Technical and Health-Care Regulations

Lecturer:

Petr Závoda (gar.)

Tutor:

Petr Závoda (gar.)

Supervisor:

Department of Dosimetry and Application of Ionizing Radiation

Synopsis:

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). Law on care and public health, Law on health care“, Law on health institutions, 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.

Requirements:

Syllabus of lectures:

1.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.

2.Problematics of judgement of accordance, in-market implementation, acquisition, commission, utilization, maintenance, service and evidence of health-care resources.

3.Problems of clinical evaluation and clinical tests.

4.„Law on technical requirements on products“, "Law on health-care resources, Law on metrology.

5.Atomic law, and related regulations, EC directives, relevant norms - CSN, EN, ISO).

6.Law on care and public health, Law on health care", Law on health institutions.

7.System of special health care for people irradiated by radiation accidents.

8.Legislation concerning radiological health professions: Laws on clinician and non-clinician health professions", and related regulations.

9.System of graduate, specialization and continuing education, certifications, registrations.

10.Indication criteria for imaging modalities.

11.Radiological medical standards, including determination and evaluation of patient doses.

12.Clinical audits.

Syllabus of tutorials:

Study Objective:

Knowledge:

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.

Abilities:

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

Study materials:

Key references:

[1] Law on Health Care(in Czech)

[2] Law on Metrology(in Czech)

[3] Atomic Act(in Czech)

[4] Law on Health Care(in Czech)

Recommended references:

[5] Law on medical devices(in Czech)

[6] Law on technical requirements for products(in Czech)

[7] Law on Medical Devices (in Czech)

Note:

Time-table for winter semester 2011/2012:

Time-table is not available yet

Time-table for summer semester 2011/2012:

Time-table is not available yet

The course is a part of the following study plans: