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Unpublished Paper
The mHealth Conundrum: Smartphones & Mobile Medical Apps – How Much FDA Medical Device Regulation is Required?
ExpressO (2013)
  • Vincent J Roth, Esq
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”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further guidance anticipated as a result of the Food and Drug Administration Safety and Innovation Act of 2012 (“FDASIA”). 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. There is clearly a need for regulation that balances the interests in safety and oversight with invention and advancement. This discussion provides recommendations on how to improve the FDA regulatory environment. This includes proposals to streamline the regulatory requirements such as defining the regulation better and implementing preliminary review assessment and accelerated approval processes. It also covers the concepts to target so that regulatory efforts can acknowledge and address marketplace interposition. 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.
  • mhealth,
  • fda regulation,
  • medical device,
  • smartphone,
  • mobile medical application
Publication Date
August 10, 2013
Citation Information
Vincent J Roth. "The mHealth Conundrum: Smartphones & Mobile Medical Apps – How Much FDA Medical Device Regulation is Required?" ExpressO (2013)
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