F7AMBELEG - European Legislation and Management in Health Care

The course focuses on an overview of legislative regulations in the healthcare sector with a subsequent focus on medical devices. The course will cover theoretical and practical issues of patients' rights in healthcare, ethics in biomedicine, healthcare systems, marketing of medical devices, technical standardization systems and industrial property protection.

Credit requirements:

The student is required to complete the assigned practical tasks in the exercises. A maximum of 70 points is possible on the exercises. A minimum of 40 points is required for credit. In addition, the student is required to write a final credit test for a minimum of 50% points.

Exam evaluation:

A student awarded credit is evaluated on the basis of an oral examination. A grading scale is used for the final assessment, which is in accordance with the ECTS grading scale.

1. Overview of legislative regulations in the field of health care (Czech Republic, EU)

2.Health Services Act.

3. Ethics in biomedicine and biomedical research

4.Establishment of a non-medical health care facility from the perspective of legislation

5.Public health insurance system. Principles of price regulation - from the point of view of legislation.

6. Legal liability in the healthcare sector

7.Placing a medical device on the market in the EU

8.Marketing of devices with a measuring function and devices with an ionising radiation source

9.Surveillance of medical devices (national and European institutions, vigilance system)

10.Placing a medical device on the market outside the EU

11. quality management systems in the healthcare sector

12.Standards in the field of medical devices

13. Industrial Property Office and its tasks. Basic overview of the subjects of protection.

14. Protection of technical solutions. Conditions for granting protection for invention and utility model.

The exercise will be conducted in 4-hour blocks with the following topics:

1. Health Services Act - medical documentation, patients' rights

2. Ethics in biomedicine - informed consent in healthcare

3.Preclinical testing of medical devices

4.Technical documentation and marketing of medical devices

5.Marketing - FDA

6. Quality management system - ISO 9001, ISO 13 485

7.Patent searches

Mandatory:

-European Union health law: treaties and legislation. Editor André den EXTER, editor Tamara K. HERVEY. Apeldoorn: Maklu, 2012. ISBN 978-90-466-0544-8.

-DEMARCO, Carl T. Medical device design and regulation. Milwaukee: ASQ Quality Press, c2011. ISBN 9780873898164

-GRISET, Pascal. The European patent: a European success story for innovation. Munich: European Patent Office, 2013. ISBN 978-3-89605-118-9.

Recommended::

-Guidance (MEDDEV). European commission [online]. [ref. 2019-05-02]. Available from: http://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en#meddevs

-POMMELIN, Petri. The Survival Guide to Eu Medical Device Regulations. Berlin: Books on Demand, 2017. ISBN 978-9515681201.

• Prospectus - magisterský (!)
• Biomedical and Clinical Engineering (compulsory course)