What is Decree No. 444 / 2024 Coll.?

Decree No. 444 / 2024 Coll., on Health Documentation — Order on medical documentation.

When it became Decree No. 444 / 2024 Coll. effectiveness?

Decree No. 444 / 2024 Coll. became effective 01.01.2025.

Is Decree No. 444 / 2024 Coll. still valid?

Yes, Decree No. 444 / 2024 Coll. is still valid and effective.

How many times was it Decree No. 444 / 2024 Coll. amended?

Decree No. 444 / 2024 Coll. has 3 time versions of the text.

Decree No. 444 / 2024 Coll. - Order on medical documentation

444

DECLARATION

of 19 December 2024

on health documentation

The Ministry of Health provides, pursuant to Section 120 of Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Act on Health Services), as amended by Act No. 111 / 2019 Coll., Act No. 326 / 2021 Coll. and Act No. 240 / 2024 Coll., to implement Sections 69 (a) to (g) and § 69c (2) of the Act on Health Services:

§ 1

Subject matter

This decree provides

(a) the content and particulars of the medical file;

(b) the methods of processing the medical file;

(c) the patient summary and other parts of the medical documentation which can be transmitted through the National Contact Point to the national contact point of the European Union State;

(d) time limits for record-keeping and authorisation of medical documentation;

(e) the storage period of the medical file; and

(f) the procedure for the disposal of medical documentation.

Contents and formalities of medical documentation

§ 2

The medical documentation shall contain information on the patient's medical condition and the facts related to the provision of the patient's health services, namely:

(a) the provider's identification data which are:

1. the name and, where applicable, the names of the provider, if any, if any,

2. in the case of a legal person, the business firm or the name and address of the registered office, in the case of a legal person having its registered office outside the Czech Republic, also the place of establishment of the establishment or organisational component of the establishment of the legal person in the Czech Republic,

3. the person's identification number, if assigned,

4. address of the place of provision of health services,

5. the name of the department or similar part where the health establishment of the provider is so divided (hereinafter referred to as "the department of the medical establishment"),

(b) patient identification and contact details, which are:

1. name and / or name of patient,

2. the date of birth, or, where appropriate, the birth number, the number of the insured person in public health insurance and the health insurance code, the number and type of the identification document; information on the number and type of identification document shall not be provided for children to whom the document has not been issued and persons restricted to freedom;

3. the address of the place of permanent residence in the territory of the Czech Republic, if it is a foreigner, the place of registered residence in the territory of the Czech Republic, and, 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, if known,

4. the address for delivery, if not identical to the address referred to in point 3, and if communicated to the patient,

5. telephone number, e-mail address and, where applicable, other contact details if communicated to the patient,

6. patient identifier,

(c) the sex of the patient identified after birth;

(d) the name and, where applicable, the name and surname of the health professional or other professional, and, in the case of a health file kept in electronic form, the identification of the health professional who made the entry into the health file; This does not apply in the case of a provider who is a natural or legal person and who carries out records in the health file as the only person within the provider;

(e) the date and time of the emergency medical care or of the patient's visit;

(f) in the case of provision of overnight or bed care

1. the date and time of taking care of the patient and the date and time of termination of care of the patient;

2. information on how a person should be informed, which should provide additional care for a patient who cannot do without the assistance of another person due to his or her medical condition, or on the manner and time of the submission of information on the intended release of that patient to the competent municipal authority,

3. the date and time of transfer of the patient to another provider or, where appropriate, to another department of the medical establishment; or

4. the date and time of death of the patient, if death occurred in the provision of overnight or bed care;

(g) information on the course and outcome of the health services provided and other relevant circumstances relating to the patient's health status and the procedure for providing health services, including the anamnistic data needed for the provision of health services and for the preparation of social security assessments;

(h) information as to whether the patient is a patient with limited competence in such a way that he has limited capacity to assess the provision of health services or, where appropriate, the consequences of such provision, and the extent of that limitation;

(i) the identification and contact details of the legal representative of the patient, the guardian of the patient or of any other person authorised to give consent for the patient, the identity and contact details of the confidant or the supporter;

(j) identification and contact details of the registered patient provider in the field of general medical practice or in the field of practical medicine for children and adolescents or pediatrics, if known;

(k) in the case of a patient with disabilities, information on the necessary medical devices and, where appropriate, specific equipment used by the patient;

(l) for a patient and legal representative with auditory impairment, combined auditory and visual impairment or severe communication problems caused by medical reasons, information on the forms of communication the patient prefers and the provider of the chosen form of communication with the patient;

(m) an indication of the communication language of the patient, if different from the Czech or Slovak language, and of the means of communication chosen,

(n) for persons carrying out epidemiologically serious activities (1) a record of the activity carried out;

o) information on substance abuse and on the implementation of short intervention under the Health Protection Act against the harmful effects of addiction2),

(p) information that the patient holds a driving licence,

(q) information that the patient holds an armaments licence;

(r) information that the patient is a person with disabilities under another legislation (3);

s) in patients performing protective treatment in constitutional form

1. a record of the individually determined risks and protective factors underlying its social hazards and a record of their periodic reassessment, at least every 6 months;

2. reports on the course of protective treatment processed by the court provider.

§ 3

(1) The medical documentation further contains:

(a) working conclusions and final diagnosis;

(b) recommendations for further treatment and information on the course of the provision of health services if the patient's medical condition so requires;

(c) a record of the scope of the health services provided or requested;

(d) a record of the current state of health as assessed by the patient and a targeted objective finding;

(e) a record of:

1. prescribing of medicinal products, food for special medical purposes, including dosage and number of prescribed packages4),

2. the administration of medicinal products or foodstuffs for special medical purposes, including the quantity administered; in the case of the administration of the transfusion product, the unique record number of the transfusion product, including the code identifying the blood-service facility, the date and time of administration of the transfusion product and the signature of the health care professional in the case of the paper-based health file, in the case of the electronic health file kept by the healthcare professional who submitted the transfusion product,

3. the equipment of the patient with medicinal products, food for special medical purposes, including indication of their quantities, or medical devices,

(f) a record of the application of human tissues and cells5) to the patient, including the date of implementation, the indication of the single European code and the tissue establishment code which released the product;

(g) a record of the issuing of the transport order, including the type of means of transport; a copy or a copy of the transport order shall be considered as such,

(h) records of nursing care provided, including records of rehabilitation care provided;

(i) the record of vaccination, including the date of vaccination, the name of the vaccine and the batch number, in the case of the provider who has carried out the vaccination;

(j) the written consent of the patient or his legal representative, guardian or other persons authorised to give consent to the provision of health services as a patient, where the obligation of the written form of consent is provided for in another legislative act (6), or where, taking into account the nature of the health performance, consent has been requested by the provider in writing;

(k) a record of consent to the provision of health services and the manner in which it is provided in the case of a patient or legal representative, guardian or other persons authorised to give consent to the provision of health services with a hearing disability or combined hearing and visual impairment;

(l) a record of refusal to provide health services;

(m) a record of the provision of urgent care without consent, which shall include a record of the indication of urgent care, including an indication of the particular reason and purpose for the provision of such care and the patient's attitude towards providing it;

(n) a record of patient hospitalisation without consent (7), which contains:

1. record of the indication of hospitalisation without consent, reason and purpose of hospitalisation;

2. the time of commencement and termination of hospitalization without consent;

3. in the case of hospitalisation of a patient without consent pursuant to § 38 (1) (b) of the Health Services Act, a description of the threats and indication of the milder procedures which have been considered and the reason why they were not used or why they were not effective if they were used,

4. records of the continuous evaluation of the duration of hospitalisation reasons without consent and of the continuous evaluation of the patient's state of health during hospitalisation without consent;

5. name and / or surname, and, in the case of a medical file kept in electronic form, also the identifier of the doctor who indicated the patient's hospitalisation without consent;

6. a record of the date and time of the patient's hospitalisation without consent to persons who are obliged to inform the provider under the Health Services Act (8),

7. written additional consent to hospitalisation if such consent was granted 9),

(o) a record of the use of limiting agents (10) against the patient containing:

1. a record of the indication of the restriction, including a specification of the type, reason and purpose of the restriction, including a description of the threat to which the restriction device has been used for the purpose of deterrence and the determination of the intervals of checks and their extent; it must also indicate the milder procedure applied unsuccessfully or why it was not sufficient to use a milder procedure than the use of limiting devices,

2. the time at which the device is to start and end,

3. records of the continuous assessment of the duration of the reasons for the use of the device;

4. records of the patient's ongoing health assessment during the restriction;

5. in the event of complications, their description and method of handling;

6. the name and, where applicable, the name and surname, in the case of a health file kept in electronic form, also the identifier of the health professional who indicated the use of the restraint; in the event that the use of the device has not been indicated by the doctor, the name or, where applicable, the name and surname, in the case of a medical file kept in electronic form, also the identifier of the doctor who was subsequently informed of the use of the device;

7. If the use of the device has not been indicated by the doctor, the doctor's record of the assessment of the justification of the restriction, including the time at which it was confirmed,

8. Name, if any, and surname, and, in the case of a medical file kept in electronic form, also the identifier of the health care professional who terminated the use of the restraint;

9. Record of the date, time and manner of informing the patient of the reasons for using the device;

10. record of the date and time of submission of information on the use of limitation devices to persons who are obliged to inform the provider under the Health Services Act (11),

11. a record of a demonstrable additional consent to the use of restrictive devices, if such consent has been given,

(p) a record of the exercise of supervision and form of supervision of a Member of the Prison Service in the case of the provision of health services to persons in custody, a custodial sentence or security detention, and persons restricted to freedom,

(q) copies of medical opinions; This does not apply to social security assessments,

(r) in the case of the provision of requested health services, also a request issued by another provider;

(s) a record of the implementation and conduct of the console, including identification details of the provider or health care professional involved in the console;

(t) a record of inspection of the patient-led medical file, indicating when, and to what extent the inspection took place, including a record of a copy or extract of the medical file, if any, a record of the lodging12) a patient-led medical file indicating when, when and to what extent the loan took place;

(u) a record of the issue of a temporary incapacity decision or of the decision to terminate temporary incapacity, the result of the health assessment during its duration, the details of the temporary work arrangements of the incapacitated insured person and the changes thereto, the record of the start of the need for care or care and its duration; a record of the need for long-term nursing care, including a record of the issuing of the corresponding decisions and certificates, of events related to the creation of entitlement to monetary assistance in maternity and compensation in pregnancy and maternity, the termination of temporary incapacity for work shall be carried out by the provider who kept the patient in the register of temporary work of incompetent citizens before its termination; if the patient has been transferred to the register of another provider or taken from another provider during a temporary incapacity for work, the health file shall also contain a record of the date on which he was transferred or taken over;

(v) medical records of the sickness insurance authority related to health assessment, temporary incapacity for work and nursing needs and long-term care,

(w) records of other relevant circumstances relating to the patient's medical condition identified in connection with the provision of health services;

(x) a record of a doctor's suspicion of an abused, abused and neglected child, of the measures taken and of the fulfilment of the reporting obligation in accordance with the relevant legislation13),

(y) a record of the doctor's suspicion of the victim of violence and of the measures taken, which shall include:

1. a description of events, treatment and subsequent physical and psychological manifestations as reported by the patient;

2. a record of an objective finding with a detailed description of the injuries or other signs of violence and their location on the body, including, if possible, colour photographs;

3. a record of the measures taken,

(z) a record of the finding of facts indicating that a patient who is a person restricted to freedom may have been subjected to maltreatment.

(2) The content and particulars requirements of the individual parts of the medical file are set out in Annex 1 to this Decree. The individual parts of the medical file shall always contain the data and information referred to in Sections 2 (a), 2 (b) and 2 (d), unless otherwise specified in Annex 1.

(3) The medical documentation of the provider who has decided to manage the patient summary shall also contain data and records which are relevant to the management of the patient summary, to the extent set out in Annex 2 to this Regulation.

§ 4

(1) The medical file also contains:

(a) reports from examinations, including laboratory reports in the form of written descriptions, graphic, audiovisual, digital or other similar records of such examinations, operational protocol, anaesthesiological record;

(b) information on the identified facts on the patient's health status, the course and termination of the provision of health services or recommendations and proposals for the provision of other health services, or social services, which are provided by providers to ensure the continuity of health services,

(c) in the case of bed care of epicrinis and a plan for further treatment if the bed care lasts for more than 7 days; epicrithesis and plan for further treatment shall be recorded in the medical file at least every 7 days, in the case of long-term bed care or subsequent bed care in the field of psychiatry at least once a month,

(d) in the case of occupational health services, data on the content and conditions of work for which the worker's health is monitored, including data on the inclusion of individual environmental factors in the relevant category14), the results of biological exposure tests, the dose of ionising radiation, and other data relevant to the assessment of the impact of working conditions on the health of the worker, as well as written information on the existing health status or the development of the occupational health status transmitted by the registered provider in the field of general practice, practical medicine for children and youth or pediatrics;

(e) records of investigative, therapeutic or administrative performances carried out under other legislation15), including patient health records, and copies of reports, information and data transmitted under these other legislations;

(f) records of adverse events related to the provision of health services, the administration of a medicinal product, using a medical device, the administration of a medicinal product in a clinical trial, including the identification of an EU clinical trial by the study number or the use of a medical device in a clinical trial, and records of a category A or B radiological event in which tissue reactions caused by faulty irradiation may adversely affect the patient's health status or, because of a radiological event, changes in his treatment procedure are necessary, to the extent that other legislation16),

(g) records of the verification of new procedures using a method which has not yet been introduced in human clinical practice (17);

(h) a record of the reporting of infectious diseases, suspicion of infectious diseases, death of infectious diseases or exclusion of infectious diseases agents locally to the competent public health authority to fulfil the obligation under the Public Health Protection Act;

(i) a record of the transmission of the medical file or part thereof, or, where appropriate, a copy thereof, an extract thereof,

(j) a record of preventive inspections carried out, including the date of their implementation.

(2) The medical documentation of the emergency care services also contains:

(a) a written, audible or, where applicable, visual record of the reception of calls to the national emergency number 155 and of calls transmitted by the operational centre to other essential components of the integrated emergency system (hereinafter referred to as emergency calls);

(b) a written record of the operator transmitted to the exit group if it is made or, where appropriate, an audio record of the operator's call for the message to the exit group;

(c) a written, sound or visual recording of the exit group, as appropriate, taken in connection with the emergency call activity of the exit group;

(d) identification and sorting card,

(e) a record of patient mass redeployment.

§ 5

Paper-based processing of medical documentation

Each sheet of the medical file kept in paper form shall bear the name and, where applicable, the name and surname and patient identifier, the date of birth and, where applicable, the patient's birth and birth number, the provider's identification details to the extent of the name and, where applicable, the name of the provider in the case of a natural person, a business name or the name of the provider in the case of a legal person and the identity of the person, if any, the name of the medical establishment department.

Electronic processing of medical documentation

§ 6

The information system in which the medical file is kept in electronic form shall record all activities carried out in the medical file and ensure the functions necessary for the disposal of the medical file.

§ 7

(1) In order to store records in electronic form, the provider is obliged to use technical means to ensure that data cannot be adjusted retrospectively in the records made; technical means are organisational technical measures, information systems, technical equipment and selected working procedures excluding the possibility of subsequent modification of the stored records.

(2) The information system in which the health file is kept electronically records the list of record identifiers in the electronic patient documentation kept by the provider.

(3) Security copies of data from information systems shall be made at least once a day if the information system has changed on that day to technical means other than those on which the original data are placed.

(4) Before the expiry of the service life of the technical record carrier, the provider shall ensure the transmission of the alert to another technical data carrier.

(5) The storage of copies of data for long-term preservation shall be carried out in a way which prevents additional interference in such copies; such copies shall be made at least once per calendar year.

(6) When retaining copies for long-term storage on a technical data medium, access to such data shall be ensured only to authorised persons and their legibility shall be ensured for at least the period provided for in the maintenance of the medical file.

(7) Documents in paper form, which are parts of the medical file, shall be accompanied by a clause confirming the transfer, signed by a departmental or recognised electronic signature, of the person who made the transfer and a time stamp, when transferred to the electronic form. A paper document which has been converted by the provider into an electronic document shall be authorised to destroy the provider.

(8) The provider will transfer the outputs from the medical file at the request of the patient into paper form. Where a transfer has taken place in paper form, the date of the transfer shall be indicated, the signature of the health professional or of any other professional who has carried out the transfer and the name and surname of the person, if any.

(9) The information system in which the health file is kept must enable the processing of the health file in a readable and processed format as well as in another information system provided for by the electronic health standard issued under the Law on the electronic health system.

Patient Summary

§ 8

(1) For the purpose of providing basic data on the patient's health status through the National Contact Point, the patient summary is conducted electronically and structurally by another provider in code systems which allow communication between the National Contact Point and the Provider who directs and transfers the patient's Summary to the National Contact Point. Code systems for patient summary management are publicly available on the Ministry of Health website. The content and structure of the patient summary is set out in Annex 2 to this Decree.

(2) A patient summary may be maintained for the purpose of transmitting to the National Contact Point, provided that the patient summary provider ensures its continued availability. The patient summary is provided through the individual interface of the provider or the exchange platform of multiple providers.

(3) The provider who decides on the management of the patient summary for the purposes of establishing access to the National Contact Point shall report to the administrator of the National Contact Point through a data message to the data box of the management of the patient summary. The notification shall include:

(a) the provider's identification details to the extent of the trading firm or the name and identification number of the person, if assigned;

(b) the address of the information system interface of the provider for communication with the National Contact Point;

(c) the provider's encryption certificate for communication with the National Contact Point; and

(d) the provision of the patient summary referred to in the second sentence of paragraph 2.

(4) The provider shall at the same time attach to the notification referred to in paragraph 3 a protocol demonstrating the conformity test of the interface of the information system operated in accordance with the operational documentation of the National Contact Point. The national contact point administrator shall ensure that the conformity test is carried out. The operational documentation of the National Contact Point is publicly available on the Ministry of Health website.

§ 9

(1) The requirement for a patient summary submitted through the National Contact Point to the provider who has notified the National Contact Point of the management and provision of the patient summary

(a) the patient's identification data according to § 2 (b) (1) and (2); and

(b) the identification data of the provider of another European Union State and its healthcare professional requesting a patient summary.

(2) The patient summary requirement is transmitted via the provider's information system interface, which has been notified to the National Contact Point pursuant to Article 8 (3) (b).

§ 10

Other parts of the medical documentation which can be transmitted via the National Contact Point to the National Contact Point of the European Union State

(1) Through the National Contact Point, the national contact point of the European Union State may be used to provide information on the termination of overnight or bed care or a report on the health services provided.

(2) Paragraphs 8 (2) to (4) and 9 shall apply mutatis mutandis to the management and transmission of other parts of the medical documentation referred to in paragraph 1.

§ 11

Time limits for record-making and authorisation of medical documentation following types and forms of healthcare

(1) Entry into the health file shall be made by the provider without delay, unless otherwise provided for in this Decree.

(2) The bed care provider shall record the healthcare provided at least once every 24 hours.

(3) Authorisation of the alert shall take place no later than during the day or the shift in which the alert was made.

§ 12

The entry in the medical file may be signed by the patient or, where appropriate, his legal representative by a qualified electronic signature, a guaranteed electronic signature, a recognised electronic signature or a dynamic biometric signature.

§ 13

Maintenance period of medical documentation

(1) The periods of retention of medical documentation or parts thereof are set out in Annex 3 to this Decree. The medical documentation shall not be destroyed before the expiry of the storage period.

(2) The maintenance period of the medical file begins on 1 January of the following calendar year after the date on which the last entry in the patient's medical file was made, unless otherwise specified in Annex 3 to this Decree.

(3) Where the medical file, or its individual parts, its inclusion or material content, are subject to different periods for its preservation in accordance with Annex 3 to this Regulation, the retention period and the event relevant to the calculation of the running time shall be determined according to the longest retention period. If the individual part of the contents of the medical file is concerned, the retention period may be determined and the event shall be determined separately for each individual part of the medical file.

Procedure for the disposal of medical documentation, details of the procedure for the selection of archives and how to destroy medical documentation after the expiry of the storage period

§ 14

(1) At the end of the maintenance period, the provider shall assess whether the health documentation is necessary for the further provision of health services ("Needs Assessment ').

(2) All medical documentation for which a retention period has elapsed shall be the subject of an assessment of the need. Without assessing the facts relevant for the expiry of the deadline set for the maintenance of the medical file and the need for the medical file, the medical file cannot be destroyed.

§ 15

(1) After assessing the need, the provider shall draw up a proposal for the disposal of the medical file containing the provider's identification data and the health care professional's identification data that has been drafted.

(2) A list of the medical file shall be attached to the proposal for the decommissioning of the medical file. The proposal to exclude the medical documentation shall be signed by the healthcare professional who drew up the proposal.

§ 16

(1) The relevant archive, after examining the list of medical documentation proposed for elimination, sent by the provider to the relevant archive by the Health Services Act and after selecting the archives, shall transmit to the provider a record of the archival selection carried out. The archive selection protocol shall contain an inventory of the medical documentation or parts thereof selected for archival purposes. The provider shall forward to the competent archives the documentation in paper form chosen as archival within the time limit specified by the archive; where the medical documentation is paper-based, registered in electronic form, the provider shall also transmit metadata belonging to it. Where health documentation is selected as archival in electronic form, the provider shall transmit its replicas and metadata to the relevant archive. If the archive concerned does not select any medical documentation or any part of it as archival, it shall indicate that fact in the archive selection report.

(2) The records concerned shall include an official record of the transmission of the medical documentation, selected as archives, including an inventory of the medical documentation transmitted; for each document in electronic form, indicate its record identifier. The official record referred to in the first sentence shall contain at least:

(a) the identification details of the provider for which the expert archive inspection was carried out;

(b) the name of the archive to which the medical file selected as the archive will be placed in custody and the address of the archive's registered office;

(c) the quantity and description of the state of the health file transmitted in paper form, selected as archivaly and replica transmitted in electronic form, selected as archivaly,

(d) the date of transmission;

(e) the name and, where appropriate, the names and the surname and function of the natural person responsible for signing the official record and its signature.

§ 17

(1) Medical documentation for disposal not selected for archival purposes must be destroyed. The provider shall proceed with the destruction of the medical documentation by devaluating the medical documentation in paper form in a form which prevents its reconstruction and identification of the contents. In the case of medical documentation in electronic form, the provider shall carry out its destruction by deleting it from the provider's electronic system and other storage sites. Similarly, the provider progresses in destroying the medical documentation in electronic form, which was selected as archival and which he passed on to the digital archive.

(2) The provider shall establish and maintain an alert containing an inventory of the destroyed medical file, together with information on when, how and by whom the medical file has been destroyed; the inventory may contain patient identification data. The record shall be kept for 40 years.

§ 18

The administrative authority, which has taken over the medical documentation under the Health Services Act, shall proceed mutatis mutandis to the disposal of the medical documentation, the selection of archives and the destruction of the medical documentation after the expiry of the retention period under § 15 to 17.

§ 19

Transitional provision

The obligation to indicate the patient identifier or the healthcare professional identifier shall not apply until 31 December 2025.

Citation	Decree No. 444 / 2024 Coll., on Health Documentation
Regulation Type	Order
Author	-
Collection	Code of Laws

Date of Promulgation	20.12.2024
Effective from	01.01.2025
Effective until	-
Status	Valid

Decree No. 444 / 2024 Coll.

Order on medical documentation

Contents

§ 1

§ 2

§ 3

§ 4

§ 5

§ 6

§ 7

§ 8

§ 9

§ 10

§ 11

§ 12

§ 13

§ 14

§ 15

§ 16

§ 17

§ 18

§ 19

Contents

Comments 0

Regulation Information

Public Contracts 5

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