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

Document types

• rulemaking notice 22
• guidance 8
• notice 8
• regulation 7
• public comment 2
• rule 1

Recent HHS OCR activity

• regulation effective 12/28/2000

  [HHS OCR] Standards for Privacy of Individually Identifiable Health Information

  This rule establishes standards for the privacy of individually identifiable health information under HIPAA, applying to health plans, clearinghouses, and providers to protect patient rights and regulate data uses and disclosures.

• regulation effective 5/1/2020

  [HHS OCR] 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program

  This final rule implements provisions of the 21st Century Cures Act regarding health IT interoperability, information blocking, and ONC Health IT Certification Program requirements.

• rulemaking notice effective 9/24/2025

  [HHS OCR] Computer Software Assurance for Production and Quality System Software; Guidance for Industry and Food and Drug Administration Staff; Availability

  FDA announces the availability of final guidance on computer software assurance for production and quality system software in medical device manufacturing.

• regulation final rule 1/9/2024

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

  This final rule updates the ONC Health IT Certification Program, establishing new requirements for health IT developers to enhance interoperability, algorithm transparency, and information sharing under the 21st Century Cures Act.

• regulation effective 6/13/2025

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

  The FDA is classifying radiological computer-assisted detection and diagnosis software into Class II (special controls) to ensure safety and effectiveness while reducing regulatory burdens.

• regulation final rule 12/16/2024

  [HHS OCR] Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA)

  This final rule from HHS amends information blocking regulations and implements provisions related to the Trusted Exchange Framework and Common Agreement (TEFCA) to advance health data interoperability, privacy, and security.

• guidance effective 12/4/2024

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

  The FDA issued final guidance recommending Predetermined Change Control Plans for AI-enabled medical device software functions to ensure ongoing safety and effectiveness.

• regulation final rule 3/25/2026

  [HHS OCR] General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed

  The FDA reclassifies optical and electrical impedance skin lesion diagnostic devices as Class II software-aided devices, establishing special controls.

• guidance effective 8/5/2025

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

  NIH issues guidance on appropriate AI use in research applications to ensure fairness and originality, and implements a new annual application limit per principal investigator.

• 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.

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