digital health regulation

Proposed framework lessens FDA's regulatory requirements for prescription drug companion apps
By Dave Muoio | 12:19 pm | November 19, 2018
The agency's proposal would classify the majority of software released by pharmas as "promotional labeling" that would not require premarket review.  
Poll results: Readers support FDA Pre-Cert
By Jonah Comstock | 11:32 am | September 17, 2018
The results to our poll about the FDA program prompt questions about the program's fairness to companies big and small.
Poll: FDA’s Pre-Cert program, is it good for the industry?
By MobiHealthNews | 03:45 pm | September 11, 2018
The agency has reinvented the process for clearing digital health products but reviews are mixed.
FTC increasingly active in OCR, FDA's traditional purviews
By Jonah Comstock | 01:44 pm | April 13, 2015
FDA medical app regulation and the art of intended use
By MHN Staff | 08:03 am | April 13, 2015
FDA finalizes plans to deregulate MDDS health software
By Brian Dolan | 07:03 am | February 09, 2015
FDA wellness clarifications helpful, accessory proposal is just a start
By Brian Dolan | 08:23 am | January 20, 2015
The rise of the seemingly serious but "just for entertainment purposes" medical app
By Brian Dolan | 11:32 am | August 07, 2014
FDA's Apple memo points to company's aim to stay unregulated by the agency
By Brian Dolan | 12:41 pm | June 10, 2014
European Commission asks for help from industry to regulate, encourage mobile health
By Brian Dolan | 09:05 am | April 10, 2014