164.512(a)·medium·Component: Privacy RuleWhat this control requires
A covered entity may use or disclose protected health information to the extent that such use or disclosure is required by law and the use or disclosure complies and is limited to the relevant requirements of such law. 164.512(a)(2) - A covered entity must meet the requirements described in paragraph (c), (e), or (f) of this section for uses or disclosures required by law.
In plain English
A covered entity may use or disclose protected health information to the extent that such use or disclosure is required by law and the use or disclosure complies and is limited to the relevant requirements of such law. In practice, this means you can prove you information requirements-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(a)) 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
- Information. Document the trigger, the owner and the cadence.
- Requirements. Document the trigger, the owner and the cadence.
- Policy. Document the trigger, the owner and the cadence.
- Law. Document the trigger, the owner and the cadence.
- Uses. Document the trigger, the owner and the cadence.
- Scope: requirements, management, policy, e, section, uses, c, disclosure.
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 required by law.
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.
- ISO/IEC 27001:2022 A.8.26 — Application security requirements
- NIST SP 800-53 Rev. 5 PL-2(1) — Concept Of Operations
- BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
- SOC 2 (2017 TSC) CC2.3 — External Communication on Internal Control Matters
- NIST SP 800-171 Rev. 3 3.13.15 — Session Authenticity
Related controls in HIPAA (45 CFR Part 164)
- § 164.514(d)(5) — Minimum Necessary - Other content requirement
- § 164.510(a)(3) — Uses and Disclosures for Facility Directories in Emergency Circumstances
- § 164.510(b)(4) — Uses and disclosures for disaster relief purposes
- § 164.530(c) — Safeguards
- § 164.510(b)(2) — Uses and disclosures with the individual present
- § 164.512(k)(6) — Uses and disclosures for specialized government functions - Providing public benefits
References
- U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
- Catalogue identifier:
§ 164.512(a)
Topics: governance riskpolicy management