HIPAA (45 CFR Part 164) 164.408 — Notification to the Secretary

What this control requires

Notification to the Secretary. (a) A covered entity shall, following the discovery of a breach of unsecured protected health information as provided in 164.404(a)(2), notify the Secretary. (b) For breaches of unsecured protected health information involving 500 or more individuals, a covered entity shall, except as provided in 164.412, provide the notification required by paragraph (a) of this section contemporaneously with the notice required by 164.404(a) and in the manner specified on the HHS Web site. (c) For breaches of unsecured protected health information involving less than 500 individuals, a covered entity shall maintain a log or other documentation of such breaches and, not later than 60 days after the end of each calendar year, provide the notification required by paragraph (a) of this section for breaches discovered during the preceding calendar year, in the manner specified on the HHS Web site.

In plain English

Notification to the Secretary. 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 Breach Notification Rule, the assessor will trace your implementation back to the catalogue reference (§ 164.408) 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.
• Other. Document the trigger, the owner and the cadence.
• Policy. Document the trigger, the owner and the cadence.
• Documentation. Document the trigger, the owner and the cadence.
• Notice. Document the trigger, the owner and the cadence.
• Scope: management, individuals, notification, web site, secretary, notice, policy, section.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Notification to the Secretary.

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-7(6) — Inability To Return To Primary Site
• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions

Related controls in HIPAA (45 CFR Part 164)

• § 164.404(a) — Notice to Individuals
• § 164.404(d) — Methods of Notification
• § 164.404(b) — Timeliness of Notification
• § 164.406 — Notification to the Media
• § 164.512(k)(1) — Uses and disclosures for specialized government functions - Military
• § 164.410 — Notification by a Business Associate

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.408

Topics: governance riskpolicy management