Cross-Framework Mapping

Regulation on the European Health Data Space (EHDS)vsMDS2 (Medical Device)

See exactly how Regulation on the European Health Data Space (EHDS) controls map to MDS2 (Medical Device). Pre-computed mappings, identified gaps, and coverage analysis.

10
Controls Mapped
0
Gaps Found
67%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Regulation on the European Health Data Space (EHDS) maps to MDS2 (Medical Device) with 67% coverage across 4 directly mapped controls. Analysis of 6 Regulation on the European Health Data Space (EHDS) controls identifies 2 compliance gaps — primarily concentrated in Governance.

Source: TheArtOfService Knowledge Graph | 6 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 10 of 10 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

EHR Requirements(3 mappings)

EHDSREG-1Mandatory Requirements for EHR Systems (Articles 14-29)3 targets
MDS2-Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-MonitoringMDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring
MDS2-PHI-Data-Handling-DATA-Storage-STCF-Transmission-TXCF-TXIG-Encryption-FIPSMDS2 PHI Handling + DATA + STCF Storage + TXCF Transmission + TXIG Integrity + Encryption + FIPS
MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUTMDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management

Secondary Use(3 mappings)

EHDSREG-3Secondary Use - Health Data for Research and Innovation3 targets
MDS2-Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-MonitoringMDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring
MDS2-PHI-Data-Handling-DATA-Storage-STCF-Transmission-TXCF-TXIG-Encryption-FIPSMDS2 PHI Handling + DATA + STCF Storage + TXCF Transmission + TXIG Integrity + Encryption + FIPS
MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUTMDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management

Cross-Border(3 mappings)

EHDSREG-5Cross-Border Health Data Flows3 targets
MDS2-Audit-Logging-AUDT-Integrity-IGAU-Cybersecurity-Risk-CYBR-MonitoringMDS2 Audit Controls + AUDT + Integrity + IGAU + Cybersecurity Risk + CYBR + Continuous Monitoring
MDS2-PHI-Data-Handling-DATA-Storage-STCF-Transmission-TXCF-TXIG-Encryption-FIPSMDS2 PHI Handling + DATA + STCF Storage + TXCF Transmission + TXIG Integrity + Encryption + FIPS
MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUTMDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management

Phased Application(1 mappings)

EHDSREG-6Phased Application and Enforcement
MDS2-Person-Node-Authentication-Authorization-Auto-Logoff-AUTH-PAUT-NAUTMDS2 Authentication + Authorization + Auto Logoff + PAUT + NAUT + AUTH + Identity Management

Related Comparisons

Other Regulation on the European Health Data Space (EHDS) comparisons

Other MDS2 (Medical Device) comparisons

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What are the key differences between Regulation on the European Health Data Space (EHDS) and MDS2 (Medical Device)?

Regulation on the European Health Data Space (EHDS) has 6 controls across its framework, while MDS2 (Medical Device) covers 8 controls. Direct mapping analysis identifies 4 overlapping controls (67% coverage). The frameworks diverge most significantly in Governance, where 1 Regulation on the European Health Data Space (EHDS) controls have no direct MDS2 (Medical Device) equivalent.

How many controls map between Regulation on the European Health Data Space (EHDS) and MDS2 (Medical Device)?

Of 6 total Regulation on the European Health Data Space (EHDS) controls, 4 map directly to MDS2 (Medical Device) controls — representing 67% coverage. The remaining 2 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Regulation on the European Health Data Space (EHDS) to MDS2 (Medical Device)?

2 Regulation on the European Health Data Space (EHDS) controls have no direct equivalent in MDS2 (Medical Device). The highest concentration of gaps is in Governance with 1 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between Regulation on the European Health Data Space (EHDS) and MDS2 (Medical Device)?

The domain with the highest gap count is Governance (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.