HIPAA (45 CFR Part 164)·§ 164.404(c)(1)·medium·Component: Breach Notification Rule

What this control requires

Content of Notification. The notification required by paragraph (a) of this section shall include, to the extent possible: (A) A brief description of what happened, including the date of the breach and the date of the discovery of the breach, if known; (B) A description of the types of unsecured protected health information that were involved in the breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved); (C) Any steps the individual should take to protect themselves from potential harm resulting from the breach; (D) A brief description of what the covered entity is doing to investigation the breach, to mitigate harm to individuals, and to protect against further breaches; and (E) Contact procedures for individuals to ask questions or learn additional information, which shall include a toll-free telephone number, an email address, Web site, or postal address. (2) The notification required by paragraph (a) of this section shall be written in plain language.
— HIPAA (45 CFR Part 164), § 164.404(c)(1)

In plain English

Content of Notification. In practice, this means you can prove you security security-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(c)(1)) 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

  • Security. Document the trigger, the owner and the cadence.
  • 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.
  • Content. Document the trigger, the owner and the cadence.
  • Scope: security, management, procedures, individuals, notification, if known, whether full name, social security number.

Evidence to collect

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

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

Common pitfalls

  • Policies that no engineer has read; the version in Confluence drifts from the version that's actually being enforced.

Related controls in HIPAA (45 CFR Part 164)

References

Topics: governance riskpolicy management