If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn’t possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try.
Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.
“It’s just not possible,” Patel said at a panel discussion of medical device security hosted by that National Institute of Standards and Technology’s (NIST’s) Information Security and Privacy Advisory Board (ISPAB) in June. (podcast available here: http://blog.secure-medicine.or...)
Estimates put the number of new, mobile health applications created each month at 500. But the FDA has reviewed no more than 80 so far – a small (and shrinking) fraction of the population.
In September, 2013, the FDA issued guidance to mobile application publishers about what kinds of mobile applications would qualify as medical devices. (https://securityledger.com/2013/09/fda-says-some-medical-apps-a-kind-of-medical-device/) The FDA said it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed “using the same regulatory standards and risk-based approach that the agency applies to other medical devices.”
Speaking on the NIST panel in June, Patel reiterated that guidance. Most mobile medical applications were really “health and wellness” tools that couldn’t adversely affect patient health. But he said the agency would treat applications that are mobile companions to regulated medical devices – like insulin pumps – differently. And he said that was a fine place to draw the line: most mobile health applications have short lifespans on the Appstore or Google Play. Diverting FDA resources to vetting them would be a waste of time.
“The whole mobile application world has its own ecosystem. Mobile apps live and die and its all user or consumer driven," he said. "The end-of-life cycle is so short compared to any other products we see. We need to focus on oversight of what is sustained and maintained.”