U.S. Department of Health and Human Services, Office for Civil Rights (HHS OCR) AI Actions

Document types

• rulemaking notice 13
• guidance 4
• public comment 2
• notice 2
• rule 1
• policy paper 1

Recent HHS OCR activity

• rulemaking notice comment period 4/29/2026

  [HHS OCR] AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information

  The FDA is soliciting information on a proposed pilot program to assess how AI can improve efficiency, speed, and quality in early-phase clinical trials.

• rule final rule 1/9/2024

  [HHS OCR] Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing

  HHS OCR final rule updates EHR Reporting Program to enhance interoperability, algorithm transparency, and information sharing.

• rulemaking notice final rule 6/13/2025

  [HHS OCR] Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software

  FDA classifies radiological computer-assisted detection and diagnosis software into class II (special controls) to ensure safety and effectiveness.

• rulemaking notice proposed rule 8/5/2024

  [HHS OCR] Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability

  HHS OCR proposes rules to advance interoperability and data exchange in healthcare, including standards, certification, and API uses.

• rulemaking notice proposed rule 1/6/2025

  [HHS OCR] HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information

  HHS OCR proposes modifications to the HIPAA Security Rule to enhance cybersecurity for electronic protected health information (ePHI).

• guidance 8/5/2025

  [HHS OCR] Supporting Fairness and Originality in NIH Research Applications

  NIH provides guidance on AI use in research applications and limits PI applications per year.

• rulemaking notice comment period 9/17/2024

  [HHS OCR] Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generati

  HHS OCR announces a public meeting of the Digital Health Advisory Committee to discuss total product lifecycle considerations for Generative AI-enabled medical devices.

• rulemaking notice final rule 9/5/2024

  [HHS OCR] Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender

  FDA classifies adjunctive open loop fluid therapy recommenders into class II (special controls) to ensure safety and effectiveness.

• rulemaking notice proposed rule 4/18/2023

  [HHS OCR] Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing

  HHS OCR proposes updates to the ONC Health IT Certification Program, including certification criteria for decision support, patient demographics, observations, and electronic case reporting, and establishes a new USCDI baseline.

• rulemaking notice comment period 8/5/2024

  [HHS OCR] Agency Information Collection Activities Comment Request

  HHS OCR is requesting public comment on revisions to data collection procedures including the option for hospitals to use machine learning with NLP for DAWN data abstraction.

• guidance final rule 12/4/2024

  [HHS OCR] Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industr

  FDA issues guidance on recommendations for Predetermined Change Control Plans for AI-enabled device software functions.

• rulemaking notice proposed rule 3/9/2026

  [HHS OCR] Agency Forms Undergoing Paperwork Reduction Act Review

  HHS OCR is reviewing agency forms under the Paperwork Reduction Act, noting the potential of machine learning in newborn screening to improve detection rates.

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