Proposal for a Regulation on the European Health Data Space (EHDS)
Proposal for a Regulation on the European Health Data Space (EHDS), currently under adoption. Aims to create a common framework for sharing and using health data across the EU, covering primary use (healthcare delivery) and secondary use (research, policy, innovation). Not yet enacted; implementation timelines are tentative, with primary use expected around 2026–2027 pending final agreement.
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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) |
Your Compliance Coverage
If you comply with Proposal for a Regulation on the European Health Data Space (EHDS), you already cover:
EDM Council CDMC — Cloud Data Management Capability Framework
24%
6 controls mapped
Compare →NAIC Insurance Data Security Model Law (MDL-668)
24%
6 controls mapped
Compare →South Korea PIPA
24%
6 controls mapped
Compare →+ 560 more: New Zealand Information Security Manual (NZISM) (24%), Chile Personal Data Protection Law (Law No. 21.719) (24%)
See all 563 mapped frameworks ↓Maps to 563 other frameworks
Frequently Asked Questions
What is Proposal for a Regulation on the European Health Data Space (EHDS)?
Proposal for a Regulation on the European Health Data Space (EHDS) is a compliance framework from European Union with 7 domains and 25 controls. Proposal for a Regulation on the European Health Data Space (EHDS), currently under adoption. Aims to create a common framework for sharing and using health data across the EU, covering primary use (healthcare delivery) and secondary use (research, policy, innovation). Not yet enacted; implementation timelines are tentative, with primary use expected around 2026–2027 pending final agreement. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does Proposal for a Regulation on the European Health Data Space (EHDS) have?
Proposal for a Regulation on the 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 Proposal for a Regulation on the European Health Data Space (EHDS) map to?
Proposal for a Regulation on the European Health Data Space (EHDS) maps to 563 other compliance frameworks. The top mapping partners are EDM Council CDMC — Cloud Data Management Capability 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 Proposal for a Regulation on the European Health Data Space (EHDS) compliance?
Start your Proposal for a Regulation on the 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 Proposal for a Regulation on the 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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