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Waiting for the app-ocalypse: Will toughening FDA regulations disconnect the medical smartphone app industry?

by Brendon Nafziger, DOTmed News Associate Editor | July 22, 2010
Calgary Scientific ResolutionMD Mobile
This report originally ran in the June 2010 edition of DOTmed Business News.

About a year and a half ago, the U.S. Food and Drug Administration made a decision that many in the booming smartphone medical app industry regard as menacing.

Shortly after the Apple Store launched, the agency told Apple to remove an image viewer produced by the Cleveland-based MIMVista from its virtual shelves. The viewer, Mobile MIM, earned the dubious distinction of being among the first radiology iPhone apps ever taken out of circulation by the agency.

In January, the FDA did something to disturb industry-watchers even more: it rejected the second of MIMVista's so-called fast-track, or 510 (k), applications, requiring the company to go through the lengthy, and expensive, premarket approval before the product could ever be sold by the Apple Store.

Of course, this was an isolated case. Mostly, smartphone users with a medical bent have been in clover. According to a recent MobiHealthNews industry survey, there are around 5,820 medical, health or fitness-themed apps for devices such as the iPhone, iPod Touch and the various Google-run Android platforms. These apps range from iTriage, which lets users check wait times at nearby hospital emergency rooms, to Epocrates, an incredibly popular guide for drug interactions for doctors, and the sundry "wellness" apps that help people schedule workouts and plan their diets. Surveys have shown between two-thirds to three-quarters of doctors own and use some sort of smartphone and often carry the device on rounds.

Yet the news of Mobile MIM's plight coupled with signs of a tougher FDA regulatory attitude compels many to wonder whether they face a brewing storm: will the FDA soon clamp down on the thousands of health care smartphone apps? Will the agency focus mostly on radiology viewers - where there is clear potential for dangerous misreadings by rushed radiologists on tiny screens - or is just the fear of coming regulations going to, in the end, do the most harm?

Light touch
After the initial pulling of the Mobile MIM, few app companies announced being contacted by the FDA, according to most reports. In fact, regulations have actually been fairly light, observed Bradley Merrill Thompson, partner at Epstein Becker and Green, P.C. in Washington D.C. and counsel for EBG Advisors.

"I think the FDA, to their credit, has been holding back to study what's going on, to try to understand the hardware and software and decide what they want to do based on risk," Thompson said.