FDA Faces Daunting Task as Health Apps Multiply
By Jenny Gold
July 4, 2012 7:36AM
Health apps are hot, but until now the field has been unregulated. It is hard to know which apps actually live up to their claims or provide accurate information. Now, the FDA is laying down the law, releasing a first draft of guidelines that require developers making medical claims to apply for FDA approval. But app developers are bristling.
Want to monitor your blood pressure and sugar level? Eat healthier meals? Screen yourself for depression? Now you can do it all with apps on your smartphone.
There are 40,000 medical applications available for smartphones and tablets, and the market is in its infancy. But that growth is in the crosshairs of new regulatory efforts by the Food and Drug Administration.
Medical apps offer the opportunity to monitor health and encourage patient wellness moment to moment, instead of only during visits to the doctor’s office. Some even replace devices used in hospitals and doctor’s offices, such as glucometers and the high-quality microscopes used by dermatologists to examine skin irregularities.
Health Apps Are Hot
“There’s a lot of enthusiasm now for the ability to use design and consumer technology to help improve people’s health at the ground level,” says Andrew Rosenthal of Massive Health, a mobile health app company in San Francisco.
But so far the field has been unregulated. It is hard to know which apps actually live up to their claims or provide accurate information.
Last year, the FDA began to lay down the law. The agency released a first draft of guidelines that require developers making medical claims to apply for FDA approval, the same way new medical devices must be proven safe and effective before they can be sold. But that can be time-consuming and expensive.
Some app developers are bristling at the thought of a rigid regulatory structure, which they fear will stifle innovation in an industry known for rapid growth and flexibility.
“The FDA’s current regulatory process was created when the floppy disk was around,” ages ago in the tech world, says Joel White, executive director of the Health IT Now Coalition, which includes chip maker Intel, pharmacy benefits manager Medco, Verizon, Aetna and the U.S. Chamber of Commerce.
The Government Accountability Office says the FDA takes six months to approve a device similar to an existing product, 20 months for a new one. That’s too slow, White says. Mobile apps are “updated and created on a daily basis. The life cycle is dramatically different.”
And expensive: The cost of FDA approval for a standard medical device is $24 million to $75 million, says a Stanford University report. The health app market is worth about $718 million, expected to double by year end, says Research2Guidance, a mobile research group.
Alain Labrique, who directs a global initiative on mobile health technology at Johns Hopkins University, says that while FDA guidelines could delay some development, they are an important consumer safeguard.
Many apps are “a lot of hype and very little evidence,” he says. Though apps are an exciting new health area, “we also want to protect the public and be sure that medical claims are supported by data assessment and some comparison to a gold standard.”
In particular, he warns that commerce and “the tendency to capitalize on the next big things” may lead app developers to overstate what products can accomplish: “Making sure the public’s best interests are met is not always the most expedient process.”
The FDA expects to release final guidelines this year, but many companies have started the formal application process, and the FDA already has approved a handful of apps.
Regulations Must Fit the Industry
White says many developers are not opposed to regulation, but they believe the FDA process doesn’t fit the industry. He suggests the government set up a new regulatory framework for mobile health, something like the National Transportation Safety Board, to accommodate the speed, flexibility and innovation necessary to the new field.
Orrin Franko, 29, is part of a new breed of doctor-innovators. He’s an orthopedic surgery resident at the University of California-San Diego and runs TopOrthoApps.com, where he reviews orthopedic apps. He also is developing several. They’ll need FDA approval, and he says he plans to apply, but with so many coming, “there’s no way the FDA is going to keep up.”
He predicts developers with apps that are not strictly medical may avoid making claims to skip the FDA process.
He has helped launch the Journal of Mobile Technology in Medicine to help doctors make sense of what’s out there.
“These apps already exist, and people are using them in hospitals to make medical decisions. But no one knows if they’re actually doing what they claim to be doing.”
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