Research Biobanks and Consent Models: Regulatory Challenges and Opportunities in the Era of the European Health Data Space

Abstract

Research biobanks are essential infrastructures for biomedical innovation, yet they raise complex legal questions relating to consent and data processing. The entry into force of the European Health Data Space (EHDS) Regulation redefines the role of biobanks within the European health data ecosystem. This contribution identifies the main challenges and opportunities arising from integrating biobanks into the EHDS. To this end, the article examines the evolution of the regulatory framework from the GDPR to the EHDS, the data access procedures, the roles of key actors, and the opt-out mechanisms designed to protect data subjects. Special attention is devoted to the Italian context, analysing biobank integration within the Electronic Health Record 2.0 architecture and the national health data ecosystem, including under Law no. 132/2025 on artificial intelligence.