The FDA Takes On Mobile Health Apps

Eliza Strickland | Spectrum | September 12, 2012

The mobile health industry has a problem: It has grown too quickly. Consumers can now download medical apps for at-home monitoring of just about any obscure ailment, and apps for general wellness, diet, and fitness are proliferating. According to one recent count, the iTunes app store now contains 13 000 health and wellness apps. 

But the public health agencies, big pharmaceutical companies, and start-ups that have pushed out apps in the past few years have outpaced U.S. government regulators. While it’s assumed that some medical apps are subject to regulations, the U.S. Food and Drug Administration (FDA) has not defined the scope of its oversight and has issued few enforcement actions. 

That’s about to change. The agency is expected to finalize guidelines within the next two months for medical apps, more than a year after releasing draft guidelines. For the industry, the expected rules bring both relief and trepidation: App makers are eager for clarity on how much red tape they’ll encounter in the future, but they’re also nervous that overly broad rules will stifle innovation.