Smartphones & Mobile Medical Apps—How Much FDA Medical Device Regulation is Required?

March 31, 2014

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries, including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) for mobile medical applications. Commentators have remarked that the FDA’s guidance is complex and unclear. Smartphone applications are so much more readily available than traditional medical devices that a new and unaddressed issue of consumer access to medical tools has emerged. This has put the power of self-treatment back in the hands of citizens through a phenomena referred to here as “marketplace interposition,” which creates new safety implications. This Article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth,” and provides recommendations on how to improve the FDA regulatory environment. While regulation of medical devices is necessary to ensure safety, the inevitable increase in mHealth and consumer access requires a more defined, targeted, and streamlined regulatory scheme for mobile devices in order to keep pace with this quickly evolving technology.
Full title- The mHealth Conundrum: Smartphones & Mobile Medical Apps—How Much FDA Medical Device Regulation is Required?