HIPAA (45 CFR Part 164)·§ 164.528(b)·medium·Component: Privacy Rule

What this control requires

Implementation specifications: Content of the accounting. The covered entity must provide the individual with a written accounting that meets the following requirements. (1) Except as otherwise provided by paragraph (a) of this section, the accounting must include disclosures of protected health information that occurred during the six years (or such shorter time period at the request of the individual as provided in paragraph (a)(3) of this section) prior to the date of the request for an accounting, including disclosures to or by business associates of the covered entity. (2) Except as otherwise provided by paragraphs (b)(3) or (b)(4) of this section, the accounting must include for each disclosure: (i) The date of the disclosure; (ii) The name of the entity or person who received the protected health information and, if known, the address of such entity or person; (iii) A brief description of the protected health information disclosed; and (iv) A brief statement of the purpose of the disclosure that reasonably informs the individual of the basis for the disclosure or, in lieu of such statement, a copy of a written request for a disclosure under 164.502(a)(2)(ii) or 164.512, if any. (3) If, during the period covered by the accounting, the covered entity has made multiple disclosures of protected health information to the same person or entity for a single purpose under 164.502(a)(2)(ii) or 164.512, the accounting may, with respect to such multiple disclosures, provide: (i) The information required by paragraph (b)(2) of this section for the first disclosure during the accounting period; (ii) The frequency, periodicity, or number of the disclosures made during the accounting period; and (iii) The date of the last such disclosure during the accounting period. (4)(i) If, during the period covered by the accounting, the covered entity has made disclosures of protected health information for a particular research purpose in accordance with 164.512(i) for 50 or more individuals, the accounting may, with respect to such disclosures for which the protected health information about the individual may have been included, provide: (A) The name of the protocol or other research activity; (B) A description, in plain language, of the research protocol or other research activity, including the purpose of the research and the criteria for selecting particular records; (C) A brief description of the type of protected health information that was disclosed; (D) The date or period of time during which such disclosures occurred, or may have occurred, including the date of the last such disclosure during the accounting period; (E) The name, address, and telephone number of the entity that sponsored the research and of the researcher to whom the information was disclosed; and (F) A statement that the protected health information of the individual may or may not have been disclosed for a particular protocol or other research activity. (ii) If the covered entity provides an accounting for research disclosures, in accordance with paragraph (b)(4) of this section, and if it is reasonably likely that the protected health information of the individual was disclosed for such research protocol or activity, the covered entity shall, at the request of the individual, assist in contacting the entity that sponsored the research and the researcher.
— HIPAA (45 CFR Part 164), § 164.528(b)

In plain English

Implementation specifications: Content of the accounting. 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 (§ 164.528(b)) 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.
  • Business. 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.
  • Scope: requirements, management, individuals, if known, policy, i, accordance, e.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Content of the Accounting.

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