HIPAA (45 CFR Part 164)·§ 164.512(i)(1)·medium·Component: Privacy Rule

What this control requires

Standard: Uses and disclosures for research purposes (1) Permitted uses and disclosures. A covered entity may use or disclose protected health information for research, regardless of the source of funding of the research, provided that: (i) Board approval of a waiver of authorization. The covered entity obtains documentation that an alteration to or waiver, in whole or in part, of the individual authorization required by 164.508 for use or disclosure of protected health information has been approved by either: (A) An Institutional Review Board (IRB), established in accordance with7 CFR 1c.107, 10 CFR 745.107, 14 CFR 1230.107, 15 CFR 27.107, 16 CFR 1028.107, 21 CFR 56.107, 22 CFR 225.107, 24 CFR 60.107, 28 CFR 46.107, 32 CFR 219.107, 34 CFR 97.107, 38 CFR 16.107, 40 CFR 26.107, 45 CFR 46.107, 45 CFR 690.107, or 49 CFR 11.107; or (B) A privacy board that: (1) Has members with varying backgrounds and appropriate professional competency as necessary to review the effect of the research protocol on the individual's privacy rights and related interests; (2) Includes at least one member who is not affiliated with the covered entity, not affiliated with any entity conducting or sponsoring the research, and not related to any person who is affiliated with any of such entities; and (3) Does not have any member participating in a review of any project in which the member has a conflict of interest. (ii) Reviews preparatory to research. The covered entity obtains from the researcher representations that: (A) Uses or disclosures is sought solely to review protected health information as necessary to prepare a research protocol or for similar purposes preparatory to research; (B) No protected health information is to be removed from the covered entity by the researcher in the course of the review; and (C) The protected health information for which use or access is sought is necessary for the research purposes. (iii) Research on decedent's information. The covered entity obtains from the researchers: (A) Representation that the use or disclosure sought is solely for research on the protected health information or decedents; (B) Documentation, at the request of the covered entity, of the death of such individuals; and (C) Representation that the protected health information for which use or disclosure is sought is necessary for the research purposes.
— HIPAA (45 CFR Part 164), § 164.512(i)(1)

In plain English

Standard: Uses and disclosures for research purposes (1) Permitted uses and disclosures. In practice, this means you can prove you information management-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(i)(1)) 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.
  • Policy. Document the trigger, the owner and the cadence.
  • Documentation. Document the trigger, the owner and the cadence.
  • Uses. Document the trigger, the owner and the cadence.
  • Scope: management, individuals, policy, i, accordance, uses, death, 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 research purposes - Permitted Uses and Disclosures.

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