Framework overlap

Does Regulation on the European Health Data Space (EHDS) cover ISO 13485?

You hold Regulation on the European Health Data Space (EHDS) and have been told to do ISO 13485. Here is how much overlaps, control by control.

48% of ISO 13485 you already have

Regulation on the European Health Data Space (EHDS) already covers about 48% of ISO 13485, leaving 15 of 29 controls as genuinely new work.

Already covered 1 Likely covered 13 New work 15

What is genuinely new work

Nothing in Regulation on the European Health Data Space (EHDS) reaches these. This is the list to scope.

5.6
Monitoring Audit Programme
7.5
Threat assessment
8.5
Control effectiveness review
ISO13485-10
Contingency planning for ePHI
ISO13485-11
Business associate management
ISO13485-13
Automatic logoff and session management
ISO13485-14
Audit controls and monitoring
ISO13485-15
Integrity controls for ePHI
ISO13485-18
Workstation security and use policies
ISO13485-19
Device and media controls
ISO13485-20
Disposal and re-use procedures
ISO13485-21
Security and privacy policies
ISO13485-22
Documentation and record retention
ISO13485-23
Compliance evaluation and review
ISO13485-24
Incident reporting procedures
Show the 14 you already have
6.4
Logging and Monitoring
8.3
Statement of Applicability linkage
ISO13485-01
ePHI access controls and authorization
ISO13485-02
ePHI encryption at rest and in transit
ISO13485-03
Minimum necessary standard enforcement
ISO13485-04
Patient data de-identification procedures
ISO13485-05
Audit trail for ePHI access
ISO13485-06
Security management process and risk analysis
ISO13485-07
Workforce security and clearance procedures
ISO13485-08
Information access management
ISO13485-09
Security awareness and training program
ISO13485-12
Unique user identification and authentication
ISO13485-16
Transmission security and encryption
ISO13485-17
Facility access controls

How this is calculated

Already covered means a mapping runs from a control in Regulation on the European Health Data Space (EHDS) to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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