164.414(a)·medium·Component: Breach Notification RuleWhat this control requires
Administrative Requirements. A covered entity is required to comply with the administrative requirements of 164.530(b), (d), (e), (g), (h), (i), and (j) with respect to 45 CFR Part 164, Subpart D ("the Breach Notification Rule"). [Training, complaints to the covered entity, sanctions, refraining from intimidating or retaliatory acts, waiver of rights, policies and procedures, and documentation]
In plain English
Administrative Requirements. In practice, this means you can prove you requirements requirements-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 (§ 164.414(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
- Requirements. 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.
- Notification. Document the trigger, the owner and the cadence.
- Administrative. Document the trigger, the owner and the cadence.
- Scope: requirements, management, procedures, notification, policy, i, e, b.
Evidence to collect
- Policy Document. A signed and version-controlled policy / standard / procedure document.
Signed policy or standard documents the safeguard. Focus: Administrative Requirements.
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-1 — Policy And Procedures
- ISO/IEC 27001:2022 A.5.32 — Intellectual property rights
- NIST SP 800-171 Rev. 3 3.7.1 — Recategorized as NCO.
- BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
- SOC 2 (2017 TSC) CC2.3 — External Communication on Internal Control Matters
Related controls in HIPAA (45 CFR Part 164)
- § 164.406 — Notification to the Media
- § 164.404(b) — Timeliness of Notification
- § 164.312(a)(1) — Access Control
- § 164.530(d)(1) — Complaints to the Covered Entity
- § 164.530(e)(1) — Sanctions
- § 164.502(j)(2) — Disclosures by workforce members who are victims of a crime
References
- U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
- Catalogue identifier:
§ 164.414(a)
Topics: governance riskpolicy management