Health Apps Bump Up Against FDA

Health Apps Bump Up Against FDA

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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. 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.

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