FDA to regulate mobile health apps

July 27, 2011

The Food and Drug Administration (FDA) has proposed its first regulations for health-related smartphone and wireless tablet applications, or apps, The Washington Post reports.

Washington - The Food and Drug Administration (FDA) has proposed its first regulations for health-related smartphone and wireless tablet applications, or apps, The Washington Post reports.

According to the proposed guidelines, three types of applications would require FDA approval: those that act as an accessory to a regulated medical device, those that turn a mobile gadget into such a device, and those that make suggestions regarding a patient’s diagnosis or treatment.

For example, an application that allows radiologists to view X-rays on an iPad or that turns an Android phone into a heart monitor would be regulated. No regulations would be required for apps that, for example, store medical records or provide training videos to physicians.

Some industry groups have pressed the agency to outline its intentions in hopes of eliminating regulatory uncertainty that make investors and companies reluctant to back or develop such products.

The guidelines won’t be enforced until the FDA collects feedback from manufacturers and providers over a 90-day period.