--- title: "45 CFR 160.534 HIPAA: The hearing" canonical: "https://dposchool.com/hipaa/section/160.534" source: "https://www.ecfr.gov/current/title-45/section-160.534" 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 160.534 HIPAA · Part 160: GENERAL ADMINISTRATIVE REQUIREMENTS · Subpart E: Procedures for Hearings # 45 CFR 160.534 HIPAA: The hearing eCFR, up to date as of 29 October 2026. Retrieved 30 October 2026. ## Official text ### 45 CFR 160.534(a) **(a)** The ALJ must conduct a hearing on the record in order to determine whether the respondent should be found liable under this part. **(b)(1)** The respondent has the burden of going forward and the burden of persuasion with respect to any: **(i)** Affirmative defense pursuant to § 160.410 of this part; **(ii)** Challenge to the amount of a proposed penalty pursuant to §§ 160.404-160.408 of this part, including any factors raised as mitigating factors; or **(iii)** Claim that a proposed penalty should be reduced or waived pursuant to § 160.412 of this part; and **(iv)** Compliance with subpart D of part 164, as provided under § 164.414(b). #### 45 CFR 160.534(a)(2) **(2)** The Secretary has the burden of going forward and the burden of persuasion with respect to all other issues, including issues of liability other than with respect to subpart D of part 164, and the existence of any factors considered aggravating factors in determining the amount of the proposed penalty. #### 45 CFR 160.534(a)(3) **(3)** The burden of persuasion will be judged by a preponderance of the evidence. ### 45 CFR 160.534(c) **(c)** The hearing must be open to the public unless otherwise ordered by the ALJ for good cause shown. **(d)(1)** Subject to the 15-day rule under § 160.518(a) and the admissibility of evidence under § 160.540, either party may introduce, during its case in chief, items or information that arose or became known after the date of the issuance of the notice of proposed determination or the request for hearing, as applicable. Such items and information may not be admitted into evidence, if introduced— **(i)** By the Secretary, unless they are material and relevant to the acts or omissions with respect to which the penalty is proposed in the notice of proposed determination pursuant to § 160.420 of this part, including circumstances that may increase penalties; or **(ii)** By the respondent, unless they are material and relevant to an admission, denial or explanation of a finding of fact in the notice of proposed determination under § 160.420 of this part, or to a specific circumstance or argument expressly stated in the request for hearing under § 160.504, including circumstances that may reduce penalties. #### 45 CFR 160.534(c)(2) **(2)** After both parties have presented their cases, evidence may be admitted in rebuttal even if not previously exchanged in accordance with § 160.518. ## 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. Source credit: \[71 FR 8428, Feb. 16, 2006, as amended at 74 FR 42767, Aug. 24, 2009; 78 FR 5692, Jan. 25, 2013\] [45 CFR 160.534 on eCFR](https://www.ecfr.gov/current/title-45/section-160.534) 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 160.534 Previous: [45 CFR 160.532 HIPAA: Collateral estoppel](https://dposchool.com/hipaa/section/160.532) Next: [45 CFR 160.536 HIPAA: Statistical sampling](https://dposchool.com/hipaa/section/160.536) ## 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