HIPAA (45 CFR Part 164)·§ 164.520(c)(2)·medium·Component: Privacy Rule

What this control requires

Specific requirements for certain covered health care providers. A covered health care provider that has a direct treatment relationship with an individual must: (i) Provide the notice: (A) No later than the date of the first service delivery, including service delivered electronically, to such individual after the compliance date for the covered health care provider; or (B) In an emergency treatment situation, as soon as reasonably practicable after the emergency treatment situation. (ii) Except in an emergency treatment situation, make a good faith effort to obtain a written acknowledgment of receipt of the notice provided in accordance with paragraph (c)(2)(i) of this section, and if not obtained, document its good faith efforts to obtain such acknowledgment and the reason why the acknowledgment was not obtained; (iii) If the covered health care provider maintains a physical service delivery site: (A) Have the notice available at the service delivery site for individuals to request to take with them; and (B) Post the notice in a clear and prominent location where it is reasonable to expect individuals seeking service from the covered health care provider to be able to read the notice. (iv) Whenever the notice is revised, make the notice available upon request on or after the effective date of the revision and promptly comply with the requirements of paragraph (c)(2)(iii) of this section, if applicable.
— HIPAA (45 CFR Part 164), § 164.520(c)(2)

In plain English

Specific requirements for certain covered health care providers. In practice, this means you can prove you requirements 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)(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

  • Requirements. Document the trigger, the owner and the cadence.
  • Policy. Document the trigger, the owner and the cadence.
  • Notice. Document the trigger, the owner and the cadence.
  • Provisions. Document the trigger, the owner and the cadence.
  • Scope: requirements, management, revision, individuals, notice, policy, i, obtain.

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 - Certain Covered Health Care Providers.

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