the medical records with the data referred to in Paragraph 1 and place it in a suitable package, which shall be sealed and marked with a security code, which shall also be forwarded to the patient. The opening of such sealed medical records is possible only on the basis of a court decision; this shall not apply if a woman who has given confidential childbirth asks to open the medical records. 
 
	(3) In the case of medical records kept in electronic form, the medical records shall be transferred to a written form in accordance with Paragraph 2; at the same time the electronic form of medical records will be removed from the information system. 
 
Handling of medical records in the event of termination of authorisation to provide health services 

Section 57 [Practical commentary] [DZ] 

	(1) If the authorisation to provide health services ceases to exist through the death of the provider and if not proceeded pursuant to Section 27, the person who lived with the deceased in a common household or the person close to him or her, or the owner of the facility in which the health services were provided, if known to him, or another person who first came into contact with the medical records, shall immediately notify the provider’s death to the competent administrative body and to secure the medical records in such a manner that they are protected from viewing or other handling by unauthorised persons or from loss. 
 
	(2) The persons referred to in Paragraph 1 shall be prohibited from viewing the medical records. These persons are obliged to 
 
a) maintain confidentiality about all the facts that they learnt about patients, the health condition of whom is maintained in medical records, and about other facts related to the provision of health services, 
 
b) enable access to a building where a medical facility was located to a person authorised by the competent administrative body in order of takeover or, where appropriate, making an inventory of medical records. 
 
	(3) Following the notification made pursuant to Paragraph 1 the competent administrative body 
 
a) immediately secures the medical records to protect them against viewing or other handling by unauthorised persons or loss, for as long as the patient chooses a new provider, 
 
b) notifies the takeover of medical records or its surrender pursuant to Section 63, Paragraph 2 to another provider in a customary manner and in such a way as to the maximum extent possible ensure the provision of information to the patients about whom the medical records are kept; in the notification it shall indicate the address of the place where requests for the surrender of medical records to the provider chosen by the patient may be submitted or, where appropriate, the address of the place of supply of the health services by the provider to whom the medical records were transferred, 
 
c) provides patients with a copy of medical records until they choose a new provider or before health records related to Occupational Health Services are transferred to the relevant provider designated by the employer, to the extent necessary to ensure the continuity of the provision of health services or if it necessary for the assessment of the health condition or fitness; these activities may be performed only by a healthcare professional, 
 
d) based on the patient’s or the selected provider’s written request, promptly demonstrates the transmission of the medical records to the provider chosen by the patient; the provider chosen by the patient adds to its request the patient's written statement concerning his/her choice; the request shall contain the patient’s name(s), surname, personal ID number, if it was assigned, or the date of birth, the address of the patient's permanent residence or the place of residence declared in the Czech Republic or the address of the residence outside the Czech Republic, if the patient is a foreigner, and the identification data of the selected provider. 
 
	(4) If the deceased provider provided Occupational Health Services for the employer, the competent administrative body shall notify the employer, if known, concerning the takeover of the medical records of the employees. The competent administrative body, on the basis of the employer's communication, will pass these medical records to another provider designated by the employer. 
 
	(5) If the authorisation to provide health services ceases to exist through the death of the provider who kept the medical records only in an electronic form, the person who lived with the deceased in a common household or the person close to him or her, or the owner of the facility in which the health services were provided will enable the access of the relevant administrative body to the information system in which the patient's medical records are kept. 
 
Section 58 [Practical commentary] 

	The natural person or the legal entity referred to in Section 27, Paragraph 1 that pursuant to Section 27 intends to continue  the provision of health services based on the authorisation for the provision of health services shall proceed mutatis mutandis in accordance with Section 57, Paragraph 3, Points a), c) and d) and Paragraph 4. This person shall, by the time the provision of  health services is commenced, notify in a manner customary at the place where the request for a procedure pursuant to Section 57, Paragraph 3, Points c) and d) should be submitted. 
 
Section 59 [Practical commentary] 

	(1) The provider who intends to discontinue the provision of health services shall be obliged to disclose information about the termination of his/her/its activity at least 60 days prior to the date of intended termination, in a health facility in a publicly accessible place or on his/her/its website. The provider shall at the same time request the competent administrative body and the municipality in the territory of which the health services are provided to publish the information on their official board; the relevant administrative body and the municipality are obliged to publish this information. The information shall indicate the date of intended termination of the activity, the date by which the request for the submission of the medical records to the provider chosen by the patient can be submitted and the address of the place where the request is to be submitted. In the case of a procedure pursuant to Section 23, Paragraph 3, the provider shall indicate in the information who intends to continue to provide health services. 
 
	(2) The provider referred to in Paragraph 1, when transmitting the medical records to the provider selected by the patient, shall proceed mutatis mutandis, in accordance with Section 57, Paragraph 3, Point d). Medical records of patients who have not submitted a request for transfer of their medical records to another provider in due time and their list will be forwarded to a person/entity who continues to provide health services. If there is not such a person, the medical records and their list shall be forwarded to the relevant administrative body. 
 
	(3) The provider of the occupational health services shall notify the intention to terminate the provision of health services at least 60 days prior to the date of intended termination to the employer of the employee whose medical records relating to the Occupational Health Services are kept. The notification shall also specify the time limit within which the employer must disclose the identification data of the new provider. On the basis of the employer's communication, the provider passes the medical records to the provider designated by the employer. If the provider does not receive the communication pursuant to the second sentence within the specified time limit, it shall forward the medical records and their list inventory to the competent administrative body. 
 
	(4) Paragraphs 1 to 3 shall apply mutatis mutandis to the expiration of the authorisation to provide health services for reasons other than those referred to in Paragraph 1 and the provider shall be aware of the termination of the authorisation in advance. 
 
Section 60 [Practical commentary] 

	(1) A natural person or a legal entity whose authorisation to provide health services has expired on the basis of a decision of the competent administrative body shall be obliged to ensure the transfer of the medical records and their inventory to the relevant administrative body within 10 working days from the date on which the decision becomes final. 
 
	(2) If the circumstances occur under which a natural person or a legal entity referred to in Section 58 can no longer continue to provide health services, he/she/it shall promptly transmit the medical records and their list to the competent administrative body. 
 
Section 61 [Practical commentary] 

	(1) In the event of the termination of the authorisation to provide health services in connection with the cancellation of the organisational unit of the state or the organisational unit of the territorial self-governing unit and the provision of health services 
 
a) is continued by another provider, the exiting organisational unit is obliged to ensure the transmission of the medical records and their list to the continuing provider, 
 
b) is not continued, the provisions of Section 57, Paragraphs 3 and 4 shall apply mutatis mutandis with the proviso that the medical records and their list shall be forwarded to the competent administrative body by this provider. 
 
	(2) The founder of the organisational unit information shall publish the information concerning the termination of activity at least 60 days prior to the date of intended termination, in the health facility and in a publicly accessible place and in a manner allowing for remote access. The provider shall at the same time request the competent administrative body and the municipality in the territory of which the health services are provided to publish the information on their official board; the relevant administrative body and the municipality are obliged to publish this information. The information shall indicate the date of the intended termination of the activity, the date by which the request for the submission of the medical records to the provider chosen by the patient can be submitted and the address of the place where the request is to be submitted; it shall be further stated in the information that medical records that have not been forwarded to the provider chosen by the patient or designated by the employer shall be forwarded to the competent administrative body and also the address of its registered office. In the case of the termination of the activities of a provider who, under a contract with the employer, provided the Occupational Health Services, the provider shall make a notification pursuant to Section 59, Paragraph 3. 
 
Section 62 [Practical commentary] 

	If the provider has forwarded the medical records to a legal entity or a natural person who intends to continue to provide health services, and if there is no material basis for the continued provision of health services, this person/entity shall proceed mutatis mutandis pursuant to Section 57, Paragraph 3, Points a), c) and d). In the case of medical records related to Occupational Health Services, it shall ensure that it is handed over to the provider designated by that employer on the basis of a communication from the employer of the employee in regard to whom the medical records are kept in the context of Occupational Health Services. 
 
Section 63 [Practical commentary] 

	(1) The competent administrative body shall, upon receipt of the medical records, pursuant to 
 
a) Section 59, Paragraph 2 proceeds accordingly pursuant to Section 57, Paragraph 3, Points c) and d), 
 
b) Section 59, Paragraph 3 proceeds accordingly pursuant to Section 57, Paragraph 4, or 
 
c) Section 60 or Section 61, Paragraph 1, Point b) proceeds accordingly pursuant to Section 57, Paragraph 3, or pursuant to Section 57, Paragraph 4. 
 
	(2) The competent administrative body may, for the purpose of securing the tasks referred to in Section 57, Paragraph 3, Points c) and d) pass the medical records to another provider, if this provider agrees to this, for a period of time before the patient chooses another provider. 
 
	(3) The competent administrative body shall transmit the medical records to the provider pursuant to Paragraph 2 on the basis of a delivery protocol listing the medical records, the identification data of the accepting provider, the date and the purpose of the takeover. A similar procedure is applied if another provider transmits the medical records to a newly selected provider. 
 
	(4) The competent administrative body, the provider or a natural person or a legal entity shall indicate the patient's name(s) and surname and his/her date of birth in the medical records pursuant to Section 59 or Section 60. 
 
	(5) Unless this Act stipulates otherwise the medical records and  their list must be submitted to the competent administrative body or to the provider or to an authorised natural person or a legal entity within 10 working days from the date on which the circumstances occurred decisive for its transmission. 
 
Section 64 [Practical commentary] 

	(1) The competent administrative body or the provider who has taken over the medical records is obliged to enable access to the medical records to the natural person who was the provider, or to the legal successor of the legal entity who was the provider, to the healthcare professional or other professional who was in labour-law or a similar relationship with the provider who maintained the medical records, for the needs of 
 
a) proceedings before the administrative bodies, 
 
(b) criminal proceedings or proceedings before a court or another body where proceedings are between a former provider or a healthcare professional or another professional and a patient or another person claiming damages or protection of personality in connection with the provision of health services, or where applicable, if there is a dispute between a former provider and a healthcare professional or another professional, 
 
c) resolving a dispute with a former patient, 
 
d) resolving a dispute with a health insurance company. 
A similar procedure shall be applied if it is a natural person who has lost competence to perform a medical profession. 
 
	(2) The persons who in accordance with Paragraph 1 were provided an access to medical records, 
 
a) have no access to data unrelated to the purpose for which access was enabled, 
 
(b) are required to maintain confidentiality of all data which they have learned in connection with access to the health records about patients, health professionals or other professionals or providers, with the exception of data communicated to the competent authorities in criminal proceedings, courts or other authorities in proceedings referred to in Paragraph 1. 
 
	(3) The competent administrative body or the provider shall inform the persons to whom access to the medical records has been provided pursuant to Paragraph 1 concerning the obligations pursuant to Paragraph 2, Point b). 
 
Viewing medical records, making excerpts from them or their copies 

Section 65 [Practical commentary] [DZ] 

	(1) In the presence of a staff member authorised by the provider the patient’s medical records may be viewed and inspected and excerpts from them and their copies may be made by 
 
a) the patient, the patient’s legal guardian or caregiver; the patient and the patient’s legal guardian or caregiver may view the records of authorised psychological methods and description of treatment by psychotherapeutic means or make excerpts from them or their copies only within the scope of the description of the symptoms of the disease, diagnosis, description of the therapeutic approach and the interpretation of the test results, 
 
(b) persons designated by the patient, the patient’s legal guardian, foster parents or another caregiver; in the case of records of authorised psychological methods and description of the treatment with psychotherapeutic means it shall be proceeded in accordance with point a), 
 
c) persons close to the deceased patient to the extent specified in Section 33, Paragraph 4; 
	procedures pursuant to Points a), b) or c) must not interfere with the provision of health services. 
 
	(2) The patient’s medical records may be without his or her consent viewed, to the extent necessary, if it is in the interest of the patient or if it is necessary for the purposes of this Act or other legislation by 
 
a) the persons with qualification for pursuing medical profession and other professionals in direct connection with the provision of health services, who are employees of the provider, and other employees of the provider to the extent necessary for pursuing the profession, and also because of the fulfilment of tasks pursuant to this Act or to any other legal regulations and when assessing the correctness of the procedure in the provision of health services, 
 
b) persons involved in the exercise of the powers of a competent administrative body in connection with a review of a medical opinion pursuant to another law, 
 
c) persons with a qualification for the performance of the medical profession 
1. authorised by the competent administrative body to process an expert opinion on the proposal for review of the medical opinion, 
2. authorised by the competent administrative body, which took over medical records pursuant to this Act, to issue statements or copies of the medical records for ensuring the continuity of the health services for the patient, 
 
d) persons with a qualification to pursue a medical profession who are involved in the exercise of powers of the administrative authorities authorised to supervision within the scope of their authorisation under this Act or other legal regulations and authorised persons with a qualification to pursue a medical profession invited for inspection to the extent of their authorisation, 
 
e) persons with a qualification to pursue a medical profession authorised by health insurance companies to carry out activities to the extent provided for by the Public Health Insurance Act, 
 
f) healthcare professionals competent under other legislation to assess health condition for social security purposes, in particular sickness or pension insurance, state social support, employment, social and legal protection of children, social services and assistance in material need, 
 
g) persons with a qualification to pursue a medical profession authorised by the State Institute for Drug Control, authorised to exercise inspection under this Act or other legal regulations to the extent stipulated by these legal regulations, 
 
h) persons involved in the recording of data or checking the communication of data to the National Health Information System pursuant to this Act, 
 
i) forensic experts in medical fields and  persons with a qualification to pursue a medical profession who have been entrusted with the task of drawing up an expert opinion by an expert body30), the provider or a healthcare professional, to the extent necessary to draw up an expert opinion for the purposes of  criminal proceedings or proceedings before a court under other legal regulations, 
 
j) physicians from the State Office for Nuclear Safety in the scope stipulated by other legal regulation, 
 
k) persons with a qualification to pursue a medical profession who are the employees of the public health authorities, in the exercise of state health surveillance, 
 
l) persons with a qualification to pursue a medical profession conducting an assessment of the quality and safety under this Act and persons with a qualification to pursue a medical profession performing external clinical audits of medical exposure under the Act on Specific Health Services, 
 
m) the Ombudsman in connection with an investigation under another Act31) in order to ensure the protection of sensitive data of third parties, 
 
n) members of the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment or members of the Subcommittee for the Prevention of Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment to the extent necessary to fulfil the task resulting from international treaties by which the Czech Republic is bound and which regulate the work of a committee or a subcommittee32). 
	The persons referred to in Points b) to n) may make extracts or copies of the medical records to the extent necessary for the purpose of the observation. 
 
	(3) Persons gaining a qualification to pursue a profession of healthcare professional or another professional and healthcare professional referred to in Section 46, Paragraph 2 can view the patient’s medical records to the extent strictly necessary to ensure the learning; this shall not apply if the patient has forbidden the viewing in a provable manner. 
 
Section 66 [Practical commentary] 

	(1) If a person who, pursuant to Section 65, Paragraph 1 or Paragraph 2, Points b) to k) is authorised to obtain a statement or a copy of the medical records, does not make an excerpt nor a copy by his own means on the spot, it is the provider who shall make a copy of the medical records. The provider shall make an excerpt from the medical records for the persons referred to in the first sentence only in the case that it is more efficient than a copy, in agreement with the authorised person. The provider shall make an excerpt from or a copy of the medical records 
 
a) for the persons referred to in Section 65, Paragraph 1  within 30 days of receipt of a request from a patient or other authorised person, 
 
b) for persons referred to in Section 65, Paragraph 2, Points b) to k) to the extent necessary to meet the purpose of the viewing within 15 days of receipt of the written request, 
	unless another law provides otherwise or no other deadline has been agreed. 
 
	(2) If the provider is unable to arrange for the persons referred to in Section 65, Paragraph 1 the viewing of the medical records, it shall obtain a copy of the medical records for them within 5 days from the date when it informed the person that the medical records cannot be inspected unless another deadline has been agreed. No reimbursement shall be required for making a copy. 
 
	(3) The provider who, at the request of a person referred to in Section 65, Paragraph 1, made an excerpt or a copy of the medical record, may require 
 
a) reimbursement in an amount that may not exceed the costs of obtaining the excerpt or the cost of obtaining a copy of the medical record; the price list for the excerpt or the copy of the medical records must be made available at the place accessible to patients, 
 
b) reimbursement for their dispatch in an amount that may not exceed the costs related to their dispatch, unless stipulated otherwise in the legal regulation or unless the extraction of an excerpt or making a copy is covered from public health insurance. 
 
	(4) Where the medical records are kept only in electronic form, the patient or other person authorised pursuant to Section 65shall be entitled to view by means of a remote access or to obtain a copy thereof on a technical data medium that s/he determines, unless prevented by the technical capabilities of the provider; this shall not apply if a paper form is required. 
 
	(5) Prior to examining the medical records the persons referred to in Section 65, Paragraph 2, Points b) to n) are required to prove their identity by means of an identity card or other document containing a photograph and also their belonging to an administrative body or institution, or to submit a written authorisation. In the case of persons referred to in Section 65, Paragraph 1, Section 41, Paragraphs 3 and 4 shall apply mutatis mutandis. 
 
	(6) Any inspection of the medical records or the acquisition of excerpts or copies thereof under this Act or other legal regulations, with the exception of viewing pursuant to Section 65, Paragraph 2, Point a) and Paragraph 3, shall be recorded to the patient's medical records. According to the first sentence, the same procedure shall apply mutatis mutandis if data or other information related to the patient has been provided to the authorised person under this Act or other legislation without the consent of the patient. 
 
Section 67 [Practical commentary] 

	If a medical record of a minor patient contains such data about his or her legal guardian, foster parent or another caregiver about which the healthcare professional has learned in the course of the provision of health services and which may be suggest abusing or maltreating the patient or endangering his or her healthy development, the provider shall be entitled to restricts disclosure of health records to that legal guardian, or to both legal guardians, foster parents or other caregivers, if s/he considers that this restriction is in the patient’s interest. Access to health records can be restricted only in relation to the data from which the facts referred to in the first sentence follow. Similarly, if a healthcare professional suspects abuse or maltreatment of a patient with a limited legal capacity or another patient who is not a minor patient nor a patient with a limited legal capacity. 
 
Section 68 [Practical commentary] 

	If the competent administrative body has taken over the medical records, the provisions of Sections 66 and 67 shall apply mutatis mutandis. 
 
Section 69 [Practical commentary] 

	The implementation legal regulation stipulates 
 
a) the extent of the patient's health information and facts related to the provision of health services and to the procedure associated with the provision of health services maintained in the medical records, 
 
b) the particulars of the medical records and the contents of their individual parts, 
 
c) details of the manner of recording, processing and handling of medical records, irrespective of the form of recording of medical records, including the requirements for creating a special copy of the medical records, 
 
d) the storage period of the medical records, the procedure for the de-listing of the medical records and the manner of their discarding after the expiration of the storage period, 
 
e) the format of the record identifier, the requirements on the format of the record identifier and the requirements on the technical means for the maintenance of the medical records in an electronic form. 
 
CHAPTER III 

THE NATIONAL HEALTH INFORMATION SYSTEM 

Section 70 [Practical commentary] [DZ] 

	(1) The National Health Information System is a unified national information system of public administration intended for 
 
a) processing data on the health condition of the population, on the activities of providers and their financial status, on health professionals and other health professionals and on the payment for health services covered by public health insurance, in order to obtain information on the scope and quality of the health services provided, for the management of the health sector and for the creation of health policy, including ensuring transparency in the provision and financing of health services, ensuring equal access to health services, and assessing quality and safety indicators of health services, 
 
b) maintaining the National Health Registers and processing data held in them, 
 
c) maintaining the National Register of Providers, the National Register of Health Professionals and the National Register of Paid Health Services and the processing of data held therein, 
 
d) implementing and processing sample surveys on the health condition of the population, on determinants of health, on the need for and consumption of health services and satisfaction with them, and the costs of health services, 
 
e) the needs of science and research in the field of healthcare, and 
 
f) processing the data referred to in Points a) and d) and also in the registers referred to in Points b) and c) for statistical purposes and providing data and statistical information to the extent determined by this or other legislation, including the provision of information to international institutions. 
 
	(2) For the processing of personal data in the National Health Information System pursuant to Paragraph 1, Points b) and c) shall be transmitted without the consent of the data subject33), unless specified otherwise, the following data, if the data subject is 
 
a) a patient, 
1. the data necessary for his/her identification, namely the number of the insured person, if assigned, or the personal ID number, if this number is not the number of the insured person, or the date of birth, if the personal ID number is not assigned, the name of the municipality and/or the district of the place of residence, the address of permanent residence and, in the case of a foreigner, the address of the place of the reported residence and nationality, 
2. data related to his or her health status in relation to the disease and its treatment, in particular the socio-demographic and diagnostic data, personal, family and occupational history of the patient related to the disease, including an assessment of his/her current state of health, data on the health services provided to the patient, as well as data on the performance of the profession or employment, or the performance of the service, necessary for the assessment of the patient's health condition, 
3. the identification date of the provider of health services, including the department and the workplace, 
4. the identification data of the last employer where the patient suffering the occupational disease was last employed under the conditions under which the occupational disease is arising, 
 
b) the provider, the data referred to in Section 74, Paragraph 1, 
 
c) the healthcare professional, the data referred to in Section 76, Paragraph 1, 
 
d) the provider of social services providing health services and the person providing the health services pursuant to  Section 20, data referred to in Section 74, Paragraph 2. 
 
	(3) The Ministry establishes the Institute of Health Information and Statistics of the Czech Republic (hereinafter referred to as the "Statistical Institute") as an organisational component of the state to fulfil its tasks in the area of provision of the National Health Information System pursuant to this Act and to the Act on the State Statistical Service. The Statistical Institute is the administrator of the National Health Information System. 
 
	(4) The data pursuant to Paragraph 2 shall be transferred to the National Health Information System, unless they are provided under another legal regulation34), 
 
a) by the providers and the providers of social services, where they provide health services; the providers that are also intelligence services do not transmit data to the National Health Information System, 
 
b) by health insurers, 
 
c) by the relevant administrators or the authorised processors of such data, in the case of data collected under this Act or other laws, 
 
d) in the case of the National Register of Providers pursuant to Section 74 also by the relevant administrative bodies, regional authorities and the person authorised by the administrator of the National Health Information System, 
 
d) in the case of the National Register of Healthcare Professionals pursuant to Section 76 also 
1. by the schools that provide secondary education in a field of medical education, higher education institutions and universities with an accredited educational or study programme by the graduation from which the graduate acquires the professional qualification for pursuing the medical profession under other legal regulations (hereinafter referred to as the "educational establishments"), 
2. by accredited facilities under the laws governing the qualification for pursuing health professions (hereinafter referred to as the "accredited facilities"), 
3. by legal entities that are authorised organisations under the laws governing the qualification for pursuing health professions (hereinafter referred to as the "authorised organisations"), 
4. by Chambers, 
5. by healthcare professionals, 
6. by the Ministry, 
 
f) in the case of the National Registry of Drug Users, also social care facilities, facilities providing social prevention services and social counselling programmes provided under the law governing the provision of social services, the target group of which are persons at risk of addiction or dependency on addictive substances, 
 
g) in the case of beneficiaries of care allowance35) the Ministry of Labour and Social Affairs. 
 
	(5) Persons referred to in Paragraph 4 
 
a) are not entitled to reimbursement of costs associated with the provision of data to the National Health Information System, 
 
b) are obliged to allow the Statistical Institute and the Ministry to check the accuracy and completeness of the communication of data to the National Health Information System. 
 
	(6) The data to the National Health Information System shall be transmitted only in an electronic form by direct recording or on technical media in the manner specified by the implementing legal regulation and with the structure in accordance with the data interface. The data interface shall be published by the Statistical Institute, on its website. 
 
Section 71 [Practical commentary] 

Co-operation between the Ministry of the Interior, the Police of the Czech Republic, the Czech Statistical Office and the Statistical Institute in the provision of data from basic registers and other public administration information systems 

	(1) The Ministry of the Interior or the Police of the Czech Republic shall provide the Statistical Institute, for the purposes of fulfilling its tasks under this Act in the area of provision of the National Health Information System with 
 
a) the reference data from the population's basic register; 
 
b) data from the population information system, 
 
c) data from the information system of foreigners, 
 
d) data from the register of the natural persons who have been assigned a personal ID number but who are not kept in the information systems referred to in Point b) or c). 
 
	(2) The data provided pursuant to Paragraph 1, Point a) comprise 
 
a) surname, 
 
b) name(s), 
 
c) the address of the place of residence or, where appropriate, the address to which documents are to be served under another legislation, 
 
d) the date, the place and the district of birth; in regard to the data concerning the person who was born abroad, the date, the place and the country of birth, 
 
e) the date, the place and the district of death; in the case of the death of a data subject outside the territory of the Czech Republic, the date of death, the place and the state in the territory of which the death occurred; if the court's decision on the declaration of death is issued, the date which is provided in the decision as the date of death or the date which the data subject who was declared dead had not survived and the effective date of that decision, 
 
f) citizenship, or multiple citizenships. 
 
	(3) The data provided pursuant to Paragraph 1, Point b) comprise 
 
a) name(s), surname, family name, 
 
b) date of birth, 
 
c) gender, 
 
d) the place and the district of birth; for a citizen of the Czech Republic who was born abroad, the place and the country of birth, 
 
e) personal identification number, 
 
f) citizenship, or multiple citizenships. 
 
g) the address of the place of residence, including previous addresses of the permanent residence, or, where appropriate, the address to which documents are to be served under another legislation, 
 
h) the commencement of the permanent residence or the date of cancellation of the data on the permanent residence or the date of termination of the permanent residence in the territory of the Czech Republic, 
 
i) restrictions on legal capacity, 
 
j) the name(s), the surname and the personal ID number of the father, the mother, or any other legal guardian; in the event that one of the parents or other legal guardian does not have a personal ID number, his or her name(s), surname and date of birth, 
 
k) the marital status, the date of its change and the place of marriage, 
 
l) the date and the place of the registered partnership, 
 
m) the name(s), the surname and the personal ID number of the spouse or the registered partner; in the event that  the spouse or the registered partner is a natural person who does not have a personal ID number, his or her name(s), surname and date of birth, 
 
n) the name(s), the surname and the personal ID number of the child; in the event that the child does not have a personal ID number, his or her name(s), surname and date of birth, 
 
o) data on the adopter, 
1. stage of adoption, 
2. the original and the new name(s) and surname of the adoptee, 
3. the original and the new personal ID number of the adoptee, 
4. the date, the place and the district of birth and in regard to the data concerning the adoptee who was born abroad, the place and the country of birth, 
5. the name(s), the surname and the personal ID numbers of adopters; in the event that the adopter does not have a personal ID number, his or her name(s), surname and date of birth, 
6. the name(s), the surname and the personal ID numbers of the father and the mother; in the event that the  father and the mother do not have a personal ID number, their name(s), surname and date of birth, 
7. the date of legal force of the adoption decisions or the decision to abolish adoption, 
 
p) the date, the place and the district of death; in the case of the death of a citizen of the Czech Republic outside the territory of the Czech Republic, the date, the place and the state in the territory of which the death occurred, 
 
q) the day, which was in the court decision on declaration of death defined as the date of death or the day on which the person who was declared dead did not survive, and the effective date of the court decision on declaration of death. 
 
	(4) The data provided pursuant to Paragraph 1, Point c) comprise 
 
a) name(s), surname, family name, 
 
b) date of birth, 
 
c) gender, 
 
d) the place and the country of birth of the foreigner; if s/he was born in the Czech Republic, the place and the district of birth, 
 
e) personal identification number, 
 
f) citizenship or nationality, g) the type and the address of residence or the address to which documents are to be delivered pursuant to other legislation 
 
h) the number and validity of the residence permit, 
 
i) the beginning of the stay or the date of termination of the stay in the territory of the Czech Republic, 
 
j) a restriction on legal capacity, 
 
k) an administrative or a judicial expulsion and the period during which the foreigner is not allowed to enter the territory of the Czech Republic, 
 
l) the marital status, the date and the place of the conclusion of marriage, 
 
m) the date and the place of the registered partnership, 
 
m) the name(s), the surname, the nationality and the personal ID number of the spouse or the registered partner; in the event that the spouse or the registered partner is a foreigner who does not have a personal ID number, his or her name(s), surname and date of birth, 
 
o) the name(s), the surname and the nationality of the child if s/he is a foreigner and his/her personal ID number; in the event that the child does not have a personal ID number, his or her name(s), surname and date of birth, 
 
p) data on the adoptee in the following extent: 
1. stage of adoption, 
2. the original and the new name(s) and surname of the adoptee, 
3. the original and the new personal ID number of the adoptee, 
4. the date and the place of birth, nationality, 
5. personal ID numbers of adopters; in the case where the adopter has not been assigned a personal ID number, the name(s), the surname and the date of birth of the adopter, 
6. Father's and mother's personal ID numbers; if not assigned, details of their name(s), their surname and date of birth, 
7. the date of legal force of the adoption decisions or the decision to abolish adoption, 
 
p) the date, the place and the district of death; in the case of the death of a foreigner outside the territory of the Czech Republic, the date, the place and the state in the territory of which the death occurred, 
 
q) the day, which was in the court decision on declaration of death defined as the date of death or the day which the foreigner who was declared dead did not survive. 
 
	(5) The data provided pursuant to Paragraph 1, Point d) comprise 
 
a) name(s), surname, family name, 
 
b) personal ID number, 
 
c) in the case of a change to the personal ID number, the original personal ID number, 
 
d) day, month and year of birth 
 
e) the place and the district of birth, in the case of a natural person born abroad, the state where s/he was born. 
 
	(6) The data, which are maintained as reference data in the population's basic register, shall be used from the Population Register Information System or the Foreign Nationals Information System only if they are in a form prior to the current state. 
 
	(7) The Statistical Institute shall pass on to the provider who carried-out birth or postpartum treatment to the newborn, the personal ID number of the born child in order to establish medical records and to transfer the data to the National Health Information System. 
 
	(8) The Police of the Czech Republic shall provide to the provider upon his/her written request the following data 
 
a) address of the place of stay of the deceased patient, 
 
b) the address of the patient's place of residence, where the communication of this information is not enabled by his/her health condition, 
 
c) the address of the patient's place of residence to whom it is necessary provide information regarding his/her health condition, where failure to provide it may result in a risk or a damage to the health of the patient or to the health of others, 
 
d) the address of the place of residence, the name(s), the surname of the living spouse or of the living child of the patient referred to in Point b), 
 
e) the address of the place of residence, the name(s) and the surname of the legal guardian of the patient who is a minor or the guardian of the patient with a limited legal capacity who, with regard to his or her health condition or age, is unable to communicate the information needed to seek a legal guardian, or a deceased patient who was a minor or a person with a limited legal capacity. 
	provided that the provider cannot find such information in any other way and it is necessary to ensure the conditions for the provision of health services. 
 
	(9) The request referred to in Paragraph 8 shall include 
 
a) the provider's identification data, 
 
b) the identification data the healthcare professional, specifically his/her name(s), surname, and his/her job position at the provider, 
 
c) the purpose for which the data are required, 
 
d) the personal ID number of the patient or of the deceased patient and, if the provider does not have this information available, other identification data, specifically the name(s), surname and the date of birth, 
 
e) the personal ID number of the spouse, children or the legal guardian of the patient or of the deceased patient and, if the provider does not have this information available, other identification data of these persons, specifically the name(s), surname and the date of birth, 
 
	(10) For the purpose of securing the provision of health services and for the performance of the state administration in regard to the National Health Information System the Czech Statistical Office shall provide the Statistical Institute with the information from the Basic Register of Persons about the entity kept in the register in the following extent: 
 
a) the business name or the name(s) and the surname, if the entrepreneur is not incorporated in the Commercial Register, 
 
b) the name(s) and the surname of the entrepreneur or a foreign person, 
 
c) the date of establishment or the date of registration in accordance with other legislation, 
 
d) the date of termination or the date of deletion from the register pursuant to other legislation, 
 
e) a legal form, 
 
f) a record of the establishment of a data mailbox and a data mailbox identifier if this data mailbox has been made available, 
 
g) a statutory body, the name(s), the surname and the address of the natural person or the name and the registered office of the legal entity, 
 
h) a legal status, 
 
i) the registered office of the entity kept in the register of persons or the address of the place of business of the natural person, 
 
e) the date of the commencement of the provision of activities in the facility, 
 
f) the date of the termination of the provision of activities in the facility, 
 
l) the address of the establishment, 
 
m) the code of the agenda, 
 
n) the date of the first entry in the register of persons, 
 
o) the date of the last change of the data entered in the register of persons, 
 
p) the identification number of the person, 
 
q) the identification number of the establishment. 
 
	(11) In a specific case, the data provided under Paragraphs 2 to 5 and 10 or the data referred to in Paragraph 8 may only be used if it is necessary to fulfil the specific task. 
 
	(12) The Statistical Institute shall pass on the data provided to it pursuant to Paragraphs 2 to 5 and 10 to providers and to health insurers upon their request to enable them to perform their tasks . The request of the provider or of the health insurance company and the data transmitted by the Statistical Institute on the basis of this request shall be transmitted in a manner enabling remote access. 
 
	(13) The request referred to in Paragraph 12 shall include 
 
a) the provider's or the health insurer’s identification data, 
 
b) the basic identification of the data subject the information about whom is to be transmitted, 
 
c) the required scope of the data concerning the data subject pursuant to Point b), 
 
d) the purpose for which the data are required, 
 
e) additional information necessary to retrieve the required data, unless the data subject has been identified in a clear manner; 
	the request shall be signed in the manner in which other legislation combines the effects of a handwritten signature51). 
 
	(14) The Statistical Institute shall verify the identity of the applicant, in the case of the provider, in the National Register of Providers and, in the case of a health insurer which has been authorised to carry out public health insurance pursuant to of the Act on Sectoral, Branch, Business and Other Health Insurance Companies, in the Commercial Register. The Statistical Institute shall additionally assess the legitimacy of the request and the justification of the requested data scope in accordance with the stated purpose and, in the case of a positive evaluation, it shall transmit the required data. If the Statistical Institute evaluates the application as unfounded or if it limit the extent of the requested data, it shall inform the provider or the health insurer. 
 
	(15) At the request of the Ministry, the Statistical Institute shall transmit to the Ministry the data obtained under Paragraphs 2 to 5 and 10 which the Ministry needs in order to perform its tasks under this or other laws. 
 
National Health Registers, the National Register of Providers, the National Register of Healthcare Professionals and the National Register of Paid Health Services 

Section 72 [Practical commentary] 

	(1) The National Health Information System comprises 
 
a) data from the Sectoral Programme of Statistical Surveys collected pursuant to the State Statistical Service Act, 
 
b) National Health Registers, which are listed in the Appendix to this Act, 
 
c) the National Register of Providers, 
 
d) the National Register of Healthcare Professionals 
 
e) National Health Registers maintained pursuant to the law governing transplantation, 
 
f) data acquired from the information systems of infectious diseases maintained pursuant to the law on public health protection, 
 
g) the National Register of Paid Health Services, 
	(hereinafter referred to as "Health Registers"). 
 
	(2) Health Registers shall form a mutually interconnected system within the National Health Information System where it is possible, for the purposes specified in Section 73, to aggregate the data contained therein. Data obtained from the information systems of public administration and health insurance companies can be used to manage these Health Registers. 
 
Section 73 [Practical commentary] 

	(1) The purpose of Health Registers is 
 
a) the collection of information to assess the health condition of the population and its development, to monitor the incidence, circumstances of the occurrence and spread of socially significant diseases and their consequences; at the same time they serve as a basis for evaluating the effectiveness and efficiency of diagnostic and therapeutic procedures and for promoting or directing their development with the possible support in terms of the equipment for healthcare facilities, 
 
b) the monitoring of the development, causes and consequences not only of serious illnesses, including the economic consequences, and their impact on the social sphere and economy of the social system, 
 
c) the recording and monitoring of patients, including the deceased, suffering selected socially significant diseases, the monitoring of the occurrence, development, causes and consequences of these diseases and the follow-up care, and the recording and monitoring of patients with accidents, and also processing of statistical and scientific data contained in the registers focused specifically on analysing the health condition of the population and the quality and use of health care with the purpose of improving the overall population health, 
 
d) recording the information of the providers, social service providers who provide health services and persons providing health services pursuant toSection 20, and also personnel provision of health services and technical and material equipment, 
 
e) recording the information of healthcare professionals in terms of their authorisation to practice the medical profession and the level of their education, 
 
f) obtaining the necessary data for statistical purposes and providing information, 
 
g) collecting information to assess the quality and safety indicators of health services, 
 
(h) collecting information to ensure the quality and sustainability of the reimbursement system for health services covered by public health insurance, 
 
i) collecting information to monitor demographic developments, reproductive health and the consequences of population ageing for the provision of health services. 
 
	(2) Unless otherwise provided in this Act, access to personal data and other data maintained in Health Registers shall be enabled to 
 
a) an authorised employee of the administrator or the operator of the Health Register, 
 
b) the provider’s authorised healthcare professional providing a patient with health services that are monitored in the Health Register in case of a register referred to inSection 72, Paragraph 1, Points b), e) or f), 
 
c) an authorised employee of the person/entity who provides the data to the Health Register, in case of a register referred to in Section 72, Paragraph 1, Point c), and a healthcare professional who provides data on his/her person to the Health Register, in case of a register referred to in Section 72, Paragraph 1, Point d), to the extent of the data provided by him/her; this shall not affect the access to public sections of Health Registers, 
 
d) an authorised employee of the Transplantation Coordination Centre for the purpose of utilisation of anamnestic data about a deceased patient kept in the Health Registers, who has been diagnosed with brain death and who is a potential donor, for the purpose of transplantation, 
 
e) an authorised employee of an institution, which is legally entitled to use data of a designated Health Register for its activities, 
	(hereinafter referred to as an "authorised employee"); entities referred to in Points a) to e) authorise the specific employee and submit the request pursuant to Paragraph 2. Understood as an entity entitled to submit the request pursuant to Paragraph 3 shall also be a healthcare professional under Point c) who provides data on his/her person to the Health Register. 
 
	(3) The Statistical Institute shall provide an access to the personal data and other data maintained in Health Registers to the authorised employee upon the request submitted by the authorised entity in accordance with Paragraph 2. The request shall be submitted in a manner enabling remote access. The request must include the identification details of the requesting body and of the authorised employee, the purpose for which the data to be accessed from the relevant Health Register are required and the extent of the access rights required. The Statistical Institute shall inform the authorised entity concerning the extent of the access rights to the personal and other data maintained in the relevant Health Register. If the Statistical Institute fails to provide access to personal data and other data maintained in the relevant Health Register, it shall inform the requesting body of the reasons which led to it. 
 
	(4) The entity pursuant to Paragraph 2 is obliged without undue delay to notify the Statistical Institute of any changes in the facts on the basis of which the authorised employee has been provided with an access to personal and other data maintained in the Health Register. The Statistical Institute will cancel or change the access based on the significance of changes. The Statistical Institute shall also cancel the access at the request of the authorised entity. 
 
	(5) The Statistical Institute provides data from the National Health Registers for statistical and scientific purposes only in the form from which no specific natural person or legal entity can be identified. For the provision of such data the Statistical Institute shall be entitled to request payment in the amount which shall not exceed the costs related to the acquisition of excerpts, copies, the provision of technical data carriers and the sending of data to the authorised entity pursuant to Paragraph 2. The Statistical Institute may also request reimbursement for extremely extensive data searches. 
 
	(6) Should the Statistical Institute request payment in accordance with Paragraph 5, it shall notify this fact in writing together with the amount of reimbursement to the authorised body which submitted the request pursuant to Paragraph 3 prior to providing the information pursuant to Paragraph 5. The notification must clearly state on the basis of what facts and how the Statistical Institute quantified the amount of the reimbursement. 
 
	(7) Should the Statistical Institute fail to comply with the notification requirement pursuant to Paragraph 6 in relation to the authorised entity that submitted the request pursuant to Paragraph 3, it shall lose the entitlement to the reimbursement of costs. 
 
	(8) Provision of the data pursuant to Paragraph 5 shall be subject to the payment of the required reimbursement. If the authorised body which submitted the request pursuant to Paragraph 3 does not pay the reimbursement within 60 days from the date of notification of the amount of the required reimbursement, the Statistical Institute shall postpone the request. While the complaint against the amount required is being processed, the time period under the second sentence is not running. 
 
	(9) Reimbursement represents the income of the Statistical Institute. 
 
National Register of Providers 

Section 74 [Practical commentary] [DZ] 

	(1) The National Register of Provider contains structured data on providers, specifically 
 
a) identification information of the provider to the extent specified in the decision to grant the authorisation to provide health services, 
 
a) identification information of the authorised representative to the extent specified in the decision to grant the authorisation to provide health services, 
 
c) the registered address, the address of the place(s) of the provision of health services and other contact details of the provider, e.g. telephone, fax, an e-mail address, website and a data box identifier, 
 
d) the form of healthcare, the fields of healthcare, or the kind of healthcare in accordance with Section 5, Paragraph 2, Points f) to i) or the name of the health service pursuant to Section 2, Paragraph 2, Points d) to f) and i), for each individual place of provision of health services, 
 
e) date of the commencement of the provision of health services. 
 
f) information concerning the interruption of the provision of health services, 
 
g) information concerning the suspension of the provision of health services, 
 
h) information concerning the termination of the authorisation to provide health services, 
 
i) information concerning the continuation of the provision of health services pursuant to Section 27, 
 
j) operation and surgery hours, 
 
k) the list of health insurance companies with which it has concluded a contract under the Public Health Insurance Act, 
 
l) information on obtaining the confirmation of the fulfilment of conditions of the assessment of quality and safety of health services provided pursuant to this Act, 
 
m) the number of beds in accordance with the form and the field of health care, or the type of health care in accordance with Section 5, Paragraph 2, Points f) to i), 
 
n) the FTE in regard to healthcare professionals broken down in accordance with the professional competence, specialised competence and special professional qualifications. 
 
	(2) Also recorded in the National Register of Providers is the information 
 
a) concerning the social service providers who provide health services within the scope referred to in Paragraph 1, Points a), c), d) and e), 
 
b) concerning persons/entities who provide health services pursuant to Section 20, to the extent of the particulars stated in a document proving their authorisation to provide health services in another Member State of the European Union, the European Economic Area or the Swiss Confederation, the contact address and other contact details pursuant to Paragraph 1, Point c), the date of commencement and termination of the provision of health services in the territory of the Czech Republic, the prohibition of the provision of health services in the territory of the Czech Republic and the duration thereof. 
 
	(3) The content of the National Register of Providers is 
 
a) publicly accessible on the Ministry 's website, with the exception of information concerning 
1. the address of the permanent or reported residence and the date of birth of the natural person and 
2. the provider authorised to provide health services by the Ministry of Defence, the Ministry of Justice or the Ministry of Interior, 
 
b) accessible to the provider, the social service provider and the healthcare provider pursuant to Section 20, to the extent of the data processed, 
 
c) accessible to the authorised employees of the competent administrative body and to the regional authority to which the provision of health services has been notified pursuant to Section 11, Paragraph 8 and Section 20, Paragraph 2, to the extent of all data processed in the register, for the purpose of performing state administration in the health sector, 
 
d) accessible to authorised employees of legal entities who provide data collection for the National Health Information System, 
 
e) accessible to authorised employees of health insurers to the extent of all data processed in the register, for the purpose of carrying out public health insurance, 
 
f) accessible to the chamber in the case of a member of a chamber who is a provider or a professional representative, to the extent of the information kept about them. 
 
Section 75 [Practical commentary] 

	(1) Data are transmitted to the National Register of Providers pursuant to 
 
a) Section 74, Paragraph 1, Points a) to i) by the competent administrative body, provided that additional contact details pursuant to Section 74, Paragraph 1, Point c) are transmitted, if known, 
 
b) Section 74, Paragraph 2 by a regional authority that has been notified of the provision of health services pursuant to Section 11, Paragraph 8 or pursuant to Section 20, Paragraph 2, 
 
c) Section 74, Paragraph 1, Point c), in the case of contact details, and pursuant to Section 74, Paragraph 1, Points j) to n) by the provider, 
 
c) Section 74, Paragraph 1, Points c) and j) to n) by the provider of social services. 
 
	(2) The competent administrative body, the regional authority referred to in Paragraph 1, Point b) and providers shall also transmit to the Register any change to this data. 
 
The National Register of Healthcare Professionals 

Section 76 [Practical commentary] [DZ] 

	(1) The National Register of Healthcare Professionals authorised to pursue the medical profession includes the data on healthcare professionals, including guests and persons who have acquired the authorisation to to pursue the medical profession outside the Czech Republic, specifically 
 
a) the name(s) and the surname of the healthcare professional and his/her academic title, scientific rank and scientific and pedagogical title, 
 
b) the date and place of birth, 
 
c) gender, 
 
d) the personal ID number, if it was assigned, in the case of foreigners, the number of the travel document or of any other identity card, 
 
e) citizenship, 
 
(f) the designation of professional or specialist qualifications, including specialised and special professional qualifications, and the date of their acquisition pursuant to other legislation; in the case of recognition of competence to practice a medical profession pursuant to other legislation, the designation of expertise and the date of its recognition, 
 
g) the identification data of the educational establishment, an accredited establishment or an authorised organisation in which the healthcare professional has acquired his/her professional, specialised or special professional qualifications; in the case of recognition of the competence to pursue the medical profession under other legislation, the identification number of the accrediting body, 
 
h) an indication whether s/he is a visiting or a settled person, 
 
i) in the case of a visiting person, the date of notification under which s/he may, under another legislation, pursue a medical profession, 
 
j) in the case of healthcare professionals subject to specialised training or who are in the course of an approval procedure, an indication whether the healthcare professional enrolled in specialised training or preparation for an approval examination and a field of specialised training or an approval examination, 
 
k) the identification information of the provider or the social service provider where the healthcare professional performs the medical profession and the type and the form of healthcare in which he or she carries out the medical profession, 
 
l) the address of the healthcare professional's permanent residence address, if s/he is a foreigner the address of the reported residence and other contact details such as telephone number, e-mail address or a data mailbox identifier, if the healthcare professional has provided the address and other contact details, 
 
m) records about 
1. final decisions on the prohibition of the exercise of the medical profession, 
2. the exclusion from the chamber. 
 
	(2) The content of the National Register of Healthcare Professionals is accessible for 
 
a) the educational establishment, the accredited establishment, the ministry or the authorised organisation that is a data editor about the healthcare professional within the scope of Paragraph 1, Points f) and g), 
 
b) the provider or the provider of social services, to the extent of the details of its staff, including the visiting persons, pursuant to Paragraph 1, Points a) to j) and l) to m), in order to ensure the provision of health services and to check the fulfilment of the requirements for the personnel provision of the health services provided, 
 
c) the chamber within the scope of the information pursuant to Paragraph 1, kept about its members, for the purpose of carrying out its activities, 
 
d) the health insurance company within the scope of the information pursuant to Paragraph 1, Points b), f), g), i), (j) and (l), for the purpose of carrying out public health insurance, 
 
e) the Ministry within the scope of the information pursuant to Paragraph 1, Points f) to m), for the purpose of performing state administration in the field of accessibility and quality control of health services, 
 
f) the competent administrative body within the scope of the information pursuant to Paragraph 1, Points a), b), f) and g) to m), for the purpose of carrying out its activities, 
 
g) the State Institute for Drug Control, to the extent of the data concerning physicians, dentists and pharmacists pursuant to Paragraph 1, Points a), b), f), j) and l), for the purpose of performing state administration in the field of drug policy, 
 
h) the healthcare professional, to the extent of the information kept about him/her. 
 
Section 77 [Practical commentary] 

	(1) Data shall be submitted to the National Register of Healthcare Professionals, pursuant to Section 76, Paragraph 1, 
 
a) Points a), d), f), g) and j), by the educational establishments, accredited establishments and authorised organisations, which initially record the healthcare professional in the register, 
 
b) Points a) to e), by the Ministry of the Interior and the Police of the Czech Republic, in accordance with Section 71, 
 
c) Points g) to j), by the Ministry and the authorised organisations, 
 
d) Points j), k) and m), by the provider and the provider of social services, 
 
e) Point l), voluntarily by the healthcare professional, 
 
f) Point m.1), by the court or the competent administrative body, 
 
f) Point m.2), by the Chamber. 
 
	(2) The healthcare professional kept in the National Register of Healthcare Professionals shall be obliged to notify the Statistical Institute without undue delay, if s/he finds out that there are erroneous data on him/her in this register. 
 
Section 77a [Practical commentary] 

The National Register of Paid Health Services 

	(1) The National Registry of Paid Health Services shall contain information on the content, date and time of the provision of the health service, the natural person or legal entity who provided the health service, the insured person to whom the health service was provided and the health insurance payments made from the public health insurance. 
 
	(2) The health insurance company which paid the health service shall transmit the data referred to in Paragraph 1 to the National Register of Paid Health Services in the extent of 
 
a) the identification data of the health insurance company which paid for the health services, 
 
b) identification data 
1. of the provider, including the workplace identification, 
2. the provider of social services that provides health services pursuant to Section 11, Paragraph 2, Point b), 
 
c) the extent of the health services, the provision and reimbursement of which is a subject to the contract between the health insurance company and the provider or the social service provider referred to in Point b.2) pursuant to the Public Health Insurance Act, 
 
d) data on the staffing and the material and technical equipment of the provider, to the provision of which it committed in the contract for the provision and reimbursement of health services concluded with the health insurance company pursuant to the Public Health Insurance Act, 
 
e) the definition of the health services for which the reimbursement has been made, 
 
f) the amount of reimbursement for health services as defined in Point e) provided by the health insurance company, 
 
g) the type of reimbursement and 
 
h) the period during which the health services defined in Point e) have been provided for which the health insurance company has provided reimbursement in the amount defined pursuant to Point f). 
 
	(3) The health insurance company referred to in Paragraph 2 shall also transmit to the National Register of Paid Health Services 
 
(a) the identification number of the insured person to whom the health service specified in Point b) has been provided and paid by the health insurance company to the provider or to the provider of social services, 
 
(b) the specification of the health service provided to the insured person, including the date of the provision of the health service. 
 
Section 78 [Practical commentary] [DZ] 

	The implementation legal regulation stipulates 
 
a) a range of providers and other persons transferring personal and other data to health registers, 
 
b) the procedure, the manner, the structure and the form of transmission of required personal and other data to health registers, 
 
c) the frequency and timing of the transmission of required personal and other data to health registers, 
 
d) the details of the request for authorisation to access personal data and other data kept in health registers and the revocation of that authorisation, 
 
e) the method of defining and specifying the health services for which the reimbursement has been made and the type of reimbursement for the purpose of transmitting the data to the National Register of Paid Health Services. 
 
PART SEVEN 

HANDLING OF THE REMOVED HUMAN BODY PARTS AND OF THE BODY OF THE DECEASED PERSON; PROCEDURES IN REGARD TO DEATH AND AUTOPSIES 

Section 79 [Practical commentary] [DZ] 

Operations performed on the body of the deceased person 

	(1) Only the following operations can be performed done on the body of the deceased person: 
 
a) examination of the deceased's body, 
 
b) an autopsy, including the collection of biological material for diagnostic purposes, 
 
c) th removal of organs for transplantation purposes pursuant to the Transplantation Act 
 
d) the removal of tissues and cells for human use, specifically 
1. in the event of the treatment of the recipient of human tissues and cells pursuant to the Transplantation Act and the Human Tissue and Cells Act, 
2. for the production of pharmaceuticals pursuant to the Drug Act and the Human Tissues and Cells Act, 
 
e) the removal of parts of the human body, including tissues and cells, for the purpose of their use for medical science, research or for teaching purposes and for other purposes, where provided by other legislation, 
 
f) the removal of implantable medical devices and of active implantable medical devices, where appropriate; the removal of fixed dental prosthetic products is forbidden, 
 
g) other acts stipulated by the Act on Funeral Services. 
 
	(2) Operations on the deceased’s body, with the exception of the examination of the deceased’s body, procedures under the transplantation law, and cases of an autopsy ordered by law enforcement authorities pursuant to other legislation37) may not be carried-out earlier than 2 hours after the death occurred. 
 
	(3) The removal of biological material from the deceased's body can only be done in connection with an autopsy, even outside the medical facility; this does not apply to the procedure pursuant to other transplantation legislation and to the procedures for ensuring the quality and safety of human organs, tissues and cells. 
 
Handling of the parts of the human body removed from the patient during the provision of health care and the handling of the deceased's body and those parts removed from the body of the deceased person 

Section 80 [Practical commentary] 

	(1) The removal of a part of a human body, including organs, tissues or cells (hereinafter referred to as a "part of the body"), may be performed only for the purposes of health care or for the purposes of science, research or for teaching purposes in the health sector, or if provided by another legal regulation, by the provider in a healthcare facility. 
 
	(2) In the case of the removal of body parts and the use of the body of the deceased person and their handling it shall be proceeded, in accordance with the purpose of use, pursuant to this Act  or other legislation governing the handling of human organs, tissues or cells. 
 
Section 81 [Practical commentary] 

	(1) A part of a body removed from a patient during the provision of a health care or a body of a deceased person, including removed parts from the body of the deceased person, can be retained and used 
 
a) for the purposes of science, research or teaching in the health sector, 
 
b) for the use for the treatment of the recipient of human tissues and cells pursuant to the Act on Human Tissues and Cells, 
 
c) for transplants under the transplantation law, 
 
d) for the production of pharmaceuticals pursuant to the Drug Act and the Human Tissues and Cells Act, 
 
e) for the purposes stipulated by other legislation. 
 
	(2) For the purposes pursuant to 
 
a) Paragraph 1, Points a), b), d) or e), a part of the body removed from a patient during the provision of healthcare may be used if: 
1. the patient has been provided with information on the possibility of its retention, donation and use by the provider and the patient has given a demonstrable consent pursuant to this Act; and 
2. in the case of use for the purposes pursuant to Paragraph 1, Point b) or d) the conditions set forth in the Act on Human Tissues and Cells have been met, 
 
b) Paragraph 1, Points a), b), d) or e), the body of the deceased, including the parts removed from the body of the deceased, may be used if 
1. the deceased during his/her life provided the demonstrable consent pursuant to this law, 
2. in the case of use for the purposes pursuant to Paragraph 1, Point b) or d) information on the possibility of donating tissues or cells for these purposes, their removal, storage and use has been provided to the deceased person during his/her life and the conditions pursuant to the Act on Human Tissues and Cells have been met; and 
3. the objective of the autopsy will not be thwarted, particularly in cases of the suspicion that the cause of death is a criminal offence or suicide; if the deceased person has not made a demonstrable consent during his/her life, this consent may be provided by a person close to the deceased person. 
 
	(3) At the request of the attending physician or the patient’s legal guardian, the provider carrying out the pathological and anatomical autopsy shall provide biological material to another provider in the field of pathological anatomy for the provision of a consultation service pursuant to Section 2, Paragraph 2, Point b). 
 
	(4) This consent is not required if it is 
 
a) the use of biological material for the purposes of teaching, science or research removed from the patient in the course of the provision of healthcare or in connection with an autopsy of a deceased person, if the biological material, or in connection with its use in teaching, science or research, does not contain data of such kind that would enable to identify a patient or a deceased person; in the case of the use of biological material for teaching, science or research in the field of genetics, it is proceeded pursuant to another legislation regulating specific health services, 
 
b) training of a life-saving medical performance of coniotomy or puncture of tensed pneumothorax; this training may be performed only in the context of pathological anatomical autopsy or medical autopsy and provided that the purpose of the autopsy is not impaired, especially in cases where it is suspected that the cause of death is a crime or suicide. 
 
	(5) Understood as the demonstration of consent to the retention and use of parts of the patient’s body or the body of the deceased person, including the parts removed from the body of the deceased person, is 
 
a) the written consent of the patient or the deceased person expressed during his/her life or of the relative of the deceased person with their notarised signature, or 
 
b) a record of the consent of the patient expressed in the health facility; the record shall be signed by the patient and the health professional; if the patient cannot sign the record with respect to his/her health condition, his/her unambiguous manifestation of will shall be certified the his/her signature of a healthcare professional and a person close to the patient and, if not present, by a witness; the record shall indicate the manner in which the patient has expressed his/her will and the medical reasons preventing the patient's signature. Written consent or a record of consent and a record of the provision of information pursuant to Paragraph 2, Point (a) (1) or Paragraph 2 Point (b) (2) represents a part of a patient's medical record; the consent shall comprise the identification of the purpose of the use. 
 
	(6) A part of the patient’s body or of a deceased person’s body, including removed parts from the body of the deceased person, can be retained and used, only if it does not endanger the health of another person. For this purpose, the medical fitness of a patient or a deceased person shall be assessed. The provider providing the health services within the framework of which the removal was implemented shall be responsible for the assessment of the medical fitness, unless otherwise provided by other legislation. 
 
	(7) The use of a part of the patient’s body or a body of a deceased person, including removed parts of the body of a deceased person, cannot be a source of financial or other compensation, or of other benefits. This does not prevent the provision of reimbursement of cost-effective, cost-efficient and demonstrably incurred costs in direct connection with the handling of the part of the patient’s body or body of a deceased person, including parts of the deceased's body, that is, their provision, examination, storage and processing. 
 
Section 82 [Practical commentary] [DZ] 

	(1) When dealing with a fetus after an abortion which was not, like another human remnant, released in accordance with the procedure pursuant to the Act on Funeral Services, and also with an amniotic egg without the fetus, the placenta or the  gestational mucosa that were removed from the body of a woman, the provisions of Section 81 shall apply mutatis mutandis, provided that the fetus after the abortion can be used only for the purposes of science, research or for teaching purposes. 
 
	(2) A fetus after an abortion is a fetus that, after complete expulsion or removal from the mother’s body, does not show any of the signs of life and at the same time his/her birth weight is less than 500 g, and if it cannot be ascertained in t e event of pregnancy being shorter than 22 weeks. Considered as biological residues of miscarriage are mainly the placenta and gestational mucosa. 
 
Procedure in the event of death 

Section 83 [Practical commentary] [DZ] 

	(1) The death of a person or the finding of the deceased's body outside the health facility of the provider shall be notified to the provider or to a physician referred to in Section 84, Paragraph 2, Point a) or b). If the providers or the physicians pursuant to the first sentence are not known, the death or the finding of the deceased's body shall be reported by calling the European common emergency telephone number - 112. The finding of the part of the deceased's body outside the health facility of the provider shall be reported by calling the European common emergency telephone number - 112. 
 
	(2) The reporting obligation under Paragraph 1 shall apply to anyone who has learned about the death or has found the body of the deceased person or a part thereof and does not know whether the death or finding of the body or a part thereof has already been reported. 
 
Section 84 [Practical commentary] 

	(1) The body of the deceased person should always be examined; the purpose of this is to determine the death of the person, the probable date and time of death, the probable cause of death, and further determine whether an autopsy will be carried-out. During the examination of the body of the deceased person the latter is labelled. 
 
	(2) The following entities are obliged to provide examinations of the deceased persons' bodies: 
 
a) providers in the field of general practical medicine and practical medicine for children and adolescents in regard to their registered patients within the opening hours and in the scope of the implementation of the visitor services, with the proviso that the examination must not lead to the disruption of the provision of health services, 
 
b) in the case of the procedure other than that referred to in Point a), the physician performing an emergency health service or the provider or the physician with whom the regional authority has concluded a contract for that purpose, 
 
c) the provider of the healthcare facility where the death occurred, 
 
d) a medical rescue service provider where the death occurred during the provision of pre-hospital emergency care. 
 
Section 85 [Practical commentary] 

	Examinations of persons who have died in a training area or facility of armed forces or when conducting service shall be carried-out by the armed forces physicians. Examinations of persons who have died in custody, imprisonment or security detention shall be performed by a Prison Service physician, if available, or by another provider, pursuant to Section 84, Paragraph 2. 
 
Section 86 [Practical commentary] 

	(1) The physician who examines the deceased's body 
 
a) fills-out the relevant sections of the Deceased’s Examination Protocol and ensures the transfer of its individual parts to the entities designated by the implementing legal regulation, 
 
b) determine whether a pathological-anatomical or a medical autopsy shall be carried out in accordance with this Act, 
 
c) informs the person close to the deceased of the death or of finding the body of the deceased person, if such person is known to him/her; this information shall also comprise the notification about the autopsy and the identification data of the provider who will carry out this autopsy, 
 
d) indicates performance of a physiological-anatomical or a medical autopsy, determined in accordance with Point b), in the Deceased’s Examination Protocol, 
 
e) in cases where it ordered an autopsy it ensures the transfer of the body of the deceased to the autopsy, 
 
f) in cases where it did not order an autopsy, it shall pass the death report to the registrar provider in the field of general practical medical or practical medicine for children and adolescents, if it knows it and if the physician carrying out the examination of the body of the deceased is not simultaneously the same registrar provider, 
 
g) immediately informs the Police of the Czech Republic in the case of 
1. the suspicion that the death was due to a crime or suicide, 
2. a deceased person of an unknown identity, 
3. a death occurring under unclear circumstances; the physician examining the deceased's body performs only the necessary steps to avoid destroying or damaging the possible evidence that a crime has been committed or suicide, 
 
h) informs the Police of the Czech Republic if a person close to the deceased is not known or could not be informed about the death, in order to find a person close to the deceased and to provide information on death. 
 
	(2) By means of the Deceased’s Examination Protocol, the birth number of the deceased patient is handed over to the registry office within the time limit under another law38), to the Statistical Institute to the Czech Statistical Office and to the operator of the Funeral Services. 
 
	(3) If a physician examining the body of a deceased person suspects that the cause of death is a dangerous infectious disease or that a patient suffered that disease if the cause of his/her death is such a disease or if the diseased patient was diagnosed with that disease, s/he shall inform the competent public health authority about this fact. The public health authority shall without delay determine the conditions for the deceased's transportation, autopsy and burial; until these conditions are determined, the body may not be passed on to the funeral service. 
 
	(4) If a physician examining the body of a deceased person suspects contamination of the deceased by a radioactive substance or in the event that cause of the patient’s death was a radioactive material or if the diseased patient was contaminated with a radioactive substance, s/he shall inform the State Office for Nuclear Safety and the public health authority about this fact. The State Office for Nuclear Safety shall without delay determine the conditions for the deceased's transportation, autopsy and burial; until the conditions are determined, the body may not be passed on to the funeral service. 
 
Section 87 [Practical commentary] 

The procedure for mass casualty events 

	(1) A mass casualty event is an event in which, usually, more than 10 people die. Physicians of the medical emergency service’s provider who arrive at the place of victims' finding intervene 
 
a) at the place of discovery of bodies, or 
 
b) in the outer zone 39), where 
1. they sort victims in accordance with a degree of their injury, or 
2. they declare the death. 
 
	(2) The Police of the Czech Republic shall identify the deceased, secure the place of their finding or the place of assembly of the deceased’s bodies. The commander of the Police of the Czech Republic40) shall ensure the appointment of a physician with competence in the field of forensic medicine and a physician pursuant to Section 84, Paragraph 2, Point b), who provides for the examination of the bodies of the deceased persons. If there is reasonable suspicion that the bodies of the deceased are contaminated with chemical, radioactive or dangerous biological materials,s/he will appoint a police or a military specialist in this field. 
 
Autopsy

Section 88 [Practical commentary] [DZ] 

	(1) Autopsies are divided into 
 
(a) pathological-anatomical tests to be carried out to detect the underlying disease and other diseases, the complications of the diagnosed diseases and to verify the clinical diagnosis and treatment of persons who died in a healthcare facility by death due to a disease, 
 
b) medical tests to determine the cause of death and to clarify other health-related circumstances and the mechanism of death in persons who died outside the health facility or in sudden, unexpected or violent deaths, including suicide, 
 
c) forensic examinations which are carried out in the event of suspicion that the death was caused by a criminal offence under another legal regulation37), 
 
d) anatomical examinations that are carried out for teaching purposes or for health science and research purposes. 
 
	(2) Pathological and anatomical autopsies are performed by providers of pathological anatomy. Unless provided otherwise in this Act, pathological-anatomical autopsy is always performed 
 
a) in women who have died in connection with pregnancy, childbirth, abortion, artificial pregnancy interruption or during puerperium, 
 
b) in fetuses from artificially interrupted pregnancies carried out for reasons of genetic indication or of indication of congenital fetal developmental defects, 
 
c) in the case of stillborn infants and in children who died before the age of 18, 
 
d) in patients who have died during a surgery, during a non-surgical intervention, in the context of a complication related to a surgery or ti a non-surgical intervention or during the introduction of anesthesia, 
 
e) if organ donation has been made from the body of the deceased for transplantation, or of tissues or cells for human use or if a part of the body has been removed for research or for teaching purposes; in cases where the transplantation law provides otherwise for autopsies, it shall be proceeded in accordance with the transplantation law, 
 
f) where death has occurred in the context of a serious adverse event during a clinical trial of a medicinal product for human use or an adverse event in clinical trials of a medical device or in connection with the validation of new findings using methods not yet practiced in a clinical practice in humans, or in case of suspicion of such facts, 
 
g) where there is a suspicion that death has occurred in connection with organ donation for its transplantation or of tissue or cells for human use, 
 
h) where the cause of death, underlying disease, other diseases or their complications or clinical diagnosis are not sufficiently clarified. 
 
	(3) Medical autopsies are performed by providers of forensic medicine. Unless provided otherwise in this Act, medical autopsy is always performed 
 
(a) in the case of sudden and unexpected deaths if the cause of death has not been ascertained during the examination of the body of the deceased or the cause of death has not been sufficiently clarified, 
 
b) in the case of all violent deaths, including suicide, 
 
c) where there is a suspicion that death may be causally related to an incorrect procedure during the provision of health services by a healthcare professional involved in the provision of health services, a physician who has carried out a physical examination of the deceased's body or a person close to the deceased, 
 
d) where there is a suspicion that death may have been caused in connection with the abuse of addictive substances, 
 
e) in persons who have died in custody, imprisonment or detention. 
 
	(4) Pathological-anatomical autopsies pursuant to Paragraph 2 and medical autopsies pursuant to Paragraph 3 shall be carried out even without the consent of the deceased51). In the event of both mandatory pathological-anatomical autopsy and medical autopsy, a medical autopsy shall be carried out done. 
 
	(5) Forensic autopsies are carried out by providers of forensic medicine. The transfer of the deceased's body for a forensic autopsy and back is provided and reimbursed by the law enforcement authority who ordered it. This authority also covers all other costs associated with an autopsy. 
 
	(6) Anatomical autopsies can only be carried out by at designated workplaces of universities which have an accredited bachelor or master degree programme, by the completion of which professional competence for the pursuit of the medical profession is acquired; they can be carried out if the conditions for use of the body of the deceased pursuant to this Act have been met. The transfer of the deceased's body for an anatomical autopsy and back, this autopsy and the storage of the body are provided and the costs are covered by the university. 
 
	(7) If a suspicion arises during the implementation of an autopsy conducted under Paragraphs 2, 3 or 6 that the death was caused by a criminal offence or that the circumstances of the deaths are unclear, the autopsy shall be interrupted. The provider shall immediately notify the Police of the Czech Republic of this fact; if the law enforcement authority does not order an autopsy in accordance with another legal regulation within 2 hours of this notice, the provider may complete the interrupted autopsy. 
 
Section 88a [Practical commentary] 

	(1) A physician examining the deceased's body may decide not to perform a pathological-anatomical autopsy in cases pursuant to Section 88, Paragraph 2, Points a), b) or c) or a medical autopsy in the cases pursuant to Section 88, Paragraph 3, Point b) or d), in the case of death, the cause of which is obvious, and the deceased patient has, in his or her life, pronounced a demonstrable disagreement with the autopsy or the legal guardian of the deceased patient, or a person close to the patient asked for a non-performance of an autopsy. Section 81, Paragraph 5 shall apply mutatis mutandis to the procedure for pronouncing the patient’s demonstrable disagreement with an autopsy. 
 
	(2) An autopsy provider may decide 
 
a) not to perform a pathological-anatomical autopsy in cases pursuant to Section 88, Paragraph 2, Points  a), b) or c) or medical autopsy in the cases pursuant to Section 88, Paragraph 3, Point b) or d), in the case of death, the cause of which is obvious, and the deceased patient has expressed a demonstrable disagreement to its performance or the legal guardian of the deceased patient, or a person close to the patient have asked for the non-performance of an autopsy, 
 
b) not to perform pathological-anatomical autopsy in cases pursuant to Section 88, Paragraph 2, Points  a), (b), (c) or (h) or medical autopsy in the cases pursuant to Section 88, Paragraph 3, Point a), b) or d) if the cause of death is obvious, in accordance with an additional expert assessment, 
 
c) to carry-out a pathological-anatomical or a medical autopsy in the cases pursuant to Section 88, Paragraphs  2 or 3, even if it has not been determined by a physician examining the body of the deceased. 
 
	(3) Section 81, Paragraph 5 shall apply mutatis mutandis to the manner of pronouncing the patient’s demonstrable disagreement with the autopsy pursuant to Paragraph 1 or Paragraph 2, Point a). The patient's demonstrable disagreement with the autopsy, a written request of the legal guardian of the deceased patient or of a person close to the patient concerning the non-performance of the autopsy pursuant to Paragraph 1 or Paragraph 2, Point a) or a record of it represent a part of the medical records kept about the deceased; in the case of a stillborn child, the record comprises medical information about his/her mother.  
 
	(4) The provider of forensic medicine is obliged to inform the Police of the Czech Republic about the decision on the non-implementation of medical autopsy pursuant to Paragraph 2, Points a) or b).   
 
Section 89 [Practical commentary] 

	(1) The provider who carried out the autopsy fills-out the relevant sections of the Deceased’s Examination Protocol and ensures the transfer of its individual parts to the entities designated by the implementing legal regulation. 
 
	(2) The provider who carried out the autopsy is obliged to inform in writing about its results 
 
a) the provider of the healthcare facility where the death occurred, 
 
b) the registrar provider in the field of general practical medicine or practical medicine for children and adolescents if it is known. 
 
Section 90 [Practical commentary] 

	The body of a deceased person must be kept in a healthcare facility during a time when no operations are carried out in a refrigerating device that maintains the temperature between 0 °C and +5 °C. Should the period of storage of the body in a healthcare facility exceed 1 week or if the body of the deceased requires it, the body of the deceased must be stored in a refrigerating device that maintains the temperature below -10 °C. 
 
Section 91 [Practical commentary] 

	Parts of the body collected in connection with the provision of health services, an amniotic egg, the placenta or the  gestational mucosa, removed parts of the body of the deceased person or tissues and cells intended for the production of medicinal products, for scientific, research or educational purposes or tissues and cells intended for use under the laws governing the handling of human organs, tissues or cells that have not been used for this purpose (hereinafter referred to as "anatomical pathological waste") shall be incinerated in the provider's incineration plant or if the provider does not own an incinerator in an incineration plant of another provider or in a crematorium, on the basis of a contract concluded with another provider or the crematorium operator. It shall be proceeded similarly, if the removed part of the body of the deceased person has been used for scientific, research or educational purposes, with the proviso that the incineration is provided and paid for by the entity who used them. Fetuses after miscarriage, which were not released for burying as other human remains in accordance with the Act on Funeral Services, are cremated separately from the anatomical-pathological waste in a crematorium, based on a contract concluded between the provider and the crematorium operator. 
 
Section 92 [Practical commentary] 

	The implementing legal regulation sets forth the details of the Deceased's Examination Protocol, the way it is filled in, the place of destination of its individual parts, the procedure for their transfer to the place of destination and the details of the termination of pregnancy, the death of the child and the death of the mother. 
 
PART EIGHT 

COMPLAINTS

Section 93 [Practical commentary] [DZ] 

	(1) Complaints may be lodged against the provider's procedure in the provision of health services or against activities related to health services by 
 
a) a patient, 
 
b) the patient's legal guardian, 
 
c) a close relative if the patient cannot do so in respect of his/her health condition or if s/he died, or 
 
d) the person authorised by the patient. 
	The complaint is filed with the provider against whom it is directed; this is without prejudice to the possibility of filing a complaint under other legislation. The complaint must not be detrimental to the person who filed the complaint nor to the patient whom the complaint concerns. 
 
	(2) If a person who has filed a complaint with the provider (hereinafter referred to as the "complainant") does not agree with its handling, s/he can submit a complaint to the competent administrative authority that granted the provider the authorisation to provide health services. S/he shall also state the reasons for disagreement with the provider's handling of the complaint. 
 
	(3) The provider is obliged 
 
a) to suggest to the complainant an oral hearing in regard to the complaint, if this is appropriate in view of the nature of the complaint, 
 
b) to deal with the complaint within 30 days of the date of its receipt; that period may be reasonably extended by a further 30 days; in the case of a complaint for which it is not competent, it shall be obliged to transfer it to the competent body within 5 days from the date of its receipt; it is obliged to inform the complainant about the extension of the deadline and the forwarding of the complaint, 
 
c) to keep records of complaints and about the manner of their processing, 
 
d) to allow the complainant to inspect a specific complaint file and to make copies of it , 
 
e) if the complaint is being investigated by the competent administrative body, provide it with timely and necessary cooperation upon its request; this also applies to the provider of the related health services. 
 
	(4) The provider of inpatient or one-day care is additionally obliged 
 
a) to develop a complaint handling procedure, 
 
b) to publish the procedure pursuant to Point a) and information on the possibility of submitting a complaint to the entities referred to in Paragraph 2  in the healthcare facility at a publicly accessible place and on its website. 
 
	(5) Authorised to investigate the complaints of persons against the procedure during the provision of health services provided by the Prison Service is the Director of the Prison Service organisational unit,  unless the General Director of the Prison Service does authorise another person to investigate the complaint. 
 
Section 94 [Practical commentary] 

	(1) The competent administrative body is obliged 
 
a) to handle a complaint 
1. within 30 days of the date of its receipt, 
2. within 90 days from the date of its receipt, in the case of a complaint for which an independent expert must be appointed, 
2. within 120 days from the date of its receipt, in the case of a complaint for which an independent expert committee must be appointed; 
the deadline for processing a complaint under Point 2 or 3 shall commence on the day on which the competent administrative body has established an independent expert or an independent expert committee; the deadline referred to in Point 1 may be reasonably extended by the competent administrative body for a further 30 days and the deadline referred to in Point 2 or 3 for a further 60 days; the competent administrative body shall establish an independent expert or an independent expert committee without undue delay; in the case of a complaint for which it is not competent, it shall be obliged to transfer it demonstrably to the competent body within 5 working days from the date of its receipt; it is obliged to inform the complainant about the extension of the deadline and the forwarding of the complaint, 
 
b) to develop a complaint handling procedure and to designate the offices of the regional authority for the receipt of complaints, 
 
c) to publish the procedure referred to in Point b) and the address of the designated workplace, its office hours and the contact information of that workplace on the official notice board, 
 
d) to keep records of complaints and about the manner of their processing, 
 
e) to allow the complainant to inspect a specific complaint file and to make copies of it, 
 
	(2) The competent administrative body may terminate the investigation of a complaint in the case of a complaint for which it is necessary to inspect the medical records about the patient in question or to obtain a copy or an excerpt from these records if the patient or the patient's legal guardian did not express his/her consent to the inspection or to the making of a copy or an excerpt. If the patient is unable to express his or her will in view of his/her health condition, this consent may be provided by the complainant referred to in Section 93, Paragraph 1, Point c) or d) within the scope of his/her authorisation. The competent administrative body is obliged to inform the patient affected, the complainant, if s/he is not the patient, and the provider to whom the complaint relates about the termination of the investigation of the complaint under the first sentence and about the reason that led to it. 
 
	(3) Complaints filed by a person not mentioned in Section 93, Paragraph 1 shall be considered by the competent administrative body as an impetus to carry out an inspection. Within 30 days of the date of its delivery, it shall notify the person mentioned in the first sentence  in writing about how the complaint was handled. 
 
	(4) The competent administrative body may, on the basis of a complaint or by virtue of an official power or another complaint, in particular for the sake of the assessment of cases where there were doubts as to the proper conduct of the provision of health services, or to exclude a causal link between the wrong procedure and the injury to the patient's health in the course of the provision of health services, appoint 
 
a) an independent expert; the expert will be always appointed if a complaint is against the correct procedure in the course of the provision of health services, or in the event of the injury to the patient's health in the course of the provision of health services and the complaint or is not obviously unfounded, 
 
b) an independent expert committee; the committee is always appointed if 
1. the independent expert, on the basis of an assessment of the medical records, proposes the appointment thereof, or 
2. at his/her discretion it is a case in which the independent expert's assessment is technically insufficient or it is necessary to assess q potential bodily harm in the course of the provision of health services that resulted to a death of the patient and the complaint is not obviously unreasonable. 
 
Section 95 [Practical commentary] 

	(1) The members of an independent expert committee who are appointed and dismissed by the competent administrative body always include 
 
a) a representative of the competent administrative body; the representative of the competent administrative body, who is always a healthcare professional, is also the chairman of the committee and manages its activities, 
 
b) at least 2 healthcare professionals with the competence to pursue the medical profession in the relevant healthcare sector, 
 
c) a physician with specialised competence in the field of pathological anatomy or forensic medicine, in the case of the patient's death, 
 
d) a representative of the relevant Chamber or of a relevant professional organisation. 
 
	(2) The meeting of the committee 
 
a) is always attended by a person who has received a university degree in a Master's degree programme in law, 
 
b) may be attended by the provider against whom the complaint is lodged and also by the complainant to provide an explanation of the facts referred to in the complaint for the necessary period of time; the complainant is always invited to the hearing at his/her request. 
 
	(3) The members of the independent expert committee can not be persons about whom there are reasonable doubts about their irreconcilability, in view of their relationship with the provider, the complainant or the patient affected, or to the subject of the complaint. 
 
	(4) The independent expert committee shall discuss the case with the participation of at least one half of all members, one of whom shall always be a healthcare professional pursuant to Paragraph 1, Point b). 
 
	(5) The independent expert committee shall assess the case on the basis of the patient's medical records and other facts ascertained for the purposes of the case assessment and shall draw up minutes which shall be forwarded without delay to the competent administrative body through the Chair of the committee. The minutes shall contain: 
 
a) a summary of the essential data from the medical records, 
 
b) the conclusion of the case 
1. with a clear statement as to whether or not a proper professional practice has been followed in the course of the provision of health services; in the case of non-compliance with the appropriate professional procedure, its description, 
2. in the absence of due professional conduct, a statement as to whether or not there is a causal link between such a procedure and injury to health or death; this does not apply if, on the basis of the facts ascertained, such a statement cannot be made, 
 
c) the proposal for remedial measures. 
 
Section 96 [Practical commentary] 

	(1) Where the competent administrative body, during the investigation of a complaint, discovers the violation of rights or obligations in the course of the provision of health services or activities related thereto provided for by this Act or by other legal regulations or other misconceptions concerning the rights and interests of patients, it 
 
a) imposes corrective measures on the provider, indicating the deadline for their fulfilment, or 
 
b) files an initiative 
1. with a body competent under other legislation41); 
2. with the competent Chamber if it finds such a misconduct by a healthcare professional who is a member of the Chamber, for the investigation of which the Chamber is responsible under the law that regulates the activities of Chambers; 
	the provider proceeds accordingly. 
 
	(2) The competent administrative body shall send information about the remedial measures imposed or about filing an initiative to the health insurance company where the patient was insured at the time of violation of rights or obligations in the course of the provision of health services. 
 
Section 97 [Practical commentary] 

	Meetings of an independent expert committee are not public. If it establishes an independent expert or an independent expert committee the competent administrative body shall inform the patient concerned and the complainant, if s/he is not the patient, about the name(s) and the surname of the independent expert or members of the independent expert committee and of the persons invited pursuant to Section 95, Paragraph 2. 
 
PART NINE 

EVALUATION OF THE QUALITY AND SAFETY OF HEALTH SERVICES 

Section 98 [Practical commentary] [DZ] 

	(1) Evaluation of the quality and safety of health services provided (hereinafter referred to as the "Quality and Safety Assessment") is a voluntary process, the purpose of which is to assess the organisational level of the provision of health services in terms of their quality and safety based on the evaluation standards. 
 
	(2) The evaluation standards represent a set of requirements for selected processes and indicators assessed in a healthcare facility in terms of ensuring the quality and safety of health services. 
 
	(3) The Quality and Safety Assessment may be carried-out by a natural person or a legal entity that has been authorized to carry out this activity pursuant to this Act. 
 
	(4) The Ministry shall decide on the granting of the authorisation to perform the Quality and Safety Assessment. This authorisation cannot be transferred nor does it pass on to another natural person or legal entity. 
 
	(5) A natural person shall be granted the authorisation to carry out the Quality and Safety Assessment upon his/her written request, if s/he 
 
a) is not the provider or a partner of a legal entity who is the provider, 
 
b) is not in agreement with the provider or with a health insurance company42), 
 
c) has developed the quality assessment and the safety assessment standards for individual forms of healthcare, or types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i), for the assessment of which the authorisation is to be granted and also the rules for the Quality and Safety Assessment process, 
 
d) meets the requirements for staffing of the Quality and Safety Assessment process in connection with the forms of healthcare, or the types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i) for the assessment of which the authorisation is to be granted. 
 
	(6) A legal entity shall be granted the authorisation to carry out the Quality and Safety Assessment upon its written request, if it 
 
a) is not the provider or a partner of a legal entity who is the provider or a health insurance company, 
 
b) its statutory body, or its member or a member of its supervisory body, is not at the same time the statutory body or a member thereof, or a member of the provider's or the health insurance's supervisory body, nor is it the provider, 
 
c) is not in agreement with the provider or with a health insurance company42), nor is its statutory body or its member or a member of its supervisory body, 
 
d) has developed the quality assessment and the safety assessment standards for individual forms of healthcare, or types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i), for the assessment of which the authorisation is to be granted and also the rules for the Quality and Safety Assessment process, 
 
e) meets the requirements for staffing of the Quality and Safety Assessment process in connection with the forms of healthcare, or the types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i) for the assessment of which the authorisation is to be granted. 
 
	(7) The implementation legal regulation stipulates 
 
a) minimum quality and safety assessment standards for individual forms of healthcare or, where appropriate, types of healthcare pursuant to Section 5, Paragraph 2, Points f) to i), 
 
b)  the quality and safety indicators of health services, the way they are created and monitored, 
 
c) the extent of the processes assessed in the healthcare facility and the requirements for such processes, 
 
(d) requirements for the method and procedures for assessing the quality and safety, 
 
(e) staffing requirements for the performance of the quality and safety assessment related to the professional competence of the persons through whom the quality and safety assessment will be carried out and the number of such persons. 
 
Section 99 [Practical commentary] 

	(1) In addition to the requirements set forth by the Administrative Code, the request for issuing the authorisation to carry-out the Quality and Safety Assessment  shall include 
 
a) where the applicant is a natural person 
1. name(s), surname, birth name, nationality, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the date of birth of the applicant, 
2. identification number17), if assigned, 
3. forms or types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i), for the assessment of which the authorisation is to be granted, 
4. the date on which the applicant intends to commence the Quality and Safety Assessment, 
 
b) where the applicant is a legal entity 
1. the business name or the name and address of the applicant's registered office, 
b) name(s), surname, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the date of birth of persons who represent the provider’s statutory body or its members or who act on behalf of a legal entity registered in a commercial or a similar register prior to its establishment, 
3. information referred to in Points a) 2 to 4). 
 
	(2) With the application for the authorisation to carry-out the Quality and Safety Assessment the applicant shall submit, 
 
a) where the applicant is a natural person 
1. a declaration that s/he meets the requirements of Section 98, Paragraph 5, Points a) and b), 
2. a list of persons through whom the Quality and Safety Assessment will be carried-out, indicating the name(s) and surnames; for health professionals it shall also indicate their professional or specialised competence to pursue the medical profession and for other persons their education, indicating the study programme and the field in which it was acquired; the list shall further specify who will be responsible to the applicant for the Quality and Safety Assessment of the individual forms or types of healthcare, 
3. evaluation quality and safety standards and rules for the quality and safety assessment process for individual forms of healthcare or, where appropriate, types of healthcare as referred to in Section 5, Paragraph 2, Points f) to i) for which the assessment of which the authorisation is to be granted, 
 
a) where the applicant is a legal entity 
1. a proof that a legal entity has been established, unless it is entered in a commercial or similar register or if the registration has not yet been completed; if the applicant is a legal entity established outside the Czech Republic, an excerpt from a commercial or similar register maintained in the state of residence should be submitted that is not older than 3 months, 
2. a declaration that it meets the requirements of Section 98, Paragraph 6, Points a) and b), 
2. a declaration of the statutory body or its members and the members of the inspection body that they meet the requirements of Section 98, Paragraph 6, Points b) and c), 
4. information referred to in Points a) 2) and 3). 
 
Section 100 [Practical commentary] 

	(1) In addition to the requirements set forth by the Administrative Code, the decision concerning granting the authorisation to carry-out the Quality and Safety Assessment  shall include 
 
a) where the applicant is a natural person, name(s), surname, nationality, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic, the date of birth of the applicant and the identification number, if assigned, 
 
b) where the applicant is a legal entity, the business name or the name, the address of the registered office and the identification number, if assigned, 
 
c) forms or types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i), for the assessment of which the authorisation is to be granted, 
 
d) the date on which the it is permissible to commence the Quality and Safety Assessment. 
 
	(2) The Ministry shall send a written copy of the decision granting the authorisation to carry-out the Quality and Safety Assessment within 30 days of the effective date of the decision to the local tax authority administering the income tax and to the local district social security administration. 
 
	(3) The Ministry shall publish a list of the persons authorised to carry-out the Quality and Safety Assessment, including the information referred to in Paragraph 1, on its website. 
 
Section 101 [Practical commentary] 

	(1) A person/ an entity authorised to carry-out the Quality and Safety Assessment shall be required to publish the assessment standards and rules of the quality and safety assessment process on his/her/its website. 
 
	(1) A person/ an entity authorised to carry-out the Quality and Safety Assessment shall be required to notify the Ministry in writing of any changes to the data contained in the decision to grant the authorisation to carry/out the Quality and Safety Assessment, in the application for the authorisation and in the documents submitted together with that application, and to substantiate these changes by the relevant documents. In the case of changes to the information in the list of persons referred to in Section 99, Paragraph 2, Point a)(2), only changes related to persons who are responsible for assessing the quality and safety of individual forms of healthcare or, where appropriate, types of healthcare. shall be communicated. 
 
	(3) Where a change concerns the information that is not listed in the decision on the granting of the authorisation to carry-out the Quality and Safety Assessment and if the conditions for the carrying-out of the Quality and Safety Assessment are still met, the Ministry shall make a record of this change in the file; in other cases, the Ministry,  depending on the circumstances, shall decide to change the authorisation or to withdraw it. 
 
Section 102 [Practical commentary] 

	(1) The authorisation to carry-out the Quality and Safety Assessment shall cease 
 
a) upon the death of the holder of the authorisation, 
 
a) upon the demise of the holder of the authorisation, or 
 
f) by the decision of the Ministry to withdraw the authorisation. 
 
	(2) The Ministry shall withdraw the authorisation to perform the Quality and Safety Assessment, if its holder 
 
a) ceased to fulfil any of the conditions pursuant to Section 98, Paragraph 5 or 6, or 
 
f) he/she/it asked for its withdrawal. 
 
	(3) The Ministry may withdraw the authorisation to perform the Quality and Safety Assessment, if the holder of the authorisation has seriously or repeatedly breached any of the obligations referred to in Section 101, Paragraph 1 or 2 or in Section 104, Paragraph 2. The Ministry may also withdraw the authorisation to perform the Quality and Safety Assessment, if the holder of the authorisation has performed the Quality and Safety Assessment through a person/ an entity that is excluded from the assessment pursuant toSection 104, Paragraph 3. 
 
Section 103 [Practical commentary] 

	The Ministry shall send a written copy of the decision concerning a change or a withdrawal of the authorisation to carry-out the Quality and Safety Assessment within 30 days from the effective date of the decision to the entities referred to in Section 100, Paragraph 2. 
 
Section 104 [Practical commentary] 

	(1) The Quality and Safety Assessment shall be carried out on the basis of a contract concluded between a person/an entity qualified to carry-out a Quality and Safety Assessment and the provider; the contract also includes an agreed fee for the evaluation carried-out. The Quality and Safety Assessment must be implemented within 12 months from the date of conclusion of the contract. 
 
	(2) The person/entity authorised to carry-out the Quality and Safety Assessment shall be obliged 
 
a) to proceed impartially, 
 
b) to comply with the quality and safety assessment standards and with the rules for the quality and safety assessment process. 
 
	(3) A person who is in a labour-law or a similar relationship with the provider at which the evaluation is to be carried-out or who performs the function of a professional representative for this provider or, if the provider is a legal entity, is the partner of this legal entity, its statutory body or a member of its statutory body or a member of its supervisory body, shall be excluded from the Quality and Safety Assessment. 
 
Section 105 [Practical commentary] 

	(1) If the level of healthcare provided by the assessed provider meets the evaluation standards, the person qualified to carry-out the Quality and Safety Assessment shall issue a certificate of quality and safety (hereinafter referred to as the "Certificate") with a validity of 3 years. 
 
	(2) The Certificate contains 
 
a) details of the person who issued the certificate, which are 
1. in the case of a natural person, name(s), surname, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the identification number, 
2. in the case of a legal entity, the business name or the name, the address of the registered office and the identification number, 
 
b) details of the provider, which are 
1. in the case of a natural person, name(s), surname, address of permanent residence in the Czech Republic or, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic and, if applicable, the address of the place of residence declared in the territory of the Czech Republic and the identification number, 
2. in the case of a legal entity, the business name or the name, the address of the registered office, in the case of a legal entity established outside the territory of the Czech Republic, also the place of establishment or an organisational unit of a legal entity in the territory of the Czech Republic, and the identification number, 
 
c) forms or types of healthcare, pursuant to Section 5, Paragraph 2, Points f) to i), for which the Certificate was issued, and the address of their provision, 
 
d) the date of issuance of the certificate. 
 
	(3) If the conditions for issuance of the certificate are not met, the person/entity who carried-out the Quality and Safety Assessment shall notify this fact in writing to the provider; he/she/it shall state in the notification which conditions the provider failed to meet. 
 
Section 106 [Practical commentary] 

	Persons/entities authorised to carry-out the Quality and Safety Assessment shall keep the records of the providers for whom they issued the Certificate. 
 
PART TEN 

INSPECTION ACTIVITIES 

Section 107 [Practical commentary] [DZ] 

	(1) The inspection of providers in connection with the provision of health services or the inspection of providers or other legal entities or entrepreneurs in connection with the carrying out of activities for which a consent, an authorisation to operate or other similar authorisation pursuant to this Act or other laws regulating health services is necessary, the inspection of the providers of social services listed in the National Register of Providers and persons providing health services pursuant to Section 20 (hereinafter referred to as "inspected persons") is carried out by 
 
a) the Ministry, 
 
b) the competent administrative body 
 
c) a regional authority that has registered a social service provider or a healthcare provider to the National Register of Providers pursuant to Section 20, 
 
d) the State Institute for Drug Control 
 
e) the State Office for Nuclear Safety if it is a provider of health services that include medical exposure; this does not affect the inspection activities of the State Office for Nuclear Safety under other legal regulations, 
 
f) the General Directorate of the Prison Service, in the case of health services provided in its healthcare facility, 
 
g) Chambers, to the extent stipulated by other legal regulation43), 
(hereinafter referred to only as the “Inspection Bodies”) 
 
	(2) The Ministry of Defence shall carry out inspections on the observance of conditions for the provision of health services in the healthcare facilities of the Czech Armed Forces located abroad. 
 
Section 108 [Practical commentary] 

	(1) During the implementation of their inspection activities, the inspection bodies pursuant to Section 107, Points a), b) or c) control the compliance with the obligations and conditions set forth in this Act or by other legislation that governs health services or healthcare related activities. 
 
	(2) As part of checking the staffing in regard to the provision of health services, the employees of the Regions included in the regional offices are entitled to inspect, in justified cases, the employment contracts of the provider's employees. 
 
	(3) The State Institute for Drug Control inspects the technical and material equipment of the healthcare facility in the case of the provision of pharmacy care, treatment of medicinal products and medical devices in the case of the provision of health care and performs the quality and safety control in the case of the provision of health services in transfusion facilities and in tissue establishments under other legislation. 
 
	(4) The State Office for Nuclear Safety shall check the provider's compliance with the rules of medical exposure. 
 
Section 109 [Practical commentary] 

	The inspection bodies shall be entitled to 
 
a) impose corrective measures to remedy the identified shortcomings, 
 
b) specify the time-limits within which the corrective measure must be taken, 
 
c) monitor the implementation of corrective measures, 
 
d) require written reports concerning the implementation of remedial measures from the inspected persons. 
 
PART ELEVEN 

REGIONAL AUTHORITIES

Section 110 [Practical commentary] [DZ] 

	(1) The regional authority is responsible for organisation and provision 
 
a) of the medical emergency services, pharmacy emergency services and emergency services in the field of dentistry; and 
 
b) examinations of the bodies of deceased persons outside the health facility in their territory; the Region shall publish on its website and forward to the entity that operates the call centre for the unified European emergency number 112 a list of physicians with whom the Region has entered into a contract pursuant to Section 84, Paragraph 2, Point b), and of the providers who provide inspections of bodies of deceased within the framework of medical emergency services, including the schedule and the definition of the territorial competence of the provision of these health services. 
 
	(2) Medical Emergency Service refers to outpatient care that is provided to patients in cases of sudden changes in the health condition or in the event of worsening of the course of illness. Emergency service is not provided in the case of outpatient care within the provider's regular office hours. The first and second sentences are also applicable in the case of dental emergency services and pharmacy emergency services. 
 
PART TWELVE 

TEACHING HOSPITALS AND CENTRES FOR HIGHLY-SPECIALISED CARE 

Section 111 [Practical commentary] [DZ] 

Teaching hospitals 

	(1) The teaching hospital is a state contributory organisation. The founding function of the teaching hospital is carried out by the Ministry. 
 
	(2) The Teaching Hospital provides health services and carries out related research and development activities. Clinical and practical training in accordance with Paragraph 4 is also carried out at the specialised departments of the Teaching Hospital. 
 
	(3) Clinics and institutes represent the joint workplaces of the teaching hospital and the university's faculty of medicine; joint workplaces are established, modified and canceled by the director of the Teaching Hospital in agreement with the Dean of the Faculty of Medicine. At the lead of the clinic and of the institute is the superior appointed or dismissed by the director of the teaching hospital in agreement with the Dean of the Faculty of Medicine. If the appointment or dismissal of a superior is not made pursuant to the second sentence, the Minister of Health shall appoint or dismiss the superior in agreement with the Rector of the relevant higher education institution. 
 
	(4) Clinic and practical training is carried out at the joint workplaces of the teaching hospital and the Faculty of Medicine, at the request of the higher education institution, in the following accredited study programmes: general medicine, dentistry and pharmacy and in accredited study programmes and educational paramedical programmes and related research and development activities pursuant to other legal regulations44). 
 
	(5) In order to provide clinical and practical education and research and development activities, the teaching hospitals conclude a contract with a university that regulates in particular the scope, the structure and staffing of clinical and practical education in the teaching hospital, conditions of use of the teaching hospital's facilities for training, conditions of use of the university's assets in the provision of health services, mutual cooperation on research and development activities and the reimbursement of related costs. This shall not prejudice any agreements concluded pursuant to current legislation. 
 
	(6)  in the case of education provided by other schools or educational establishments, Paragraphs 4 and 5 shall also apply mutatis mutandis to the provision of clinical and practical education and research and development activities at the specialised departments of the teaching hospitals. 
 
Section 112 [Practical commentary] 

The centre of highly specialised care 

	(1) At its request filed upon the Ministry's invitation, the Ministry may grant the provider that provides healthcare in the given field the status of a centre of highly specialised healthcare (hereinafter referred to as the "Centre"), provided that this provider meets the technical and material requirements of the healthcare facility and staffing requirements for highly specialised healthcare facility, and is able to provide healthcare in the defined area. The statute of the Centre may also be granted within one or more disciplines or parts thereof, or for highly demanding diagnostics, treatment or monitoring of a specific disease. 
 
	(2) The Ministry shall publish on its website and in the Bulletin of the Ministry of Health the requirements placed on the providers who apply for the Centre status (hereinafter referred to as the "Candidate for the Centre Status"). The Ministry's invitation for the application for the Centre Status includes 
 
a) the place where the applications are to be submitted, 
 
b) the deadline for the submission of applications, 
 
c) the definition of the healthcare sector or a part thereof, or any disease for which diagnostics, treatment or monitoring the Centre Status is granted, 
 
d) requirements for the technical and physical equipment of a healthcare facility for the provision of highly specialised healthcare and a deadline for their fulfillment, 
 
e) staffing requirements for highly specialised healthcare, including qualification requirements, and deadlines for meeting them, 
 
f) the area for which highly specialised healthcare is to be provided, 
 
g) the period for which the Centre Status is granted, and 
 
h) other requirements necessary to assess the feasibility of the provision of highly specialised healthcare, such as the number of patients treated and the health performance during a specified period of time in the health centre of a Candidate for a Centre Status. 
 
	(3) The application for the Centre Status shall comprise 
 
a) identification data of the Candidate for the Centre Status, 
 
b) a copy of the authorisation to provide health services, 
 
c) data on the scope and volume of highly specialised healthcare that the Candidate for the Centre Status is able to ensure, 
 
d) data on the technical and physical equipment of the healthcare facility of the Candidate for the Centre Status where the highly specialized healthcare is to be provided, and its personnel security, 
 
e) a declaration by the Candidate for the Centre Status on being able to meet the technical and material requirements of a healthcare facility for the provision of highly specialized healthcare and the personnel requirements for the provision of such healthcare to the extent and within the time limit specified in the invitation, 
 
f) other particulars and documents referred to in the invitation pursuant to paragraph 2. 
 
	(4) The Ministry, after examining the applications of the individual Candidates for the Center status, shall exclude candidates who have not complied with the conditions specified in the invitation and shall determine the ranking of the other candidates. In determining the ranking of Candidates for the Centre Status, the Ministry shall take into account, in particular, the qualifications of their healthcare professionals for the provision of highly specialized healthcare, the time and extent of provision of such healthcare and its availability and, if it is the subject of the invitation, the number of treated patients, performed health procedures over a specified time period and other requirements set out in the invitation. When deciding on granting Centre Status, the Ministry will take into account the candidates' ranking; there is no legal claim on granting Centre Status. 
 
	(5) The Ministry shall publish a list of centres on its website and in the Bulletin of the Ministry of Health; the list shall include the identification data of the provider who has been granted the Centre Status and the data referred to in paragraph 2 c), f) and g). 
 
	(6) The provider is obliged to notify the Ministry in writing of any changes in the data and conditions under which the Centre Status was granted, no later than 15 days from the date of their origin. 
 
Section 113 [Practical commentary] 

	(1) Centre Status is terminated 
 
(a) on the date of the termination of authorization to provide the health services for which the Centre Status was granted; or 
 
(b) upon withdrawal of the Centre Status. 
 
	(2) The Ministry shall withdraw the Centre status if the provider so requests. 
 
	(3) The Ministry may withdraw the Centre Status if 
 
(a) the provider no longer fulfills any of the conditions for granting the Centre Status; or 
 
b) The centre's further activity to provide highly specialized health care is no longer required due to a reduction in the need for such healthcare. 
 
PART THIRTEEN 

INFRINGEMENTS

Section 114 [Practical commentary] [DZ] 

	(1) A natural person commits an infringement by: 
 
a) contrary to Section 11 (2), providing health services without authorization to provide health services, 
 
(b) as a person referred to in Section 20 (1), failing to comply with the reporting obligation under Section 20 (2) 
 
(c) as a person referred to in Section 57 (1), violating the obligation of confidentiality pursuant to Section 57 (2) a), 
 
(d) as a person referred to in Section 57 (1), contrary to Section 57 (2) b) not allowing entry into the premises to a person authorized by the competent administrative authority, 
 
e) as a person referred to in Section 27 (1), which intends to continue to provide health services under the authorization to provide the health services of the deceased provider, contrary to Section 58, failing to fulfill any of the obligations concerning the medical records of the patients of the deceased provider pursuant to Section 57 (3) a), c) or d),or (4), the performance of which would, in case of lack of interest in the continuation of the provision of health services, fall within the competence of the competent administrative body to which the death of the provider was notified, or the address of the place where the applications for ensuring the procedure may be submitted under Section 5 Article 3 c) or d), 
 
(f) as a person whose authorization to provide health services has expired as a result of a decision by the competent administrative authority, contrary to Section 60 (1) or (2), not providing the medical records or the inventory of the medical records or not passing the medical records or their inventory to the competent authority administrative authority, 
 
g) as a medical worker, contrary to Section 70 (4) e) point 5, not passing data to the National Health Information System, 
 
(h) retaining or using a body part taken from the patient, the body of the deceased or the part taken from the body of the deceased contrary to Section 81 (1) or (2); 
 
i) failing to comply with the reporting obligation under Section 83, 
 
(j) performing an assessment of the quality and safety of provided health services without authorization under Section 98 (3) under a contract with a provider under Section 104 (1), or 
 
(k) forging or performing an intentional unauthorized modification of a medical report or medical opinion or misusing medical records. 
 
	(2) A fine may be imposed for an infringement of up to 
 
b) CZK 1,000,000 in the case of an infringement under Paragraph 1, Point a) or c), 
 
b) CZK 500,000 in the case of an infringement under Paragraph 1, Point h) or j), 
 
c) CZK 200,000 in the case of an infringement under Paragraph 1, Point d). 
 
c) CZK 100,000 in the case of an infringement under Paragraph 1, Points b), e), f), g) or i), or 
 
c) CZK 15,000 in the case of an infringement under Paragraph 1, Point k). 
 
Section 115 [Practical commentary] 

	(1) A legal person or a natural person doing business commits an infringement by: 
 
a) contrary to Section 11 (2), providing health services without authorization to provide health services, 
 
b) as a person who has been granted authorization to provide health services prior to being entered in a business or other law designated register, or as a person established outside the territory of the Czech Republic who has been granted authorization to provide health services prior to being entered in the relevant Commercial Register, not sending to the competent administrative authority a document demonstrating the filing of an application for registration or a document demonstrating registration in accordance with Section 19 (5), 
 
c) as a person referred to in Section 20 (1), failing to comply with the reporting obligation under Section 20 (2) 
 
d) as a person referred to in Section 27 (1), which intends to continue to provide health services under the authorization to provide the health services of the deceased provider, contrary to Section 58, failing to fulfill any of the obligations concerning the medical records of the patients of the deceased provider pursuant to Section 57 (3) a), c) or d),or (4), the performance of which would, in case of lack of interest in the continuation of the provision of health services, fall within the competence of the competent administrative body to which the death of the provider was notified, or the address of the place where the applications for ensuring the procedure may be submitted under Section 5 Article 3 c) or d), 
 
e) as a person whose authorization to provide health services has expired as a result of the decision of the competent administrative authority, contrary to Section 60 (1) or (2), not providing the medical records or the inventory of the medical records or does not pass the medical records or their inventory to the competent authority administrative authority, 
 
f) as a person referred to in Section 70 (4) b), c) or d), if it is not a regional authority, or in Section 70 (4) e) Points 1, 2, 3 or 4 not passing data to the National Health Information System, 
 
g) retaining or using a body part taken from the patient, the body of the deceased or the part taken from the body of the deceased contrary to Section 81 (1) or (2); 
 
h) performing an assessment of the quality and safety of provided health services without authorization under Section 98 (3) under a contract with a provider under Section 104 (1), or 
 
i) forging or performing an intentional unauthorized modification of a medical report or medical opinion or misusing medical records. 
 
	(2) A university commits an infringement by performing an anatomical autopsy contrary to Section 88 (6). 
 
	(3) A fine may be imposed for an infringement of up to 
 
c) CZK 1,000,000 in the case of an infringement under Paragraph 1, Point a). 
 
b) CZK 500,000 in the case of an infringement under Paragraph 1, Point g) or h) or Paragraph 2, or 
 
c) CZK 100,000 in the case of an infringement under Paragraph 1, Points b), c), d), e), f) or i). 
 
Section 116 [Practical commentary] 

	(1) A person authorized to carry out a quality and safety assessment shall commit an infringement by: 
 
a) failing to disclose the assessment standards or rules for the quality and safety assessment process as referred to in Section 101 (1), 
 
b) failing to comply with the reporting obligation under Section 101 (2), 
 
c) in the case of quality and safety assessment, proceeding contrary to Section 104 (2) b)), or 
 
d) performing the assessment of quality and safety by a person excluded from this assessment under Section 104 (3). 
 
	(2) A fine may be imposed for an infringement of up to 
 
a) CZK 500,000 in the case of an infringement under Paragraph 1, Point c) or d), 
 
b) CZK 200,000 in the case of an infringement under Paragraph 1, Point a), or 
 
c) CZK 100,000 in the case of an infringement under Paragraph 1, Point b). 
 
Section 117 [Practical commentary] 

	(1) The Provider commits an infringement by: 
 
a) contrary to Section 11 (1), providing health services without authorization to provide health services, 
 
(b) contrary to Section 11 (3), providing health services through a person who is not competent to perform a medical profession or to perform healthcare related activities, 
 
c) contrary to Section 11 (6), providing health services in a medical facility which is not technically or materially equipped for the provision of health services, 
 
d) not appointing a professional representative under  Section 12 (2)  or  Section 14 (5)  
 
e) failing to comply with the reporting obligation pursuant to  Section 21 (1) and (2)  or  Section 27 (1) c) , 
 
f) failing to comply with the reporting obligation or disclose information pursuant to  Section 26 (2)  or  (4)  
 
g) contrary to Section 26 (3), not ensuring the transfer of a copy of the medical documentation or extract from the medical records to another provider, 
 
h) contrary to  Section 28 (3) e),  Points 1, 2 or 3, not allowing the presence of other persons in the provision of health services, 
 
i) allowing the presence of other persons in the provision of health services, even if the patient has refused their presence according to  Section 28 (3) h) , 
 
j) contrary to  Section 28 (3) i) , not allowing a patient to receive visits at the health facility, 
 
k) contrary to  Section 28 (3) j) , not allowing a patient to receive spiritual care or spiritual support in the health facility, 
 
l) not allowing a patient with a sensory disorder or with severe communication problems to communicate in a manner that is understandable to him/herself by the means of his/her own choices, according to Section 30 (1), 
 
m) contrary to Section 30 (3), not permitting the patient have a guide or assistance dog with him/her in the health facility, 
 
n) in violation of  Section 28 (1) , providing the patient with a health service without his/her consent, 
 
o) not informing the patient about the price of the provided health services or not issuing a receipt for paid medical services according to  Section 45 (2) a) , 
 
p) contrary to  Section 45 (2) b) , not listing the prices of provided healthcare in a manner accessible to patients, 
 
q) not indicating the operating or ordination time so that this information is accessible to patients according to  Section 45 (2) c) , 
 
r) failing to provide medical devices marked according to  Section 45 (2) d) , 
 
s) not disclosing to patients, in the absence or temporary interruption of the provision of health services, information on the provision of emergency care by another provider pursuant to Section 45 (2) e) , 
 
t) contrary to  Section 45 (2) f) , not transmitting a report on the provided health services, 
 
u) not passing on the necessary information about a patient's medical condition according to  Section 45 (2) g) , 
 
v) not notifying the court, contrary to  Section 40 , of hospitalizing a patient or of further limiting free movement or contact with the outside world of the patient; or 
 
w) not providing a medical opinion or confirmation to a job seeker pursuant to  Section 45 (3) a) . 
 
	(2) The Provider further commits an infringement by 
 
a) not preparing a traumatological plan according to  Section 47 (1) d) , 
 
b) contrary to  Section 45 (2) h) , not preparing a list of health services that require written consent, 
 
c) contrary to  Section 45 (2) j)  point 1, not accepting a patient for the prescribed isolation, quarantine, treatment or medical supervision, 
 
d) not passing data to the National Health Information System according to  Section 45, (2) m) , 
 
e) contrary to Section 45 (3) (b) or (c), not allowing access to the premises of a healthcare facility by authorized persons, 
 
f) failing to provide supporting documents or data to the regional authority or Ministry pursuant to  Section 45 (3) d) , 
 
g) not informing the patient according to  Section 45 (2) i) , 
 
h) not providing medical services indicated by a physician of the Prison Service to a person accused, convicted or placed under security detention pursuant to Section 45 (2) k), 
 
i) violating the obligation to participate in the provision of medical emergency services or emergency services provided by dentists or pharmacists pursuant to Section 45 (2) l) , 
 
j) not informing the person mentioned in  Section 45 (4) a)  or the Police of the Czech Republic that the patient has willfully left a health facility, 
 
k) not ensuring the disclosure of information about the health condition of the patient that is strictly necessary for the provision of consulting services pursuant to  Section 46 (1) d) , 
 
l) failing to ensure, at the request of the healthcare provider, cooperation in the provision of health services pursuant to  Section 46 (1) e) , 
 
m) failing to ensure, at the invitation or according to measures of a public health protection authority, the participation of healthcare workers in the provision of health services pursuant to  Section 46 (1) f) , 
 
n) not ensuring the hospitalization of children separately from adults according to  Section 47 (1) a),  Point 1, or 
 
o) not ensuring the hospitalization of women separately from men according to  Section 47 (1) a),  Point 2. 
 
	(3) The Provider also commits an infringement by 
 
a) contrary to Section 48 (1), (3) or (4), refusing to accept the patient, 
 
b) contrary to  Section 48, (2) or (3) , terminating patient care, 
 
c) not providing a record to the patient according to  Section 48 (5) , 
 
d) violating the obligation of confidentiality according to  Section 51 , 
 
e) violating the obligation to maintain or retain medical records or dispose of medical records pursuant to  Section 53 (1) , 
 
f) not allowing access to medical records according to  Section 64 (1) , 
 
g) not allowing access to medical records according to  Section 65 , 
 
h) allowing access to medical records contrary to  Section 65 , 
 
i) not holding a statement or a copy of the medical records referred to in  Section 66 (1) or (2) , 
 
j) not maintaining medical records according to Section 66 (6), 
 
k) retaining or using a body part taken from the patient, the body of the deceased or the part taken from the body of the deceased contrary to Section 81 (1) or (2); 
 
l) promising or granting another financial or other compensation, or an advantage in connection with the use of a part of the body of the patient, the body of the deceased or part of the deceased's body, 
 
m) failing to inspect the body of the deceased according to Section 84 (2) (a), (c) or (d), 
 
n) failing to comply with the reporting obligation under  Section 88 (7) , 
 
o) failing to comply with the informing obligation under  Section 89 (2) , 
 
p) not ensuring that the body of the deceased is stored in the refrigeration device according to  Section 90  
 
q) not keeping records of complaints or how they are processed pursuant to  Section 93 (3) c) , 
 
r) not allowing the complainant to look into the complaint file or to obtain a copy of the complaint file in accordance with  Section 93 (3) d) , 
 
s) not cooperating with the relevant administrative authority in investigating a complaint pursuant to  Section 93 (3) e) , or 
 
t) not preparing a complaint handling procedure under  Section 93 (4) a) . 
 
	(4) A fine may be imposed for an infringement of up to 
 
b) CZK 1,000,000 in the case of an infringement under Paragraph 1, Point a), or Paragraph 3, Point d), 
 
b) CZK 500,000 in the case of an infringement under Paragraph 1, Points b), c), d) or n), or Paragraph 3, Points e), f), g), h), i) or k), 
 
c) CZK 300,000 in the case of an infringement under Paragraph 1, Points e), f) or g), or Paragraph 2, Points c), l) or m), or Paragraph 3, Points a), b), l) or m), 
 
d) CZK 200,000 in the case of an infringement under Paragraph 1, Points r) or v), or Paragraph 2, Point h), or Paragraph 3, Points n) or p), 
 
e) CZK 100,000 in the case of an infringement under Paragraph 1, Points h), i), j), k), l), m), q), s), t), u) or w), Paragraph 2, Points a), b), d), e), f) or i), or Paragraph 3, Points c), j), o) or s), or 
 
f) CZK 50,000 in the case of an infringement under Paragraph 1, Points o) or p), or Paragraph 2, Points g), j), k), n) or o), or Paragraph 3, Points q), r) or t). 
 
Section 118 [Practical commentary] 

	Infringements under this Act are handled by 
 
(a) the regional authority, in the case of infringements under Section 114 (1) or Section 115 (1) 
 
b) an administrative authority competent for granting authorization to provide health services, in the case of infringements as referred to in Section 117 (1), (2) or (3) 
 
c) the Ministry, in the case of infringements under Section 115 (2) or Section 116 (1). 
 
PART FOURTEEN 

JOINT, ENABLING, TRANSITIONAL AND CANCELLATION PROVISIONS 

Section 119 [Practical commentary] [DZ] 

Joint provisions 

	(1) The competence provided for by this Act to regional authorities, regions, municipal offices or municipalities with extended powers is the exercise of delegated competence, with the exception of the competences under Section 44 (5). The provisions of this Act shall apply to the provision of medical rescue services, the provision of specific health services and the provision of health services under the Transplantation Act, unless the Act on medical rescue service, the Act on specific health services, and the Transplantation Act specify otherwise. 
 
	(2) The activities of independent experts and members of independent expert committees established under this Act shall be deemed another act of general interest45), in which such experts shall be entitled to remuneration or salary. Experts who are not in employment or a similar employment relationship but are gainful, are entitled to compensation for loss of earnings during the period of their participation in the activity of the committee, at the amount stated therein, but not higher than the average wage in the national economy declared and published by the Ministry Labor and Social Affairs in the Collection of Laws for Employment46). Independent experts, members of commissions and invited persons according to Section 95 (2) a) are subject to reimbursement of demonstrated travel expenses. 
 
Section 120 [Practical commentary] [DZ] 

Enabling provisions 

	The Ministry shall issue a decree to transpose Section 5 (3), Section 11 (4), 6 and 7, Section 44 (4) Paragraph 1, Point e), Section 69, Section 70 (6), Section 75 (3), Section 77 (3), Section 7 , 92 and Section 98, Paragraph 7. 
 
Transitional provisions 

Section 121 [Practical commentary] [DZ] 

	(1) A person authorized to operate a non-state health establishment on the basis of a marketing authorization pursuant to the existing Health Care Act in non-state health establishments (hereinafter referred to as "registration") may, on the basis of registration, provide health services corresponding to the type and extent of healthcare listed in the registration; this person is considered a provider. Holders of registration under existing legislation have the right to issue authorization to provide health services under this Act, provided that they provide evidence necessary for the granting of registration under this Act. 
 
	(2) A person who is authorized to operate a medical rescue service under the registration and who does not meet the requirements for granting a medical rescue service authorization pursuant to this Act and the Emergency Medical Service Act, may, upon registration, provide a medical rescue service to the extent of the kind and of the scope of healthcare specified in the registration, for a maximum period of 12 months from the date of entry into force of this Act; this person is considered a provider. 
 
	(3) The competent administrative body may change or cancel the registration if the provider ceases to comply with the conditions under which the registration was issued. The competent administrative body may also change, cancel or suspend the registration for a reason for which it is possible to change, withdraw or suspend the authorisation to provide health services pursuant to this Act; the provisions governing the grounds and other conditions for the change, withdrawal or suspension of the authorisation shall apply mutatis mutandis. 
 
	(4) The registration shall cease to be valid as of the day on which the decision on the granting of the authorisation for the provision of health services takes effect. The registration that provides the authorisation for the operation of the medical emergency services by the provider referred to in Paragraph 2 shall expire 12 months from the effective date of this Act. 
 
	(5) cancelled 
 
	(6) Proceedings that were initiated under the existing Health Care Act in non-state healthcare facilities and which have not been legally terminated before the date of entry into force of this Act shall be completed in accordance with the existing legislation, with the exception of the procedure of registration of a medical rescue service or of its change that shall cease as of the date of entry into force of this Act. 
 
Section 122 [Practical commentary] [DZ] 

	(1) Unless stated otherwise the person/entity that is authorised to operate a state healthcare facility may provide health services, without the authorisation for the provision of health services, corresponding to the type and the extent of healthcare provided as of the date of entry into force of this Act for a maximum of 12 months from the date of entry into force of this Act; this person/entity is considered to be a provider. 
 
	(2) If the provider referred to in Paragraph 1 intends to provide health services after the expiration of 12 months from the effective date of this Act, he/she/it shall file an application for the granting of the authorisation for the provision of health services within 3 months of the date on which this Act enters into force; in this case he/she/it may provide health services without authorisation until the decision on the application has become final. An application for the authorisation to provide health services shall contain the particulars listed in Section 18, Paragraphs 1, 2 and 4. The competent administrative body is obliged to issue a decision concerning the application no later than 12 months after the effective date of this Act. 
 
Section 123 [Practical commentary] [DZ] 

	(1) The activities of the territorial and central expert commissions commenced before the effective date of this Act shall be completed in accordance with the existing legal regulations. 
 
	(2) For the purposes of assessing the integrity pursuant to Section 13, the provision of health services also means the provision of healthcare under existing legislation. 
 
Section 124 [Practical commentary] [DZ] 

	(1) The operation of nurseries as a health facility pursuant to the existing legislation shall end by the 31st December 2013; until then, the right to operate these health facilities to the same extent as it was in operation at the date when this Act came into effect is not affected. 
 
	(2) Infant establishments operated as of the date of entry into force of this Act in accordance with the existing legislation shall be considered as child care homes for children under 3 years of age pursuant to this Act. 
 
Section 125 [Practical commentary] [DZ] 

	(1) Providers of one-day care and of inpatient care are obliged to prepare a traumatology plan in accordance with Section 47, Paragraph 1, Point d) within 12 months of the date of entry into force of this Act. 
 
	(2) Providers of inpatient care are obliged to prepare a program for the prevention and control of healthcare associated infections pursuant to Section 47, Paragraph 4 within 12 months from the date of entry into force of this Act. 
 
Section 126 [Practical commentary] [DZ] 

	(1) The provider who has been granted the status of the centre prior to the effective date of this Act, if he intends to continue in the centre's activities, is obliged to notify the Ministry no later than 6 months after the Act comes into effect, otherwise the statute of the centre ceases upon the expiration of this period. 
 
	(2) The provider who fulfils the condition under Paragraph 1 may exercise the activities of a centre pursuant to this Act for as long as the centre's status has been granted, unless the centre's status is terminated pursuant to Section 113, Paragraph 1, Points a) or b). 
 
Section 127 [Practical commentary] [DZ] 

	(1) The Ministry shall establish 
 
a) the National Register of Providers and the National Register of Healthcare Professionals within 24 months from the date of entry into force of this Act, 
 
b) the National Register of Accidents, the National Register of Persons Permanently Excluded from Blood Donation, the National Registry of Autopsy and Toxicological Investigations carried out at the Department of Forensic Medicine within 24 months from the date of entry into force of this Act. 
 
	(2) The data kept in the National Register of Healthcare Facilities by the Institute of Health Information and Statistics of the Czech Republic pursuant to the State Statistical Service Act shall be transferred by the Institute to this register no later than on the date of establishment of the National Register of Providers. 
 
	(3) Data entered in the Register of Physicians, Dentists and Pharmacists by the Institute of Health Information and Statistics of the Czech Republic pursuant to the Act on Public Health Care shall be transferred by the Institute to this register no later than on the date of establishment of the National Register of Healthcare Professionals. 
 
	(4) The entities referred to in Section 75 shall transmit the necessary data to the register within 180 days from the date of establishment of the National Register of Providers. Providers who are authorized to operate a non-state medical facility on the date of entry into force of this Act shall transmit data to the National Register of Providers pursuant to Section 74, Paragraph 1, Point d). 
 
	(5) A natural person exercising a health care profession in the territory of the Czech Republic shall be obliged to register with the National Register of Healthcare Professionals within 180 days from the date of establishment of the National Register of  Healthcare Professionals,  and to provide the Ministry, or the authorised legal person, data in accordance with Section 76. 
 
	(6) The data kept by the Institute of Health Information and Statistics of the Czech Republic in accordance with the legislation in the version effective prior to the date of entry into force of this Act in the National Register of Mothers, the National Register of Newborns, the National Register of Congenital Development Defects, the National Register of Abortions and the National Register of Assisted Reproduction  shall be transferred by the Institute to the National Reproductive Health Register at the latest on the day of the establishment of this register. 
 
	(7) The data kept in the National Cardiac Surgical Register and the National Register of Cardiovascular Interventions by the Institute of Health Information and Statistics of the Czech Republic, pursuant to the Act on Public Health Care, shall the Institute transfer to the register no later than on the date of establishment of the National Register of Cardiovascular Surgeries and Interventions. 
 
	(8) The data kept in the National Register of Users of Medically Indicated Substitutes by the Institute of Health Information and Statistics of the Czech Republic, pursuant to the Act on Public Health Care, shall the Institute transfer to the register no later than on the date of establishment of the National Register of Treatment of Drug Users. 
 
	(9) When maintaining the registers referred to in Paragraphs 2, 3 and 6 to 8 and the provision of data by the obliged entities in these registers it shall be proceeded in accordance with the existing legislation in force until the effective date of this Act until the registers referred to in Paragraph 1 have been set up. 
 
	(10) The administrator of the National Health Information System shall ensure the anonymisation and archiving of historical data maintained in the National Register of Vascular Surgery within 30 days from the entry into force of this Act. 
 
§ 128 [DZ] 

Repealing Provisions 

	Cancelling: 
 
1. Act No. 20/1966 Coll., On Public Health Care. 
 
2. Act No. 548/1991 Coll. that is amending and supplementing Act No. 20/1966 Coll. On Public Health Care, as amended by the Czech National Council Act No. 210/1990 Coll. and by the Czech National Council Act No. 425/1990 Coll. 
 
3. Act No. 160/1992 Coll., On health care in non-state health establishments. 
 
4. Act No. 260/2001 Coll., amending Act No. 20/1966 Coll., On Public Health Care, as amended. 
 
5. Act No. 156/2004 Coll., amending Act No. 20/1966 Coll., On Public Health Care, as amended. 
 
6. Act No. 28/2008 Coll., amending Act No. 20/1966 Coll., On Public Health Care, as amended. 
 
7. Decree No. 62/1968 Coll., On providing preventive care in the armed forces and the National Security Corps, and on the cooperation of state health authorities in the provision of such care (the Medical Regulations). 
 
8. Decree No. 242/1991 Coll., On a system of health facilities established by district authorities and municipalities. 
 
9. Decree No. 11/1988 Coll., On compulsory reporting of termination of pregnancy, child death and death of a mother. 
 
10. Decree No. 19/1988 Coll., On the procedure in the case of death and on funeral services. 
 
11. Decree No. 61/1990 Coll., On the management of drugs and medical supplies. 
 
12. Decree No. 394/1991 Coll., On the status, organisation and activities of university hospitals and other hospitals, selected specialised treatment institutes and regional public health authorities in the managing authority of the Ministry of Health of the Czech Republic. 
 
13. Decree No. 427/1992 Coll., amending and supplementing Decree No. 427/1992 Coll., On the management of drugs and medical supplies. 
 
14. Decree No.  434/1992 Coll., On emergency medical services. 
 
15. Decree No. 139/1993 Coll., which repeals the Decree of the Ministry of Health and Social Affairs of the Czechoslovak Republic on the management of precious metals in dental care in national health institutions and other healthcare organisations. 
 
16. Decree of the Ministry of Health No. 247/1993 Coll. on the selection procedure for leading positions in health organisations and healthcare facilities within the competence of the Ministry of Health, District Offices and Municipalities. 
 
17. Decree No. 51/1995 Coll., amending and supplementing the Decree of the Ministry of Health of the Czech Republic No. 49/1993 Coll., On Requirements for Physical and Technical Equipment of Healthcare Facilities and amending the Decree of the Ministry of Health No. 434/1992 Coll., , and amends the Decree of the Ministry of Health of the Czech Republic No. 434/1992 Coll., On Medical Emergency Service. 
 
18. Decree No. 221/1995 Coll., On expert committees. 
 
19. Decree No. 105/2002 Coll., which amends Decree No. 221/1995 Coll., On expert committees. 
 
20. Decree No. 552/2004 Coll., On the transfer of personal and other data to the National Health Information System for the purpose of maintaining national health registers. 
 
21. Decree No. 259/2006 Coll., which amends the Decree of the Ministry of Health of the Czech Republic No. 394/1991 Coll., On the status, organisation and activities of university hospitals and other hospitals, selected specialised treatment institutes and regional public health authorities in the managing authority of the Ministry of Health of the Czech Republic. 
 
22. Decree No. 385/2006 Coll., On medical records. 
 
23. Decree No. 479/2006 Coll., amending Decree No. 385/2006 Coll., On medical records. 
 
24. Decree No. 64/2007 Coll., amending Decree No. 385/2006 Coll., On medical records, as amended by Decree No. 479/2006 Coll. 
 
25. Decree No. 187/2008 Coll., amending Decree No. 385/2006 Coll., On medical records, as amended. 
 
26. Decree No. 232/2008 Coll. amending the Decree of the Ministry of Health No 247/1993 Coll. on the selection procedure for leading positions in health organisations and healthcare facilities within the competence of the Ministry of Health , District Offices and Municipalities. 
 
27. Decree No. 221/2010 Coll., On Requirements for Physical and Technical Equipment of Healthcare Facilities and on Amendments to Decree of the Ministry of Health No. 51/1995 Coll., which amends and supplements the Decree of the Ministry of Health of the Czech Republic No. 49/1993 Coll., On Requirements for Physical and Technical Equipment of Healthcare Facilities, and amends the Decree of the Ministry of Health of the Czech Republic No. 434/1992 Coll., On Medical Emergency Service (hereinafter referred to as the Decree on Requirements for Physical and Technical Equipment of Healthcare Facilities). 
 
28. Decree No. 234/2011 Coll., which amends the Decree No. 221/2010 Coll., On Requirements for Physical and Technical Equipment of Healthcare Facilities and on Amendments to Decree of the Ministry of Health No. 51/1995 Coll., which amends and supplements the Decree of the Ministry of Health of the Czech Republic No. 49/1993 Coll., On Requirements for Physical and Technical Equipment of Healthcare Facilities, and amends the Decree of the Ministry of Health of the Czech Republic No. 434/1992 Coll., On Medical Emergency Service (hereinafter referred to as the Decree on Requirements for Physical and Technical Equipment of Healthcare Facilities). 
 
PART FIFTEEN 

EFFECTIVENESS

Section 129 [DZ] 

	This Act shall enter into force on the first day of the fourth calendar month following the day of its promulgation. 

Němcová m. p. 

Klaus m. p. 

Nečas m. p. 

Appendix
National Health Registers 

	1. National Oncology Register 
 
	The personal data necessary for the identification of the patient is processed in the register; socio-demographic data (age, gender, occupation) affecting the patient's health condition, data related to the disease and its treatment, the patient’s personal and family history related to the disease including the neoplasm classification, treatment data (surgery, radiotherapy, chemotherapy, hormonal therapy, other); provision of dispensary care and concerning the patient’s death; identification of the provider who diagnoses, treats and provides dispensary care. 
	25 years after the patient's death, personal data is anonymised. 
	2. National Register of Hospitalisation 
 
	The personal data necessary for the identification of the patient is processed in the register; socio-demographic data (age, gender, occupation) affecting the patient's health condition, data related to the hospitalisation, about the admission, diagnostic data concerning the course and treatment of the disease (surgery, complications, infections), personal history, the patient’s condition when discharged from the hospital and the need for other health services; identification of the provider who provides inpatient care. 
	25 years after the completion of inpatient care, personal data is anonymised. 
	3. National Reproductive Health Register 
 
	The personal data necessary for the identification of a pregnant woman, a parent and a newborn child, a woman undergoing artificial insemination, a woman whose pregnancy was artificially interrupted, who have been subject to induced abortion or spontaneous abortion is processed in the register; socio-demographic data (age, gender, occupation) affecting the health condition of a pregnant woman, a parent and a newborn child, a woman and a man who are together undergoing artificial insemination (hereinafter referred to as the "infertile couple"), (personal and family history, diagnostic data, pregnancy and childbirth data, treatment data, including outcomes and complications) related to the health of the pregnant woman and the course of pregnancy and birth and the health of the newborn child, details of the infertile couple's health condition and on methods of assisted reproduction provided to him/her. Additionally processed in the register is the data on pre-implantation and prenatal examinations, the data on artificial abortion of pregnancies, spontaneous or induced abortions, about the method of artificial abortion, the method of induction of abortion, the reason for termination of artificial abortion of pregnancy and about aborted embryos, as well as the data on diagnosed inborn and developmental defects and genetic diseases in embryos and persons, the data necessary for the identification of the provider in whose facility the birth took place or the postpartum treatment of the woman, where a birth defect has been diagnosed, artificial abortion of pregnancy took place or induced abortion or treatment after abortion or where assisted reproduction or one of the procedures and methods of assisted reproduction took place. 
	The personal data of the woman who has requested confidentiality at birth pursuant to Section 37 is not processed in the register. 
	30 years after the recording of data or 5 years after death, personal data is anonymised. 
	4. National Register of Cardiovascular Surgery and Intervention 
 
	The personal data necessary for the identification of the patient is processed in the register; the data related to the patient's health condition in relation to the disease, pre-surgery information (personal and family history, diagnostic data on the treatment and course of the illness, reason, type and schedule of the anticipated surgery), surgery information (the date of surgery, identification of the healthcare professional carrying out the surgery, professional details of the surgery) and post-surgery information (professional information concerning the patient’s stay in the intensive care unit of the healthcare facility or death of the patient); the date of cardiovascular intervention of coronary arteries by means of catheterisation (indications, course of complaints, personal history, results of angiography, description including procedures, associated procedures and status), the data on possible non-coronary vascular interventions (of limbs); the data needed for the identification of the provider in whose healthcare facility cardiovascular surgeries and interventions were implemented. 
	5 years after the patient's death, personal data is anonymised. 
	5. National Register of Joint Replacement 
 
	The personal data necessary for the identification of the patient is processed in the register; the data related to the patient's health condition in relation to the disease, pre-surgery information (personal and family history, diagnostic data on the treatment and course of the illness, reason, type and schedule of the anticipated surgery), surgery information (the date of surgery, identification of the healthcare professional carrying out the surgery, professional details of the implemented surgery including the joint identification and detailed identification of all components of the artificial joint replacement utilised); the data needed for the identification of the provider in whose healthcare facility the implantation was implemented. 
	5 years after the patient's death, personal data is anonymised. 
	6. National Register of Occupational Diseases 
 
	The personal data necessary for the identification of the patient is processed in the register; socio-demographic data related to the patient's health condition, occupational disease data (the date of diagnosis of occupational disease, diagnosis of illness, the corresponding item from the list of occupational diseases listed in another legal regulation, the date from which the illness is no longer an occupational disease); the data necessary to characterise the risk of occupational disease (occupation in the course of which the occupational disease occurred, risk factor of working conditions that caused the occupational disease, exposure to this factor, category of work), identification of the employer (headquarter's address, the organisation identification number, sectoral classification of economic activity); identification of the provider and reporting date. 
	40 years after the recording of data or 5 years after death, personal data is anonymised. 
	7. National Register of Drug Addict Therapy 
 
	The personal data necessary for the identification of multiple recordings in regard to the same patient who is undergoing professional care in accordance with the Act on the Protection of Health against the Harmful Effects of Addictive Substances is processed in the register, with different providers in one calendar year (Personal Identification Number - in the event of a substitution or detoxification treatment, in the event of other forms of care provided the identifier is constructed in accordance with predefined rules, which are defined by the register administrator) and other data: the code and the name of the municipality of residence; the district and country of the place of residence, nationality, age, gender, marital status, the date, circumstances and nature of contact with the provider, information about previous treatment, employment, the highest education attained, character of housing (permanent, temporary residence, in the institution, homeless, unknown), information on current and past drug use, risk factors of drug(s) use, tests for HIV and other infections (viral hepatitis) and their outcomes, the type of treatment, conclusion of the treatment, information about the termination of treatment; the data necessary for the identification of the reporting provider. Specific information on substitution treatment (substitution compound/medicinal product, date of first substitution, discontinuation of the treatment for regime reasons, transfer of the patient to the care of another provider) is also monitored. 
	In the case of substitution therapy personal data is anonymised after the expiration of 5 years after the patient's death. 
	For other drug therapies, only anonymised data is processed. 
	8. National Register of Injuries 
 
	The personal data necessary for the identification of the patient is processed in the register; the data related to injuries treated during hospitalisation, the data related to the patient's health condition in relation to the injury and its diagnosis and treatment, the circumstances in which the injury occurred, its causes, a detailed description of the place and time of the injury, the speed of intervention of the medical rescue service provider, data on primary transport, a detailed record of care at urgent reception and subsequent provision of health services, and the data needed for the identification of the provider in whose healthcare facility the patient was hospitalised. 
	25 years after the injury or 5 years after death, personal data is anonymised. 
	9. National Register of Persons Permanently Excluded from Blood Donation 
 
	Personal data needed to identify a person permanently excluded from blood donation is processed in the register.47) Data identifying the donor shall be entered in the register of the transfusion facility that has permanently excluded the donor from donation, together with the coded reason for exclusion from donation and the identification code of that facility48). 
	5 years after the patient's death, personal data is anonymised. 
	10. National Register of Autopsy and Toxicological Examination performed at Forensic Medicine Departments 
 
	The personal data necessary for the identification of the deceased patient is processed in the register; the data related to the deceased patient's condition in relation to the death, including personal history, data on the occupation, the hour, date and place and other circumstances of death, the information obtained by the autopsy (the date of the autopsy, the autopsy protocol number, expert data on the autopsy performed, including the diagnosis of the primary, mediating and immediate cause of death and the secondary diseases that contributed to the death, death mechanism and toxicological examination); the data needed for the identification of the autopsy provider and the data needed for the identification of the physician who performed the autopsy (name(s) and surname). 
	5 years after the patient's death, personal data is anonymised. 
	11. National Diabetology Register 
 
	The personal data necessary for the identification of the patient is processed in the register; socio-demographic data (age, gender, occupation) affecting the patient's health condition, risk and prognostic factors of the disease, data related to the disease and its treatment, the patient’s personal and family history related to the disease including the classification of the type and status of diabetes and laboratory values, the provision of dispensary care and the death of the patient; identification of the provider who diagnoses, treats and provides dispensary care. 
	25 years after the patient's death, personal data is anonymised. 
	12. National Intensive Care Register 
 
	The personal data necessary for the identification of the patient is processed in the register; socio-demographic data (age, gender, occupation) affecting the patient's health condition, risk and prognostic factors of the disease, data related to the disease and its treatment, the patient’s personal and family history related to the disease, diagnosis of the disease the laboratory values, the provision of dispensary care and the death of the patient; identification of the provider who diagnoses and provides acute intensive inpatient care and intensive after-care. 
	5 years after the patient's death, personal data is anonymised. 
	Note: Personal data maintained in the National Health Registers pursuant to this Appendix that are anonymised after the expiry of certain period from the patient’s death shall be the personal data maintained in the relevant register about the patient or other person who died and who was provided with the health service monitored in the register . 
Selected Provisions of the Amendments 

 Article II of Act No. 66/2013 Coll. 

Transitional provisions 

	1. Proceedings for the establishment of a caregiver on the basis of a notification pursuant to Section 35, Paragraph 3 of the Act on Health Services in the version in force prior to the effective date of this Act shall be suspended by the court. 
 
	2. If a court based on the notification pursuant to Section 35, Paragraph 3 of the Act on Health Services in the version in force prior to the effective date of this Act appointed a caregiver, who as of the date of entry into force of this Act did not fulfil the purpose defined in Section 35, Paragraph 3, Point a) or b) of the Act on Health Services in the version in force prior to the effective date of this Act, it shall be proceeded in accordance with Section 35 of the Act on Health Services in the version in force prior to the effective date of this Act. 
 
	3. The provision of clinical and practical education and practical training and professional experience in accordance with Section 46, Paragraph 2 of the Health Services Act, in the version effective from the date of entry into force of this Act, shall be ensured by the Provider no later than 12 months after the effective date of this Act. 
 
 Article II of Act No. 147/2016 Coll. 

Transitional provisions 

	1. The Ministry of Health will establish 
 
a) the National Register of Healthcare Professionals within 12 months from the date of entry into force of this Act, 
 
b) The National Register of Paid Health Services within 6 months from the date of entry into force of this Act, 
 
c) the National Diabetes Register and the National Intensive Care Register within 12 months from the date of entry into force of this Act. 
 
	2. Data entered in the Register of Physicians, Dentists and Pharmacists by the Institute of Health Information and Statistics of the Czech Republic pursuant to Act No. 372/2011 Coll., in the version in force prior to the effective date of this Act, shall be transferred by the Institute as of the date of establishment of the National Register of Healthcare Professionals into this Register. 
 
	3. The entities referred to in Section 77, Paragraph 1 of Act No. 372/2011 Coll., in the version in force as of the effective date of this Act, shall transmit to the National Register of Healthcare Professionals data pursuant to Section 77, Paragraph 1 of Act No. 372/2011 Coll., in the version in force as of the effective date of this Act, within 180 days from the date of the establishment of this Register. 
 
	4. Health Insurance Companies shall transmit data to the National Registry of Paid Health Services within 180 days from the date of the establishment of this Register pursuant to Section 77a, Paragraph 2 of Act No. 372/2011 Coll., in the version in force as of the effective date of this Act, if they refer to health services provided after the 1st January 2010. 
 
	5. Access rights acquired pursuant to Section 73, Paragraph 2 of Act No. 372/2011 Coll., in the version in force prior to the effective date of this Act, shall remain in force. 
 
	6. The obligation to ensure the temperature in the refrigeration system in accordance with § Section 90 of Act No. 372/2011 Coll., in the version effective after the date of entry into force of this Act, must be fulfilled within 60 days from the date of entry into force of this Act. 
 
	7. If a death has occurred prior to the date of entry into force of this Act, the determination and execution of autopsies should be carried out pursuant to Act No. 372/2011 Coll., in the version in force prior to the effective date of this Act. 
 
 Article XI of Act No. 192/2016 Coll. 

Transitional provisions 

	The National Health Information System Administrator shall reconcile the National Health Service Providers Register in accordance with Section 74, Paragraph c) of Act No. 372/2011 Coll., in the version in force as of the effective date of this Act, within 6 months from the date of entry into force of this Act. 
 
 Section 60 of Act No. 65/2017 Coll. 

Transitional provisions 

	A healthcare provider who, on the day preceding the date of entry into force of this Act, was authorised to provide health services in an anti-alcoholic and anti-drug detention facility pursuant to Act No. 379/2005 Coll., in the version in force prior to the effective date of this Act, is authorised, from the date of entry into force of this Act, to provide an anti-alcoholic and anti-drug detention service. 
 
____________________

1) Act No. 95/2004 Coll., On the conditions for acquiring and recognising professional qualification and specialised qualification for performing the medical profession of a Physician, a Dentist and a Pharmacist, as amended. 
 
2) Act No. 96/2004 Coll., On the conditions for acquiring and recognising qualification for performing non-medical professions and activities related to the provision of health care, as amended (Non-Medical Professions Act), as amended 
 
3) Directive of the European Parliament and of the Council 2011/24/EU of the 9th March 2011 on the application of patients' rights in cross-border healthcare. 
 
4) Act No. 256/2001 Coll., On funeral services and amending certain laws, as amended. 
 
5) Act No. 374/2011 Coll., On emergency medical services, as amended 
 
6) Act No. 285/2002 Coll., On the Donation, Procurement and Transplantation of Tissues and Organs and on the Amendment to Certain Laws (the Transplantation Act), as amended. 
 
Act No. 296/2008 Coll., On ensuring the Quality and Safety of Human Tissues and Cells intended for Human Use and on the Amendment to Related Acts (the Human Tissues and Cells Act), as amended. 
 
7) Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Certain Related Acts (Pharmaceuticals Act), as amended. 
 
8) Act No. 285/2002 Coll., as amended. 
 
Act No. 66/1986 Coll., On the Induced Termination of Pregnancy. 
 
9) Sections 48 to 51 of Act No. 108/2006 Coll., On Social Services, as amended. 
 
10) Section 18(d), Point 2 of Act No. 326/1999 Coll., On the Residence of Foreign Nationals in the Territory of the Czech Republic and on Amendments to Certain Acts, as amended. 
 
11) Section 2, Paragraph 12 of Act No. 325/1999 Coll., On Asylum and on the Amendment to Act No. 283/1991 Coll., On the Police of the Czech Republic, as amended (the Asylum Act), as amended. 
 
12) Act No. 164/2001 Coll., On Natural Healing Resources, Sources of Natural Mineral Waters, Natural Healing Spas and Spa Centres and on the Amendment to Certain Related Acts (the Spa Act), as amended. 
 
13) Act No. 123/2000 Coll., On Medical Devices and on Amendments to Certain Related Acts, as amended. 
 
14) Act No. 18/2004 Coll., On the recognition of professional qualifications and other competences of nationals of the Member States of the European Union and of certain nationals of other states and on the amendment to certain laws (Act on the Recognition of Professional Qualifications), as amended. 
 
15) Act No. 18/1997 Coll., On the peaceful use of nuclear energy and ionizing radiation (the Atomic Act) and on the amendment and supplementation of certain acts, as amended. 
 
16) Act No. 258/2000 Coll., On the Protection of Public Health and on the Amendment to Certain Related Acts, as amended. 
 
17) Section 24, Point c) of Act No. 111/2009 Coll., On the basic registers. 
 
18) Act No. 111/2009 Coll., as amended. 
 
19) Section 21, Paragraph 2 of Act No. 435/2004 Coll., On Employment, as amended. 
 
20) For example Act No. 582/1991 Coll., On the Organisation and Implementation of Social Security, as amended, and Act No. 187/2006 Coll., On Sickness Insurance, as amended. 
 
21) For example Act No. 285/2002 Coll., as amended, Act No. 373/2011 Coll., On Specific Health Services. 
 
22) The Family Law Act. 
 
23) Section 26, Paragraph 1 and Section 28, Point c) of Act No. 117/1995 Coll., On State Social Support, as amended. 
 
24) Act No. 435/2004 Coll., as amended. 
 
25) Act No. 187/2006 Coll., as amended. 
 
26) Act No. 582/1991 Coll., as amended. 
 
27) Act No. 563/2004 Coll., On Educational Employees and on the Amendment to Certain Acts, as amended. 
 
28) Act No. 111/1998 Coll., On Higher Education Institutions and on the Amendment to Other Acts (the Higher Education Act), as amended. 
 
29) Act No. 300/2008 Coll., On Electronic Acts and on Authorised Conversion of Documents, as amended. 
 
30) Section 21 of Act No. 36/1967 Coll., On Experts and Interpreters. 
 
31) Act No. 349/1999 Coll., On the Ombudsman, as amended. 
 
32) The European Convention for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment, promulgated by the Notification of the Ministry of Foreign Affairs under No. 9/1996 Coll. 
 
The Option Protocol to the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment promulgated by the Notification of the Ministry of Foreign Affairs under No. 78/2006 Collection of International Treaties 
 
33) Section 4, Point d) of Act No. 101/2000 Coll., On the Protection of Personal Data and on the Amendment to Certain Acts. 
 
34) For example Act No. 89/1995 Coll., On the State Statistical Service, as amended. 
 
35) Act No. 108/2006 Coll., as amended. 
 
36) Act No. 585/2004 Coll., On Conscription and its Ensuring (the Conscription Act), as amended. 
 
37) Act No. 141/1961 Coll., On Criminal Proceedings (the Criminal Procedure Code), as amended. 
 
38) Act No.301/2000 Coll., On Offices of Vital Records, First Names and Surnames, and on the Amendments to Certain Related Acts, as amended. 
 
39) Decree No.328/2001 Coll., On certain details of providing an integrated rescue system, as amended by Decree No.429/2003 Coll. 
 
40) Act No.273/2008 Coll., On the Police of the Czech Republic, as amended. 
 
41) For example, Act No. 258/2000 Coll., as amended, Act No. 378/2007 Coll., as amended, and Act No. 296/2008 Coll., as amended. 
 
42) Section 66b of the Commercial Code. 
 
43) Act No. 220/1991 Coll., On the Czech Medical Chamber, the Czech Dental Chamber and the Czech Chamber of Pharmacists, as amended. 
 
44) For example Act No. 111/1998 Coll., as amended. 
 
45) Section 200 et seq. of the Labour Code. 
 
46) Act No. 435/2004 Coll., as amended. 
 
47) Part B, Point 1 of Appendix No. 3 to Decree No. 143/2008 Coll., On defining detailed conditions to assure the quality and safety of human blood and its components (Decree on Human Blood), as amended. 
 
48) Point 7.1.4. (a) of Appendix No. 1 to Decree No. 143/2008 Coll. on Human Blood. 
 
49) The Civil Code. 
 
Act No. 94/1963 Coll., On Family, as amended. 
 
50) Section 14c of Act No. 48/1997 Coll.,On Public Health Insurance and on Amendments to Certain Related Acts, as amended. 
 
51) Section 18, Paragraph 2 of Act No. 300/2008 Coll., On Electronic Actions and Authorized Document Conversion. 
 
 Section 6, Paragraph 1 of Act No. 297/2016 Coll., On Trust Services for Electronic Transactions. 
 
52) Act No. 373/2011 Coll., as amended. 
 
53) Act No. 65/2017 Coll., On health protection from the harmful effects of addictive substances.