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17ABBZLN - Legislation in Health Care and Technical Standards

Code Completion Credits Range Language
17ABBZLN KZ 2 1+1
Lecturer:
Ivana Kubátová, Peter Kneppo (guarantor)
Tutor:
Ivana Kubátová
Supervisor:
Department of Biomedical Technology
Synopsis:

Public health law. Law No. 96/2004 and applicable regulations.EU Directives. Legal technical product requirements. National government decrees. Institutional requirements for publication of technical norms. Technical norms in health care. Nuclear law. Procedures concerning introduction of medical devices. Clinical testing. Functional position of the testing rooms. Legislation concerning GMP, GLP and GCP.

Requirements:

- From each topic - will award individual work (worksheet, flow chart,...) - 5 points from each.

- Final test - max. 35 points.

- Total - max. 100 points.

Syllabus of lectures:

1.Organization of learning and credit conditions. Practice: Introduction to law.

2. Health Insurance.

3. Competition in HealthCare.

4. The law about technical requirements for products. Council Directive 93/42/EEC. Medical Device Law.

5. Creation of technical normalization in the world, in Europe and in the Czech Republic. The structure of institutions in a health care technical norms area.

6. Metrology in Healthcare.

7. The nuclear law and its application in the resort of health care.

8. Clinical Trials.

9. Public Health.

10. Patient Safety and Mobility.

11. Quality in Hospitals. Quality of Medical Devices. Standards, certification, ISO 9000. Risk Management.

12. Final Test.

Syllabus of tutorials:

1.Organization of learning and credit conditions. Practice: Introduction to law.

2. Health Insurance.

3. Competition in HealthCare.

4. The law about technical requirements for products. Council Directive 93/42/EEC. Medical Device Law.

5. Creation of technical normalization in the world, in Europe and in the Czech Republic. The structure of institutions in a health care technical norms area.

6. Metrology in Healthcare.

7. The nuclear law and its application in the resort of health care.

8. Clinical Trials.

9. Public Health.

10. Patient Safety and Mobility.

11. Quality in Hospitals. Quality of Medical Devices. Standards, certification, ISO 9000. Risk Management.

Study Objective:

The goal of this subject is to inform students about laws and responsibilities resulting from the health care legislature.

Study materials:

[1]Ian Kennedy, Andrew Grubb: Medical Law, 3rd Edition. Reed Elsevier / Butterworth-Heinemann, 2005. 2380 s.

[2]David Dranove: Health Care Law and Ethics, 6th Edition. Aspen Health Care Compliance Center, 2003. 1274 s.

[3]Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability. Multiple. Distributed through American National Standards Institute (ANSI) (2007). 156 s.

Note:
The course is a part of the following study plans:
Downloads: