164.526(c)·medium·Component: Privacy RuleWhat this control requires
Implementation specifications: Accepting the amendment. If the covered entity accepts the requested amendment, in whole or in part, the covered entity must comply with the following requirements. (1) Making the amendment. The covered entity must make the appropriate amendment to the protected health information or record that is the subject of the request for amendment by, at a minimum, identifying the records in the designated record set that are affected by the amendment and appending or otherwise providing a link to the location of the amendment. (2) Informing the individual. In accordance with paragraph (b) of this section, the covered entity must timely inform the individual that the amendment is accepted and obtain the individual's identification of an agreement to have the covered entity notify the relevant persons with which the amendment needs to be shared in accordance with paragraph (c)(3) of this section. (3) Informing others. The covered entity must make reasonable efforts to inform and provide the amendment within a reasonable time to: (i) Persons identified by the individual as having received protected health information about the individual and needing the amendment; and (ii) persons, including business associates, that the covered entity knows have the protected health information that is the subject of the amendment and that may have relied, or could foreseeably rely, on such information to the detriment of the individual.
In plain English
Implementation specifications: Accepting the amendment. 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 (§ 164.526(c)) 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.
- Requirements. Document the trigger, the owner and the cadence.
- Policy. Document the trigger, the owner and the cadence.
- Minimum. Document the trigger, the owner and the cadence.
- Scope: requirements, management, policy, i, obtain, accordance, section, b.
Evidence to collect
- Policy Document. A signed and version-controlled policy / standard / procedure document.
Signed policy or standard documents the safeguard. Focus: Accepting the Amendment.
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)
- § 164.520(e) — Documentation
- § 164.530(b) — Training
- § 164.528(b) — Content of the Accounting
- § 164.514(d)(3) — Minimum Necessary - Disclosures of PHI
- § 164.520(c)(2) — Provisions of Notice - Certain Covered Health Care Providers
- § 164.524(a)(2) — Unreviewable grounds for denial
References
- U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
- Catalogue identifier:
§ 164.526(c)
Topics: governance riskpolicy management