Health Legislation and Standards

Lecturer:

Ivana Juřičková, Peter Kneppo (gar.)

Tutor:

Ivana Juřičková, Věra Filipcová

Supervisor:

Department of Biomedical Technology

Synopsis:

Principles of the formation of healthcare legislation. Law on public health. Law on professional capability of performing healthcare professions and further education in the healthcare system (law on healthcare professions) and appropriate executive regulations. EU directives related to means 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. Formation of technical standardization in the world, in Europe and in the Czech Republic. Structure of institutions in the field of technical standards in healthcare services. Technical standards related to tools of healthcare technique. Practical implementation of laws, regulations and standards in clinical practice. Procedures in marketing new healthcare technique means. 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 intangible property. Technology centres, parks, spin-off companies.

Bonds between legal and electrical engineering regulations. Risks and causes of injuries in electrical engineering. Expert capability in electrical engineering - Regulation No. 50/78 Sb. Competence of persons depending on the degree of electrical engineering qualification, revisions and controls of installations and electric appliances. Standards related to the above mentioned problems.

Requirements:

100% participation in lectures,

demonstration of the knowledge mastered by a written test,

passing the examination (the classified credit) by the method set.

Syllabus of lectures:

Lectures:

1st week Principles of the formation of healthcare legislation.

2nd week Law on 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 technical means.

7th week Clinical tests of instruments.

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

9th week Technology centres.

10th week Injuries in electric engineering.

11th week Competences of persons depending on degree of electrical engineering qualification.

12th week Atomic Act and its applications.

13th week Industrial property and its protection.

14th week Law on 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 Radiology Assistant.

Study materials:

Sádovský, S.: Základy práva. Praha, Karolinum 2003

Vondráček, L.: Základy zdravotnického práva pro posluchače 2. LF UK. Praha, Karolinum 2004

http://osz.cmkos.cz/CZ/Pravo/zdr_predpis.html - výběr nejdůležitějších předpisů pro potřeby zdravotnických odborových organizací k listopadu 2007

http://forum.czechmed.cz/nove/?q=node/34 - přehled základních zákonných předpisů ČR a evropských regulátorů, týkajících se oblasti zdravotnických pomůcek

http://www.mvcr.cz/sbirka/ - sbírka zákonů ČR

http://europa.eu.int/eur-lex/en/search/search_lif.html - legislativa EU

http://europa.eu.int/comm/enterprise/medical_devices/meddev/ - Guidelines relating to medical devices Directives

Vejrosta, V.: Konstrukce zdravotnických elektrických přístrojů - aplikace požadavků mezinárodních a evropských norem. Praha, Česká společnost pro zdravotnickou techniku, 2001

Note:

Further information:

http://www.pepim.cz/fbmi/index.php?id=2

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	roomKL:GDM5 Juřičková I. 10:00–11:50 EVEN WEEK (lecture parallel1 parallel nr.102) Kladno FBMI Učebna GDM5_19
Tue
Fri
Thu	roomKL:B-507 Kneppo P. 08:00–09:50 ODD WEEK (lecture parallel1) Kladno FBMI Učebna
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 Radiologický asistent - prezenční (compulsory course)