On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT
The Office of Management and Budget (“OMB”) has released its 2026 Unified Agenda, which identifies regulatory actions that federal agencies expect to propose or finalize during the remainder of the year. Below, we highlight several notable health privacy, interoperability, and
On March 24, 2026, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule establishing a Health Insurance Portability and Accountability Act (“HIPAA”) standard for electronic signatures in connection with health care claims attachments transactions, as well as
On Tuesday, March 31, FDA published a Request for Information seeking input on the use of digital health technologies (“DHTs”) in clinical investigations for drugs and biological products (the “RFI”). Building on commitments under PDUFA VII and prior Agency publications
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
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
On December 16, 2025, the EU Commission unveiled its proposal for the Biotech Act. The proposal, which is only the first part of a bigger initiative for regulating biotechnologies, focuses primarily on the health sector. The Commission took the
On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing,
The Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices. The DHAC will discuss
On July 30, 2025, the U.S. Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) announced a new Health Technology Ecosystem Initiative—a collaborative effort between government and industry to unlock innovation by modernizing healthcare data
