# HIPAA (45 CFR Part 164) 164.308(a)(1)(ii)(A) — Security Management Process - Risk Analysis - Source: https://support.icompaas.com/compliance/hipaa/164-308-a-1-ii-a-security-management-process-risk-analysis - Section: [Compliance](https://support.icompaas.com/compliance) › [HIPAA Security, Privacy & Breach-Notification Rules](https://support.icompaas.com/compliance/hipaa) › Security Rule — §164.308 - Last updated: 2026-06-05 - Publisher: iCompaas, Inc. (https://www.icompaas.com) **HIPAA (45 CFR Part 164)**·§ `164.308(a)(1)(ii)(A)`·medium·Component: **Security Rule** ## What this control requires > Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate. > > — HIPAA (45 CFR Part 164), § 164.308(a)(1)(ii)(A) ### In plain English Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate. In practice, this means you can prove you security management process-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 **Security Rule**, the assessor will trace your implementation back to the catalogue reference (§ 164.308(a)(1)(ii)(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. - **Information.** Document the trigger, the owner and the cadence. - **Business.** Document the trigger, the owner and the cadence. - **Integrity.** Document the trigger, the owner and the cadence. - **Policy.** Document the trigger, the owner and the cadence. - **Scope:** management process, management process - risk analysis, security, availability, business associate, policy. ## Evidence to collect - **Policy Document.** A signed and version-controlled policy / standard / procedure document. - **Infra Scan.** Continuous infrastructure-posture telemetry — AWS Config, Azure Policy compliance, GCP Organisation Policy, Wiz / Prisma findings. Signed policy or standard documents the safeguard. Focus: Security Management Process - Risk Analysis. ## 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](https://support.icompaas.com/compliance/bsi-c5-2020/sp-01-documentation-communication-and-provision-of-policies-and-instructions) - [**NIST SP 800-53 Rev. 5 SA-8(4)** — Partially Ordered Dependencies](https://support.icompaas.com/compliance/nist-sp-800-53-rev-5/sa-8-4-partially-ordered-dependencies) - [**ISO/IEC 27001:2022 A.5.1** — Policies for information security](https://support.icompaas.com/compliance/iso-27001-2022/a-5-1-policies-for-information-security) - [**NIST SP 800-171 Rev. 3 3.4.4** — Impact Analyses](https://support.icompaas.com/compliance/nist-sp-800-171-rev-3/3-4-4-impact-analyses) - [**SOC 2 (2017 TSC) CC9.1** — Business Disruption Risk Mitigation](https://support.icompaas.com/compliance/soc-2-trust-services-criteria/cc9-1-business-disruption-risk-mitigation) ## Related controls in HIPAA (45 CFR Part 164) - [**§ 164.308(a)(1)(ii)(B)** — Security Management Process - Risk Management](https://support.icompaas.com/compliance/hipaa/164-308-a-1-ii-b-security-management-process-risk-management) - [**§ 164.308(a)** — Security Management Process](https://support.icompaas.com/compliance/hipaa/164-308-a-security-management-process) - [**§ 164.308(a)(1)(ii)(C)** — Security Management Process - Sanction Policy](https://support.icompaas.com/compliance/hipaa/164-308-a-1-ii-c-security-management-process-sanction-policy) - [**§ 164.314(a)(2)(i)(C)** — Business associate contracts.](https://support.icompaas.com/compliance/hipaa/164-314-a-2-i-c-business-associate-contracts) - [**§ 164.306(a)** — General Requirements](https://support.icompaas.com/compliance/hipaa/164-306-a-general-requirements) - [**§ 164.316(b)(2)(ii)** — Documentation- Availability](https://support.icompaas.com/compliance/hipaa/164-316-b-2-ii-documentation-availability) ## References - [U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)](https://www.hhs.gov/hipaa/for-professionals/index.html) - Catalogue identifier: `§ 164.308(a)(1)(ii)(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.