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.

20
Controls Mapped
24
Gaps Found
30%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to FTC GLBA Safeguards Rule (16 CFR Part 314) with 30% coverage across 13 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 31 compliance gaps — primarily concentrated in Product Realisation.

Source: TheArtOfService Knowledge Graph | 44 controls analysed | 730 frameworks | 488K+ cross-framework mappings

Control Mappings

Showing 20 of 20 mapped controls across 5 domains. Sign up to explore all 488K+ mappings across 730 frameworks.

Resource Management(3 mappings)

6.3Information security awareness, education and training2 targets
→Sec. 314.2(a)Definition of financial institution
→Sec. 314.2(b)Definition of customer information
6.4Logging and Monitoring
→Sec. 314.4(c)(5)Multi-factor authentication

ISO 13485: Patient Data Protection(9 mappings)

ISO13485-01ePHI access controls and authorization
→Sec. 314.4(c)(1)Access controls
ISO13485-02ePHI encryption at rest and in transit
→Sec. 314.4(c)(3)Encryption of customer information
ISO13485-03Minimum necessary standard enforcement2 targets
→NGC-5.260(i)Patron and Employee Data Protection
→Sec. 314.4(c)(6)Data disposal procedures
ISO13485-04Patient data de-identification procedures2 targets
→NGC-5.260(i)Patron and Employee Data Protection
→Sec. 314.4(c)(6)Data disposal procedures
ISO13485-05Audit trail for ePHI access3 targets
→NGC-5.260(i)Patron and Employee Data Protection
→Sec. 314.4(c)(6)Data disposal procedures
→Sec. 314.4(c)(8)Monitoring and logging

ISO 13485: Administrative Safeguards(5 mappings)

ISO13485-06Security management process and risk analysis3 targets
→FTC-314.4gProgram Evaluation and Adjustment
→FTC-314.4iBoard / Senior Officer Reporting
→FTC-314.5Exemption for Small Institutions
ISO13485-08Information access management
→Sec. 314.4(c)(1)Access controls
ISO13485-09Security awareness and training program
→Sec. 314.4(e)Security awareness training

ISO 13485: Technical Safeguards(2 mappings)

ISO13485-12Unique user identification and authentication
→Sec. 314.4(c)(5)Multi-factor authentication
ISO13485-16Transmission security and encryption
→Sec. 314.4(c)(3)Encryption of customer information

ISO 13485: Physical Safeguards(1 mappings)

ISO13485-17Facility access controls
→Sec. 314.4(c)(1)Access controls

Related Comparisons

Other ISO 13485 comparisons

ISO 13485 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements16 mappingsISO 13485 vs FAA Cybersecurity Framework for Aviation14 mappingsISO 13485 vs GLI-33 - Gaming Laboratories International Event Wagering Systems14 mappingsISO 13485 vs TISAX - Trusted Information Security Assessment Exchange14 mappingsISO 13485 vs MDS2 (Medical Device)13 mappingsISO 13485 vs FDA 21 CFR Part 1113 mappingsISO 13485 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)13 mappingsISO 13485 vs MARS-E13 mappings

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

FTC Safeguards Rule (16 CFR Part 314) vs FTC GLBA Safeguards Rule (16 CFR Part 314)22 mappingsTISAX - Trusted Information Security Assessment Exchange vs FTC GLBA Safeguards Rule (16 CFR Part 314)20 mappingsSouth Korea Cloud Security Assurance Program (CSAP) vs FTC GLBA Safeguards Rule (16 CFR Part 314)19 mappingsPAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments vs FTC GLBA Safeguards Rule (16 CFR Part 314)19 mappingsNew Zealand Information Security Manual (NZISM) vs FTC GLBA Safeguards Rule (16 CFR Part 314)19 mappingsMARS-E - Minimum Acceptable Risk Standards for Exchanges vs FTC GLBA Safeguards Rule (16 CFR Part 314)19 mappingsNRC 10 CFR 73.54 - Nuclear Facility Cybersecurity vs FTC GLBA Safeguards Rule (16 CFR Part 314)19 mappingsISO 27018 vs FTC GLBA Safeguards Rule (16 CFR Part 314)18 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 44 controls across its framework, while FTC GLBA Safeguards Rule (16 CFR Part 314) covers 58 controls. Direct mapping analysis identifies 13 overlapping controls (30% coverage). The frameworks diverge most significantly in Product Realisation, where 7 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 44 total ISO 13485 controls, 13 map directly to FTC GLBA Safeguards Rule (16 CFR Part 314) controls — representing 30% coverage. The remaining 31 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)?

31 ISO 13485 controls have no direct equivalent in FTC GLBA Safeguards Rule (16 CFR Part 314). The highest concentration of gaps is in Product Realisation with 7 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 Product Realisation (7 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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