FDA Launches Inquiry of Unapproved Medical Diagnosis Smartphone App

There may be an app for that, but the U.S. Food and Drug Administration wants to make sure some are safe enough for smartphone users before they hit “install.”

In a first-of-its-kind letter to India-based Biosense Technologies Private Ltd., the FDA said the company needs regulatory approval for uChek, an app that allows users to check levels of blood, protein and other substances in their urine. To do so, uChek users need only dip an FDA-approved test strip, manufactured and widely retailed in the U.S. by Siemens AG and Bayer AG, in urine and use their iPhone camera to allow the app to process and generate the test results.  

The issue, according to the FDA, is the test strips required by uChek, available on all Apple devices, have only been approved for visual reading and need separate approval for automated analysis via photograph.

“We intend to work very closely with the U.S. FDA over the coming months,” said Biosense co-founder Abhishek Sen in an emailed media statement, “to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world.”

With thousands of health entrepreneurs packing both the iPhone and Android markets with apps claiming to aid with everything from weight loss to fetal development, this may be the first instance of the FDA flexing its regulatory muscle in the interest of the smartphone-addicted public’s safety.  

While Washington has had its eye on the health IT sector for some time, many developers, who currently operate under looser guidelines passed down in 2011, are waiting for some resolution on how the FDA plans to police mobile medical apps going forward. Though entrepreneurs and investors worry how an FDA health app ruling might affect their bottom line, other parties fear an “overarching software policy” could be a step in the wrong direction for both users and the progress made by mobile medical device community.

“These laws were created before this new medical technology was imaginable and before it was understood, and this may hamper innovation,” Lauren Fifield, a health policy adviser at San Francisco-based startup Practice Fusion, told VentureBeat.com’s tech reporters. “The gap between D.C. and Silicon Valley is 3,000 miles, but it feels like 20 years in terms of understanding.”

While Congress keeps health app entrepreneurs waiting, some experts are worried about a small portion of the mobile medical device arena used in clinical settings that may get past the FDA’s watchful eyes. Even more troublesome, according to others, are medical apps that fall into an ever-expanding “grey area.”

“Would a device marketed to diabetic patients that connects a smartphone to a glucose meter need to be regulated?” asked Ben Chodor, CEO of health app store Happtique, in an emailed statement to VentureBeat.  “To put it bluntly, that is the area that no one gets.” 

What all mobile medical app makers can agree on, however, is that it’s time for the FDA to make a decision.

“In short,” said Chodor, “the FDA needs to come up with their guidelines already—sooner rather than later.”