iPhone medical app regulation

By Jonah Comstock April 2, 2013
A British team at the University of Essex recently announced the launch of a free, open source app called BioAid to explore the project of turning the iPhone into a hearing aid. The core concept is very simple, and has, in fact, been thought of and implemented by various companies at least since 2009: Smartphones have built in microphones and they can play audio through headphones. By creating an...
By Brian Dolan July 19, 2011
This morning the US Food and Drug Administration offered up a set of draft guidelines for how it might regulate certain mobile medical apps. While this set of guidelines was years in the making, it became clear a few months ago that the FDA would publish draft guidelines around this time. The FDA is seeking comments on these guidelines between now and October 19. This FDA guidance does not cover...