Cross-Framework Mapping

ISO 13485vsFlorida Digital Bill of Rights (FDBR)

See exactly how ISO 13485 controls map to Florida Digital Bill of Rights (FDBR). Pre-computed mappings, identified gaps, and coverage analysis.

9
Controls Mapped
35
Gaps Found
16%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to Florida Digital Bill of Rights (FDBR) with 16% coverage across 7 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 37 compliance gaps — primarily concentrated in Product Realisation.

Source: TheArtOfService Knowledge Graph | 44 controls analysed | 715 frameworks | 418K+ cross-framework mappings

Control Mappings

Showing 9 of 9 mapped controls across 4 domains. Sign up to explore all 418K+ mappings across 715 frameworks.

Resource Management(3 mappings)

6.3Information security awareness, education and training
FDBR-Scope-DefsScope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704)
6.4Logging and Monitoring2 targets
FDBR-Scope-DefsScope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704)
FDBR-SensitiveData-Children-VoiceFacialSensitive Data, Children's Privacy and Voice/Facial Recognition (Fla. Stat. 501.711, 501.1735)

Measurement(1 mappings)

8.3Statement of Applicability linkage
FDBR-ConsumerRightsConsumer Rights (Fla. Stat. 501.705, 501.706, 501.707)

ISO 13485: Patient Data Protection(3 mappings)

ISO13485-03Minimum necessary standard enforcement
FDBR-ControllerObligations-DPA-NoticeController + Processor Obligations + Data Protection Assessments (Fla. Stat. 501.707, 501.708, 501.71, 501.711)
ISO13485-04Patient data de-identification procedures
FDBR-ControllerObligations-DPA-NoticeController + Processor Obligations + Data Protection Assessments (Fla. Stat. 501.707, 501.708, 501.71, 501.711)
ISO13485-05Audit trail for ePHI access
FDBR-ControllerObligations-DPA-NoticeController + Processor Obligations + Data Protection Assessments (Fla. Stat. 501.707, 501.708, 501.71, 501.711)

ISO 13485: Technical Safeguards(2 mappings)

ISO13485-12Unique user identification and authentication2 targets
FDBR-Scope-DefsScope, Applicability Thresholds and Definitions (Fla. Stat. 501.701, 501.702, 501.703, 501.704)
FDBR-SensitiveData-Children-VoiceFacialSensitive Data, Children's Privacy and Voice/Facial Recognition (Fla. Stat. 501.711, 501.1735)

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What are the key differences between ISO 13485 and Florida Digital Bill of Rights (FDBR)?

ISO 13485 has 44 controls across its framework, while Florida Digital Bill of Rights (FDBR) covers 12 controls. Direct mapping analysis identifies 7 overlapping controls (16% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct Florida Digital Bill of Rights (FDBR) equivalent.

How many controls map between ISO 13485 and Florida Digital Bill of Rights (FDBR)?

Of 44 total ISO 13485 controls, 7 map directly to Florida Digital Bill of Rights (FDBR) controls — representing 16% coverage. The remaining 37 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 Florida Digital Bill of Rights (FDBR)?

37 ISO 13485 controls have no direct equivalent in Florida Digital Bill of Rights (FDBR). 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 Florida Digital Bill of Rights (FDBR)?

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.

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.