# HIPAA (45 CFR Part 164) 164.524(e) — Documentation - Source: https://support.icompaas.com/compliance/hipaa/164-524-e-documentation - Section: [Compliance](https://support.icompaas.com/compliance) › [HIPAA Security, Privacy & Breach-Notification Rules](https://support.icompaas.com/compliance/hipaa) › Privacy Rule — §164.524 - Last updated: 2026-06-05 - Publisher: iCompaas, Inc. (https://www.icompaas.com) **HIPAA (45 CFR Part 164)**·§ `164.524(e)`·medium·Component: **Privacy Rule** ## What this control requires > Implementation specification: Documentation. A covered entity must document the following and retain the documentation as required by 164.530(j): (1) the designated record sets that are subject to access by individuals; and (2) the titles of the persons or offices responsible for receiving and processing requests for access by individuals. > > — HIPAA (45 CFR Part 164), § 164.524(e) ### In plain English Implementation specification: Documentation. In practice, this means you can prove you policy management-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 **Privacy Rule**, the assessor will trace your implementation back to the catalogue reference (§ 164.524(e)) 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 - **Policy.** Document the trigger, the owner and the cadence. - **Documentation.** Document the trigger, the owner and the cadence. - **Scope:** management, individuals, policy. ## 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 SC-15(4)** — Explicitly Indicate Current Participants](https://support.icompaas.com/compliance/nist-sp-800-53-rev-5/sc-15-4-explicitly-indicate-current-participants) - [**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.5.5** — Contact with authorities](https://support.icompaas.com/compliance/iso-27001-2022/a-5-5-contact-with-authorities) - [**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) - [**NIST SP 800-171 Rev. 3 3.5.11** — Authentication Feedback](https://support.icompaas.com/compliance/nist-sp-800-171-rev-3/3-5-11-authentication-feedback) ## Related controls in HIPAA (45 CFR Part 164) - [**§ 164.528(d)** — Documentation](https://support.icompaas.com/compliance/hipaa/164-528-d-documentation) - [**§ 164.502(f)** — Deceased individuals](https://support.icompaas.com/compliance/hipaa/164-502-f-deceased-individuals) - [**§ 164.530(d)(1)** — Complaints to the Covered Entity](https://support.icompaas.com/compliance/hipaa/164-530-d-1-complaints-to-the-covered-entity) - [**§ 164.502(j)(2)** — Disclosures by workforce members who are victims of a crime](https://support.icompaas.com/compliance/hipaa/164-502-j-2-disclosures-by-workforce-members-who-are-victims-of-a-crime) - [**§ 164.512(h)** — Uses and disclosures for cadaveric organ, eye or tissue donation](https://support.icompaas.com/compliance/hipaa/164-512-h-uses-and-disclosures-for-cadaveric-organ-eye-or-tissue-donation) - [**§ 164.512(k)(3)** — Uses and disclosures for specialized government functions - Protective Services](https://support.icompaas.com/compliance/hipaa/164-512-k-3-uses-and-disclosures-for-specialized-government-functions-protective-services) ## References - [U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)](https://www.hhs.gov/hipaa/for-professionals/index.html) - Catalogue identifier: `§ 164.524(e)` 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.