The European Health Data Space (EHDS): what changes for healthcare?
Adopted 2026-06-20 · ≈ 1 min read · 
edited by Dirk Baaijen
The EHDS gives citizens access to and control over their electronic health data and enables cross-border exchange (primary use), and governs the reuse of health data for research and policy via access bodies (secondary use). Application is phased.
Short answer: The European Health Data Space (EHDS) is an EU regulation that governs two things. Under primary use, citizens gain access to and control over their own electronic health data, which can be shared cross-border for care. Under secondary use, health data can — under strict safeguards — be reused for research, innovation and policy via designated access bodies. Application is phased.
Primary use: the patient in control
The EHDS requires that people can view, add to and share their electronic health data (such as summaries, prescriptions, images, lab results) — including across borders, via European infrastructure. Electronic health record (EHR) systems must meet interoperability and security requirements. For care providers this means changes to systems and processes.
Secondary use: data for research and policy
The EHDS also opens health data for reuse: researchers, innovators and policymakers can request access to (usually pseudonymised or anonymised) data via health data access bodies, under conditions and oversight. This is intended to support research and — relevant for healthcare AI — the development of trustworthy medical AI, while preserving privacy.
How it connects to other rules
The EHDS does not stand alone. It builds on the GDPR (health data is special-category personal data), connects to the Data Act for data sharing, and touches the AI Act where health data is used to train medical AI. See also AI in healthcare.
What to do
- Map your data flows: which health data do you hold, in which systems, and do they meet the interoperability requirements?
- Prepare for primary use: access and portability for patients.
- Assess secondary use: whether you want to share data or use it for research/AI, via the access body.
- Track the phased dates and align with your GDPR basis and DPIA.
The EHDS makes health data both more available and better protected — becoming the backbone of trustworthy healthcare AI in Europe.
Sources
- https://eur-lex.europa.eu/eli/reg/2025/327/oj
Regulation (EU) 2025/327 (European Health Data Space): primary and secondary use of electronic health data. - https://eur-lex.europa.eu/eli/reg/2016/679/oj
General Data Protection Regulation (GDPR): the EHDS builds on and complements the GDPR for health data.
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