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 draft Commission Implementing Regulation laying down rules as regards the technical specifications for the EU SoHO Platform to exchange information concerning substances of human origin intended for human application.
The EDPS Annual Report 2024 is about acting for the future of data protection, preparing for the diverse possibilities and risks that the digital landscape presents.
Guided by our 2020 - 2024 strategy and its principles: Foresight, Action and Solidarity, the EDPS has: unveiled and taken steps to start executing its Strategy for AI, monitored and analysed technologies, including AI- led technologies, advised EU-co legislator on upcoming EU regulations directly impacting people’s privacy and data protection, providing tools to EUIs to ensure their compliance with EU data protection laws, influence the development of data protection globally.
EDPS formal comments on the draft Implementing Regulation laying down procedural rules for the cooperation with EMA as regards the joint clinical assessment and joint scientific consultation
EDPS Formal comments on the draft Commission Implementing Regulation laying down rules for the application of Regulation(EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups.
Executive Summary of the Audit report on Eudravigilance at the European Medicines Agency (EMA).