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HHS OCR audit package

The HHS Office for Civil Rights audit package (Reports, for organization administrators, once a HIPAA assessment is offered) gathers what an HHS Office for Civil Rights (OCR) investigator commonly asks for in a HIPAA compliance review or audit: the security risk analysis, the open findings from your HIPAA assessments, policies and procedures, workforce training and sanctions, access reviews, business associate agreements, devices and media, security incidents and breach notifications, individuals' requests and the accounting of disclosures, and the contingency plan.

Each item says what is recorded in Backsplice and links to the record. An item Backsplice does not hold, such as your notice of privacy practices or the configuration of your systems' technical safeguards, says so, so you can add it from your own records.

What it is not

The package is not an attestation. It does not state that any requirement is met, it gives no score, and it has no signature line. An OCR data request names the items and the period it wants: answer that request, not this list, and consider having counsel review your response before you send it to HHS.

Open findings are the gaps recorded in your own HIPAA assessments against the Security and Privacy Rule questions; findings against other frameworks your assessments selected, such as voluntary guidance, stay on the findings register.

Downloading it

The page shows every section; Download PDF and Markdown give the same document as a file. Each list shows its first rows and says how many there are in all, so export the full list from the record when a request asks for it. If a section cannot be read when the package is built, it says so and the package is marked incomplete: generate it again before you send it.

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AI governance and HIPAA compliance, in one program.

NIST AI RMF 1.0 NIST AI 600-1 (Generative AI Profile) NIST Cyber AI Profile (IR 8596 initial preliminary draft) NIST COSAiS Predictive AI (built from NIST's January 2026 outline) ISO/IEC 42001:2023 ISO/IEC 42005:2025 ISO/IEC 23894:2023 EU AI Act (Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744) EU AI Act GPAI model obligations (Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744) NYC Local Law 144 of 2021 (AEDT) Colorado ADMT Act (C.R.S. 6-1-1701 to 6-1-1709, SB 26-189) California CCPA Regulations on ADMT and Risk Assessments (2025) California Civil Rights Council Regulations on Automated-Decision Systems (2025) Illinois Human Rights Act (775 ILCS 5), as amended by P.A. 103-0804 (HB 3773) Texas Responsible Artificial Intelligence Governance Act (H.B. 149, 2025) Utah AI Laws (Utah Code 13-72, 13-72a, 13-77 and 58-60-118, as amended through 2026) UK AI Cyber Security Code of Practice (2025) Singapore Model AI Governance Framework (2nd ed., 2020) Singapore Model AI Governance Framework for Generative AI (2024) Singapore Model AI Governance Framework for Agentic AI (v1.5, 2026) OWASP Top 10 for LLM Applications 2026 MITRE ATLAS 2026.09 HIPAA Security and Breach Notification Rules (45 CFR 164 Subparts C–D, eCFR 2026-10-06) HIPAA Privacy Rule (45 CFR 164 Subpart E, eCFR 2026-10-06) 42 CFR Part 2 (Substance Use Disorder Patient Records, eCFR 2026-10-05) HHS 405(d) HICP (2023 Edition) NIST SP 800-66 Rev. 2 (February 2024) ONC Information Blocking (45 CFR 171, eCFR 2026-10-06)

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Backsplice provides tools to run an AI governance and HIPAA program; it does not confer compliance with any law or standard and does not constitute legal advice. Consult qualified legal counsel for specific compliance guidance.