AI for business · Regulation
European Health Data Space
Gives patients digital access to their health data across the EU and creates rules for reusing health data for research, innovation and AI development.
Applies in phasesEUData and privacyRegulation (EU) 2025/327
What it means for AI
Health AI developers will be able to request access to anonymised or pseudonymised health data through national health data access bodies — under strict conditions and in secure environments.
What you must do
- Makers of electronic health record systems: interoperability and security requirements.
- Data holders in health: make certain data available for secondary use when a permit is issued.
Examples
A start-up trains an AI to read X-rays
In future it can apply for a data permit instead of negotiating with each hospital separately.
Key dates
The EHDS Regulation enters into force.
General date of application; key parts follow in phases until 2031.
Official sources
Industry guides
General information, not legal advice — consult a lawyer for borderline cases. Regulations reviewed on 29 Sep 2026.