EDPS Decision authorising, subject to conditions, the use of the administrative arrangement between the European Commission and the Turkish Medicines and Medical Devices Agency in the context of the Turkish participation in the EU regulatory system for medical devices Eudamed (Case 2021-0347)
The General Data Protection Regulation (GDPR) recognises data concerning health as a special category of data and provides a definition for health data for data protection purposes. Though the innovative principles introduced by the GDPR (privacy by design or the prohibition of discriminatory profiling) remain relevant and applicable to health data as well, specific safeguards for personal health data and for a definitive interpretation of the rules that allows an effective and comprehensive protection of such data have now been addressed by the GDPR. Processes that foster innovation and better quality healthcare, such as clinical trials or mobile health, need robust data protection safeguards in order to maintain the trust and confidence of individuals in the rules designed to protect their data.
EDPS Formal comments on the Proposal for a Regulation of the European Parliament and of the Council on establishing a European Centre for Disease Prevention and Control amending Regulation (EC) No 851/2004
EDPS Formal comments on the Commission proposal for a Regulation of the Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices
EDPS preliminary opinion on the European Commission's Communication on "A European strategy for data" and the creation of a common space in the area of health, namely the European Health Data Space ('EHDS').
Speech by Wojciech Wiewiórowski delivered at the 'Digital Health 2020 - EU on the Move' Panel, as part of an event organised by the German Presidency of the Council of the European Union (via video link), Brussels, Belgium