European Health Data Space Regulation (EU) 2025/327

European Union, regulation. Regulation (EU) 2025/327 on the European Health Data Space was published in the Official Journal on 5 March 2025 and entered into force on 26 March 2025, with its provisions applying in stages over the following years. Primary text: EUR-Lex.

What it does: for primary use, patients gain a right to access and share their electronic health data in a common format across member states through the MyHealth@EU infrastructure, and electronic health record systems must meet interoperability rules. For secondary use, each member state sets up a health data access body that can issue data permits for research, innovation, policy and regulatory purposes over defined categories of data, including registries, genomic data and claims, delivered in secure processing environments, with a Union-level HealthData@EU network. Patients may opt out of secondary use. Uses such as marketing, insurance underwriting and decisions harmful to individuals are prohibited.

Why it matters for oncology and the arguments: cancer registries, molecular tumour boards and real-world evidence studies are among the prime intended beneficiaries, and the European Commission's Cancer Mission and the Beating Cancer Plan both counted on it. Industry welcomed a route through the GDPR's national maze; privacy groups and some medical associations fought for the opt-out and worry about re-identification of genomic data; hospitals worry about cost. The secondary-use provisions apply from 2029 for most data categories, so the system's real test lies ahead.