CDS regulation

FDA reneged on its promise to take a risk-based approach to CDS software
By Bradley Merrill Thompson | 02:23 pm | April 11, 2018
About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.
Roundup: FDA digital health clearances and news in Q1 2018
By MobiHealthNews | 02:39 pm | April 06, 2018
In the last quarter the FDA gave the nod to 10 digital health devices.
The social cost of FDA’s bias against new technology
By MHN Staff | 11:09 am | October 08, 2015
By Bradley Merrill Thompson If I invented an unprecedented mobile technology for treating tennis elbow, the law would require me to do substantial and expensive clinical trials before bringing it to market.
FDA makes clear it won't regulate apps like Apple's HealthKit
By Brian Dolan | 10:49 am | June 16, 2014
As MobiHealthNews noted last week in the introduction to our In-Depth report on Apple's Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device.