FDA lays Out Rules for Some Smartphone Health Apps 9/23/13
WASHINGTON - Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to help users monitor their health.
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 these 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, like a heart monitor, or medical attachments that plug into smartphones, like arm cuffs that measure blood pressure.