Cross-Framework Mapping

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.

20
Controls Mapped
38
Gaps Found
21%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FTC GLBA Safeguards Rule (16 CFR Part 314) maps to ISO 13485 with 21% coverage across 12 directly mapped controls. Analysis of 58 FTC GLBA Safeguards Rule (16 CFR Part 314) controls identifies 46 compliance gaps — primarily concentrated in Incident Response and Reporting.

Source: TheArtOfService Knowledge Graph | 58 controls analysed | 730 frameworks | 503K+ cross-framework mappings

Control Mappings

Showing 20 of 20 mapped controls across 4 domains. Sign up to explore all 503K+ mappings across 730 frameworks.

Incident Response and Reporting(6 mappings)

FTC-314.4gProgram Evaluation and Adjustment
ISO13485-06Security management process and risk analysis
FTC-314.4iBoard / Senior Officer Reporting
ISO13485-06Security management process and risk analysis
FTC-314.5Exemption for Small Institutions
ISO13485-06Security management process and risk analysis
NGC-5.260(i)Patron and Employee Data Protection3 targets
ISO13485-03Minimum necessary standard enforcement
ISO13485-04Patient data de-identification procedures
ISO13485-05Audit trail for ePHI access

Purpose, Scope and Definitions(2 mappings)

Sec. 314.2(a)Definition of financial institution
6.3Information security awareness, education and training
Sec. 314.2(b)Definition of customer information
6.3Information security awareness, education and training

Safeguard Elements(11 mappings)

Sec. 314.4(c)(1)Access controls3 targets
ISO13485-01ePHI access controls and authorization
ISO13485-08Information access management
ISO13485-17Facility access controls
Sec. 314.4(c)(3)Encryption of customer information2 targets
ISO13485-02ePHI encryption at rest and in transit
ISO13485-16Transmission security and encryption
Sec. 314.4(c)(5)Multi-factor authentication2 targets
6.4Logging and Monitoring
ISO13485-12Unique user identification and authentication
Sec. 314.4(c)(6)Data disposal procedures3 targets
ISO13485-03Minimum necessary standard enforcement
ISO13485-04Patient data de-identification procedures
ISO13485-05Audit trail for ePHI access
Sec. 314.4(c)(8)Monitoring and logging
ISO13485-05Audit trail for ePHI access

Testing, Training and Oversight(1 mappings)

Sec. 314.4(e)Security awareness training
ISO13485-09Security awareness and training program

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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 58 controls across its framework, while ISO 13485 covers 44 controls. Direct mapping analysis identifies 12 overlapping controls (21% coverage). The frameworks diverge most significantly in Incident Response and Reporting, where 12 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 58 total FTC GLBA Safeguards Rule (16 CFR Part 314) controls, 12 map directly to ISO 13485 controls — representing 21% coverage. The remaining 46 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?

46 FTC GLBA Safeguards Rule (16 CFR Part 314) controls have no direct equivalent in ISO 13485. The highest concentration of gaps is in Incident Response and Reporting with 12 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 Incident Response and Reporting (12 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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