A Walk in the Labyrinth. Evolving EU Regulatory Framework for Secondary Use of Electronic Personal Health Data for Scientific Research

While the digital transformation allows the secondary use of personal health data to advance scientific medical research, the existing EU regulatory framework creates uncertainty. The new legislative proposals, namely the European Health Data Space Regulation Proposal, Data Governance Act, and Data Act, not only do not deliver simplification but expand already elaborate enforcement structures without adequate cooperation and consistency mechanisms. This issue is a symptom of tension between divergent approaches towards personal data, which, in the context of the Europeanization of administrative law, will be a challenge for data sharing that will arise within the EU data commons. This paper examines the current and upcoming regulatory framework and provides examples of anticipated overlaps from the perspective of cooperation and consistency mechanisms.