HIPAA (45 CFR Part 164)·§ 164.512(k)(4)·medium·Component: Privacy Rule

What this control requires

Medical suitability determinations.- A covered entity that is a component of the Department of State may use protected health information to make medical suitability determinations and may disclose whether or not the individual was determined to be medically suitable to the officials in the Department of State who need access to such information for the following purposes: (i) For the purpose of a required security clearance conducted pursuant to Executive Orders 10450 and 12698; (ii) As necessary to determine worldwide availability or availability for mandatory service abroad under sections 101(a)(4) and 504 of the Foreign Service Act; or (iii) For a family to accompany a Foreign Service member abroad, consistent with section 101(b)(5) and 904 of the Foreign Service Act.
— HIPAA (45 CFR Part 164), § 164.512(k)(4)

In plain English

Medical suitability determinations.- A covered entity that is a component of the Department of State may use protected health information to make medical suitability determinations and may disclose whether or not the individual was determined to be medically suitable to the officials in the Department of State who need access to such information for the following purposes: (i) For the purpose of a required security clearance conducted pursuant to Executive Orders 10450 and 12698; (ii) As necessary to determine worldwide availability or availability for mandatory service abroad under sections 101(a)(4) and 504 of the Foreign Service Act; or (iii) For a family to accompany a Foreign Service member abroad, consistent with section 101(b)(5) and 904 of the Foreign Service Act. In practice, this means you can prove you security security-level controls on a defined cadence.

Why it matters

HIPAA non-compliance is a strict-liability matter: OCR civil monetary penalties are assessed per-record per-violation (up to USD 1.9 million per identical-violation calendar year as of 2024), and willful neglect can trigger criminal referral.

What an auditor looks for

HHS OCR investigators and SOC-2+HIPAA auditors look for the specific 45 CFR § citation, whether the safeguard is required vs addressable (and if addressable, the documented decision), the implementation specification, the workforce member responsible, and the records that show it runs.

Within Privacy Rule, the assessor will trace your implementation back to the catalogue reference (§ 164.512(k)(4)) and look for objective evidence on the latest two assessment cycles.

How to implement

Policy Management

Docs. Keep each policy in version-controlled Markdown alongside the code that implements it; ship a signed PDF snapshot at each annual review and link the SHA into the SoA.

Operational checklist

  • Security. Document the trigger, the owner and the cadence.
  • Information. Document the trigger, the owner and the cadence.
  • Policy. Document the trigger, the owner and the cadence.
  • Uses. Document the trigger, the owner and the cadence.
  • Disclosures. Document the trigger, the owner and the cadence.
  • Scope: security, management, availability, policy, i, section, uses, b.

Evidence to collect

  • Policy Document. A signed and version-controlled policy / standard / procedure document.

Signed policy or standard documents the safeguard. Focus: Uses and disclosures for specialized government functions - Medical Suitability Determinations.

Common pitfalls

  • Policies that no engineer has read; the version in Confluence drifts from the version that's actually being enforced.

How it maps to other frameworks

Computed from shared tags, control component and key-operation subjects — handy when you are reconciling controls across an audit.

Related controls in HIPAA (45 CFR Part 164)

References

Topics: governance riskpolicy management