HIPAA (45 CFR Part 164)·§ 164.514(f)·medium·Component: Privacy Rule

What this control requires

Fundraising communications. (1) Standard: Uses and disclosures for fundraising. Subject to the conditions of paragraph (f)(2) of this section, a covered entity may use, or disclose to a business associate or to an institutionally related foundation, the following protected health information for the purpose of raising funds for its own benefit, without an authorization meeting the requirements of 164.508: (i) Demographic information relating to an individual, including name, address, other contact information, age, gender, and date of birth; (ii) Dates of health care provided to an individual; (iii) Department of service information; (iv) Treating physician; (v) Outcome information; and (vi) Health insurance status. (2) Implementation specifications: Fundraising requirements. (i) A covered entity may not use or disclose protected health information for fundraising purposes as otherwise permitted by paragraph (f)(1) of this section unless a statement required by 164.520(b)(1)(iii)(A) is included in the covered entitys notice of privacy practices. (ii) With each fundraising communication made to an individual under this paragraph, a covered entity must provide the individual with a clear and conspicuous opportunity to elect not to receive any further fundraising communications. The method for an individual to elect not to receive further fundraising communications may not cause the individual to incur an undue burden or more than a nominal cost. (iii) A covered entity may not condition treatment or payment on the individuals choice with respect to the receipt of fundraising communications. (iv) A covered entity may not make fundraising communications to an individual under this paragraph where the individual has elected not to receive such communications under paragraph (f)(2)(ii) of this section. (v) A covered entity may provide an individual who has elected not to receive further fundraising communications with a method to opt back in to receive such communications.
— HIPAA (45 CFR Part 164), § 164.514(f)

In plain English

Fundraising communications. 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 (§ 164.514(f)) 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.
  • 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, individuals, business associate, notice, policy, i, communications.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Uses and Disclosures for Fundraising.

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