TheArtOfService
Cross-Framework Mapping

ISO 13485vsFTC GLBA Safeguards Rule (16 CFR Part 314)

See exactly how ISO 13485 controls map to FTC GLBA Safeguards Rule (16 CFR Part 314). Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
18
Gaps Found
38%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to FTC GLBA Safeguards Rule (16 CFR Part 314) with 38% coverage across 11 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 18 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 29 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

Resource Management(1 mappings)

6.4Logging and Monitoring
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))

ISO 13485: Patient Data Protection(5 mappings)

ISO13485-01ePHI access controls and authorization
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))
ISO13485-02ePHI encryption at rest and in transit
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))
ISO13485-03Minimum necessary standard enforcement
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))
ISO13485-04Patient data de-identification procedures
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))
ISO13485-05Audit trail for ePHI access
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))

ISO 13485: Administrative Safeguards(2 mappings)

ISO13485-08Information access management
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))
ISO13485-09Security awareness and training program
→FTC-Safeguards-ServiceProvider-EvaluationService Provider Oversight + Program Evaluation + Personnel Training (16 CFR 314.4(d-g))

ISO 13485: Technical Safeguards(2 mappings)

ISO13485-12Unique user identification and authentication
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))
ISO13485-16Transmission security and encryption
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))

ISO 13485: Physical Safeguards(1 mappings)

ISO13485-17Facility access controls
→FTC-Safeguards-9-Elements9 Safeguard Elements - Access, Inventory, Encryption, Secure-Dev, MFA, Disposal, Change-Mgmt, Monitoring, Pen-Test (16 CFR 314.4(c))

Related Comparisons

Other ISO 13485 comparisons

ISO 13485 vs NIST SP 800-6613 mappingsISO 13485 vs MDS2 (Medical Device)13 mappingsISO 13485 vs MARS-E13 mappingsISO 13485 vs ISO 2779913 mappingsISO 13485 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements12 mappingsISO 13485 vs NIST Privacy Framework12 mappingsISO 13485 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)12 mappingsISO 13485 vs Oman National Cybersecurity Framework11 mappings

Other FTC GLBA Safeguards Rule (16 CFR Part 314) comparisons

Vietnam Law on Cybersecurity (No. 24/2018/QH14) vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsVermont Artificial Intelligence and Consumer Data Act (AICDA) vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsPrivacy Act 1988 (Australia) vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsLey Orgánica de Protección de Datos Personales (LOPDP) vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsLaw No. 172-13 on the Protection of Personal Data vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsIndia DPDP Act vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsIndia CERT-In Cyber Security Directions 2022 vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappingsHKMA Cyber Resilience Assessment Framework (C-RAF) vs FTC GLBA Safeguards Rule (16 CFR Part 314)6 mappings

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What are the key differences between ISO 13485 and FTC GLBA Safeguards Rule (16 CFR Part 314)?

ISO 13485 has 29 controls across its framework, while FTC GLBA Safeguards Rule (16 CFR Part 314) covers 11 controls. Direct mapping analysis identifies 11 overlapping controls (38% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct FTC GLBA Safeguards Rule (16 CFR Part 314) equivalent.

How many controls map between ISO 13485 and FTC GLBA Safeguards Rule (16 CFR Part 314)?

Of 29 total ISO 13485 controls, 11 map directly to FTC GLBA Safeguards Rule (16 CFR Part 314) controls — representing 38% coverage. The remaining 18 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 13485 to FTC GLBA Safeguards Rule (16 CFR Part 314)?

18 ISO 13485 controls have no direct equivalent in FTC GLBA Safeguards Rule (16 CFR Part 314). The highest concentration of gaps is in ISO 13485: Organizational Requirements with 4 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 ISO 13485 and FTC GLBA Safeguards Rule (16 CFR Part 314)?

The domain with the highest gap count is ISO 13485: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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