The European Health Data Space, or EHDS, is an EU framework that sets common rules for using electronic health data. It has two strands. Primary use covers giving individuals control over their own health records and enabling those records to be shared across borders for care through interoperable electronic health record systems. Secondary use covers making health data available, under strict governance and safeguards, for research, innovation, policy making, and regulatory activities through health data access bodies. The EHDS complements the General Data Protection Regulation rather than replacing it, and it introduces requirements for electronic health record systems and data holders. It is one of the central building blocks of the EU's wider strategy for a single market in data and for digital health.
What is the European Health Data Space?
The European Health Data Space is an EU framework for the primary and secondary use of health data across member states.
How does the EHDS relate to GDPR?
The EHDS builds on the GDPR. It adds sector-specific rules for the primary and secondary use of health data while the GDPR continues to govern personal data protection more broadly.
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Version 2.1 of the health data hosting certification framework, published October 2026, strengthens transparency requirements on third-country data transfers and foreign legislation submission.
ANS - French Digital Health Agency · FranceAEPD analysis of data quality, accuracy and minimisation in processing by AI systems
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The Iberoamerican Network of Data Protection Authorities has approved a reference document establishing enhanced safeguards for processing neurodata outside healthcare contexts.
AEPD (Spanish Data Protection Agency) · SpainM11 Clinical Electronic Structured Harmonised Protocol (CeSHarP); Guidance for Industry
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US Federal Register - FDA Guidance Notices · United StatesSégur du numérique en santé: regulatory framework for paramedical professionals and midwives published
Official publication of the decree establishing the Ségur du numérique en santé programme for paramedical professionals and midwives, setting the regulatory framework for software interoperability and secure health data exchange.
ANS - French Digital Health Agency · FranceEuropean Health Data Space (EHDS) Regulation: overview
The EHDS is the EU's first sector-specific common data space, establishing a framework for health data access and use across member states.
European Health Data Space · EU-wideEuropean Health Data Space Regulation: entry into force
EHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideUpdating of the information sheet Guidance for Industry on the electronic exchange of ICSRs in E2B(R3) format through B2B gateway
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Swissmedic · Switzerland