Liveblog Day 2: Congressional hearing on FDA regulating apps

By Brian Dolan
Share

10:52AM: Pitts asks Bialick for examples of patients whose lives were changed thanks to this kind of technology. Bialick says these technologies enable the new house call.

MITUS2

1051AM: Pitts asks if FDA is the right agency does it have the right experience. Smith says in short no. Bialick says it does have the right experience to regulate apps that are actually medical devices. Mitus says FDA should regulate medical devices but health IT requires a different process. Classen says, citing IOM, if FDA got further involved in HIT beyond medical devices then a new framework should be created.

10:49AM: Bialick says the definition of an app is changing thanks to widespread adoption of cloud computing. Definition of an app has changed since the draft guidance was written he argued.

PITTS

10:48AM: Rep. Pitts asks if data should be classified as a medical device. Everyone says no but Bechtel. Bialick asked if apps should be regulated as medical devices and he says as the draft guidance is written he says they should not.

10:48AM: Classen now explaining that health IT doesn't necessarily work the way it is intended to right "out of the box."