HIPAA (45 CFR Part 164) 164.404(a) — Notice to Individuals

What this control requires

Notice to Individuals. A covered entity shall, following the discovery of a breach of unsecured protected health information, notify each individual whose unsecured protected health information has been, or is reasonably believed by the covered entity to have been, accessed, acquired, used, or disclosed as a result of such breach. (2) Breaches treated as discovered. For purposes of paragraph (a)(1) of this section, 164.406(a), and 164.408(a), a breach shall be treated as discovered by a covered entity as of the first day on which such breach is known to the covered entity, or, by exercising reasonable diligence would have been known to the covered entity. A covered entity shall be deemed to have knowledge of a breach if such breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is a workforce member or agent of the covered entity (determined in accordance with the federal common law of agency).

In plain English

Notice to Individuals. In practice, this means you can prove you workforce 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 Breach Notification Rule, the assessor will trace your implementation back to the catalogue reference (§ 164.404(a)) 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

• Workforce. Document the trigger, the owner and the cadence.
• 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.
• Policy. Document the trigger, the owner and the cadence.
• Scope: management, individuals, notification, notice, policy, accordance, section.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Notice to Individuals.

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 PT-5(1) — Just-In-Time Notice
• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
• ISO/IEC 27001:2022 A.5.5 — Contact with authorities
• SOC 2 (2017 TSC) CC2.3 — External Communication on Internal Control Matters
• NIST SP 800-171 Rev. 3 3.5.11 — Authentication Feedback

Related controls in HIPAA (45 CFR Part 164)

• § 164.404(b) — Timeliness of Notification
• § 164.410 — Notification by a Business Associate
• § 164.408 — Notification to the Secretary
• § 164.406 — Notification to the Media
• § 164.528(d) — Documentation
• § 164.404(d) — Methods of Notification

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.404(a)

Topics: governance riskpolicy management