Medical Legislation and Standards

Lecturer:

Peter Kneppo (gar.)

Tutor:

Věra Filipcová, Ivana Juřičková

Supervisor:

Department of Biomedical Technology

Synopsis:

Principles of healthcare legislation. Law on the public health. Law on professional ability of healthcare professionals and further education in healthcare services (law on healthcare professions) and its executive regulations. EU directives related to tools of healthcare technique. Law on technical requirements for products. Decision of the government concerning the law on technical requirements for products. Atomic Act and its application to the healthcare sector. Technical standardization in the world, Europe and Czech Republic. Structure of institutions in the field of technical standards in healthcare services. Technical standards related to means of healthcare technique. Practical implementation of laws, regulations and standards in clinical practice. Procedures in marketing new tools of healthcare technique. Clinical tests of instruments. The role of testing stations. Certain facts and experience from abroad. Importance, principles and legal arrangements of so called good manufacture, laboratory and clinical practice (GMP, GLP and GCP). Industrial property and its protection (patents, samples). Legal protection of the intellectual property. Technological centres, parks, spin-off companies.

Association between legal and electrical regulations. Risks and causes of injuries in electrical engineering. Professional capability in electrical engineering - Regulation No. 50/78 Sb. Competence of persons by the degree of the qualification in electrical engineering, revisions and controls of installations and electrical appliances. Standards related to the above specified problems.

Requirements:

demonstration of the knowledge mastered by a written test

passing the classified examination by the method set

Syllabus of lectures:

Lectures

1st week Principles of the formation of healthcare legislation

2nd week Law on the professional capability

3rd week EU directives

4th week Law on technical requirements for products

5th week Formation of technical standardization

6th week Procedures in marketing healthcare technique products

7th week Clinical tests of instruments

8th week So called good manufacture, laboratory and clinical practice

9th week Technological centres

10th week Injuries in electrical engineering

11th week Competences of persons divided by the degree of qualification in electrical engineering

12th week Atomic Act and its applications

13th week Industrial property and its protection. Law on the public health

Syllabus of tutorials:

Study Objective:

Targets:

to master basic knowledge within the subject to the extent necessary for the performance of the profession in the branch physiotherapist.

Study materials:

Note:

Time-table for winter semester 2011/2012:

	06:00–08:0008:00–10:0010:00–12:0012:00–14:0014:00–16:0016:00–18:0018:00–20:0020:00–22:0022:00–24:00
Mon
Tue
Fri
Thu	roomKL:GDM212 Kneppo P. 10:00–11:50 (lecture parallel1) Kladno FBMI Učebna GDM 212
Fri

Time-table for summer semester 2011/2012:

Time-table is not available yet

The course is a part of the following study plans:

• Bakalářský studijní obor Fyzioterapie - prezenční (compulsory course)