EU European Health Data Space (EHDS)
Regulation (EU) 2025/327 establishing the European Health Data Space. Creates a common framework for sharing and using health data across the EU, covering both primary use (direct healthcare) and secondary use (research, policymaking, AI). Entered into force 26 March 2025, with primary use from 2027 and secondary use from 2029.
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Framework Domains (7)
Cross-Border Secondary Use Infrastructure
Chapter IV Section 4: HealthData@EU cross-border infrastructure
| Code | Title |
|---|---|
| EHDS-ART52 | HealthData@EU Infrastructure |
EHR Systems Requirements
Chapter III: Essential requirements for EHR systems (Articles 25-49)
| Code | Title |
|---|---|
| EHDS-ART25 | Economic Operator Obligations |
| EHDS-ART33 | Technical Documentation |
| EHDS-ART37 | EU Declaration of Conformity |
| EHDS-ART41 | Conformity Assessment |
| EHDS-ART49 | EHR System Registration |
Governance and Enforcement
Chapters V-IX: Governance board, enforcement, and transitional provisions (Articles 59-105)
| Code | Title |
|---|---|
| EHDS-ART105 | Phased Application |
| EHDS-ART59 | Digital Health Literacy |
| EHDS-ART92 | EHDS Board |
Primary Use - Infrastructure and Governance
Chapter II: Digital health authorities and cross-border infrastructure (Articles 10-23)
| Code | Title |
|---|---|
| EHDS-ART10 | Digital Health Authorities |
| EHDS-ART12 | Identification and Authentication |
| EHDS-ART23 | MyHealth@EU Cross-Border Infrastructure |
Primary Use - Patient Rights and Access
Chapter II: Rights of natural persons and health professionals for primary use of electronic health data (Articles 3-15)
| Code | Title |
|---|---|
| EHDS-ART14 | Priority Data Categories |
| EHDS-ART15 | Machine-Readable Format |
| EHDS-ART3 | Rights of Natural Persons |
| EHDS-ART5 | Right to Access Health Data |
| EHDS-ART7 | Health Professional Access |
Secondary Use - Data Holder Obligations
Chapter IV Section 3: Obligations on data holders for secondary use
| Code | Title |
|---|---|
| EHDS-HOLD-1 | Obligation to Make Data Available |
| EHDS-HOLD-2 | Secure Processing Environment |
| EHDS-HOLD-3 | Dataset Descriptions and Catalogues |
Secondary Use - Governance and Access
Chapter IV Sections 1-2: Secondary use governance, permitted purposes, and access bodies (Articles 51-69)
| Code | Title |
|---|---|
| EHDS-ART51 | Minimum Data Categories for Secondary Use |
| EHDS-ART53 | Permitted Purposes for Secondary Use |
| EHDS-ART53-PROHIB | Prohibited Secondary Use Purposes |
| EHDS-ART67 | Data Permit Applications |
| EHDS-ART69 | Health Data Requests (Anonymised) |
Maps to 563 other frameworks
Frequently Asked Questions
What is EU European Health Data Space (EHDS)?
EU European Health Data Space (EHDS) is a compliance framework from European Union with 7 domains and 25 controls. Regulation (EU) 2025/327 establishing the European Health Data Space. Creates a common framework for sharing and using health data across the EU, covering both primary use (direct healthcare) and secondary use (research, policymaking, AI). Entered into force 26 March 2025, with primary use from 2027 and secondary use from 2029. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does EU European Health Data Space (EHDS) have?
EU European Health Data Space (EHDS) has 25 controls organised across 7 domains. The largest domains are EHR Systems Requirements (5 controls), Primary Use - Patient Rights and Access (5 controls), Secondary Use - Governance and Access (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does EU European Health Data Space (EHDS) map to?
EU European Health Data Space (EHDS) maps to 563 other compliance frameworks. The top mapping partners are EDM Council CDMC — Cloud Data Management Capabilities Framework (24% coverage), NAIC Insurance Data Security Model Law (MDL-668) (24% coverage), South Korea PIPA (24% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with EU European Health Data Space (EHDS) compliance?
Start your EU European Health Data Space (EHDS) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about EU European Health Data Space (EHDS) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 25 controls and track your progress.
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