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 Opinion on the Proposal for a Regulation on standards of quality and safety for substances of human origin intendedfor human application and repealing Directives 2002/98/EC and 2004/23/EC
EDPB-EDPS Joint Opinion 03/2022 on the Proposal for a Regulation on the European Health Data Space
EDPS Opinion on the Commission draft Decision as regards additional specific health and safety rules for the Commission site of Ispra (Verification of Digital COVID certificates for staff and visitors) (Case 2021-1000)
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)
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