# HIPAA (45 CFR Part 164) 164.312(b) — Audit Controls - Source: https://support.icompaas.com/compliance/hipaa/164-312-b-audit-controls - Section: [Compliance](https://support.icompaas.com/compliance) › [HIPAA Security, Privacy & Breach-Notification Rules](https://support.icompaas.com/compliance/hipaa) › Security Rule — §164.312 - Last updated: 2026-06-05 - Publisher: iCompaas, Inc. (https://www.icompaas.com) **HIPAA (45 CFR Part 164)**·§ `164.312(b)`·medium·Component: **Security Rule** ## What this control requires > Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information. > > — HIPAA (45 CFR Part 164), § 164.312(b) ### In plain English Implement hardware, software, and/or procedural mechanisms that record and examine activity in information systems that contain or use electronic protected health information. 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 **Security Rule**, the assessor will trace your implementation back to the catalogue reference (§ 164.312(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. - **Information.** Document the trigger, the owner and the cadence. - **Audit.** Document the trigger, the owner and the cadence. - **Policy.** Document the trigger, the owner and the cadence. - **Scope:** security, management, controls, policy, activity. ## 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: Audit Controls. ## 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 PL-6** — Security-Related Activity Planning](https://support.icompaas.com/compliance/nist-sp-800-53-rev-5/pl-6-security-related-activity-planning) - [**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) - [**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) - [**SOC 2 (2017 TSC) PI1.4** — Output Controls](https://support.icompaas.com/compliance/soc-2-trust-services-criteria/pi1-4-output-controls) - [**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) ## Related controls in HIPAA (45 CFR Part 164) - [**§ 164.312(e)(2)(i)** — Transmission Security - Integrity Controls](https://support.icompaas.com/compliance/hipaa/164-312-e-2-i-transmission-security-integrity-controls) - [**§ 164.316(b)(1)** — Documentation](https://support.icompaas.com/compliance/hipaa/164-316-b-1-documentation) - [**§ 164.308(a)(5)(i)** — Security Awareness and Training](https://support.icompaas.com/compliance/hipaa/164-308-a-5-i-security-awareness-and-training) - [**§ 164.308(a)(7)(ii)(E)** — Contingency Plan -Application and Data Criticality Analysis](https://support.icompaas.com/compliance/hipaa/164-308-a-7-ii-e-contingency-plan-application-and-data-criticality-analysis) - [**§ 164.310(c)** — Workstation Security](https://support.icompaas.com/compliance/hipaa/164-310-c-workstation-security) - [**§ 164.312(a)(2)(iv)** — Access Control - Encryption and Decryption](https://support.icompaas.com/compliance/hipaa/164-312-a-2-iv-access-control-encryption-and-decryption) ## References - [U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)](https://www.hhs.gov/hipaa/for-professionals/index.html) - Catalogue identifier: `§ 164.312(b)` 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.