Cross-Framework Mapping

NIST Privacy FrameworkvsISO 13485

See exactly how NIST Privacy Framework controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.

22
Controls Mapped
0
Gaps Found
62%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NIST Privacy Framework maps to ISO 13485 with 62% coverage across 5 directly mapped controls. Analysis of 8 NIST Privacy Framework controls identifies 3 compliance gaps — primarily concentrated in Protect-P Data Security.

Source: TheArtOfService Knowledge Graph | 8 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 22 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Control-P(1 mappings)

NISTPF-3Control-P - Privacy Controls, Data Management, and Disassociated Processing
ISO13485-01ePHI access controls and authorization

Communicate-P(3 mappings)

NISTPF-4Communicate-P - Privacy Notice, Transparency, and Individual Awareness3 targets
ISO13485-03Minimum necessary standard enforcement
ISO13485-04Patient data de-identification procedures
ISO13485-05Audit trail for ePHI access

Protect-P Access(5 mappings)

NISTPF-5Protect-P Access Control (PR.AC-P)5 targets
6.4Logging and Monitoring
ISO13485-01ePHI access controls and authorization
ISO13485-08Information access management
ISO13485-12Unique user identification and authentication
ISO13485-17Facility access controls

Protect-P Maintenance and Technology(3 mappings)

NISTPF-7Protect-P Maintenance and Protective Technology (PR.MA-P, PR.PT-P)3 targets
ISO13485-03Minimum necessary standard enforcement
ISO13485-04Patient data de-identification procedures
ISO13485-05Audit trail for ePHI access

Protect-P Processes(8 mappings)

NISTPF-8Protect-P Information Protection Processes (PR.PO-P)8 targets
ISO13485-01ePHI access controls and authorization
ISO13485-02ePHI encryption at rest and in transit
ISO13485-03Minimum necessary standard enforcement
ISO13485-04Patient data de-identification procedures
ISO13485-05Audit trail for ePHI access
ISO13485-06Security management process and risk analysis
ISO13485-08Information access management
ISO13485-09Security awareness and training program

+2 more mappings

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What are the key differences between NIST Privacy Framework and ISO 13485?

NIST Privacy Framework has 8 controls across its framework, while ISO 13485 covers 29 controls. Direct mapping analysis identifies 5 overlapping controls (62% coverage). The frameworks diverge most significantly in Protect-P Data Security, where 1 NIST Privacy Framework controls have no direct ISO 13485 equivalent.

How many controls map between NIST Privacy Framework and ISO 13485?

Of 8 total NIST Privacy Framework controls, 5 map directly to ISO 13485 controls — representing 62% coverage. The remaining 3 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NIST Privacy Framework to ISO 13485?

3 NIST Privacy Framework controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Protect-P Data Security 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 NIST Privacy Framework and ISO 13485?

The domain with the highest gap count is Protect-P Data Security (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.