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On December 29, 2025, the U.S. Department of Health and Human Services (“HHS”), through the Assistant Secretary for Technology Policy (“ASTP”)/Office of the National Coordinator for Health Information Technology (“ONC”) (collectively, “ASTP/ONC”), issued a proposed rule to update its Health Data, Technology, and Interoperability (“HTI”) regulations, as well as a notice to withdraw prior proposals

With 2026 underway, signs point to another year focused on enhancing health IT and digital health innovation.  From new payment models to deregulatory efforts, these developments show that digital health continues to be increasingly central to the healthcare and life sciences sectors.  Below are five key developments to watch unfold in the year ahead.

  • Reducing
  • On December 19, New York Governor Kathy Hochul (D) signed the Responsible AI Safety & Education (“RAISE”) Act into law, making New York the second state in the nation to codify public safety disclosure and reporting requirements for developers of frontier AI models.  Prior to signing, Governor Hochul secured several commitments from the legislature to

    With innovation comes regulatory scrutiny. On December 9, 2025, the Financial Industry Regulatory Authority, Inc. (“FINRA”) released its 2026 Annual Regulatory Oversight Report (the “2026 Report”), which includes a new section dedicated to generative artificial intelligence (“GenAI”). The 2026 Report is the latest iteration of FINRA’s yearly summary of insights from its regulatory oversight activities,