HP&M’s Jeff Shapiro Addresses FDA’s Role in Digital Health Regulation: Unclear and Evolving

Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro participated in a panel discussion at a recent Food and Drug Law Institute conference that focused on the regulation of digital health software. Mr. Shapiro’s talk emphasized the limits of FDA’s expertise and the need for caution to prevent over regulation of digital health software from impeding innovation that can help improve healthcare. Mr. Shapiro’s talk, and follow-up correspondence on the topic, has garnered significant attention, and is discussed further in recent trade press articles (here and here) (Reproduced with permission from Medical Devices Law & Industry Report, 10 MELR 01 (Jan. 6, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033).)