Regulation on the European Health Data Space (EHDS)
Regulation on the European Health Data Space (EHDS) establishes a common EU framework for the sharing and use of health data for primary purposes (healthcare delivery) and secondary purposes (research, policy making, and innovation). Adopted in 2024 and entered into force on 1 July 2025, it sets obligations for health data holders, creates a European Health Data Space, and defines rights for individuals and entities accessing health data.
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Framework Domains (25)
Cross-Border Exchange
| Code | Title |
|---|---|
| EHDS-ART23 | MyHealth@EU cross-border services |
Cross-Border Secondary Use Infrastructure
Chapter IV Section 4: HealthData@EU cross-border infrastructure
| Code | Title |
|---|---|
| EHDS-ART52 | HealthData@EU Infrastructure |
Data Interoperability
| Code | Title |
|---|---|
| EHDS-ART5 | Priority categories for electronic health data |
EHR System Compliance
| Code | Title |
|---|---|
| EHDS-ART14 | Mandatory requirements for EHR systems placed on the market |
EHR Systems Requirements
Chapter III: Essential requirements for EHR systems (Articles 25-49)
| Code | Title |
|---|---|
| EHDS-ART25 | Economic Operator Obligations |
| EHDS-ART33 | Minimum categories of electronic data for secondary use |
| EHDS-ART37 | Tasks of health data access bodies |
| 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 |
Identity and Access
| Code | Title |
|---|---|
| EHDS-ART9 | Identification management for natural persons and health professionals |
International Transfers
| Code | Title |
|---|---|
| EHDS-ART61 | International transfers of non-personal electronic health data |
Penalties
| Code | Title |
|---|---|
| EHDS-ART66 | Penalties |
Primary Use - Data Quality
| Code | Title |
|---|---|
| EHDS-ART7 | Registration and recording of personal electronic health data |
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 services |
Primary Use - Patient Rights
| Code | Title |
|---|---|
| EHDS-ART11 | Right to restrict access and rectification |
| EHDS-ART3 | Right of natural persons to access their electronic health data |
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 | Mandatory requirements for EHR systems placed on the market |
| EHDS-ART15 | Machine-Readable Format |
| EHDS-ART3 | Right of natural persons to access their electronic health data |
| EHDS-ART5 | Priority categories for electronic health data |
| EHDS-ART7 | Registration and recording of personal electronic health data |
Primary Use - Professional Access
| Code | Title |
|---|---|
| EHDS-ART4 | Health professional access to electronic health data |
Primary Use - Telemedicine
| Code | Title |
|---|---|
| EHDS-ART8A | Telemedicine in the context of cross-border care |
Secondary Use - Access Process
| Code | Title |
|---|---|
| EHDS-ART45 | Data permit for access to electronic health data |
Secondary Use - Data Altruism
| Code | Title |
|---|---|
| EHDS-ART51 | Data altruism in the context of EHDS |
Secondary Use - Data Categories
| Code | Title |
|---|---|
| EHDS-ART33 | Minimum categories of electronic data for secondary use |
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 - Data Protection
| Code | Title |
|---|---|
| EHDS-ART46 | Anonymisation and pseudonymisation for secondary use |
Secondary Use - Governance
| Code | Title |
|---|---|
| EHDS-ART36 | Health data access bodies |
| EHDS-ART37 | Tasks of health data access bodies |
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 | Data altruism in the context of EHDS |
| 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) |
Secondary Use - Infrastructure
| Code | Title |
|---|---|
| EHDS-ART58 | HealthData@EU central platform |
Secondary Use - Purpose Limitation
| Code | Title |
|---|---|
| EHDS-ART34 | Purposes for which electronic health data can be processed for secondary use |
Secondary Use - Security
| Code | Title |
|---|---|
| EHDS-ART50 | Secure processing environment |
Your Compliance Coverage
If you comply with Regulation on the European Health Data Space (EHDS), you already cover:
NAIC Insurance Data Security Model Law (MDL-668)
16%
6 controls mapped
Compare →EDM Council CDMC - Cloud Data Management Capability Framework
16%
6 controls mapped
Compare →Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data
16%
6 controls mapped
Compare →+ 585 more: EU AI Act (16%), Chile Personal Data Protection Law (Law No. 21.719) (16%)
See all 588 mapped frameworks ↓Maps to 588 other frameworks
Frequently Asked Questions
What is Regulation on the European Health Data Space (EHDS)?
Regulation on the European Health Data Space (EHDS) is a compliance framework from European Union with 25 domains and 45 controls. Regulation on the European Health Data Space (EHDS) establishes a common EU framework for the sharing and use of health data for primary purposes (healthcare delivery) and secondary purposes (research, policy making, and innovation). Adopted in 2024 and entered into force on 1 July 2025, it sets obligations for health data holders, creates a European Health Data Space, and defines rights for individuals and entities accessing health data. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does Regulation on the European Health Data Space (EHDS) have?
Regulation on the European Health Data Space (EHDS) has 45 controls organised across 25 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 Regulation on the European Health Data Space (EHDS) map to?
Regulation on the European Health Data Space (EHDS) maps to 588 other compliance frameworks. The top mapping partners are NAIC Insurance Data Security Model Law (MDL-668) (16% coverage), EDM Council CDMC - Cloud Data Management Capability Framework (16% coverage), Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data (16% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with Regulation on the European Health Data Space (EHDS) compliance?
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