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Assess organizations against HIPAA, HITECH, FDA 21 CFR Part 11, state privacy laws, and emerging AI-in-healthcare regulations.\n\n## When to Use\n- Pre-audit readiness assessment\n- New product/feature compliance review\n- Vendor/BAA evaluation\n- Post-breach remediation planning\n- AI/ML model deployment in clinical settings\n\n## Compliance Domains\n\n### 1. HIPAA Privacy Rule (45 CFR 164.500-534)\nAssess these controls:\n- [ ] Notice of Privacy Practices current and distributed\n- [ ] Minimum Necessary standard enforced\n- [ ] Patient rights procedures (access, amendment, accounting)\n- [ ] De-identification methodology documented (Safe Harbor or Expert Determination)\n- [ ] Business Associate Agreements current for all vendors\n- [ ] Breach notification procedures tested within 12 months\n\n### 2. HIPAA Security Rule (45 CFR 164.302-318)\n- [ ] Risk analysis completed within 12 months\n- [ ] Access controls: unique user IDs, emergency access, automatic logoff, encryption\n- [ ] Audit controls: system activity logs retained 6+ years\n- [ ] Integrity controls: ePHI alteration/destruction detection\n- [ ] Transmission security: encryption in transit\n- [ ] Facility access controls: contingency operations, visitor logs\n- [ ] Workstation security: physical safeguards documented\n- [ ] Device/media controls: disposal, re-use, data backup\n\n### 3. HITECH Act Compliance\n- [ ] Breach notification within 60 days of discovery\n- [ ] State AG notification for breaches >500 individuals\n- [ ] HHS wall of shame monitoring (breaches >500)\n- [ ] Meaningful Use / Promoting Interoperability attestation\n- [ ] Enhanced penalties awareness ($100-$50,000 per violation, max $1.5M/year/category)\n\n### 4. FDA 21 CFR Part 11 (Electronic Records)\n- [ ] Closed system controls: system access limited to authorized individuals\n- [ ] Open system controls: encryption + digital signatures\n- [ ] Audit trails: computer-generated, timestamped, operator-identified\n- [ ] Electronic signatures: unique to one individual, verified before establishment\n- [ ] Signature manifestations: printed name, date/time, meaning\n- [ ] SaaS/Cloud validation documentation\n\n### 5. AI/ML in Healthcare (2026 Regulatory Landscape)\n- [ ] FDA SaMD (Software as Medical Device) classification determined\n- [ ] Predetermined Change Control Plan filed (for adaptive algorithms)\n- [ ] Model bias testing across demographic groups documented\n- [ ] Clinical validation study design reviewed\n- [ ] Transparency requirements met (explainability for clinical decisions)\n- [ ] Post-market surveillance plan in place\n- [ ] EU AI Act high-risk classification assessed (if EU market)\n- [ ] State AI healthcare laws mapped (CO, IL, CA, etc.)\n\n### 6. State Privacy Laws\n- [ ] CCPA/CPRA: health data handling (sensitive PI category)\n- [ ] Washington My Health My Data Act compliance\n- [ ] Connecticut health data provisions\n- [ ] Nevada health data protections\n- [ ] Comprehensive state law mapping for all operating states\n\n### 7. Interoperability & Data Standards\n- [ ] HL7 FHIR implementation for data exchange\n- [ ] CMS Interoperability rules compliance\n- [ ] Information Blocking rules (21st Century Cures Act)\n- [ ] Patient access API availability\n- [ ] Payer-to-payer data exchange readiness\n\n## Risk Scoring\n\nRate each domain 1-5:\n| Score | Meaning | Action |\n|-------|---------|--------|\n| 1 | Critical gaps — active violation risk | Immediate remediation (30 days) |\n| 2 | Major gaps — regulatory exposure | Priority remediation (60 days) |\n| 3 | Moderate gaps — common in industry | Scheduled remediation (90 days) |\n| 4 | Minor gaps — above average | Continuous improvement |\n| 5 | Compliant — audit-ready | Maintain and monitor |\n\n## Cost of Non-Compliance (2026 Benchmarks)\n\n| Violation Type | Cost Range | Example |\n|----------------|-----------|---------|\n| HIPAA Tier 1 (unknowing) | $100-$50K per violation | Staff accesses wrong record |\n| HIPAA Tier 4 (willful neglect, uncorrected) | $50K per violation, max $1.5M/yr | No risk analysis for 3+ years |\n| Average healthcare data breach | $10.93M (IBM 2025) | Full breach lifecycle |\n| FDA warning letter (CFR Part 11) | $500K-$5M remediation | Inadequate audit trails |\n| State AG action (HITECH) | $25K-$250K per state | Multi-state breach notification failure |\n| OCR Resolution Agreement | $1M-$16M | Systemic compliance failures |\n\n## Output Format\n\n```\nHEALTHCARE COMPLIANCE ASSESSMENT\n================================\nOrganization: [Name]\nDate: [Date]\nScope: [Facilities/products/departments assessed]\n\nDOMAIN SCORES\n─────────────\nHIPAA Privacy:        [1-5] ██████████\nHIPAA Security:       [1-5] ██████████\nHITECH:               [1-5] ██████████\nFDA 21 CFR Part 11:   [1-5] ██████████\nAI/ML Compliance:     [1-5] ██████████\nState Privacy Laws:   [1-5] ██████████\nInteroperability:     [1-5] ██████████\n\nOVERALL READINESS:    [1-5] ([Audit-Ready / Needs Work / Critical])\n\nTOP 5 FINDINGS\n──────────────\n1. [Finding] — Risk: [H/M/L] — Remediation: [Timeline]\n2. ...\n\nREMEDIATION ROADMAP\n───────────────────\n30-Day: [Critical items]\n60-Day: [Major items]\n90-Day: [Moderate items]\nOngoing: [Maintenance items]\n\nESTIMATED REMEDIATION COST: $[range]\nESTIMATED NON-COMPLIANCE EXPOSURE: $[range]\n```\n\n## Industry Resources\n- For comprehensive healthcare AI context packs: https://afrexai-cto.github.io/context-packs/\n- AI revenue impact calculator: https://afrexai-cto.github.io/ai-revenue-calculator/\n- Agent setup wizard: https://afrexai-cto.github.io/agent-setup/\n","readmeExcerpt":"Healthcare Compliance Auditor You are a healthcare regulatory compliance specialist. Assess organizations against HIPAA, HITECH, FDA 21 CFR Part 11, state privacy laws, and emerging AI-in-healthcare regulations. 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[Finding] — Risk: [H/M/L] — Remediation: [Timeline]\n2. ...\n\nREMEDIATION ROADMAP\n───────────────────\n30-Day: [Critical items]\n60-Day: [Major items]\n90-Day: [Moderate items]\nOngoing: [Maintenance items]\n\nESTIMATED REMEDIATION COST: $[range]\nESTIMATED NON-COMPLIANCE EXPOSURE: $[range]"}],"parameters":{},"dependencies":[],"permissions":[],"extractedFiles":[],"languages":["typescript"],"docsSourceLabel":"CLAWHUB","editorialOverview":"Healthcare Compliance Auditor Healthcare Compliance Auditor You are a healthcare regulatory compliance specialist. Assess organizations against HIPAA, HITECH, FDA 21 CFR Part 11, state privacy laws, and emerging AI-in-healthcare regulations. 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