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hipaa-test-patterns

Reference catalog of HIPAA Security Rule-aligned test patterns - administrative safeguards (45 CFR §164.308: workforce training, access management, contingency planning), physical safeguards (§164.310: facility access, workstation security, device disposal), technical safeguards (§164.312: access control, audit logs, integrity, transmission security); PHI handling assertions in fixtures; minimum-necessary tests per §164.502(b); BAA-scope boundary verification. Use when authoring HIPAA-readiness tests for any product handling Protected Health Information.

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包含的文件(3)

  • SKILL.md6.1 KB
  • .tessl-plugin/plugin.json715 B
  • references/security-rule-test-patterns.md5.3 KB

SKILL.md(原文)

安装前可以查看交给 AI 代理的指令内容。

hipaa-test-patterns

Reference catalog of test patterns by HIPAA Security Rule section (45 CFR §164). Pair with audit-trail-test-author for §164.312(b) audit-log requirements. Anchors: hhs.gov/hipaa and NIST SP 800-66.

When to use

  • Product is a Business Associate handling PHI for a Covered Entity (or is itself a Covered Entity).
  • BAA (Business Associate Agreement) signed; need test evidence.
  • HIPAA risk assessment requires test coverage evidence.
  • New feature touches PHI (medical records, billing, scheduling, clinical decision support).

What is PHI?

Per HHS, PHI = individually identifiable health information + created/received/maintained/transmitted by a covered entity. The 18 HIPAA identifiers per §164.514(b)(2) (Safe Harbor):

1. Name
2. Geographic subdivisions smaller than state (ZIP codes need restrictions)
3. All elements of dates (except year) for dates directly related to an individual
4. Telephone numbers
5. Vehicle identifiers + license plates
6. Fax numbers
7. Device identifiers + serial numbers
8. Email addresses
9. Web URLs
10. SSN
11. IP addresses
12. Medical record numbers
13. Biometric identifiers (fingerprints, voiceprints)
14. Health plan beneficiary numbers
15. Full-face photos + comparable images
16. Account numbers
17. Any other unique identifying number / characteristic / code
18. Certificate / license numbers

Test fixtures for HIPAA-scope systems MUST avoid these 18 identifiers (or use synthetic-pii-generator in the qa-test-data plugin to generate safe substitutes).

How to use

  1. Confirm your role - Business Associate or Covered Entity - and pull the signed BAA's allowed purposes; they bound every access test.
  2. Scrub fixtures of all 18 Safe Harbor identifiers (above); generate substitutes with synthetic-pii-generator.
  3. Pick the Security Rule sections the feature touches (access control, audit, integrity, transmission, minimum-necessary, disposal, BAA scope).
  4. Copy the matching pattern from references/security-rule-test-patterns.md and point it at your framework's client + models.
  5. For every PHI read or write, assert an audit record with a tamper-evident hash per §164.312(b); pair with audit-trail-test-author.
  6. Assert minimum-necessary per role (§164.502(b)) - a positive access check AND negative checks for out-of-role PHI types.
  7. Run in CI; the pass/fail history is itself risk-assessment evidence.

Test patterns by Security Rule section

Full per-section patterns live in references/security-rule-test-patterns.md, covering administrative safeguards (§164.308 workforce access management, workforce training), physical safeguards (§164.310 device + media disposal), technical safeguards (§164.312 access control, audit controls, integrity, transmission security), the §164.502(b) minimum-necessary standard, and §164.504(e) BAA-scope boundaries. Each entry is a copy-ready pytest-style test keyed to its CFR section.

Worked example

A billing clerk's role is added to the scheduling service. The team runs the §164.502(b) minimum-necessary pattern against /patient/123/billing-summary with the billing-clerk token. The response asserts amount_due and insurance_provider are present and that clinical_notes, medications, and genetic_test_results are absent. The negative assertion fails: the summary serializer eager-loads the full patient record, leaking medications. The team narrows the serializer to billing fields, re-runs, and the test passes, proving the role sees only the minimum-necessary PHI, with the read logged via the §164.312(b) audit pattern.

Anti-patterns

Anti-patternWhy it failsFix
Real PHI in test fixturesHIPAA violation in testssynthetic-pii-generator + de-identified data
Audit log without tamper-evidenceLogs can be modified post-incidentHash-chain or signed-batch log integrity (§164.312(b))
Role-based access without minimum-necessary checkOver-broad access; minimum-necessary violationPer-PHI-type test (Step §164.502(b))
Skip BAA scope testsVendor accesses PHI outside agreementStep §164.504(e) scope test
Allow plaintext HTTP for PHI even in devProduction drift; eventual leakAlways enforce HTTPS (Step §164.312(e))

Limitations

  • This skill targets HIPAA Security Rule. HIPAA Privacy Rule (45 CFR §164 Subpart E) has additional requirements (use/disclosure rules, accounting of disclosures); test patterns there are use-case specific.
  • HITECH Act (2009) added breach-notification + enforcement; tests intersect with §164.404 - §164.414.
  • State laws (e.g., California CMIA) may add additional requirements beyond HIPAA.
  • This skill doesn't replace a HIPAA risk analysis or compliance consultant.

References

  • hipaa-hhs - HHS HIPAA reference
  • ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164 - HIPAA regulations text (45 CFR §164)
  • nist.gov/publications/sp-800-66-revision-1-introductory-resource-guide-implementing-hipaa-security - NIST SP 800-66 implementation guidance
  • nist.gov/publications/sp-800-88-revision-1-guidelines-media-sanitization - NIST SP 800-88 device sanitization
  • gdpr-test-patterns - sister privacy-pattern catalog (CCPA/CPRA in its references/ccpa.md)
  • audit-trail-test-author - §164.312(b) audit log requirements
  • synthetic-pii-generator - cross-plugin: safe PHI fixture generation

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