FDA Steps Back From App Regulation, Good News For Apple Watch

The buzz around Apple Inc.’s AAPL smart-watch debut has been on the rise in past weeks as developers scramble to create apps that will be compatible with the device’s operating system. Biometric apps are expected to be in high demand upon the device’s release, as consumers look to the watch to bridge the gap between technology and healthcare. 

FDA Loosens Regulation

Last week, the Food and Drug Administration announced that it would allow medical device data systems to innovate and change without much regulatory interference, something that will allow developers more space to create. Biometric measurement apps promise to make health tracking easier and more streamlined, but strict rules governing how those apps work has made innovation in that space difficult.

Innovation In Data Recording

The new policy allows apps to be developed without FDA regulation if their failure to perform wouldn’t create a serious health risk to the user.  In that way, software that diagnoses or treats a disease will still face scrutiny from the FDA, but those that simply record, store and display data will be free expand and change as developers see fit.

Making Data Easy To Understand

The decision’s most notable impact is giving developers of FDA regulated devices the ability to make that information more accessible without being burdened by regulatory compliance. DexCom Inc. DXCM, the medical device maker responsible for a comprehensive diabetes glucose monitor, is using the ruling to create a watch-compatable app that monitors a diabetes’ patient’s glucose level and makes it available to the user at a moment’s notice. The app, said to become available on Apple’s smart-watch, receives data from the company’s FDA approved device and converts it into an easy to understand graphs.