FDA Will Regulate Some Health Apps

WASHINGTON (September 23, 2013)—The U.S. Food and Drug Administration will begin regulating a new wave of applications and gadgets that work with smartphones to help users monitor their health, agency officials say.

With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy.

Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to high-tech heart monitors.

The FDA said Monday that the vast majority of the health care apps don't pose much of a risk to consumers and will not be federally regulated.

Instead, the agency will focus on a handful of apps that turn smartphones into devices, such as heart monitors, or medical attachments that plug into smartphones, such as arm cuffs that measure blood pressure.


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