HIPAA (45 CFR Part 164) 164.402(b) — Definitions: Breach - exceptions (unsecured PHI)

What this control requires

Definitions: Breach Exceptions - Unsecured PHI 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. (1) Breach excludes: (i) Any unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of a covered entity or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under subpart E of this part. (ii) Any inadvertent disclosure by a person who is authorized to access PHI at a covered entity or business associate to another person authorized to access PHI at the same covered entity or business associate, or organized health care arrangement in which the covered entity participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under subpart E of this part. (iii) A disclosure of PHI where a covered entity or business associate has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information. (2) Except as provided in paragraph (1) of this definition, an acquisition, access, use, or disclosure of protected health information 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 protected health information has been compromised based on a risk assessment of at least the following factors: (i) The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification; (ii) The unauthorized person who used the protected health information or to whom the disclosure was made; (iii) Whether the protected health information was actually acquired or viewed; and (iv) The extent to which the risk to the protected health information has been mitigated. Unsecured protected health information means protected health information that is not rendered unusable, unreadable, or indecipherable to unauthorized persons through the use of a technology or methodology specified by the Secretary in the guidance issued under section 13402(h)(2) of Public Law 111-5.

In plain English

Definitions: Breach Exceptions - Unsecured PHI 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. 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(b)) 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.
• Workforce. 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.
• Scope: security, management, notification, secretary, 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 - exceptions (unsecured PHI).

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 PL-2(3) — Plan And Coordinate With Other Organizational Entities
• ISO/IEC 27001:2022 A.5.1 — Policies for information security

Related controls in HIPAA (45 CFR Part 164)

• § 164.402(a) — Definitions: Breach - Risk Assessment
• § 164.414(b) — Burden of Proof
• § 164.410 — Notification by a Business Associate
• § 164.514(d)(1) — Minimum necessary requirements - standard
• § 164.514(d)(2) — Minimum necessary requirements - implementation specifications
• § 164.412 — Law Enforcement Delay

References

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

Topics: governance riskpolicy management