What is Act No. 325 / 2021 Coll.?

Act No. 325 / 2021 Coll., on Electronic Health — The Act on Electronic Health.

When it became Act No. 325 / 2021 Coll. effectiveness?

Act No. 325 / 2021 Coll. became effective 01.01.2022.

Is Act No. 325 / 2021 Coll. still valid?

Yes, Act No. 325 / 2021 Coll. is still valid and effective.

How many times was it Act No. 325 / 2021 Coll. amended?

Act No. 325 / 2021 Coll. has 11 time versions of the text.

Act No. 325 / 2021 Coll. - The Act on Electronic Health

325

THE LAW

of 18 August 2021

on the electronic treatment of health

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

INTRODUCTORY PROVISIONS

§ 1

Subject matter

(1) This Act regulates electronic health services using telecommunications and information technologies and lays down conditions for secure data sharing within it.

(2) This law further regulates

(a) the rights and obligations of patients, health service providers, healthcare professionals, health insurance companies and other persons in the field of electronic health; and

(b) the competence of the Ministry of Health (hereinafter referred to as "the Ministry") in the performance of the State administration in the field of electronic health.

Basic concepts

§ 2

(1) For the purposes of this Act, electronic healthcare means the provision and use of services and information systems of the Integrated Data Interface ("Integrated Data Interface"), services linked to the Integrated Data Interface and Information Systems of health service providers serving to maintain or transmit health documentation in electronic form, including systems enabling remote access to the patient under this Act.

(2) Patient identifier means a unique and insignificant client identifier of a natural person serving to identify a patient in electronic health services and in medical documentation.

(3) The health professional identifier is a unique, insignificant identifier used to identify a health worker in electronic health services and in health documentation.

(4) Stem data means data kept in the stem health registers.

(5) Services connected to the Integrated Data Interface are services using central electronic health services under another legislation (2).

(6) Electronic health standards are those defining the structure, content and format of data sets, data messages and data interfaces, their security, classification, nomenclature and terminology for their use for:

(a) the use of electronic health services;

(b) information systems using electronic health services;

(c) keeping and transmitting health documentation in electronic form;

(d) transmission of data to the National Health Information System under the Health Services Act.

§ 3

For the purposes of this Act:

(a) a person entering a legal, natural or business natural person, an organisational component of a State or an organisational component of a local self-governing body entering data in the national health registers;

(b) an authorised person is a legal, natural or entrepreneurial natural person, an organisational component of a State or an organisational component of a local authority which is entitled to use the services of an Integrated Data Interface within the scope of this Act;

(c) an authorised worker is a natural person who is in an employment relationship or similar relationship with the authorised person and who is assigned access rights to the information system of the authorised person using the Integrated Data Interface;

(d) a third party, by a legal, natural or commercial natural person, who has been authorised by the patient to exercise rights on his behalf under this law or other legislation.

Status of authorised and registered persons

§ 4

The health service provider is obliged as a beneficiary

(a) comply with the standards of electronic health issued by the Ministry pursuant to § 38 (2) (c); e-health standards shall be deemed to be complied with if it is applied under other legislation instead;

(b) use and comply with the tribal data for the purposes laid down by this law;

c) register in your information system

1. identifiers for health professionals who engage in the health profession in an occupational or similar relationship; and

2. the patient identifiers to which it provides or provided health services; and

(d) record in its information system the activities of all authorised personnel logged into its information system using the Integrated Data Interface.

§ 5

Authorised persons and subscribers, except the patient, shall:

(a) designate authorised staff; and

1. verify their identity before assigning access data to their integrated data interface information systems; if the authorised worker is a health care professional, verify his data in the Stem Register of Medical Workers; and

2. assign, modify and cancel access data to their information system in accordance with the operational documentation of the Integrated Data Interface pursuant to Section 10; and

(b) ensure that their information systems designed to use the Integrated Data Interface with it are fully compatible and correspond to the specification published in the operational documentation of the Integrated Data Interface pursuant to Section 10.

§ 6

(1) The Ministry uses the Ministry for the purpose of carrying out its tasks under this Act in the field of electronic health

(a) reference data from the population base register;

(b) data from the population registration agendas information system;

(c) data from the agency information system of aliens,

(d) data from the register of birth numbers of natural persons to whom the birth number has been assigned but not kept in the information systems referred to in (b) or (c).

(2) The data used under paragraph 1 (a) are:

(a) surname;

(b) surname,

(c) the name and, where appropriate, the names,

(d) the address of the place of residence (3) and, where appropriate, the address to which the documents are to be served under another legislation (4); the addresses indicated are kept in the form of a reference link (address location code) to the address reference in the territorial identification register; in the case of an address to which documents are to be served under another legislature4), an indication of the identification of the post office or delivery box or an address which is outside the territory of the Czech Republic and which has not been assigned an address location code in the territorial identification register shall be kept; in the case of the address of the residence (3), this information shall be indicated as the address of the office if it is marked in the same way in the resident information system or in the alien information system;

(e) date, place and district of birth; the date, place and state of birth of the data subject born abroad;

(f) the date, place and district of death; if the death of the data subject is outside the territory of the Czech Republic, the date of death, the place and the State in whose territory the death occurred; if the court's decision on the declaration of death is given, the date indicated in the decision as the date of death or the date on which the data subject declared to be dead did not survive, and the date on which the decision was acquired,

(g) citizenship and, where appropriate, multiple citizenship;

(h) the telephone number for the public mobile telephone network or e-mail address for sending the selected information circuit; and

(i) the numbers and types of electronically readable identification documents.

(3) The data used under paragraph 1 (b) are:

(a) surname;

(b) surname,

(c) the name and, where appropriate, the names,

(d) the address of the place of residence and, where applicable, the address to which the documents are to be served under another legislation, including the beginning of the permanent residence or the date of cancellation of the residence or the date of termination of the permanent residence in the Czech Republic;

(e) date, place and district of birth; the date, place and state of birth of the data subject born abroad;

(f) the date, place and district of death; if the death of the data subject is outside the territory of the Czech Republic, the date of death, the place and the State in whose territory the death occurred; if the court's decision on the declaration of death is given, the date indicated in the decision as the date of death or the date on which the data subject declared to be dead did not survive, and the date on which the decision was acquired,

(g) birth number,

(h) sex,

(i) limitation of inefficiency;

(j) the name and, where appropriate, the name, surname and birth number of the father, mother or other legal representative; where one of the parents or other legal representative does not have a birth number, his name and, where applicable, his name, surname and date of birth;

(k) the name and, where applicable, the name, surname and birth number of the spouse or registered partner; if the spouse or registered partner is a natural person who does not have a birth number, name or names, and the surname of the spouse or registered partner and date of birth,

(l) the name and, where appropriate, the name, surname and birth number of the child; if the child is a stranger who is not assigned a birth number, the name and, where applicable, the name, surname and date of birth of the child; and

(m) data on the ova to the extent

1. the name and, where appropriate, the names, surnames and birth numbers of the adopters; in the event that the acquirer has not been assigned a birth number, name details, names, surname and date of birth of the acquirer,

2. the name, names, surnames and birth numbers of the father and mother; if they have not been allocated, their name and, where appropriate, their names, surnames and date of birth; and

3. the date on which the adoption or revocation decision becomes final.

(4) Data which are kept as references in the population base register shall be used from the population registration information system only if they are in the form preceding the current situation.

(5) The data used under paragraph 1 (c) are:

(a) the name and, where applicable, the names and surnames,

(b) surname,

(c) birth number,

(d) date of birth;

(e) the address of the place of stay;

(f) sex,

(g) citizenship or nationality, where appropriate;

(h) the name and, where applicable, the name, surname, nationality, nationality of the spouse or registered partner and his / her birth number; if the spouse or registered partner is a stranger who is not assigned a birth number, his name and, where applicable, his name, and the surname of the spouse and the date of birth;

(i) the name and, where applicable, the name, surname, nationality or nationality of the child if he is a foreigner, and his / her birth number; where the child has not been assigned a birth number, the name and, where applicable, the names, surnames and date of birth; and

(j) data on the endowment to the extent:

1. the birth numbers of the adopters; in the event that the acquirer has not been assigned a birth number, name details, names, surname and date of birth of the acquirer,

2. birth numbers of the father and mother; if they have not been allocated, the names, surnames and date of birth, and

3. the date on which the adoption or revocation decision becomes final.

(6) The indication used under paragraph 1 (d) is the birth number.

ČÁST DRUHÁ

INTEGRATED DATA BREAKDOWN

HLAVA I

COMMON PROVISIONS

§ 7

(1) An integrated data interface is a public administration information system, the interconnected components of which consist of the following information systems and services:

(a) tribal health registers;

(b) trust services;

(c) central electronic health services; and

(d) journalism of activities.

(2) The administrator of the Integrated Data Interface is the Ministry, the operator is the Institute of Health Information and Statistics of the Czech Republic (hereinafter referred to as the Statistical Institute). The Statistical Institute is the processor of personal data according to the legislation governing the processing of personal data (5) for the needs of the management of tribal health registers.

(3) The integrated data interface ensures free of charge

(a) immediate communication to the beneficiaries

1. an identifier of a health worker kept in the Stem Register of Health Workers referred to in Article 21 (1) (a);

2. the patient identifier kept in the Stem Patient Register pursuant to Article 23 (1) (a); and

3. the identity number of the person (hereinafter referred to as "the identification number") of the health service provider maintained in the Stem Register of health service providers referred to in Article 19 (1) (a);

(b) continuous access by authorised persons, except the patient, to trust services pursuant to Article 26 (1);

(c) continuous access by authorised persons to the data kept in the tribal health registers referred to in Article 16 (1);

(d) patients' access to all data on them in the Integrated Data Interface; and

(e) access by the health service provider to the Stem Register of Health Service Providers for registration under § 19 (3) (b), the Health Service Provider for registration under § 23 (2) (c) and the patient for registration under § 23 (2) (d).

§ 8

(1) The Ministry processes the log data through the central health registers in the Integrated Data Interface

(a) providers of health services and persons established or established in another Member State of the European Union, the European Economic Area or the Swiss Confederation (hereinafter referred to as "another Member State") providing health services on the territory of the Czech Republic without authorisation to provide health services under the Health Services Act (hereinafter referred to as "a person established or established in another Member State providing health services") to the extent maintained in the Stem Register of Health Service Providers pursuant to Article 19 (1) and (2);

(b) a health worker to the extent kept in the Stem Register of Medical Workers referred to in Article 21 (1); and

(c) the patient to the extent kept in the Tribal Patient Register pursuant to Article 23 (1).

(2) The Ministry, as administrator of the Integrated Data Interface, records activities carried out by authorised and registered persons in the Integrated Data Interface in the Journal of Activities under Section 37.

(3) The Ministry shall keep:

(a) tribal data in the Stem Register of Health Service Providers for a period of 10 years from the date of expiry of the authorisation to provide health services;

(b) tribal data in the Stem Register of Health Workers for a period of 10 years from the date of death of the healthcare professional they are kept for or from the date on which the decision on the court's death declaration is taken;

(c) tribal data in the Tribal Register of Patients for a period of 50 years from the date of death of the patient or from the date on which the decision on the court's death declaration was taken; and

(d) records in the journal of activities for a period of 2 years from the date of their creation.

§ 9

An integrated data interface is not publicly available unless otherwise provided by this law.

§ 10

The Statistical Institute creates and publishes operational documentation of the Integrated Data Interface on the Electronic Health Portal. This dossier shall specify:

(a) the procedure, the description of the interface and the conditions for communication of authorised and registered persons with the Integrated Data Interface, including their mobile applications and portal solutions for patients;

(b) the form of the health care professional identifier in which this information is provided from the Stem Register to authorised persons;

(c) the form of the patient identifier in which this data from the Patient Stem Register is provided to authorised persons;

(d) the process of issuing department certificates for guaranteed electronic signatures and department system and personal certificates for access to an Integrated Data Interface for health service providers;

(e) a description of the service providing and providing departmental electronic time stamps and remote sealing services;

(f) the procedure, manner, structure and form of entry of personal and other data in the national health registers;

(g) the characteristics of the instrument for managing the identities of authorised personnel, including rules on the allocation, modification and deletion of access data of authorised personnel pursuant to Article 5 (a) (2);

(h) a description of the service providing and providing communication with the information systems of authorised and registered persons and the interconnection of the central services of electronic health; and

(i) a description of the service providing and providing the EZKarta communication with information systems under other legislation.

HLAVA II

ACCESS TO INTEGRATED DATA BREAKDOWN

§ 11

(1) An authorised or recording person accedes to the integrated data interface, with the exception of a patient and a third person who is:

(a) a legal or business natural person, through his information system, which has been equipped with a departmental system certificate for access to an Integrated Data Interface by automated means or through an authorised staff member;

(b) by a natural person, using remote access using electronic identification means under the Electronic Identification Act (6) through the Electronic Health Portal;

(c) by a health professional, by means of personal access certificates to ensure access of health professionals to an Integrated Data Interface.

(2) The authorised or registered person who has assigned access data to his information system is accessing the Integrated Data Interface.

§ 12

(1) The patient and third party approach the Integrated Data Interface using remote access using electronic identification under the Electronic Identification Act (6) via the Electronic Health Portal.

(2) The patient and third party are required to demonstrate their identity in connection with the use of the Integrated Data Interface.

HLAVA III

IDENTIFICATION OF HEALTH WORKERS AND PATIENTS

§ 13

(1) The health professional identifier is assigned by the Ministry when the health worker is entered in the Stem Register of Health Workers.

(2) The patient identifier is assigned by the Ministry when the patient is entered in the Tribal Patient Register.

(3) Each health professional shall be identified by only one health professional identifier. Each patient is identified by only one patient identifier. The health care professional's identifier shall not be consistent with the patient's identifier.

(4) The health professional identifier and patient identifier cannot be changed after allocation unless otherwise provided for in this law.

§ 14

(1) If the same identifier has been assigned to a health professional and patient, or to two or more healthcare professionals or patients, the Ministry shall cancel and assign a new identifier to all healthcare professionals and patients concerned.

(2) Where two or more health professional or patient identifiers are assigned to one health professional or patient, the same procedure shall be applied mutatis mutandis in accordance with paragraph 1.

§ 15

(1) The Ministry will assign a new health professional identifier or a new patient identifier based on:

(a) a request from a health professional, if it is a health worker's identifier or a patient, if the patient's identifier is misused or suspected of being misused; or

(b) ex officio in the case of a procedure under Paragraph 14, or where the Ministry assesses the high risk of misuse of the identifier in the context of an identified cyber security incident.

(2) The Ministry will assign a new health professional identifier or patient identifier within the deadline

(a) within 30 days of the date of receipt of the request referred to in paragraph 1 (a); or

(b) without undue delay if there is an ex officio change in the health professional identifier or patient identifier referred to in paragraph 1 (b).

(3) The application referred to in paragraph 1 (a) shall contain:

(a) identification of the health care professional or patient;

(b) the identifier or identifiers of the health care professional or patient whose change is required; and

(c) the justification for the required change of identifier.

(4) The application referred to in paragraph 1 (a) shall be accompanied by documents showing who the health professional identifier or the patient's identity has been identified and misused. If such documents cannot be attached, the applicant shall accompany the application with a description of the facts giving rise to the presumption that the health professional identifier or patient identifier has been misused.

(5) The application referred to in paragraph 1 (a) may be made in paper form with an officially certified signature or in a way that allows remote access, where the application is signed in a manner which links the effects of the handwritten signature to another legislation).

(6) In the event of a change or cancellation of a health worker's or patient's identifier, the Ministry will ensure that historical data linked to the changed or deleted health worker's or patient's identifier is paired with the newly assigned health worker's or patient's identifier in the Integrated Data Interface.

HLAVA IV

PARTS OF INTEGRATED DATA BREAKDOWN

Díl 1

Stem medical registers

§ 16

(1) Stem medical registers are:

(a) Stem register of health service providers,

(b) the Stem Register of Health Workers; and

c) Stem registry of patients.

(2) Stem medical registers are used for

(a) keeping clear and correct data on health service providers, healthcare professionals and patients; and

(b) identification of health service providers, healthcare professionals and patients.

(3) Services providing links to basic registers under the Basic Registers Act (8) are part of the tribal health registers.

(4) The tribal indication is used by the beneficiary without verifying its accuracy.

§ 17

(1) The tribal indication is considered to be correct if the opposite is not demonstrated or if there is no legitimate doubt as to its correctness. In the event of a legitimate doubt as to the correctness of the data, the recording person shall identify that data as incorrect without undue delay. This marking shall be removed by the recording person without delay after verifying the accuracy of the data.

(2) For the period during which it is so designated, the tribal indication identified as incorrect only has an informative nature.

(3) It is considered that the beneficiary, which is based on the tribal data, is in good faith that the situation of the data is consistent with the actual situation of the case, unless he or she knew or should have known of the error.

(4) The person who acts in confidence in the accuracy of the tribal data may not object to the fact that the data does not correspond to the facts unless he proves that the data is incorrect and did not cause it to be incorrect.

§ 18

(1) The entry person shall enter or make an amendment or rectification without undue delay, but no later than 3 working days from the date on which he or she becomes aware of the occurrence or change of the fact which he or she describes, unless otherwise specified. Changes to the patient and health care professionals' log data shall be entered by the Ministry in the tribal register concerned.

(2) An authorised person who is not a recording person, if, in his or her activity, he or she finds a non-compliance of the tribal data with the actual situation, or if he or she has reasonable doubts as to the accuracy of the tribal data, he or she shall immediately inform the Ministry of the entry of the data concerned in the relevant tribal health register, or if he or she is not aware of the entry of the data concerned.

(3) If the Ministry finds, in the course of an inspection or other activity under its jurisdiction under this Act, that the log data is not in conformity with the actual situation, or where there is reasonable doubt as to the accuracy of the log data, it shall immediately inform the person entering the data concerned in the relevant log health register. The Ministry, where it receives the information referred to in paragraph 2, shall proceed mutatis mutandis in accordance with the first sentence.

Citation	Act No. 325 / 2021 Coll., on Electronic Health
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	08.09.2021
Effective from	01.01.2022
Effective until	-
Status	Valid

Act No. 325 / 2021 Coll.

The Act on Electronic Health

Contents

ČÁST PRVNÍ

§ 1

§ 2

§ 3

§ 4

§ 5

§ 6

ČÁST DRUHÁ

HLAVA I

§ 7

§ 8

§ 9

§ 10

HLAVA II

§ 11

§ 12

HLAVA III

§ 13

§ 14

§ 15

HLAVA IV

Díl 1

§ 16

§ 17

§ 18

Contents

Comments 0

Regulation Information

Public Contracts 5

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