HIPAA (45 CFR Part 164) 164.402(a) — Definitions: Breach - Risk Assessment

What this control requires

Definitions: Breach - Risk Assessment. Breach means the acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E of this part which compromises the security or privacy of the PHI. (2) Except as provided in paragraph (1) of this definition, an acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the PHI has been compromised based on a risk assessment of at least the following factors: (i) The nature and extent of the PHI involved, including the types of identifiers and the likelihood of re-identification; (ii) The unauthorized person who used the PHI or to whom the disclosure was made; (iii) Whether the PHI was actually acquired or viewed; and (iv) The extent to which the risk to the PHI has been mitigated.

In plain English

Definitions: Breach - Risk Assessment. 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 (§ 164.402(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

• Security. 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.
• Policy. Document the trigger, the owner and the cadence.
• Definitions:. Document the trigger, the owner and the cadence.
• Scope: security, management, breach - risk assessment, notification, business associate, policy, i, e.

Evidence to collect

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

Signed policy or standard documents the safeguard. Focus: Definitions: Breach - Risk Assessment.

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 800-171 Rev. 3 3.12.1 — Security Assessment
• BSI C5:2020 SP-01 — Documentation, communication and provision of policies and instructions
• SOC 2 (2017 TSC) CC3.3 — Fraud Risk Assessment
• NIST SP 800-53 Rev. 5 PL-2(3) — Plan And Coordinate With Other Organizational Entities

Related controls in HIPAA (45 CFR Part 164)

• § 164.402(b) — Definitions: Breach - exceptions (unsecured PHI)
• § 164.414(b) — Burden of Proof
• § 164.410 — Notification by a Business Associate
• § 164.412 — Law Enforcement Delay
• § 164.514(d)(3) — Minimum Necessary - Disclosures of PHI
• § 164.314(a)(2)(i)(A) — Business associate contracts

References

• U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)
• Catalogue identifier: § 164.402(a)

Topics: governance riskpolicy management