Wanted: a watchdog for the mobile medical app explosion

Coverage Type: 

A smartphone app that rids you of acne. Another that monitors your heart rate 24-7. One that detects skin cancer by looking at your birthmarks. If they sound too good to be true, they may be. Patients today use a number of apps that purport to track and treat a panoply of ailments, a headache for regulators and patient safety advocates.

Now, the advent of wearable devices bristling with sophisticated biotracking sensors is stirring concern in the medical community about misdiagnoses that could have serious consequences for consumers.

Some are asking whether Apple and Google should do more to police their fast-growing app marketplaces.

"Most of the health apps out there are built by people with zero medical experience," said Paris Wallace, chief executive officer of Ovuline, a popular fertility app. Worse, many developers don't have the resources for legal counsel, Wallace said, and are more likely to make false claims to patients without seeking FDA clearance.

The Food and Drug Administration in 2013 published guidelines on the kinds of mobile apps it will supervise. But industry insiders fear the agency may get overwhelmed as apps mushroom.

"The FDA wasn't designed for post-market surveillance," said Jason Brooke, chief executive officer and general counsel at Vasoptic Medical, maker of a mobile diagnostic that competes with a number of unregulated apps. The FDA needs to act soon to ensure that developers will "comply on their own."

Wanted: a watchdog for the mobile medical app explosion