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.
AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.953v01-00
AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.939v01-00
AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs - PE789.094v01-00
DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and...
European Parliament - SANT Subcommittee (Public Health)Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations
Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks inpu...
US Federal Register - CMS RulesRéférentiel HDS v2.1 : les évolutions à anticiper dès maintenant
Actualité
ANS - French Digital Health AgencyDRAFT REPORT with recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare - PE790.010v03-00
DRAFT REPORT with recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare<br />Committee on Public Health<br />Giorgos Georgiou<br /> <br />Source : <a href="https://www.e...
European Parliament - SANT Subcommittee (Public Health)Summary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026)
News announcement 8 July 2026 Summary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026) 1 min read
European Health Data SpaceRecission of the National Cancer Institute Clinical Cancer Education Program Regulation
The Department of Health and Human Services (HHS), in consultation with the National Institutes of Health (NIH), is proposing to rescind the existing regulation concerning grants under the National Cancer Institute (N...
US Federal Register - HHS Rules