Dunne, Williams and Knapp Dorell Address Mobile Medical Apps in FDLI's Update

Shook, Hardy & Bacon Pharmaceutical & Medical Device attorneys Debra Dunne, Wendy Williams and Virginia Knapp Dorell have co-authored an article, “Analyzing Risk in Mobile Medical Apps,” appearing in the November/December 2014 Food & Drug Law Institute (FDLI) Update magazine.

They describe the “complicated regulatory landscape with overlapping agencies eyeing the risks that these new devices could pose to users.” And they outline how agencies, such as the Food and Drug Administration, Federal Trade Commission, Office of the National Coordinator for Health Information Technology, and Federal Communications Commission, are approaching app safety, consumer privacy and truth-in-marketing issues. Concluding that “[m]obile medical applications are a new frontier that government agencies are only just beginning to address,” they caution developers to gain “a clear understanding” of applicable regulations and agency expectations to successfully navigate any potential risks in bringing these products to market.