FDA Regulation of Mobile Health Technologies

Abstract

Mobile health (“mHealth”) technologies that employ portable devices such as smartphones and tablets for medical purposes are rapidly transforming the medical profession. Yet adapting existing regulatory processes to ensure the safety and efficacy of this new set of products has proved challenging for the U.S. Food and Drug Administration (FDA). In this Article, we highlight issues encountered by the agency in applying its authority and its established approval and monitoring processes to this new genre of medical devices. After reviewing legislative proposals and recommendations by the FDA as to the appropriate scope of agency oversight of mHealth products, we present policy recommendations for updating the FDA’s authority. We conclude that preserving the FDA’s premarket and postmarket authority and providing the agency with additional funding and expertise provide a more promising solution than strictly limiting FDA’s authority, which could impede the agency’s ability to adapt to future innovation by tying it to existing products.

Keywords: mobile health, FDA, liability, congress, premarket, postmarket