# HIPAA (45 CFR Part 164) 164.402(a) — Definitions: Breach - Risk Assessment - Source: https://support.icompaas.com/compliance/hipaa/164-402-a-definitions-breach-risk-assessment - Section: [Compliance](https://support.icompaas.com/compliance) › [HIPAA Security, Privacy & Breach-Notification Rules](https://support.icompaas.com/compliance/hipaa) › Breach Notification Rule — §164.402 - Last updated: 2026-06-05 - Publisher: iCompaas, Inc. (https://www.icompaas.com) **HIPAA (45 CFR Part 164)**·§ `164.402(a)`·medium·Component: **Breach Notification Rule** ## 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. > > — HIPAA (45 CFR Part 164), § 164.402(a) ### 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](https://support.icompaas.com/compliance/nist-sp-800-171-rev-3/3-12-1-security-assessment) - [**BSI C5:2020 SP-01** — Documentation, communication and provision of policies and instructions](https://support.icompaas.com/compliance/bsi-c5-2020/sp-01-documentation-communication-and-provision-of-policies-and-instructions) - [**SOC 2 (2017 TSC) CC3.3** — Fraud Risk Assessment](https://support.icompaas.com/compliance/soc-2-trust-services-criteria/cc3-3-fraud-risk-assessment) - [**NIST SP 800-53 Rev. 5 PL-2(3)** — Plan And Coordinate With Other Organizational Entities](https://support.icompaas.com/compliance/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)](https://support.icompaas.com/compliance/hipaa/164-402-b-definitions-breach-exceptions-unsecured-phi) - [**§ 164.414(b)** — Burden of Proof](https://support.icompaas.com/compliance/hipaa/164-414-b-burden-of-proof) - [**§ 164.410** — Notification by a Business Associate](https://support.icompaas.com/compliance/hipaa/164-410-notification-by-a-business-associate) - [**§ 164.412** — Law Enforcement Delay](https://support.icompaas.com/compliance/hipaa/164-412-law-enforcement-delay) - [**§ 164.514(d)(3)** — Minimum Necessary - Disclosures of PHI](https://support.icompaas.com/compliance/hipaa/164-514-d-3-minimum-necessary-disclosures-of-phi) - [**§ 164.314(a)(2)(i)(A)** — Business associate contracts](https://support.icompaas.com/compliance/hipaa/164-314-a-2-i-a-business-associate-contracts) ## References - [U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)](https://www.hhs.gov/hipaa/for-professionals/index.html) - Catalogue identifier: `§ 164.402(a)` Topics: governance riskpolicy management ## Related compliance guidance - [HIPAA compliance for SaaS: a practical implementation guide](https://support.icompaas.com/compliance/hipaa): Start with the full HIPAA implementation guide — scope, roadmap, evidence and how the assessment runs. - [SOC 2 compliance: a practical implementation guide for cloud-native SaaS teams](https://support.icompaas.com/compliance/soc-2-trust-services-criteria): Most covered-entity customers accept a SOC 2 Type II report as the independent evidence that your HIPAA controls operate, since no HIPAA attestation exists. - [NIST SP 800-53 Rev. 5: a practical implementation guide for cloud teams](https://support.icompaas.com/compliance/nist-sp-800-53-rev-5): NIST publishes mappings of the Security Rule standards and implementation specifications to SP 800-53 Rev. 5 controls alongside SP 800-66 Rev. 2, so an 800-53 control set doubles as a HIPAA crosswalk.