HIPAA (45 CFR Part 164)·§ 164.520(c)(1)·medium·Component: Privacy Rule

What this control requires

Implementation specifications: Provision of notice. A covered entity must make the notice required by this section available on request to any person and to individuals as specified in paragraphs (c)(1) through (c)(3) of this section, as applicable. (1) Specific requirements for health plans. (i) A health plan must provide the notice: (A) no later than the compliance date for the health plan, to individuals then covered by the plan; (B) thereafter, at the time of enrollment, to individuals who are new enrollees. (ii) No less frequently than once every three years, the health plan must notify individuals then covered by the plan of the availability of the notice and how to obtain the notice. (iii) The health plan satisfies the requirements of paragraph (c)(1) of this section if notice is provided to the named insured of a policy under which coverage is provided to the named insured and one or more dependents. (iv) If a health plan has more than one notice, it satisfies the requirements of paragraph (c)(1) of this section by providing the notice that is relevant to the individual or other person requesting the notice. (v) If there is a material change to the notice: (A) A health plan that posts its notice on its web site in accordance with paragraph (c)(3)(i) of this section must prominently post the change or its revised notice on its web site by the effective date of the material change to the notice, and provide the revised notice, or information about the material change and how to obtain the revised notice, in its next annual mailing to individuals then covered by the plan. (B) A health plan that does not post its notice on a web site pursuant to paragraph (c)(3)(i) of this section must provide the revised notice, or information about the material change and how to obtain the revised notice, to individuals then covered by the plan within 60 days of the material revision to the notice.
— HIPAA (45 CFR Part 164), § 164.520(c)(1)

In plain English

Implementation specifications: Provision of notice. 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 (§ 164.520(c)(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.
  • 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, revision, availability, individuals, web site, notice, enrollment.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Provisions of Notice - Health Plans.

Common pitfalls

  • Policies that no engineer has read; the version in Confluence drifts from the version that's actually being enforced.

Related controls in HIPAA (45 CFR Part 164)

References

Topics: governance riskpolicy management