FDA Lays Out Rules For Some Smartphone Health Apps

Staff Writer | USA Today | September 24, 2013

Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and 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 if they malfunction, 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.