D2.3 Project position paper on regulatory and ethical aspects

The evolution of national regulatory frameworks to facilitate the reuse of health data in compliance with GDPR principles is a critical issue in the European research landscape. This document seeks to gather insights from key stakeholders on how their respective countries have motivated and accelerated these regulatory changes. The focus includes limitations on purpose in data reuse, legal exemptions for research, and the principle of data minimisation in the context of AI and Big Data. Discussions with the European Data Protection Supervisor and the establishment of a Satellite Events on the European Health Data Space have driven these efforts. That culminates in the final approval of the European Health Data Space Regulation (EHDS) in January 2025 and is expected to be published in the European Official Journal in March 2025. The findings have contribute to shaping policy recommendations that support secure data reuse while maintaining compliance with GDPR.