Legislation in Healthcare and Clinical Evaluation

Garant předmětu:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

Requirements:

Mandatory participation in 80% of the seminars. Credit test (written for min. 50%).

Written examination test for 50 points, the student must write the test for at least 50% of the points to be admitted to the oral examination (possibility of earning up to 50 points).

The overall assessment is a combination of points for the written test and the oral examination. In total, the student has the opportunity to obtain 100 points, a minimum of 50 points is required to complete the course. Evaluation according to the ECTS scale.

Syllabus of lectures:

• Fundamentals of law. Types of legal norms. Legal system (types of legislative regulations in the Czech Republic and the EU). Legislative process in the Czech Republic and the EU.

• Regulation of free movement and goods in the EU. Harmonization at EU level. Technical standardization system.

• MDR 2017/745 on medical devices. Placing a medical device on the market.

• MDR 2017/745 conformity assessment procedures, notified bodies

• MDR 2017/745 - Technical documentation and description of individual parts. Pre-clinical and clinical evaluation.

• Legislation on the use of medical devices (medical devices law) specifics of medical devices with sources of ionizing radiation („atomic law“).

• Legislative framework of measuring devices. Metrological system in the Czech Republic. Legal metrology in healthcare.

• Law on Public Procurement.

• Healthcare as part of the public sector and their legislative framework (selected parts of the Act on Health Services, their implementing regulations and the Act on Medical and Non-Medical Health Professions).

• Healthcare as part of the public sector and their legislative framework (health insurance legislation).

• System and legislative regulation of quality assessment. Legislation related to the evaluation of the quality and safety of health services according to the Act on Health Services.

• Legislative regulation of the protection of industrial property.

Syllabus of tutorials:

• Search in legal regulations. Analysis of selected legal regulations (structure, hypothesis-disposition-sanctions, conditions for implementation of the legal regulation).

• Technical standards in the healthcare sector – search in technical standards, analysis of safety requirements for products in connection with proof of conformity.

• Classification of medical devices into risk classes according to EU Regulation MDR 2017/745.

• Putting a medical device on the market - creation of technical documentation, creation of risk analysis.

• Putting a medical device on the market – creation of technical documentation, information provided by the manufacturer (draft instructions for use, labeling of the medical device).

• Clinical evaluation of medical devices – processing of clinical evaluation.

• Process requirements and service documentation according to the applicable law on medical devices, work with the register of medical devices.

• Metrological system – design of a metrological system in a medical facility, verification and calibration of meters.

• Health Services Act – analysis of the procedure for establishing a non-state health facility in the Czech Republic.

• Rights and obligations of patients. Medical documentation.

• Health care reporting and reimbursement options.

• Search in the databases of the industrial property office (patents, utility models, trademarks).

Study Objective:

Study materials:

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Systematic Integration of Prosesses of Healthcare (compulsory course)