Framework overlap

Does ISO 13485 cover HL7 FHIR Security Framework?

You hold ISO 13485 and have been told to do HL7 FHIR Security Framework. Here is how much overlaps, control by control.

43% of HL7 FHIR Security Framework you already have

ISO 13485 already covers about 43% of HL7 FHIR Security Framework, leaving 4 of 7 controls as genuinely new work.

Already covered 1 Likely covered 2 New work 4

What is genuinely new work

Nothing in ISO 13485 reaches these. This is the list to scope.

HL7-FHIR-Authorization-Scopes-Consent-Bulk-Break-Glass
HL7 FHIR Authorization - OAuth 2.0 Scopes + Security Labels + Consent + Patient Compartment + Bulk Data + Break the Glass
HL7-FHIR-Coord-HIPAA-ONC-Cures-USCDI-TEFCA
HL7 FHIR Coordination with HIPAA, ONC Information Blocking, 21st Century Cures Act, USCDI, TEFCA + 2024-2025 Pipeline
HL7-FHIR-Resilience-RateLimit-CORS-AntiAbuse-SmartHealth
HL7 FHIR Resilience - Rate Limiting + Anti-Abuse + CORS + SMART Health Cards + De-identification + Privacy
HL7-FHIR-Scope-Versions-HL7-Specification
HL7 FHIR Security Framework Scope, FHIR Versions (R4/R4B/R5/R6), HL7 Specification + Security/Privacy Module
Show the 3 you already have
HL7-FHIR-Auth-SMART-OAuth-OIDC-Backend
HL7 FHIR Authentication - SMART App Launch + OAuth 2.0 + OpenID Connect + Backend Services + Token Lifetime
HL7-FHIR-Audit-Provenance-DigitalSignatures-Integrity
HL7 FHIR Audit + Provenance + Digital Signatures + AuditEvent Resource + Audit Log Integrity + Retention
HL7-FHIR-Transport-TLS-Communication
HL7 FHIR Transport Security - TLS 1.2+, Communication Security, Time Keeping, Server CapabilityStatement

How this is calculated

Already covered means a mapping runs from a control in ISO 13485 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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