164.528(c)·medium·Component: Privacy RuleWhat this control requires
Implementation specifications: Provision of the accounting. (1) The covered entity must act on the individuals request for an accounting, no later than 60 days after receipt of such a request, as follows. (i) The covered entity must provide the individual with the accounting requested; or (ii) If the covered entity is unable to provide the accounting within the time required by paragraph (c)(1) of this section, the covered entity may extend the time to provide the accounting by no more than 30 days, provided that: (A) The covered entity, within the time limit set by paragraph (c)(1) of this section, provides the individual with a written statement of the reasons for the delay and the date by which the covered entity will provide the accounting; and (B) The covered entity may have only one such extension of time for action on a request for an accounting. 164.528(c)(2) The covered entity must provide the first accounting to an individual in any 12 month period without charge. The covered entity may impose a reasonable, cost-based fee for each subsequent request for an accounting by the same individual within the 12 month period, provided that the covered entity informs the individual in advance of the fee and provides the individual with an opportunity to withdraw or modify the request for a subsequent accounting in order to avoid or reduce the fee.
In plain English
Implementation specifications: Provision of the accounting. In practice, this means you can prove you policy 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 (§ 164.528(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
- Policy. Document the trigger, the owner and the cadence.
- Limit. Document the trigger, the owner and the cadence.
- Provision. Document the trigger, the owner and the cadence.
- Scope: management, - time limit, individuals, policy, i, section, b, ii.
Evidence to collect
- Policy Document. A signed and version-controlled policy / standard / procedure document.
Signed policy or standard documents the safeguard. Focus: Provision 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.
- NIST SP 800-53 Rev. 5 SC-15(4) — Explicitly Indicate Current Participants
- NIST SP 800-171 Rev. 3 3.3.7 — Time Stamps
- BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
- ISO/IEC 27001:2022 A.5.5 — Contact with authorities
- SOC 2 (2017 TSC) CC2.3 — External Communication on Internal Control Matters
Related controls in HIPAA (45 CFR Part 164)
- § 164.528(d) — Documentation
- § 164.524(e) — Documentation
- § 164.530(d)(2) — Complaints to the Covered Entity
- § 164.530(g) — Refraining from Intimidating or Retaliatory Acts
- § 164.316(b)(2)(i) — Documentation - Time Limit
- § 164.502(f) — Deceased individuals
References
- U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
- Catalogue identifier:
§ 164.528(c)
Topics: governance riskpolicy management