Health Law Highlights

HHS Finalizes Regulation of Certain AI

From Manatt, Phelps & Phillips, LLP, by Alex Dworkowitz, Alice Leiter, and Randi Seigel:

  • The U.S. Department of Health and Human Services (HHS) has finalized a rule to regulate the use of artificial intelligence (AI) in health care.
  • The rule applies to predictive algorithms used in electronic health record (EHR) systems. It requires transparency in the use of AI, including information about the purpose, funding sources, training data, fairness measures, and validation process.
  • The rule aims to promote the development of fair, valid, and safe algorithms and address concerns about biased decision-making.
  • The regulation currently applies to developers of certified EHR software and may foreshadow future regulations for health care providers.
  • The rule also includes updates to the ONC Health IT Certification Program and provisions to improve interoperability and secure exchange of health information.