FTC GLBA Safeguards Rule (16 CFR Part 314)vsISO 13485
See exactly how FTC GLBA Safeguards Rule (16 CFR Part 314) controls map to ISO 13485. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FTC GLBA Safeguards Rule (16 CFR Part 314) maps to ISO 13485 with 18% coverage across 2 directly mapped controls. Analysis of 11 FTC GLBA Safeguards Rule (16 CFR Part 314) controls identifies 9 compliance gaps — primarily concentrated in FTC Safeguards Rule: Effective Date, Small Institution Exemption and 2024-2025 Pipeline (314.5, 314.6, Coordination).
Source: TheArtOfService Knowledge Graph | 11 controls analysed | 723 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 11 of 11 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 723 frameworks.
FTC Safeguards Rule: 9 Safeguard Elements - Access, Encryption, MFA, Disposal, Change, Monitoring, Pen Test (314.4(c))(10 mappings)
FTC Safeguards Rule: Service Provider Oversight and Program Evaluation (314.4(d-g))(1 mappings)
Related Comparisons
Other FTC GLBA Safeguards Rule (16 CFR Part 314) comparisons
Other ISO 13485 comparisons
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What are the key differences between FTC GLBA Safeguards Rule (16 CFR Part 314) and ISO 13485?
FTC GLBA Safeguards Rule (16 CFR Part 314) has 11 controls across its framework, while ISO 13485 covers 29 controls. Direct mapping analysis identifies 2 overlapping controls (18% coverage). The frameworks diverge most significantly in FTC Safeguards Rule: Effective Date, Small Institution Exemption and 2024-2025 Pipeline (314.5, 314.6, Coordination), where 5 FTC GLBA Safeguards Rule (16 CFR Part 314) controls have no direct ISO 13485 equivalent.
How many controls map between FTC GLBA Safeguards Rule (16 CFR Part 314) and ISO 13485?
Of 11 total FTC GLBA Safeguards Rule (16 CFR Part 314) controls, 2 map directly to ISO 13485 controls — representing 18% coverage. The remaining 9 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FTC GLBA Safeguards Rule (16 CFR Part 314) to ISO 13485?
9 FTC GLBA Safeguards Rule (16 CFR Part 314) controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in FTC Safeguards Rule: Effective Date, Small Institution Exemption and 2024-2025 Pipeline (314.5, 314.6, Coordination) with 5 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 FTC GLBA Safeguards Rule (16 CFR Part 314) and ISO 13485?
The domain with the highest gap count is FTC Safeguards Rule: Effective Date, Small Institution Exemption and 2024-2025 Pipeline (314.5, 314.6, Coordination) (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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