Act No. 240 / 2024 Coll.
Act amending Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Health Services Act), as amended, and other related laws
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Law
Effective from 01.10.2024
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240
THE LAW
of 10 July 2024
amending Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Health Services Act), as amended, and other related laws
Parliament has decided on this law of the Czech Republic:
Amendment to the Health Services Act
Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Act on Health Services), as amended by Act No. 167 / 2012 Coll., Act No. 437 / 2012 Coll., Act No. 66 / 2013 Coll., Act No. 45 / 2019 Coll., Act No. 2019 Coll., Act No. 60 / 2014 Coll., Act No. 205 / 2015 Coll., Act No. 251 / 2017 Coll., Act No. 290 / 2017 Coll., Act No. 126 / 2016 Coll., Act No. 147 / 2016 Coll., Act No. 183 / 2017 Coll., Act No. 193 / 2017 Coll., Act No. 205 / 2017 Coll., Act No. 264 / 2016 Coll.
1. in Article 2 (2) (e) (3), the words "and medical devices" shall be replaced by the words "and medical devices and in vitro diagnostic medical devices (" medical devices ")."
2. in Article 5 (2) (i), the words "the Law on medical devices (13)" shall be replaced by the words "the Law on medical devices and diagnostic medical devices in vitro13";
Footnote 13 reads:
"13) Act No. 375 / 2022 Coll., on in vitro medical devices and diagnostic medical devices."
3. In Article 11 (5), at the end of point (g), the word "or 'is replaced by a comma.
4. In Article 11 (5), at the end of point (h), the dot is replaced by "or 'and the following point (i) is added:
"(i) telemedicine health services pursuant to § 11c (2)."
5. Paragraph 11 (5) reads as follows:
"(5) Health services may be provided only in medical establishments in the places specified in the authorisation to provide health services, unless otherwise specified. Outside medical facilities may be provided
(a) consulting services;
(b) health services provided by the mental health centre pursuant to Section 44b;
(c) preventive care under Article 11a;
(d) health care provided in the patient's own social environment;
(e) medical transport services and the transport of patients with urgent care;
(f) pre-hospital emergency care provided in the framework of the emergency care service;
(g) health services provided in crisis situations and in medical security of military training in mobile equipment of the armed forces intended to provide health services in such situations;
(h) inspection of the body of the deceased outside the health care establishment pursuant to Article 84 (2) (a) or (b);
(i) the transport of the body of the deceased to and from the autopsy in accordance with the mortician law; or
(j) telemedicine health services pursuant to § 11c (2).
Consultation services outside a medical facility may be provided via remote access or in the patient's own social environment or at a different location of its actual occurrence. A provider which provides only domestic care or only inspections of the bodies of the deceased outside a medical facility shall have contact centres. ';
6. In Article 11 (8), the text "§ 53 (1) 'is replaced by" § 54'.
7. Paragraph 11a (8) is deleted.
8. After Paragraph 11b, the following Section 11c is inserted:
Telemedicine health services
(1) Telemedicine health services are health services provided at a distance using information and telecommunications technologies or a medical device. Telemedicine health services can only be provided if technical requirements for communication quality and safety are met, the communication channel is encrypted and a demonstration of the identity of the communicating parties is ensured. The communication log can only be recorded by the provider with the consent of the patient.
(2) Telemedicine medical services may also be provided outside medical facilities, provided that:
(a) their provision without the presence of a patient consists only in the use of information and telecommunications technologies, possibly using remote access or a medical device; or
(b) their provision shall consist only in the fact that the information referred to in Article 53 (1) is obtained remotely or using a medical device and is automatically sent to the provider.
(3) The implementing act provides for:
(a) technical requirements for the quality and safety of communication and encryption of the communication channel;
(b) means of demonstrating the identity of the communicating parties;
(c) the method of expressing and recording the patient's consent or disagreement with the recording of the communication log between the provider and the patient. ';
9. In Article 15 (1) (b), the words "if the applicant is a legal person established by those ministries or 'shall be inserted after the words" the Ministry of Justice'.
10. in Article 15 (1) (c), the words "where the applicant is a legal person established by that Ministry" shall be inserted after the words "Ministry of the Interior."
11. in § 20 (3), the text "§ 53 (1)" is replaced by "§ 54."
12. In Part Six, Title I, including the title, is deleted.
Titles II and III shall be renumbered Titles I and II.
13.
(1) Health documentation is a set of information maintained, processed and stored by the provider for the purpose of providing health services to a specific patient, regardless of whether it was obtained from a patient, from another provider or from other persons or from the provider's own activities.
(2) Health documentation shall not be considered to be the information obtained by the provider in connection with the provision of health services, including from the medical documentation processed by him, provided that the purpose of their processing is not to provide health services to a specific patient but solely to a different purpose.
(3) In the context of processing personal data in medical documentation, the patient's birth number may be used.
The provider is required to maintain, process and store the medical documentation, unless:
(a) provision of pharmacy care at the pharmacy;
(b) the provision of health performance in the framework of preventive care outside medical facilities pursuant to § 11a except:
1. vaccination,
2. health services at least partially covered by public health insurance. ';
14. Article 54a is deleted.
15.
(1) The medical documentation shall be kept in paper form, electronic form or in combination with both.
(2) The medical documentation must be kept and processed in a verifiable, true, comprehensible and legible manner. ';
16. The following Sections 55a to 55c are inserted after Section 55:
(1) Any entry in a health file kept in electronic form shall be accompanied by an alert identifier which is always unique and in a format established by the standard of electronic health issued under the Health Electro-Management Act.
(2) The provider authorises individual records in the medical file.
(3) The provider shall authorise the records in paper-based health documentation or parts thereof in paper-based form by indicating the date and time of the record, the signature of the health professional or any other professional who has provided the health service and has confirmed the correctness of the record, and its name, if any, and surname.
(4) The provider shall authorise the records in the health file kept in electronic form or part thereof, which he shall transmit to another person, by providing them with:
(a) a ministerial electronic time stamp or qualified electronic time stamp and a guaranteed electronic seal based on an electronic seal certificate issued by the Ministry or recognised electronic seal of the provider; or
(b) a competent electronic time stamp or a qualified electronic time stamp; and
1. a guaranteed electronic signature of the health care professional who has made it, based on an electronic signature certificate issued by the Ministry containing the identification of the provider; or
2. a recognised electronic signature of the health care professional who has made them out if the signature is based on a qualified electronic signature certificate containing the identification of the provider.
(5) The provider shall authorise the records in the health file kept in electronic form or part thereof, which he does not transmit to another person, in a manner specified by that provider, which ensures that the authorisation can identify which person has confirmed its correctness, indicating the date and time of such recording.
(6) The provider shall not be obliged to authorise an alert in a medical file which is created by an automated medical device or other apparatus, provided that it is evident from such an alert or the information attached thereto that it has been created by a medical device or other apparatus and at what date and time it has been created.
(7) Corrections and additions to the authorised alert shall be made by a new alert and shall be carried out in such a way that the content of the alert can be established before the correction or addition. The addition or correction of the entry in the medical file at the request of the patient shall indicate that it is a repair or a supplement at the request of the patient.
If the provider processes data from the medical documentation for the purposes of science and research, it anonymises them so that the patient's identity is not identifiable. The information thus obtained shall not be considered as a medical dossier.
The information system in which the health documentation is kept in electronic form must enable the health documentation to be transferred to the output data format established by the electronic health standard under the Act on Electronic Health. '
17. the following § 55d is inserted after § 55c:
The provider shall be obliged to process written rules for the processing of medical documentation, including appropriate technical and organisational measures to ensure and be able to demonstrate that the processing of medical documentation is carried out under this law and is in accordance with the protection of personal data under other legislation. ';
18. in Paragraph 57 (3) (c), the words "these activities may only be carried out by a healthcare professional" shall be deleted;
19. In Paragraph 65 (2) of the Introductory Part of the provision, the words "for purposes arising from 'are replaced by the words" for the purpose of fulfilling the purposes of their mandate or for the exercise of the powers conferred upon them under'.
20. Paragraph 65 (2) (a), including footnote 64, reads as follows:
"(a) a provider's worker and a person in a similar position to the provider, where:
1. a person with competence to pursue a medical profession or another professional and involved in the provision of health services to a patient; or
2. a person performing other tasks under this Act or other legislation64),
64) For example Act No. 48 / 1997 Coll., as amended. '
21. in Article 65 (2) (c) and (d):
"(c) persons with a medical capacity authorised by the competent authority to draw up an expert opinion on the proposal for a review of the medical opinion;
(d) persons involved in the exercise of their duties and who are:
1. authorised to exercise control within the scope of their mandate under this law or other legislation;
2. persons with competence to pursue a medical profession entrusted and admitted to control within the scope of their mandate under this Act or other legislation;
3. responsible for handling the complaint under Part Eight of this Act in connection with the complaint;
4. established as an independent expert or appointed as a member of an independent expert commission pursuant to Paragraph 94 (3); or
5. authorised by the competent administrative authority, which has taken over the medical documentation under this Act, by making extracts or copies of the medical documentation to ensure the continuity of the patient's health services; ';
22. in Paragraph 65 (2) (f), the words "benefits for disabled persons" shall be inserted after the words "social services."
23. in Article 65 (2) (g), the words "with competence to pursue the health profession" shall be deleted;
24. in Article 65 (2) (i), the words "for the purposes of criminal proceedings or judicial proceedings under other laws" shall be replaced by the words "awarded by an authority acting in criminal proceedings or by a court."
25. in Paragraph 65 (2) (m), the words "and, under his authority, the staff of the Ombudsman's Office" shall be inserted after the words "rights," and the word "inquiries" shall be replaced by the words "exercise of their powers."
26. In Article 65 (2), at the end of point (p), the dot is replaced by a comma and the following points (q) and (r) are inserted:
"(q) a staff member of the appropriate archive who, after disabling the health documentation by the provider, carries out a selection of archives from the medical documentation according to § 68a;
r) an authorised member or employee of the Chamber in the framework of the exercise of disciplinary authority under the Act on the Czech Medical Chamber, the Czech Dental Chamber and the Czech Pharmacy Chamber. "
27. in Paragraph 65 (2) of the final part of the provision, the words "and (r)" shall be inserted after the words "to (n)."
28. in Paragraph 66 (3):
"(3) The provider may not, at the request of the person referred to in Article 65 (1) (a), require payment in connection with the acquisition of an extract or a copy of the medical file; This does not apply if that person requests to obtain an extract or a copy of the medical file repeatedly. In the case of a repeated application under the first sentence or the request of a person referred to in Article 65 (1) (b) or (c), the provider may require a remuneration of a amount which may not exceed the sum of the costs incurred in making and dispatching an extract or a copy of the medical file. The provider may not make the provision of an extract or a copy of the medical file subject to prior payment in accordance with the second sentence. '
29. The following Section 68a is inserted after Section 68:
Selection of archives from medical documentation
(1) The provider of which the Ministry is the founder will allow the relevant archive to be selected from the medical file after the time of storage of the medical file. Other providers may allow the appropriate archive to be selected from the medical file after the storage period has expired. To this end, the provider shall transmit to the relevant archive a list of the medical documentation proposed for the selection of the archives, indicating the time of its creation.
(2) Upon completion of the archival selection, the archives concerned shall draw up a record of the archival selection carried out and determine whose care the documents selected as archival will belong to. ';
30. Paragraph 69 reads:
Implementing legislation provides for:
(a) the content and formalities of the medical file and its individual parts, including the method of formulation, content and structure of the patient summary;
(b) the particulars of the requirement for a patient summary or parts of the medical file other than the patient summary submitted via the National Contact Point, including the manner in which it is requested and transmitted to the provider of another European Union State through the National Contact Point;
(c) parts of medical documentation other than patient summary which can be transmitted via the National Contact Point to the national contact point of the European Union State;
(d) details of the management and processing of medical documentation in their various forms, including requirements for technical means for the management and processing of medical documentation in electronic form;
(e) time limits for record-making and authorisation of medical documentation following the types and forms of healthcare;
(f) the storage period of the medical file, the procedure for the disposal of the medical file and the method of its destruction after the storage period and the details of the procedure for selecting the archives from the medical file;
(g) the form and method of signing the patient in case of entry into the medical file. ';
31. in Article 70 (1) (a), the words "clinical recommended procedures" shall be inserted after the words "quality indicators."
32. in Article 70 (1) (d), the words "on the effectiveness and performance of screening programmes," shall be inserted after the words "health."
33. In Paragraph 70, at the end of paragraph 1, the dot is replaced by a comma and the following point (g) is added:
"(g) to develop and optimise the classification system for setting up the system of emergency bed care payments.";
34. in Paragraph 70 (2) of the introductory part of the provision, "and (c)" is replaced by "to (d)."
35. In Paragraph 70, the following paragraph 9 is added:
"(9) In the processing of personal data in the National Health Information System, the patient's home number may be used. '
36. in Paragraph 72 (1) (e), the words "national health registers maintained" are replaced by the words "data taken from national health registers maintained."
37. in Article 72 (1) (f), the words "infectious diseases" shall be deleted;
38. in Article 73 (1) (a), the words "quality," and the words "treatment procedures" shall be inserted after the words "including clinical recommended procedures,"
39. in Paragraph 73 (1) (e), the word "gender" shall be inserted after the word "age."
40. In Paragraph 73 (1) (g), the words "clinical recommended procedures" shall be inserted after the word "quality."
41. in Paragraph 73 (2), the dot is replaced by a comma at the end of point (b) and the following points 3 and 4 are added:
"3. is a registered provider in the field of general practical medicine or practical medicine for children and adolescents, where data on the provision of health services in connection with the screening programme,
4. is a registered provider in the field of gynecology and obstetrics, if data on the provided health services in connection with the screening programme, which is entitled to indicate, '.
42.In Paragraph 74 (1) (c), the words "the address of the registered office of the entrepreneur," shall be deleted.
43. In Paragraph 74 (1) (m), the words "for each place of provision of health services" shall be inserted after the words "beds defined."
44. in § 74 (1) (p) (1), the words "pursuant to § 19 (4)" shall be inserted after the words "health services."
45. in Paragraph 74 (1) (p), point 2 is deleted;
Points 3 and 4 shall become points 2 and 3.
46. in Paragraph 74 (1) (p), at the end of point 2, the word "a" is replaced by a comma and point (3) is deleted;
47. In Article 74, at the end of paragraph 1, the dot is replaced by a comma and the following points (r) and (s) are added:
"(r) an indication of the award of the status of a centre of highly specialised health care according to § 112, a centre of highly specialised health care for patients with rare diseases under § 113a and a screening centre under § 113c,
(s) information on the interruption of the provision of health services referred to in Article 26 (2), including the indication of the date from which the interruption takes place, and information on the continuation of the provision of health services after the interruption referred to in Article 26 (4), including the date from which the continuation takes place. ";
48. in § 74 (3) (a) (3), the words "and at the same time it is an operator" shall be inserted after the words "Ministry of Defence."
49. In Paragraph 74 (3), at the end of the text in point (d), the words "except for the information on the occupancy of beds referred to in paragraph 1 (m) 'shall be added.
50. in Paragraph 74 (3), the words "except for the availability of beds referred to in paragraph 1 (m)" shall be added at the end of the text in point (h).
51. in Paragraph 75 (1) of the introductory part of the provision, the words "or their amendment" shall be inserted after the words "to transmit the particulars."
52. in Article 75 (1) (a), "and (p)" shall be replaced by "(p) and (s)."
53. In Paragraph 75, at the end of paragraph 1, the dot is replaced by a comma and the following point (e) is added:
"(e) § 74 (1) (r) of the Ministry."
54. Paragraph 75 (2) is deleted.
Paragraph 3 shall become paragraph 2.
55. in Paragraph 75 (2), the word "Persons" shall be replaced by the words "Administrative authorities and persons."
56. In Paragraph 76 (1), point (p) is replaced by the dot and point (q) is deleted.
57. in Paragraph 76 (2) (a), "(i)" is replaced by "(k)."
58. in Paragraph 76 (2) (b), the text "(j)" is replaced by "(l)";
59.In Paragraph 76 (2) (d), "o)" is replaced by "p)."
60. in Paragraph 76 (2) (g), the words "(h), (j)" shall be replaced by "(h) to (j)."
61. in Paragraph 77 (1) (a), the text "(d)" shall be deleted;
62. In Paragraph 77 (1) (c), "(i) to (k)" is replaced by "(a) to (e) and (h) to (k)."
63.In Paragraph 77 (1) (d), "l) and (m)" is replaced by "a) to (e), (l) and (m)."
64. in Article 77a (4) (b), the word "medical" shall be inserted after the word "specialised."
65.In Paragraph 77a, at the end of paragraph 4, the dot is replaced by a comma and the following point (e) is added:
"(e) the insured person's number or patient identifier."
66. In Article 77a, the following paragraph 7 is added:
"(7) The Statistical Institute shall, upon request, transmit to the Ministry of Finance or the Ministry the information referred to in paragraph 2 in an anonymous form requested by the Ministry of Finance or the Ministry for the purpose of carrying out public control of health insurance undertakings. ';
67.In Paragraph 88 (2) (f), the words "or in vitro diagnostic medical devices' shall be inserted after the words" in clinical testing '.
68. Paragraph 94 (2) is deleted.
Paragraphs 3 and 4 shall become paragraphs 2 and 3.
69. In the heading of Part Twelve, the word "health 'shall be inserted after the word" specialised'.
70. In Paragraph 111, the words "if the provider to which the Ministry of Defence has been authorised is the provider of the Ministry of Defence 'shall be added at the end of the text of paragraph 1.
71. In Section 112, the word "medical 'is inserted after the word" specialised'.
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Regulation Information
| Citation | Act No. 240 / 2024 Coll., amending Act No. 372 / 2011 Coll., on Health Services and Conditions of Provision (Health Services Act), as amended, and other related laws |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 08.08.2024 |
|---|---|
| Effective from | 01.10.2024 |
| Effective until | - |
| Status | Valid |
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