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F7AMSLKH - Legislation in Healthcare and Clinical Evaluation

Code Completion Credits Range Language
F7AMSLKH Z,ZK 5 2P+2S English
Lecturer:
Vojtěch Kamenský, Peter Kneppo (guarantor)
Tutor:
Vojtěch Kamenský, Anna Erfányuková, Ondřej Gajdoš, Mariia Gorelova, Jana Chocholatá, Barbora Klíčová, Karolína Vostracká
Supervisor:
Department of Biomedical Technology
Synopsis:

Learning outcomes of the course unit The goal is to acquaint students with the rights and obligations arising from current legislation on health care issues. Emphasis is not placed on memorizing the literal wording of the legislation, but on familiarizing students with the main points and ideas contained in EU directives, regulations, laws, standards and EU directives in healthcare. The student should have a comprehensive overview of health legislation after completing the course.

Requirements:

The guarantor guides, coordinates and supervises the entire course and course of the subject. He is actively involved in lectures and is responsible for checking the validation of the study results (checking the preparation of the credit test on the content page).

Syllabus of lectures:

•Fundamentals of law. Types of legal standards. The rule of law. Convention on Human Rights and Biomedicine. System of European law

•Technical standardization system. Standards in healthcare.

•The Law on Medical Devices. EP 2017/745 on medical devices.

•Placing a medical device on the market. Risk analysis. System of vigilance. Technical documentation. MEDDEV Documents.

•Clinical trials. Clinical evaluation.

•Clinical evaluation of medical devices - risk analysis, preclinical evaluation, clinical evaluation

•Quality management systems. ISO 9000, ISO 13485.

•Metrological system in EU. Legal metrology in healthcare, metrological confirmation. Metrological Hospital Order.

•Public Health. Data Protection. Health Insurance.

•Patient safety and Mobility.

•Medical law. Informed consent, instruction of the patient. Law artis. Rejection of patient admission, refusal of health care. Rights and duties of a health worker. Ending patient care.

•Ionizing radiation in hospitals and medical technology.

Syllabus of tutorials:

•Fundamentals of law. Types of legal standards. The rule of law. Convention on Human Rights and Biomedicine. System of European law

•Technical standardization system. Standards in healthcare.

•The Law on Medical Devices. EP 2017/745 on medical devices.

•Placing a medical device on the market. Risk analysis. System of vigilance. Technical documentation. MEDDEV Documents.

•Clinical trials. Clinical evaluation.

•Clinical evaluation of medical devices - risk analysis, preclinical evaluation, clinical evaluation

•Quality management systems. ISO 9000, ISO 13485.

•Metrological system in EU. Legal metrology in healthcare, metrological confirmation. Metrological Hospital Order.

•Public Health. Data Protection. Health Insurance.

•Patient safety and Mobility.

•Medical law. Informed consent, instruction of the patient. Law artis. Rejection of patient admission, refusal of health care. Rights and duties of a health worker. Ending patient care.

•Ionizing radiation in hospitals and medical technology.

Study Objective:
Study materials:

[1] EXTER, André den a Tamara HERVEY. European Union Health Law: Treaties and Legislation. Antwerpen - Apeldoorn: Maklu, 2012. ISBN 978-90-466-0544-8.

[2] GRONDEN, Johan Willem, Erika SZYSZCZAK, Ulla NEERGAARD a Markus KRAJEWSKI. Health Care and EU Law: Legal Issues of Services of General Interest. Hague: T.M.C. Asser Press, 2011. ISBN 978-90-6704-727-2.

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