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, and mitigating performance changes over time (the “Request”).
The Request acknowledges the opportunities for AI,
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 potential “benefits, risks to health, and risk mitigations” for such devices, “including premarket evidence and
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 flows among patients, providers, payers, and technology platforms. The new initiative does not contemplate any
As the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced its own intentions to aggressively scale the use of AI in regulatory review and launched
On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) announced a request for information seeking stakeholder input on the market of digital health products for Medicare beneficiaries,
FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.” Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a panel discussion around guiding principles
In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS
On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle. The paper, entitled “Artificial Intelligence & Medical Products:
On September 27, 2023, Governor Newsom signed AB 254 and AB 352, which both amend the California Confidentiality of Medical Information Act (“CMIA”). Specifically, AB 254 expands the scope of the CMIA to expressly cover reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from