Overview of Legislation in Health Care

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Code Completion Credits Range Language
16TZPB Z 2 2+0 Czech
Petr Závoda (guarantor)
Petra Dostálová
Department of Dosimetry and Application of Ionizing Radiation

This course provides an overview of technical and health-care specific legal and other regulations associated with utilization of health-care devices based on ionizing radiation and/or nuclear energy in health care. Problematics of judgement of accordance, in-market implementation, acquisition, commission, utilization, maintenance, service and evidence of health-care resources and problems of clinical evaluation and clinical tests. („Law on technical requirements on products“, „Law on health-care resources, Law on metrology, Atomic law, and related regulations, EC directives, relevant norms - CSN, EN, ISO). Furthermore, the “Law on health services„, the “Law on specific health services„, system of special health care for people irradiated by radiation accidents. Legislation concerning radiological health professions: Laws on clinician and non-clinician health professions“, and related regulations, including system of graduate, specialization and continuing education, certifications, registrations. Indication criteria for imaging modalities and radiological medical standards, including determination and evaluation of patient doses, and audits of patient doses.

Syllabus of lectures:

1. Overview of technical and sanitary laws and other regulations of the CR associated with the use of medical devices using ionizing radiation and / or nuclear energy in providing health care.

2. The harmonized and specified technical standards - DIN, EN, ISO, IEC - relating to medical exposure.

3. „Law on technical requirements for products“, „The law on medical devices“, the „Law on metrology“ and its implementing regulations (decrees and government regulations).

4. 'Atomic Act „and related regulations, incl. new “Council Directive 2013/59 / Euratom (effective as of 02.06.2014), laying down basic safety standards for protection against the risk of exposure to ionizing radiation."

5. Problems of conformity assessment, marketing, acquisition, commissioning, use, maintenance, servicing and registration of medical devices.

6. Problems of clinical trials and clinical trials of medical devices.

7. „Law on health services“, „Law on specific health services,“ „Laws of nonmedical and medical professions“ and related regulations.

8. The system of undergraduate, specialization and lifelong education of health professionals, certification and registration.

9. National and local radiological standards, incl. methods of determination and evaluation of the benefits to patients; Indication criteria for imaging; national and local diagnostic reference levels.

10. Internal and external clinical audits.

11. System of special medical care for persons irradiated during radiation accidents.

Syllabus of tutorials:
Study Objective:


Knowledge about technical and health-care specific legal and other regulations associated with utilization of health-care devices based on ionizing radiation and/or nuclear energy in health care.


Use of appropriate laws and regulations related to the use of medical equipment using ionizing radiation.

Study materials:

Key references:

[1] Law on health services Act (No. 372/2011 Coll.). (in Czech)

[2] Law on metrology (No. 505/1990 Coll.). (in Czech)

[3] Atomic Law (No. 263/2016 Coll.). (in Czech)

[4] National Radiological Standards - RDG, RT, NM and RF (including recommended literature). (in Czech)

[5] Technical standards ČSN EN harmonized with Government Decree No. 336/2004 Coll. (in Czech)

Recommended references:

[6] Law on Specific Health Services (No. 373/2011 Coll.). (in Czech)

[7] Law on technical requirements for products   (No. 22/1997 Coll.). (in Czech)

[8] Law on Medical Devices (No. 268/2014 Coll.). (in Czech)

[9] Recommendations of the European Commission; IAEA; ICRP; EFOMP; ESTRO, EANM, SÚJB - related to medical exposure. (in Czech)

[10] Klener, V. et al .: Principy a praxe radiační ochrany, AZIN Praha, 2000. (in Czech)

Time-table for winter semester 2020/2021:
Time-table is not available yet
Time-table for summer semester 2020/2021:
Time-table is not available yet
The course is a part of the following study plans:
Data valid to 2021-03-02
For updated information see http://bilakniha.cvut.cz/en/predmet4563906.html