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Regulation on the European Health Data Space (EHDS)
European Union
v2024 (Regulation)
8 domains
11 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 (8)
Cross-Border
1 controls
| Code | Title |
|---|---|
| EHDSREG-5 | Cross-Border Health Data Flows |
Cross-Border Telemedicine
1 controls
Cross-Border Telemedicine
| Code | Title |
|---|---|
| EHDS-ART8A | Telemedicine in the context of cross-border care |
Data Holder Obligations and Secondary Use
4 controls
Data Holder Obligations and Secondary Use
| Code | Title |
|---|---|
| EHDS-ART53-PROHIB | Prohibited Secondary Use Purposes |
| EHDS-HOLD-1 | Obligation to Make Data Available |
| EHDS-HOLD-2 | Secure Processing Environment |
| EHDS-HOLD-3 | Dataset Descriptions and Catalogues |
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:
Qatar DPL
36%
4 controls mapped
Compare →Privacy Act 2020
36%
4 controls mapped
Compare →POPIA
36%
4 controls mapped
Compare →+ 174 more: Personal Data Act (personopplysningsloven) (36%), PDPA Thailand (36%)
See all 177 mapped frameworks ↓Maps to 177 other frameworks
11 total controls
Qatar DPL
4 source controls mapped|2 target controls covered
36%
Privacy Act 2020
4 source controls mapped|3 target controls covered
36%
POPIA
4 source controls mapped|5 target controls covered
36%
Personal Data Act (personopplysningsloven)
4 source controls mapped|3 target controls covered
36%
PDPA Thailand
4 source controls mapped|3 target controls covered
36%
PDPA Singapore
4 source controls mapped|3 target controls covered
36%
Oregon Consumer Privacy Act
4 source controls mapped|2 target controls covered
36%
NIST SP 800-122
4 source controls mapped|3 target controls covered
36%
Nigeria Data Protection Regulation (NDPR)
4 source controls mapped|4 target controls covered
36%
Nigeria Data Protection Act 2023 (NDPA)
4 source controls mapped|5 target controls covered
36%
Nebraska Data Privacy Act
4 source controls mapped|3 target controls covered
36%
New Jersey Data Privacy Act
4 source controls mapped|2 target controls covered
36%
New Hampshire Data Privacy Act
4 source controls mapped|3 target controls covered
36%
Montana Consumer Data Privacy Act
4 source controls mapped|2 target controls covered
36%
Minnesota Consumer Data Privacy Act
4 source controls mapped|2 target controls covered
36%
Mexico LFPDPPP
4 source controls mapped|3 target controls covered
36%
Mauritius DPA
4 source controls mapped|3 target controls covered
36%
Maryland Online Data Privacy Act of 2024
4 source controls mapped|3 target controls covered
36%
Malaysia PDPA 2010
4 source controls mapped|3 target controls covered
36%
Liechtenstein DPA
4 source controls mapped|3 target controls covered
36%
LGPD
4 source controls mapped|3 target controls covered
36%
South Korea PIPA
4 source controls mapped|4 target controls covered
36%
Kentucky Consumer Data Protection Act
4 source controls mapped|3 target controls covered
36%
Jamaica Data Protection Act 2020
4 source controls mapped|4 target controls covered
36%
Iowa Consumer Data Protection Act
4 source controls mapped|4 target controls covered
36%
Indiana Consumer Data Protection Act
4 source controls mapped|3 target controls covered
36%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
4 source controls mapped|3 target controls covered
36%
Family Educational Rights and Privacy Act (FERPA)
4 source controls mapped|5 target controls covered
36%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
4 source controls mapped|4 target controls covered
36%
Bahrain PDPL
4 source controls mapped|4 target controls covered
36%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
4 source controls mapped|4 target controls covered
36%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
4 source controls mapped|4 target controls covered
36%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
4 source controls mapped|2 target controls covered
36%
TEFCA - Trusted Exchange Framework and Common Agreement
4 source controls mapped|2 target controls covered
36%
Armenia Law on Protection of Personal Data (2015)
4 source controls mapped|2 target controls covered
36%
Florida Digital Bill of Rights (FDBR)
4 source controls mapped|2 target controls covered
36%
MDS2 (Medical Device)
4 source controls mapped|3 target controls covered
36%
MTCS (Singapore)
4 source controls mapped|4 target controls covered
36%
NAIC Insurance Data Security Model Law (MDL-668)
4 source controls mapped|1 target controls covered
36%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
3 source controls mapped|5 target controls covered
27%
GLI-33 - Gaming Laboratories International Event Wagering Systems
3 source controls mapped|3 target controls covered
27%
ISMAP (Japan)
3 source controls mapped|2 target controls covered
27%
NIST SP 800-146
3 source controls mapped|2 target controls covered
27%
NIST SP 800-145
3 source controls mapped|3 target controls covered
27%
NIST SP 800-144
3 source controls mapped|1 target controls covered
27%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
3 source controls mapped|2 target controls covered
27%
Aged Care Quality Standards 2019 (repealed edition)
3 source controls mapped|3 target controls covered
27%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
27%
IEC 60601-1 - Medical Electrical Equipment Safety
3 source controls mapped|3 target controls covered
27%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|3 target controls covered
27%
GAMP 5 - Good Automated Manufacturing Practice
3 source controls mapped|2 target controls covered
27%
HITECH Act
3 source controls mapped|3 target controls covered
27%
ICH Q10 - Pharmaceutical Quality System
3 source controls mapped|3 target controls covered
27%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|1 target controls covered
27%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|2 target controls covered
27%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
3 source controls mapped|4 target controls covered
27%
Barbados Data Protection Act 2019
3 source controls mapped|2 target controls covered
27%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|2 target controls covered
27%
Australian Privacy Principles (APPs)
3 source controls mapped|1 target controls covered
27%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|3 target controls covered
27%
OECD AI Principles
2 source controls mapped|2 target controls covered
18%
Japan AI Guidelines
2 source controls mapped|2 target controls covered
18%
Indonesia PDP Law
2 source controls mapped|2 target controls covered
18%
IEEE 7000
2 source controls mapped|3 target controls covered
18%
SWIFT CSCF
2 source controls mapped|2 target controls covered
18%
ISO 19011
2 source controls mapped|3 target controls covered
18%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
2 source controls mapped|3 target controls covered
18%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|4 target controls covered
18%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
2 source controls mapped|3 target controls covered
18%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
2 source controls mapped|2 target controls covered
18%
Illinois Biometric Information Privacy Act (BIPA)
2 source controls mapped|2 target controls covered
18%
FedRAMP Rev 5
2 source controls mapped|2 target controls covered
18%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|2 target controls covered
18%
MITRE ATT&CK
2 source controls mapped|2 target controls covered
18%
PTES
2 source controls mapped|2 target controls covered
18%
OWASP SAMM
2 source controls mapped|2 target controls covered
18%
OWASP MASVS
2 source controls mapped|2 target controls covered
18%
OpenSSF Scorecard
2 source controls mapped|2 target controls covered
18%
O-RAN WG11 Security Specification
2 source controls mapped|3 target controls covered
18%
NIST SP 800-92
2 source controls mapped|2 target controls covered
18%
NIST SP 800-88
2 source controls mapped|1 target controls covered
18%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
2 source controls mapped|4 target controls covered
18%
NIST SP 800-63-4
2 source controls mapped|2 target controls covered
18%
NIST SP 800-61
2 source controls mapped|2 target controls covered
18%
NIST SP 800-137
2 source controls mapped|2 target controls covered
18%
NIST SP 800-123
2 source controls mapped|2 target controls covered
18%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
2 source controls mapped|2 target controls covered
18%
NIST Privacy Framework
2 source controls mapped|2 target controls covered
18%
FedRAMP High
2 source controls mapped|2 target controls covered
18%
NIST SP 800-53 Revision 5.1 HIGH
2 source controls mapped|2 target controls covered
18%
FedRAMP Moderate
2 source controls mapped|2 target controls covered
18%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|2 target controls covered
18%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|2 target controls covered
18%
Singapore AI Governance Framework
1 source controls mapped|1 target controls covered
9%
Virginia CDPA
1 source controls mapped|2 target controls covered
9%
Vietnam PDPD
1 source controls mapped|1 target controls covered
9%
Uruguay DPL
1 source controls mapped|1 target controls covered
9%
UNESCO Recommendation on the Ethics of AI
1 source controls mapped|2 target controls covered
9%
UK AI Regulation Framework
1 source controls mapped|1 target controls covered
9%
Turkey KVKK
1 source controls mapped|1 target controls covered
9%
Texas Data Privacy Act
1 source controls mapped|1 target controls covered
9%
Taiwan PDPA
1 source controls mapped|2 target controls covered
9%
Peru DPL
1 source controls mapped|1 target controls covered
9%
GS1 Global Standards - Supply Chain Traceability and Data Security
1 source controls mapped|2 target controls covered
9%
Saudi Arabia PDPL
1 source controls mapped|3 target controls covered
9%
ISO/IEC 23894:2023
1 source controls mapped|2 target controls covered
9%
ISO/IEC 25012:2008 - Data Quality Model
1 source controls mapped|3 target controls covered
9%
WHO Global Strategy on Digital Health 2020-2025
1 source controls mapped|1 target controls covered
9%
RICS Professional Standards - Data and Technology in Property
1 source controls mapped|1 target controls covered
9%
AICPA Privacy Management Framework (PMF)
1 source controls mapped|1 target controls covered
9%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
9%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
9%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
1 source controls mapped|1 target controls covered
9%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
1 source controls mapped|3 target controls covered
9%
ISO 13485
1 source controls mapped|1 target controls covered
9%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|1 target controls covered
9%
ISO/IEC 27400:2022
1 source controls mapped|1 target controls covered
9%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
9%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
1 source controls mapped|1 target controls covered
9%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
9%
ASD Strategies to Mitigate Cyber Security Incidents
1 source controls mapped|2 target controls covered
9%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
1 source controls mapped|1 target controls covered
9%
FDA 21 CFR Part 11
1 source controls mapped|1 target controls covered
9%
FIDO2 / WebAuthn
1 source controls mapped|2 target controls covered
9%
FISMA
1 source controls mapped|1 target controls covered
9%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
9%
HL7 FHIR Security Framework
1 source controls mapped|1 target controls covered
9%
ITU-T X.805 - Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
9%
MARS-E
1 source controls mapped|2 target controls covered
9%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
1 source controls mapped|1 target controls covered
9%
OWASP Top 10 for LLM Applications 2025
1 source controls mapped|2 target controls covered
9%
Oman National Cybersecurity Framework
1 source controls mapped|1 target controls covered
9%
NIST SP 800-66
1 source controls mapped|1 target controls covered
9%
NIS2 Directive Implementing Acts
1 source controls mapped|1 target controls covered
9%
GRI Standards
1 source controls mapped|1 target controls covered
9%
ISSB Standards
1 source controls mapped|1 target controls covered
9%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|1 target controls covered
9%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|1 target controls covered
9%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
9%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
1 source controls mapped|2 target controls covered
9%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
9%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
9%
COBIT 2019
1 source controls mapped|1 target controls covered
9%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
1 source controls mapped|2 target controls covered
9%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|3 target controls covered
9%
IEC 62351 - Power Systems Communication Security
1 source controls mapped|1 target controls covered
9%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
9%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|1 target controls covered
9%
ISO/IEC 27004:2016
1 source controls mapped|2 target controls covered
9%
Annex 11 to EU GMP - Computerised Systems
1 source controls mapped|3 target controls covered
9%
ISO/IEC 38500:2024 - Governance of IT
1 source controls mapped|3 target controls covered
9%
ISO/IEC 29100:2024
1 source controls mapped|1 target controls covered
9%
ISO/IEC 30111:2019
1 source controls mapped|1 target controls covered
9%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
9%
PCI DSS 4.0
1 source controls mapped|1 target controls covered
9%
ISO 31000:2018
1 source controls mapped|1 target controls covered
9%
FATF Recommendation 16 - Virtual Asset Travel Rule
1 source controls mapped|1 target controls covered
9%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|1 target controls covered
9%
GLBA
1 source controls mapped|1 target controls covered
9%
HKMA SPM
1 source controls mapped|1 target controls covered
9%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
1 source controls mapped|3 target controls covered
9%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
9%
IATF 16949:2016 - Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
9%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
1 source controls mapped|1 target controls covered
9%
ITAR - International Traffic in Arms Regulations
1 source controls mapped|1 target controls covered
9%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
9%
Monetary Authority of Singapore Technology Risk Management Guidelines
1 source controls mapped|1 target controls covered
9%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
1 source controls mapped|2 target controls covered
9%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
9%
Notifiable Data Breaches Scheme (Australia)
1 source controls mapped|1 target controls covered
9%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
1 source controls mapped|2 target controls covered
9%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|1 target controls covered
9%
Open Banking Security
1 source controls mapped|1 target controls covered
9%
OSFI B-13
1 source controls mapped|1 target controls covered
9%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
9%
Philippines Cybercrime Prevention Act (RA 10175)
1 source controls mapped|1 target controls covered
9%
PSD2 SCA
1 source controls mapped|1 target controls covered
9%
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 8 domains and 11 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 11 controls organised across 8 domains. The largest domains are Data Holder Obligations and Secondary Use (4 controls), Cross-Border (1 controls), Cross-Border Telemedicine (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 177 other compliance frameworks. The top mapping partners are Qatar DPL (36% coverage), Privacy Act 2020 (36% coverage), POPIA (36% 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 11 controls and track your progress.
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