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Regulation on the European Health Data Space (EHDS)
European Union
v2024 (Regulation)
6 domains
6 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.
Verified
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (6)
Cross-Border
1 controls
| Code | Title |
|---|---|
| EHDSREG-5 | Cross-Border Health Data Flows |
EHR Requirements
1 controls
| Code | Title |
|---|---|
| EHDSREG-1 | Mandatory Requirements for EHR Systems (Articles 14-29) |
Governance
1 controls
| Code | Title |
|---|---|
| EHDSREG-4 | Digital Health Authorities, Governance, MyHealth@EU |
Phased Application
1 controls
| Code | Title |
|---|---|
| EHDSREG-6 | Phased Application and Enforcement |
Primary Use
1 controls
| Code | Title |
|---|---|
| EHDSREG-2 | Primary Use - Right to Restrict Access and Rectification |
Secondary Use
1 controls
| Code | Title |
|---|---|
| EHDSREG-3 | Secondary Use - Health Data for Research and Innovation |
Your Compliance Coverage
If you comply with Regulation on the European Health Data Space (EHDS), you already cover:
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
67%
4 controls mapped
Compare →TEFCA - Trusted Exchange Framework and Common Agreement
67%
4 controls mapped
Compare →Armenia Law on Protection of Personal Data (2015)
67%
4 controls mapped
Compare →+ 163 more: Florida Digital Bill of Rights (FDBR) (67%), MDS2 (Medical Device) (67%)
See all 166 mapped frameworks ↓Maps to 166 other frameworks
6 total controls
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
4 source controls mapped|2 target controls covered
67%
TEFCA - Trusted Exchange Framework and Common Agreement
4 source controls mapped|2 target controls covered
67%
Armenia Law on Protection of Personal Data (2015)
4 source controls mapped|2 target controls covered
67%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|2 target controls covered
67%
MDS2 (Medical Device)
4 source controls mapped|3 target controls covered
67%
MTCS (Singapore)
4 source controls mapped|4 target controls covered
67%
NAIC Insurance Data Security Model Law (MDL-668)
4 source controls mapped|1 target controls covered
67%
AWS Well-Architected Security Pillar
3 source controls mapped|3 target controls covered
50%
Azure Security Benchmark
3 source controls mapped|3 target controls covered
50%
GLI-33 - Gaming Laboratories International Event Wagering Systems
3 source controls mapped|3 target controls covered
50%
ISMAP (Japan)
3 source controls mapped|2 target controls covered
50%
NIST SP 800-146
3 source controls mapped|2 target controls covered
50%
NIST SP 800-145
3 source controls mapped|3 target controls covered
50%
NIST SP 800-144
3 source controls mapped|1 target controls covered
50%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
3 source controls mapped|2 target controls covered
50%
Aged Care Quality Standards (Australia)
3 source controls mapped|3 target controls covered
50%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
50%
Bahrain PDPL
3 source controls mapped|2 target controls covered
50%
IEC 60601-1 - Medical Electrical Equipment Safety
3 source controls mapped|3 target controls covered
50%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|3 target controls covered
50%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
3 source controls mapped|2 target controls covered
50%
Family Educational Rights and Privacy Act (FERPA)
3 source controls mapped|2 target controls covered
50%
GAMP 5 - Good Automated Manufacturing Practice
3 source controls mapped|2 target controls covered
50%
HITECH Act
3 source controls mapped|3 target controls covered
50%
ICH Q10 - Pharmaceutical Quality System
3 source controls mapped|3 target controls covered
50%
Indiana Consumer Data Protection Act
3 source controls mapped|2 target controls covered
50%
Iowa Consumer Data Protection Act
3 source controls mapped|2 target controls covered
50%
Jamaica Data Protection Act 2020
3 source controls mapped|2 target controls covered
50%
South Korea PIPA
3 source controls mapped|3 target controls covered
50%
LGPD
3 source controls mapped|2 target controls covered
50%
Liechtenstein DPA
3 source controls mapped|2 target controls covered
50%
Malaysia PDPA 2010
3 source controls mapped|2 target controls covered
50%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|1 target controls covered
50%
Nebraska Data Privacy Act
3 source controls mapped|3 target controls covered
50%
New Hampshire Data Privacy Act
3 source controls mapped|2 target controls covered
50%
New Jersey Data Privacy Act
3 source controls mapped|2 target controls covered
50%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|2 target controls covered
50%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|5 target controls covered
50%
Nigeria Data Protection Regulation (NDPR)
3 source controls mapped|2 target controls covered
50%
NIST SP 800-122
3 source controls mapped|2 target controls covered
50%
Oregon Consumer Privacy Act
3 source controls mapped|2 target controls covered
50%
PDPA Singapore
3 source controls mapped|2 target controls covered
50%
PDPA Thailand
3 source controls mapped|2 target controls covered
50%
Personal Data Act (personopplysningsloven)
3 source controls mapped|2 target controls covered
50%
POPIA
3 source controls mapped|2 target controls covered
50%
Privacy Act 2020
3 source controls mapped|2 target controls covered
50%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
3 source controls mapped|4 target controls covered
50%
Qatar DPL
3 source controls mapped|2 target controls covered
50%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
3 source controls mapped|2 target controls covered
50%
Barbados Data Protection Act 2019
3 source controls mapped|2 target controls covered
50%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|2 target controls covered
50%
Australian Privacy Principles (APPs)
3 source controls mapped|1 target controls covered
50%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|3 target controls covered
50%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
50%
Kentucky Consumer Data Protection Act
3 source controls mapped|1 target controls covered
50%
Montana Consumer Data Privacy Act
3 source controls mapped|1 target controls covered
50%
Minnesota Consumer Data Privacy Act
3 source controls mapped|1 target controls covered
50%
Mexico LFPDPPP
3 source controls mapped|1 target controls covered
50%
Mauritius DPA
3 source controls mapped|1 target controls covered
50%
Maryland Online Data Privacy Act of 2024
3 source controls mapped|1 target controls covered
50%
SWIFT CSCF
2 source controls mapped|2 target controls covered
33%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
2 source controls mapped|4 target controls covered
33%
ISO 19011
2 source controls mapped|3 target controls covered
33%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
2 source controls mapped|3 target controls covered
33%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|4 target controls covered
33%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|3 target controls covered
33%
ISO/IEC 27400:2022
2 source controls mapped|4 target controls covered
33%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
2 source controls mapped|3 target controls covered
33%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
2 source controls mapped|2 target controls covered
33%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|4 target controls covered
33%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
2 source controls mapped|4 target controls covered
33%
FedRAMP Rev 5
2 source controls mapped|2 target controls covered
33%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|2 target controls covered
33%
MITRE ATT&CK
2 source controls mapped|2 target controls covered
33%
PTES
2 source controls mapped|2 target controls covered
33%
OWASP SAMM
2 source controls mapped|2 target controls covered
33%
OWASP MASVS
2 source controls mapped|2 target controls covered
33%
OpenSSF Scorecard
2 source controls mapped|2 target controls covered
33%
O-RAN WG11 Security Specification
2 source controls mapped|3 target controls covered
33%
NIST SP 800-92
2 source controls mapped|2 target controls covered
33%
NIST SP 800-88
2 source controls mapped|1 target controls covered
33%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
2 source controls mapped|4 target controls covered
33%
NIST SP 800-63-4
2 source controls mapped|2 target controls covered
33%
NIST SP 800-61
2 source controls mapped|2 target controls covered
33%
NIST SP 800-137
2 source controls mapped|2 target controls covered
33%
NIST SP 800-123
2 source controls mapped|2 target controls covered
33%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
2 source controls mapped|2 target controls covered
33%
NIST Privacy Framework
2 source controls mapped|2 target controls covered
33%
FedRAMP High
2 source controls mapped|2 target controls covered
33%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|2 target controls covered
33%
FedRAMP Moderate
2 source controls mapped|2 target controls covered
33%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|2 target controls covered
33%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|2 target controls covered
33%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
17%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
17%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
1 source controls mapped|1 target controls covered
17%
Tennessee Information Protection Act (TIPA)
1 source controls mapped|1 target controls covered
17%
ISO 13485
1 source controls mapped|1 target controls covered
17%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
1 source controls mapped|3 target controls covered
17%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
17%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
17%
ASD Strategies to Mitigate Cyber Security Incidents
1 source controls mapped|2 target controls covered
17%
FDA 21 CFR Part 11
1 source controls mapped|1 target controls covered
17%
FIDO2 / WebAuthn
1 source controls mapped|2 target controls covered
17%
FISMA
1 source controls mapped|1 target controls covered
17%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
17%
HL7 FHIR Security Framework
1 source controls mapped|1 target controls covered
17%
ITU-T X.805 - Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
17%
MARS-E
1 source controls mapped|2 target controls covered
17%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
17%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|2 target controls covered
17%
Oman National Cybersecurity Framework
1 source controls mapped|1 target controls covered
17%
NIST SP 800-66
1 source controls mapped|1 target controls covered
17%
NIS2 Directive Implementing Acts
1 source controls mapped|1 target controls covered
17%
GRI Standards
1 source controls mapped|1 target controls covered
17%
IEEE 7000
1 source controls mapped|1 target controls covered
17%
Indonesia PDP Law
1 source controls mapped|1 target controls covered
17%
ISSB Standards
1 source controls mapped|1 target controls covered
17%
Japan AI Guidelines
1 source controls mapped|1 target controls covered
17%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|1 target controls covered
17%
OECD AI Principles
1 source controls mapped|1 target controls covered
17%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|1 target controls covered
17%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
17%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
17%
NIST AI Risk Management Framework (AI RMF 1.0)
1 source controls mapped|2 target controls covered
17%
ISO/IEC 27011:2024
1 source controls mapped|3 target controls covered
17%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|4 target controls covered
17%
COBIT 2019
1 source controls mapped|1 target controls covered
17%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
1 source controls mapped|2 target controls covered
17%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|3 target controls covered
17%
ISO/IEC 29134:2023
1 source controls mapped|3 target controls covered
17%
ISO/IEC 27014:2020
1 source controls mapped|3 target controls covered
17%
IEC 62351 - Power Systems Communication Security
1 source controls mapped|1 target controls covered
17%
ISO/IEC 29147:2018
1 source controls mapped|3 target controls covered
17%
21 CFR Part 58 - Good Laboratory Practice (GLP)
1 source controls mapped|2 target controls covered
17%
ISO/IEC 29100:2024
1 source controls mapped|3 target controls covered
17%
ISO/IEC 30111:2019
1 source controls mapped|3 target controls covered
17%
21 CFR Part 211 - Current Good Manufacturing Practice
1 source controls mapped|1 target controls covered
17%
ISO/IEC 27004:2016
1 source controls mapped|3 target controls covered
17%
Annex 11 to EU GMP - Computerised Systems
1 source controls mapped|3 target controls covered
17%
ISO/IEC 38500:2024 - Governance of IT
1 source controls mapped|3 target controls covered
17%
APRA CPS 234
1 source controls mapped|1 target controls covered
17%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
17%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
1 source controls mapped|1 target controls covered
17%
ISO 31000:2018
1 source controls mapped|1 target controls covered
17%
FATF Recommendation 16 - Virtual Asset Travel Rule
1 source controls mapped|1 target controls covered
17%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|1 target controls covered
17%
GLBA
1 source controls mapped|1 target controls covered
17%
HKMA SPM
1 source controls mapped|1 target controls covered
17%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
1 source controls mapped|3 target controls covered
17%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
17%
IATF 16949:2016 - Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
17%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
1 source controls mapped|1 target controls covered
17%
ITAR - International Traffic in Arms Regulations
1 source controls mapped|1 target controls covered
17%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
17%
Monetary Authority of Singapore Technology Risk Management Guidelines
1 source controls mapped|1 target controls covered
17%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
1 source controls mapped|2 target controls covered
17%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
17%
Notifiable Data Breaches Scheme (Australia)
1 source controls mapped|1 target controls covered
17%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
1 source controls mapped|2 target controls covered
17%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|1 target controls covered
17%
Open Banking Security
1 source controls mapped|1 target controls covered
17%
OSFI B-13
1 source controls mapped|1 target controls covered
17%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
17%
Philippines Cybercrime Prevention Act (RA 10175)
1 source controls mapped|1 target controls covered
17%
PSD2 SCA
1 source controls mapped|1 target controls covered
17%
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 6 domains and 6 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 6 controls organised across 6 domains. The largest domains are Cross-Border (1 controls), EHR Requirements (1 controls), Governance (1 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 166 other compliance frameworks. The top mapping partners are USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement) (67% coverage), TEFCA - Trusted Exchange Framework and Common Agreement (67% coverage), Armenia Law on Protection of Personal Data (2015) (67% 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?
Start your 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 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 6 controls and track your progress.
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