HIPAA (45 CFR Part 164)·§ 164.524(d)(2)·medium·Component: Privacy Rule

What this control requires

Implementation specifications: Denial of access. If the covered entity denies access, in whole or in part, to protected health information, the covered entity must comply with the following requirements. (1) Making other information accessible. The covered entity must, to the extent possible, give the individual access to any other protected health information requested, after excluding the protected health information as to which the covered entity has a ground to deny access. 164.524(d)(2) Denial. The covered entity must provide a timely, written denial to the individual, in accordance with paragraph (b)(2) of this section. The denial must be in plain language and contain: (i) The basis for the denial; (ii) If applicable, a statement of the individual's review rights under paragraph (a)(4) of this section, including a description of how the individual may exercise such review rights; and (iii) A description of how the individual may complain to the covered entity pursuant to the complaint procedures in 164.530(d) or to the Secretary pursuant to the procedures in 160.306. The description must include the name, or title, and telephone number of the contact person or office designated in 164.530(a)(1)(ii).
— HIPAA (45 CFR Part 164), § 164.524(d)(2)

In plain English

Implementation specifications: Denial of access. 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 (§ 164.524(d)(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, procedures, secretary, policy, i, accordance, section.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Denial of Access.

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