EHDS

The European Health Data Space regulation creates common EU rules for electronic health data. For primary use, it gives patients free, immediate access to their electronic health data and the ability to share it with health professionals across borders, and it sets requirements for electronic health record systems. For secondary use, it creates a permit system, run by national health data access bodies, for using health data in research, innovation and policy.

It entered into force on 26 March 2025 and applies in phases over the following years.

• Health care providers and the systems they use to record and exchange electronic health data.
• Manufacturers of electronic health record systems, which must meet harmonized requirements for interoperability and logging.
• Health data holders, a broad group including many organizations holding health data, which must make data available for secondary use when a permit is granted.
• Health data users applying for permits for research and similar purposes.

Individuals can access their electronic health data immediately and free of charge in the priority categories, add information, ask for corrections, share it with health professionals, restrict access to parts of it, see who accessed it, and opt out of secondary use.

Member states set penalties, including fines. Health data access bodies can impose fines on data holders and users that breach secondary use rules, and revoke permits.

1. Identify your role: provider, EHR system manufacturer, data holder, or prospective data user.
2. For EHR systems, plan to the harmonized requirements and self-certification ahead of 2029.
3. For providers, prepare patient access to the priority categories.
4. For data holders, catalogue the health data you hold and prepare for data access body requests.
5. Track national implementing measures and the Commission's implementing acts.