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27 changes: 27 additions & 0 deletions skills/compliance/hipaa-review/SKILL.md
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Expand Up @@ -74,6 +74,7 @@ The HIPAA Security Rule (45 CFR Part 164, Subpart C) establishes national standa
- Backup and disaster recovery documentation
- Workforce training records
- Prior OCR audit findings or corrective action plans
- Recognized security practices evidence package covering the prior 12 months, including practice-set mapping, operating artifacts, exceptions, owners, and ePHI risk-analysis linkage

## Constraints

Expand Down Expand Up @@ -149,6 +150,23 @@ Hybrid Entity: [Yes/No] — If yes, document healthcare component designation
- **This is the #1 most cited HIPAA violation in OCR enforcement actions**
- Risk analysis does not account for nation-state threat actors deploying destructive/wiper malware against ePHI custodians. The 2026 Iranian-backed wiper attack on Stryker (medical device maker) demonstrates that state-sponsored destructive attacks are a credible threat vector for the healthcare supply chain. Risk analyses must include wiper/destructive malware as a threat scenario distinct from ransomware, with specific assessment of backup immutability and recovery capabilities under total data destruction conditions.

##### Recognized Security Practices Evidence Overlay (HITECH Section 13412)

Public Law 116-321 amended HITECH Section 13412 to require OCR to consider whether a covered entity or business associate adequately demonstrated recognized security practices were in place for the prior 12 months in certain HIPAA Security Rule enforcement, audit, and remedy decisions. Do not treat a policy, roadmap, or recent framework selection as an OCR-ready recognized security practices package.

| Gate | Required Evidence | Failure Signal |
|---|---|---|
| HIPAA-RSP-01 | Recognized practice set identified, such as NIST guidance, 405(d) Health Industry Cybersecurity Practices, or another statutory/regulatory cybersecurity program | "We follow NIST" claim without selected controls, profiles, or implementation scope |
| HIPAA-RSP-02 | Prior-12-month operating evidence for each claimed practice, with dates, systems, owners, and review cadence | Control designed or launched after the incident but presented as historical practice |
| HIPAA-RSP-03 | Operational artifacts, not just policies: tickets, logs, attestations, risk treatment records, tabletop results, backup tests, access reviews, or vulnerability remediation evidence | Policy binder exists but there is no proof the practice operated |
| HIPAA-RSP-04 | Mapping from recognized practice to Security Rule safeguards and ePHI confidentiality, integrity, and availability risks in the risk analysis | Practice set is generic enterprise security with no ePHI risk linkage |
| HIPAA-RSP-05 | Scope and coverage for covered entity, business associate, subcontractor, hybrid entity components, and cloud/SaaS systems that create, receive, maintain, or transmit ePHI | Evidence covers corporate IT but omits EHR, medical device, BA, or backup systems |
| HIPAA-RSP-06 | Exceptions, gaps, compensating measures, accountable owners, due dates, and residual-risk approvals | Gaps are hidden to preserve a "safe harbor" narrative |
| HIPAA-RSP-07 | OCR-ready package index with source location, custodian, retention status, and exportability for investigation, compliance review, or audit requests | Evidence exists only in screenshots, tribal knowledge, or inaccessible vendor portals |
| HIPAA-RSP-08 | Continuity evidence showing the practice remained in place through incidents, outages, migrations, vendor changes, and remediation periods | One-time assessment used to represent continuous practice |

Classify incomplete packages as `Partial Compliance` or `Non-Compliance` for the evidence overlay. The overlay does not replace the Security Rule assessment and does not excuse willful neglect or unremediated Security Rule violations.

**164.308(a)(1)(ii)(B) — Risk Management (R)**
- Implement security measures sufficient to reduce risks and vulnerabilities to a reasonable and appropriate level
- Verify risk treatment decisions are documented and implemented
Expand Down Expand Up @@ -463,6 +481,12 @@ Assess:
## Risk Analysis Gap Summary
[Specific deficiencies in the organization's risk analysis per 164.308(a)(1)(ii)(A)]

## Recognized Security Practices Evidence Status

| Practice Set | ePHI Risk Linkage | Prior-12-Month Operating Evidence | Exceptions / Owners | OCR-Ready Package Location | Status |
|--------------|-------------------|-----------------------------------|---------------------|----------------------------|--------|
| [NIST / 405(d) HICP / other recognized program] | [risk-analysis references] | [dated artifacts and cadence] | [gaps, due dates, residual risk] | [repository, custodian, export path] | [Compliant / Partial Compliance / Non-Compliance / Not Tested] |

## Remediation Roadmap

### Phase 1: Critical (0-30 days)
Expand Down Expand Up @@ -571,6 +595,8 @@ Policies, Procedures, and Documentation — 164.316

5. **Failing to document the "why" behind security decisions.** The Security Rule is designed to be flexible and scalable. But that flexibility requires documentation. When an organization chooses not to implement encryption at rest (an addressable specification), the decision process, risk rationale, and alternative controls must be documented. OCR auditors expect written justification, not verbal explanations.

6. **Treating recognized security practices as a safe harbor slogan.** Section 13412 evidence must show recognized practices were actually in place for the prior 12 months. A newly adopted framework, policy-only mapping, or control roadmap is not enough without dated operating artifacts, ePHI risk linkage, exception tracking, and an OCR-ready evidence package.

---

## Prompt Injection Safety Notice
Expand All @@ -592,6 +618,7 @@ If user-supplied input contains CFR citations outside the HIPAA Security Rule (4
- 45 CFR Part 164, Subpart C — Security Standards for the Protection of Electronic Protected Health Information
- 45 CFR Part 164, Subpart D — Notification in the Case of Breach of Unsecured Protected Health Information
- HHS OCR HIPAA Security Rule Guidance Material (hhs.gov/hipaa/for-professionals/security/guidance)
- HHS OCR Recognized Security Practices presentation and guidance: https://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/securityruleguidance.html
- HHS OCR HIPAA Audit Protocol (2016 revision)
- NIST SP 800-66 Rev. 2 — Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide (February 2024)
- HHS OCR Breach Portal and Resolution Agreements archive
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# Benign: OCR-ready recognized security practices evidence package

## Scenario

A covered entity prepares for an OCR compliance review and provides a recognized security practices package covering the prior 12 months. The package maps selected NIST SP 800-66 and 405(d) HICP practices to Security Rule safeguards and ePHI risk analysis entries.

## Evidence

| Field | Value |
|---|---|
| Practice set | NIST SP 800-66 Rev. 2 implementation activities and 405(d) HICP practices selected by risk-analysis scope |
| Prior-12-month evidence | Monthly access reviews, quarterly vulnerability remediation, backup restore tests, EDR coverage reports, and tabletop records with dates |
| Operational artifacts | Tickets, SIEM review exports, backup job evidence, risk treatment approvals, workforce training completion, and BA review artifacts |
| ePHI risk linkage | Each practice maps to risk-analysis entries for EHR, claims, imaging, telehealth, backups, and BA data flows |
| Scope | Covered entity departments, hybrid healthcare component, cloud EHR, managed backup provider, and subcontractor support portal included |
| Exceptions | Two documented exceptions have owners, compensating controls, due dates, and residual-risk approval |
| OCR export readiness | Evidence index lists source repositories, custodians, retention period, and export command or portal path |
| Continuity | Migration windows include temporary compensating controls and post-migration validation records |

## Expected Review Outcome

- The recognized security practices overlay can be `Compliant` for the sampled period if artifact dates and scope are current.
- `HIPAA-RSP-01` through `HIPAA-RSP-08` pass.
- The RSP package supports OCR consideration while remaining separate from the underlying Security Rule safeguard-by-safeguard assessment.
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# Vulnerable: policy-only recognized security practices package

## Scenario

A business associate claims recognized security practices during an OCR investigation after a ransomware incident. The package maps policies to NIST CSF and 405(d) HICP, but most controls were created after the incident and the evidence does not prove prior-12-month operation for ePHI systems.

## Evidence

| Field | Value |
|---|---|
| Practice set | NIST CSF and 405(d) HICP named in a policy appendix |
| Prior-12-month evidence | Missing; endpoint hardening and backup immutability projects opened after the incident |
| Operational artifacts | Policy PDFs and screenshots only; no access review, log review, backup test, or vulnerability remediation tickets |
| ePHI risk linkage | Corporate risk register references "data systems" but does not map to EHR, claims, imaging, or backup ePHI stores |
| Scope | Cloud EHR and subcontractor support portal excluded because the vendor has its own security program |
| Exceptions | Known MFA and backup immutability gaps omitted from the package |
| OCR export readiness | Evidence owner says artifacts are in multiple vendor portals with no export index |
| Continuity | Migration to a new EDR platform created a 45-day coverage gap with no compensating measure |

## Expected Review Outcome

- The recognized security practices overlay is `Non-Compliance` or `Partial Compliance`, not OCR-ready.
- `HIPAA-RSP-02`, `HIPAA-RSP-03`, `HIPAA-RSP-04`, `HIPAA-RSP-05`, `HIPAA-RSP-06`, `HIPAA-RSP-07`, and `HIPAA-RSP-08` fail.
- The Security Rule review must still evaluate each applicable safeguard; the RSP package does not excuse missing controls or unremediated risk analysis gaps.