Legislation in Health Care and Technical Standards

Garant předmětu:

Lecturer:

Tutor:

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:

Credit conditions: compulsory school attendance and delivered semestral work.

Exam conditions: completion credit.

Syllabus of lectures:

1.Principles and fundamentals of health care legislature creation. The law about populace haleness.

2.The law about professional competence to work in health care occupation and about additional education in health care.

3.The EU directives about health care equipment.

4.The law about technical requirements for products.

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

6.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.

7.The health care equipments technical norms.

8.Practical application of the laws, public notices and norms in clinical practices.

9.Processes by placing new health care equipment on the market.

10.Equipments clinical tests.

11.The role of testing department. Facts and experience from abroad (EZÚ Praha).

12.The role of testing department. Facts and experience from abroad (SZÚ Brno)

13.Meaning, fundamentals and legal regulations of right productive, laboratory and clinical practices (GMP, GLP a GCP).

14.Proprietorship of a patent and its protection. A legal protection of intellectual property. Technological centres, industrial parks, spin-off firms (ČVUT).

Syllabus of tutorials:

1.Principles and fundamentals of health care legislature creation. The law about populace haleness.

2.The law about professional competence to work in health care occupation and about additional education in health care.

3.The EU directives about health care equipment.

4.The law about technical requirements for products.

5.The nuclear law and its application in the resort of

health care.

6.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.

7.The health care equipments technical norms.

8.Practical application of the laws, public notices and norms in clinical practices.

9.Processes by placing new health care equipment on the market.

10.Equipments clinical tests.

11.The role of testing department. Facts and experience from abroad (EZÚ Praha).

12.The role of testing department. Facts and experience from abroad (SZÚ Brno)

13.Meaning, fundamentals and legal regulations of right productive, laboratory and clinical practices (GMP, GLP a GCP).

14.Proprietorship of a patent and its protection. A legal protection of intellectual property. Technological centres, industrial parks, spin-off firms (ČVUT).

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:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Biomedical Informatics - combined study (compulsory elective course)