HITECH ActvsFDA Quality Management System Regulation (QMSR)
See exactly how HITECH Act controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
HITECH Act maps to FDA Quality Management System Regulation (QMSR) with 27% coverage across 3 directly mapped controls. Analysis of 11 HITECH Act controls identifies 8 compliance gaps — primarily concentrated in HITECH 2024-2025 Pipeline: NPRM Security Rule Modernisation, Reproductive Health, Information Blocking, Sectoral Application.
Source: TheArtOfService Knowledge Graph | 11 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
HITECH Coordination with HIPAA Privacy + Security Rules (Verified Separately) + 21st Century Cures Act + ONC(2 mappings)
HITECH Enforcement: 4-Tier Civil Monetary Penalties, State AGs, HHS OCR, Recent Settlements(2 mappings)
HITECH Subtitle D: Breach Notification Rule, BA Direct Liability, Subcontractors(2 mappings)
Related Comparisons
Other HITECH Act comparisons
Other FDA Quality Management System Regulation (QMSR) comparisons
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What are the key differences between HITECH Act and FDA Quality Management System Regulation (QMSR)?
HITECH Act has 11 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 3 overlapping controls (27% coverage). The frameworks diverge most significantly in HITECH 2024-2025 Pipeline: NPRM Security Rule Modernisation, Reproductive Health, Information Blocking, Sectoral Application, where 4 HITECH Act controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.
How many controls map between HITECH Act and FDA Quality Management System Regulation (QMSR)?
Of 11 total HITECH Act controls, 3 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 27% coverage. The remaining 8 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping HITECH Act to FDA Quality Management System Regulation (QMSR)?
8 HITECH Act controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in HITECH 2024-2025 Pipeline: NPRM Security Rule Modernisation, Reproductive Health, Information Blocking, Sectoral Application 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 HITECH Act and FDA Quality Management System Regulation (QMSR)?
The domain with the highest gap count is HITECH 2024-2025 Pipeline: NPRM Security Rule Modernisation, Reproductive Health, Information Blocking, Sectoral Application (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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.