Developments and Trends in Digital Health, eHealth and Health IT
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…
Continue Reading FDA Requests Public Comment on Real-World Evaluation of AI-Enabled Medical DevicesThe 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…
Continue Reading FDA to Convene Advisory Committee Meeting on GenAI Mental Health DevicesAs 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…
Continue Reading Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards. …
Continue Reading FDA Requests Comments on Substantial Proposed Changes to Data Standards
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 “…
Continue Reading FDA Medical Product Centers Continue Focus on AIOn March 15, 2023, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance). The 2023 Draft Guidance revises the draft guidance for industry the Agency issued in June…
Continue Reading FDA Releases Draft Guidance on Electronic Systems, Records, and Signatures in Clinical Investigations