HIPAA (45 CFR Part 164) 164.410 — Notification by a Business Associate

What this control requires

Notification by a Business Associate. (a) Standard. (1) General Rule. A business associate shall, following the discovery of a breach of unsecured protected health information, notify the covered entity of such breach. (2) For purposes of paragraph (a)(1) of this section, a breach shall be treated as discovered by a business associate as of the first day on which such breach is known to the business associate or, by exercising reasonable diligence, would have been known to the business associate. A business associate shall be deemed to have knowledge of a breach if the breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the breach, who is an employee, officer, or other agent of the business associate (determined in accordance with the federal common law of agency). (b) Except as provided in 164.412, a business associate shall provide the notification required by paragraph (a) of this section without unreasonable delay and in no case later than 60 calendar days after discovery of a breach. (c)(1) The notification required by paragraph (a) of this section shall include, to the extent possible, the identification of each individual whose unsecured protected health information has been, or is reasonably believed by the business associate to have been, accessed, acquired, used, or disclosed during the breach. (2) A business associate shall provide the covered entity with any other available information that the covered entity is required to include in notification to the individual under 164.404(c) at the time of the notification required by paragraph (a) of this section or promptly thereafter as information becomes available.

In plain English

Notification by a Business Associate. In practice, this means you can prove you general 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 (§ 164.410) 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

• General. Document the trigger, the owner and the cadence.
• Information. Document the trigger, the owner and the cadence.
• Business. 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.
• Scope: management, notification, business associate, policy, accordance, section, b, c.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Notification by a Business Associate.

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.

• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
• NIST SP 800-53 Rev. 5 CP-7(2) — Accessibility
• ISO/IEC 27001:2022 A.5.5 — Contact with authorities
• SOC 2 (2017 TSC) CC2.3 — External Communication on Internal Control Matters

Related controls in HIPAA (45 CFR Part 164)

• § 164.404(b) — Timeliness of Notification
• § 164.404(a) — Notice to Individuals
• § 164.414(b) — Burden of Proof
• § 164.402(b) — Definitions: Breach - exceptions (unsecured PHI)
• § 164.412 — Law Enforcement Delay
• § 164.406 — Notification to the Media

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.410

Topics: governance riskpolicy management