# HIPAA (45 CFR Part 164) 164.316(b)(1) — Documentation - Source: https://support.icompaas.com/compliance/hipaa/164-316-b-1-documentation - Section: [Compliance](https://support.icompaas.com/compliance) › [HIPAA Security, Privacy & Breach-Notification Rules](https://support.icompaas.com/compliance/hipaa) › Security Rule — §164.316 - Last updated: 2026-06-05 - Publisher: iCompaas, Inc. (https://www.icompaas.com) **HIPAA (45 CFR Part 164)**·§ `164.316(b)(1)`·medium·Component: **Security Rule** ## What this control requires > Maintain the policies and procedures implemented to comply with this subpart in written (which may be electronic) form; and (ii) If an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record or the action, activity, or assessment. > > — HIPAA (45 CFR Part 164), § 164.316(b)(1) ### In plain English Maintain the policies and procedures implemented to comply with this subpart in written (which may be electronic) form; and (ii) If an action, activity or assessment is required by this subpart to be documented, maintain a written (which may be electronic) record or the action, activity, or 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 **Security Rule**, the assessor will trace your implementation back to the catalogue reference (§ 164.316(b)(1)) 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. - **Policy.** Document the trigger, the owner and the cadence. - **Documentation.** Document the trigger, the owner and the cadence. - **Scope:** security, management, procedures, policy, activity, ii. ## Evidence to collect - **Policy Document.** A signed and version-controlled policy / standard / procedure document. Signed policy or standard documents the safeguard. Focus: Documentation. ## 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) - [**NIST SP 800-171 Rev. 3 3.15.1** — Policy and Procedures](https://support.icompaas.com/compliance/nist-sp-800-171-rev-3/3-15-1-policy-and-procedures) - [**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) CC2.3** — External Communication on Internal Control Matters](https://support.icompaas.com/compliance/soc-2-trust-services-criteria/cc2-3-external-communication-on-internal-control-matters) ## Related controls in HIPAA (45 CFR Part 164) - [**§ 164.308(a)(5)(ii)(B)** — Security Awareness, Training, and Tools - Protection from Malicious Software](https://support.icompaas.com/compliance/hipaa/164-308-a-5-ii-b-security-awareness-training-and-tools-protection-from-malicious-software) - [**§ 164.308(a)(5)(ii)(C)** — Security Awareness, Training, and Tools - Log-in Monitoring](https://support.icompaas.com/compliance/hipaa/164-308-a-5-ii-c-security-awareness-training-and-tools-log-in-monitoring) - [**§ 164.308(a)(5)(ii)(D)** — Security Awareness, Training, and Tools - Password Management](https://support.icompaas.com/compliance/hipaa/164-308-a-5-ii-d-security-awareness-training-and-tools-password-management) - [**§ 164.308(a)(7)(i)** — Contingency Plan](https://support.icompaas.com/compliance/hipaa/164-308-a-7-i-contingency-plan) - [**§ 164.310(b)** — Workstation Use](https://support.icompaas.com/compliance/hipaa/164-310-b-workstation-use) - [**§ 164.308(a)(3)(i)** — Workforce Security](https://support.icompaas.com/compliance/hipaa/164-308-a-3-i-workforce-security) ## References - [U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)](https://www.hhs.gov/hipaa/for-professionals/index.html) - Catalogue identifier: `§ 164.316(b)(1)` 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.