Thomas M. Maddox MD, SM, Professor of Medicine, Division of Cardiology at Washington University School of Medicine and head of the BJC/WUSM Healthcare Innovation Lab, has been appointed to the inaugural FDA Digital Health Advisory Committee.
The Digital Health Advisory Committee will advise the Commissioner of Food and Drugs on issues related to Digital Health Technologies (DHTs), and FDA policies and regulations about these technologies, providing relevant expertise and perspective to improve the FDA’s understanding of the benefits, risks, and clinical outcomes associated with use of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. This also may include advice on the use of DHTs in clinical trials or post-market studies subject to the FDA’s regulation.
“I’m thrilled to serve on this committee. Digital health is a critical and growing tool for effective patient care. It’s essential that the FDA and other regulators ensure its safe use without stifling innovation. I’m looking forward to working with my colleagues on the Digital Health Advisory Committee to achieve that goal.”
On November 20-21, 2024, the FDA plans to hold the inaugural Digital Health Advisory Committee to discuss how the use of Generative AI may impact safety and effectiveness of medical devices enabled with this technology.