The Food and Drug Administration ruled on Friday that it will be taking a hands-off approach when it comes to the regulation of health apps and software.
VentureBeat reports apps that simply convey and track data will be left alone and won’t need specific approval by the FDA like apps that provide specific medical advice. This is big news for the Apple Watch when it ships in April.
“This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices,” the FDA statement reads. “We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”
The Wall Street Journal reports that following the regulation, medical-device maker DexCom is designing an app that will display readings on the Apple Watch from its diabetes glucose monitor that is widely used on the market. Its app, currently still in development, converts data into a simple graph that is just a glance at the wrist away.
The convenience of having easy-to-read data on a user’s wrist will likely be the big selling point for these types of medical apps. Presumably, an app like a glucose tracker could alert a user if their glucose levels were getting to low.
Apple hasn’t begun accepting apps for the Apple Watch ahead of its launch in April, however it has provided tools for developers to get started.
Good on the FDA for taking a hands-off approach. But will it stay that way?
The FDA statement continues: “It’s exciting, because it means that innovation in this space can truly flourish. This is a very natural extension from the recent FDA guidance on accessories where FDA acknowledges that the risk associated with an accessory is not necessarily the same as the risk of the parent medical device.”