HIPAA (45 CFR Part 164) 164.506(b) — Consent for uses and disclosures

What this control requires

Standard: Consent for uses and disclosures permitted. 164.506(b)(1) A covered entity may obtain consent of the individual to use or disclose protected health information to carry out treatment, payment, or health care operations. 164.506(b)(2) Consent, under paragraph (b) of this section, shall not be effective to permit a use or disclosure of protected health information when an authorization, under 164.508, is required or when another condition must be met for such use or disclosure to be permissible under this subpart.

In plain English

Standard: Consent for uses and disclosures permitted. In practice, this means you can prove you information 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 (§ 164.506(b)) 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.
• Policy. Document the trigger, the owner and the cadence.
• Uses. Document the trigger, the owner and the cadence.
• Disclosures. Document the trigger, the owner and the cadence.
• Consent. Document the trigger, the owner and the cadence.
• Scope: management, policy, obtain, section, uses, b, payment, health care operations.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Consent for uses and disclosures.

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 CP-8 — Telecommunications Services
• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions

Related controls in HIPAA (45 CFR Part 164)

• § 164.506(b)(1) — Permitted uses and disclosures
• § 164.506(b)(2) — Required provisions
• § 164.508(a)(1) — Authorization requirements - general rule
• § 164.508(a)(2) — Authorization requirements - psychotherapy notes
• § 164.508(a)(3) — Authorization requirements - marketing
• § 164.508(b)(1) — Authorization - defective authorizations

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.506(b)

Topics: governance riskpolicy management