HIPAA (45 CFR Part 164)·§ 164.404(d)·medium·Component: Breach Notification Rule

What this control requires

Methods of Notification. The notification required by paragraph (a) of this section shall be provided in the following form: (1)(i) Written notification by first-class mail to the individual at the last known address of the individual or, if the individual agrees to electronic notice and such agreement has not been withdrawn, by electronic mail. The notification may be provided in one or more mailings as information becomes available. (ii) If the covered entity knows the individual is deceased and has the address of the next of kin or personal representative of the individual (as specified under 164.502(g)(4) of subpart E) , written notification by first-class mail to either the next of kin or personal representative of the individual is required. The notification may be provided in one or more mailings as information is available. (2) Substitute notice. In the case in which there is insufficient or out-of-date contact information that precludes written notification to the individual under this paragraph (d)(1)(i) of this section, a substitute form of notice reasonably calculated to reach the individual shall be provided. Substitute notice need not be provided in the case in which there is insufficient or out-of-date contact information that precludes written notification to the next of kin or personal representative of the individual under paragraph (d)(1)(ii). (i) In the case in which there is insufficient or out-of-date contact information for fewer than 10 individuals, then substitute notice may be provided by an alternative form of written notice, telephone, or other means. (ii) In the case in which there is insufficient or out-of-date contact information for 10 or more individuals, then such substitute notice shall: (A) Be in the form of either a conspicuous posting for a period of 90 days on the home page of the Web site of the covered entity involved, or conspicuous notice in a major print or broadcast media in geographic areas where the individuals affected by the breach likely reside; and (B) Include a toll-free number that remains active for at least 90 days where an individual can learn whether the individual's unsecured protected health information may be included in the breach. (3) In any case deemed by the covered entity to require urgency because of possible imminent misuse of unsecured protected health information, the covered entity may provide information to individuals by telephone or other means, as appropriate, in addition to notice provided under paragraph (d)(1) of this section.
— HIPAA (45 CFR Part 164), § 164.404(d)

In plain English

Methods of Notification. 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 (§ 164.404(d)) 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.
  • Notice. Document the trigger, the owner and the cadence.
  • Methods. Document the trigger, the owner and the cadence.
  • Scope: management, individuals, notification, web site, media, notice, policy, i.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Methods of Notification.

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