FDA Sets Rules for Smartphone Medical Apps

The U.S. Food and Drug Administration on Monday drew a line between which smartphone medical apps it will regulate and which ones it will not, saying it will focus only on those that turn the phone into an actual diagnostic tool.

"Today, mobile apps are fast becoming a staple of everyday life," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said during a news conference. "Although many mobile apps pertain to health, we are only continuing our oversight for a very small subset of those mobile apps."

In essence, those applications include software that enables the phone to read a patient's heart rhythm, take a blood pressure reading or measure a person's health in some other way.

For example, an ECG machine that diagnoses heart rhythms is "still an ECG machine whether it is the size of a breadbox or the size of a smartphone," Shuren said. "It's not about the platform, it's about the functionality. An ECG is an ECG.

"If the mobile app specifically transforms a mobile platform into a medical device, like an ECG machine, or it is an accessory to a medical device, like an app that acts as a remote control for a CT scanner and is a functionality we already regulate, we would continue to regulate that kind of technology," he added.

Those apps will be reviewed by the agency and must meet the same standards as other medical devices, the agency said.

According to one industry source, some 500 million smartphone users worldwide will be using some kind of health care app by 2015, Shuren noted.

Medical apps already on the market can not only diagnose abnormal heart rhythms, but can also transform smartphones into an ultrasound device, or help people with insulin-dependent diabetes monitor their blood sugar levels.

The FDA will not regulate apps that help keep track of medications, health records, doctor correspondences, or dieting and exercise efforts, Shuren said.

The use of mobile apps is revolutionizing health care, potentially letting doctors diagnose patients outside of traditional health-care settings, he said, and some apps can also help consumers manage their own health and access medical information.

To date, the agency has cleared about 100 mobile medical applications over the past decade, with about 40 of those cleared in the past two years.

More information

For more information on mobile medical apps, visit the U.S. Food and Drug Administration.