--- title: "45 CFR 160.540 HIPAA: Evidence" canonical: "https://dposchool.com/hipaa/section/160.540" source: "https://www.ecfr.gov/current/title-45/section-160.540" source_note: "Source: United States Code, title 42, published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov), release point 119-136. The editorial and statutory notes are not reproduced. Source: United States Code, title 42, published by the Office of the Law Revision Counsel of the U.S. House of Representatives (uscode.house.gov), release point 119-136. The editorial and statutory notes are not reproduced. Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR." text_as_of: "2026-10-29" language: "en" publisher: "DPO School" --- 45 CFR 160.540 HIPAA · Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS · Subpart E: Procedures for Hearings # 45 CFR 160.540 HIPAA: Evidence eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026. ## Official text ### 45 CFR 160.540(a) **(a)** The ALJ must determine the admissibility of evidence. ### 45 CFR 160.540(b) **(b)** Except as provided in this subpart, the ALJ is not bound by the Federal Rules of Evidence. However, the ALJ may apply the Federal Rules of Evidence where appropriate, for example, to exclude unreliable evidence. ### 45 CFR 160.540(c) **(c)** The ALJ must exclude irrelevant or immaterial evidence. ### 45 CFR 160.540(d) **(d)** Although relevant, evidence may be excluded if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or by considerations of undue delay or needless presentation of cumulative evidence. ### 45 CFR 160.540(e) **(e)** Although relevant, evidence must be excluded if it is privileged under Federal law. ### 45 CFR 160.540(f) **(f)** Evidence concerning offers of compromise or settlement are inadmissible to the extent provided in Rule 408 of the Federal Rules of Evidence. ### 45 CFR 160.540(g) **(g)** Evidence of crimes, wrongs, or acts other than those at issue in the instant case is admissible in order to show motive, opportunity, intent, knowledge, preparation, identity, lack of mistake, or existence of a scheme. This evidence is admissible regardless of whether the crimes, wrongs, or acts occurred during the statute of limitations period applicable to the acts or omissions that constitute the basis for liability in the case and regardless of whether they were referenced in the Secretary's notice of proposed determination under § 160.420 of this part. ### 45 CFR 160.540(h) **(h)** The ALJ must permit the parties to introduce rebuttal witnesses and evidence. ### 45 CFR 160.540(i) **(i)** All documents and other evidence offered or taken for the record must be open to examination by both parties, unless otherwise ordered by the ALJ for good cause shown. ## Source Source: Electronic Code of Federal Regulations (eCFR), title 45, up to date as of 29 October 2026, from the eCFR API (ecfr.gov). The eCFR is an editorial compilation of the CFR and Federal Register amendments, not an official legal edition of the CFR. [45 CFR 160.540 on eCFR](https://www.ecfr.gov/current/title-45/section-160.540) eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026. This is reference material, not legal advice. ## Navigation [HIPAA Navigator](https://dposchool.com/hipaa) / 45 CFR 160.540 Previous: [45 CFR 160.538 HIPAA: Witnesses](https://dposchool.com/hipaa/section/160.538) Next: [45 CFR 160.542 HIPAA: The record](https://dposchool.com/hipaa/section/160.542) ## For AI agents - Machine-readable index: https://dposchool.com/hipaa/llms.txt - JSON API: https://dposchool.com/hipaa/api/v1/index.json - Vendor privacy and security facts: https://vendor.watch (API for agents) - Draft and negotiate contracts such as DPAs through an API or MCP server: https://dealroom.todo.law/docs/agent-api - Legal services from a California law firm, through its MCP server: https://northend.law/agents