Healthcare Technology Featured Article

June 25, 2012

FDA Taking Long Look at Regulating mHealth Apps



For some time, we’ve been able to do a lot more than make telephone calls on our smartphones. Text, send photos, take glucose readings (if you’re diabetic), graph your progress if you’re a runner…even take your blood pressure.

GPs are even prescribing smartphones to their patients to help them manage their health. In fact, the market for these apps soared to $718 million last year (some say $1.3 billion by the end of this year) – more than seven times its growth in 2010.

There are 40,000 medical applications available for download on smartphones and tablets, according to a story by Jenny Gold. And the market is only just getting started.

Now the Food and Drug Administration (FDA) is thinking it might be time to stick its nose in to regulate it.

Mobile health (mHealth) apps are so popular because they nix the need to go sit in a doctor’s office for who knows how many hours, wait for a prescription, then take it to the drugstore to fill it. 

Instead, mHealth apps allow individuals to diagnose themselves over the phone, with or without a doctor’s consultation, and have a prescription routed to your pharmacist. (Too bad the medical robots out there today aren’t delivering medicine, yet. Wait, they are! But only in the hospital.)

"There's a lot of enthusiasm now for the ability to use design and to use consumer technology to help improve people's health at the ground level," Andrew Rosenthal of Massive Health, a mobile health app company in San Francisco, told Gold.

But so far, anyone and everyone can put out an app on the market. The FDA is rightfully judging the quality of these apps, and how many might be dangerous and misleading.

Last year, the FDA released a first draft of guidelines that make mobile apps developers apply for FDA approval if they’re making medical claims, which no software writer wants to do, as the process can be both time-consuming and expensive.

And as Gold reports, some “fear will stifle innovation in an industry known for rapid growth and flexibility.”

Even the FCC is getting involved. In June, FCC Chair Julius Genachowski discussed the future of mobile health technology and wireless medical devices with private sector, academic and government leaders.

For now, it’s all in the planning stages. But mHealth developers can be sure their run of anything goes may just about be ending. 


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Edited by Braden Becker




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