Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
Understanding the European Health Data Space Regulation
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847
11 February 2025
26 March 2027. Application timelines for some Articles differ (Article 105)
European Health Data Space Board (EHDS Board)
Article 93 Stakeholder Forum
Steering Groups for MyHealth@EU and HealthData@EU
Digital health authorities
Health data access bodies
Market surveillance authorities
To facilitate access to electronic health data for its primary and secondary use.
Manufacturers, importers and distributors of electronic health record (EHR) systems
Health data holders and health data users
Health data intermediation entities
European Commission
EU Member States
Member States: Establish digital health authorities, designate national contact points, and ensure service implementation.
Manufacturers of EHR systems: Before placing an EHR system on the market, ensure that the system provides capabilities of two harmonized components (interoperability and logging), including passing automated tests, preparing technical documentation, providing an information sheet, issuing an EU declaration of conformity, affixing the CE marking, and registering the system in the designated database.
Importers of EHR systems: Place on the market only EHR systems which are in conformity with the essential requirements as well as the common specifications referred to in the EHDS.
- Health data holders: Make enumerated minimum electronic health data categories (Article 51) available for secondary use.
Health data users: Process electronic health data for secondary use only under a data permit, an approved data request, or an access approval from an authorized HealthData@EU participant in specific cases.
EHDSon StreamLex, what can I find?
Guidance (guidelines, recommendations, etc.) and templates issued by the EHDS Board and the European Commission relevant to the EHDS
Legislation (decisions, implementing decisions, implementing regulation, etc.) adopted by the European Commission relevant to the EHDS
Relevant registers maintained by the EHDS Board and the European Commission relevant to the EHDS
EHDS Board and European Commission consultations, press releases, internal documents, annual reports, leaflets and similar information materials and ad hoc statements that do not constitute guidance
Draft versions of the EHDS Board and the European Commission guidance or templates (e.g., issued for the purposes of public consultation) and invalidated guidance and templates (e.g., documents superseded by other guidance)
Documents issued by the national authorities relevant to the EHDS
EU and national court judgments