Could health apps save your life? That depends on the FDA

The next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels. The Food and Drug Administration’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.

FDA spokeswoman Jennifer Rodriguez wrote that her agency is mainly concerned with two types of app/device combinations:

• Apps that are used as an accessory to medical device already regulated by the FDA
• Apps that turn a regular smartphone or tablet into a medical device by using the device’s sensors, software or accessories for some diagnostic purpose