FDA outlines rules for medical apps on phones, tablets

The Food and Drug Administration (FDA) is taking a look at smartphone and tablet applications that help patients monitor their health and connect with doctors remotely.

The FDA released formal guidance for creators of medical apps, laying out which programs it thinks need to be regulated to protect patient safety. The apps allow doctors to check an X-ray, perform an ultrasound or help someone with diabetes easily monitor their blood sugar from a distance. But if they malfunction, those apps could recommend an unnecessary medical treatment or unsafe prescription dosage, potentially posing a threat to patients. Those devices can pose a threat if they don’t work as intended, the FDA said. To make sure the tools are up to snuff, the FDA will treat those apps like any other medical device.