It might have been overlooked that the General Data Protection Regulation (GDPR) that entered into force in May 2018 also governs scientific research, including clinical trials, when it involves the processing of personal data concerning people in the EU. In this regard, the European Data Protection Supervisor (EDPS) published its preliminary opinion on data protection in relation to scientific research on 6 January 2020.
Structure of the Preliminary Opinion
The Preliminary Opinion underlines the importance of a more informed discussion between the data protection and research communities. The document covers the following:
1. Landscape of scientific research and issues arising thereof;
2. What is understood by scientific research under the GDPR;
3. Outline of the governance framework for research in the EU within which data protection is situated, including with regards to clinical trials;
4. The special data protection regime for the purposes of scientific research and its key principles;
5. Consent, presumption of compatibility and derogations to data subjects’ rights;
6. Further considerations.
Medical device manufacturers should not forget that clinical trials involving participants from the EU will be covered by the GDPR rules. Furthermore, if personal data of EU citizens is used for clinical evaluation (e.g. feedback from customers) under the new Medical Device Regulation, manufacturers should respect the GDPR rules as well.
Obelis at Your Service
If you wish to know more about the General Data Protection Regulation, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will answer any questions you may have and will gladly assist you in the process of ensuring the compliance of your data processing activities and the appointment of a GDPR Representative.
27/01/2020
Efrosina Zhivkova
Deputy manager legal department