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.
Here we are again with the latest EDPS Newsletter!
This time around, we look at upcoming events, our strategic vision under the AI Act, two more joint opinions we issued with the European Data Protection Board (relating to cybersecurity and biotech proposals), and more.
EDPB-EDPS Joint Opinion 3/2026 on the Proposal for a Regulation on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health (European Biotech Act).
EDPS Formal comments on the draft Commission Implementing Regulationlaying down the necessary measures for the establishment and operation of the European Health Data Space Board.
EDPS Formal comments on the draft Implementing Regulation laying down procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments.
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.