HIPAA (45 CFR Part 164)·§ 164.508(c)(2)·medium·Component: Privacy Rule

What this control requires

Documentation. A covered entity must document and retain any signed authorization under this section as required by 164.530(j). 164.508(c) Implementation specifications: Core elements and requirements. (1) Core elements. A valid authorization under this section must contain at least the following elements: (i) A description of the information to be used or disclosed that identifies the information in a specific and meaningful fashion. (ii) The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure. (iii) The name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure. (iv) A description of each purpose of the requested use or disclosure. The statement at the request of the individual is a sufficient description of the purpose when an individual initiates the authorization and does not, or elects not to, provide a statement of the purpose. (v) An expiration date or an expiration event that relates to the individual or the purpose of the use or disclosure. The statement end of the research study, none, or similar language is sufficient if the authorization is for a use or disclosure of protected health information for research, including for the creation and maintenance of a research database or research repository. (vi) Signature of the individual and date. If the authorization is signed by a personal representative of the individual, a description of such representative's authority to act for the individual must also be provided. 164.508(c)(2) Required Statements. In addition to the core elements, the authorization must contain statements adequate to place the individual on notice of all of the following: (i) The individual's right to revoke the authorization in writing and either: (ii) The ability or inability to condition treatment, payment, enrollment or eligibility for benefits on the authorization. (iii) The potential for information disclosed pursuant to the authorization to be subject to redisclosure by the recipient can no longer be protected by this subpart. 164.508(c)(3) The authorization must be written in plain language. 164.508(c)(4) If a covered entity seeks an authorization from an individual for a use or disclosure of protected health information, the covered entity must provide the individual with a copy of the signed authorization.
— HIPAA (45 CFR Part 164), § 164.508(c)(2)

In plain English

Documentation. 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 (§ 164.508(c)(2)) 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.
  • Person. Document the trigger, the owner and the cadence.
  • Other. 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.
  • Scope: requirements, management, notice, enrollment, policy, i, section, creation.

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 which an Authorization is Required - Documentation and Content.

Common pitfalls

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

Related controls in HIPAA (45 CFR Part 164)

References

Topics: governance riskpolicy management