FDA regulated apps

By MHN Staff October 15, 2015
By the MobiHealthNews team This morning a number of big name medical institutions launched new studies using Apple's ResearchKit, iPhones and, in at least one case, the Apple Watch. As more ResearchKit study apps become available on Apple's app store, it appears that many of them are laying the groundwork for future FDA-cleared medical apps. It not only seems to be the case, the medical...
By Brian Dolan January 16, 2015
As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days. "A general...
By Brian Dolan June 10, 2014
When we first learned that a small team of Apple executives met with FDA officials last December to discuss mobile medical applications, it seemed likely that the discussion was intended to help Apple better avoid FDA regulation for its rumored health products. Thanks to a successful Freedom of Information Act request from the Apple-focused resources site Apple Toolkit, the FDA has furnished a...
By Brian Dolan March 19, 2014
Six US senators sent the FDA a letter this week to check in on the agency's interactions with mobile health app developers since it published its final guidelines for mobile medical app regulation last year. The senators who signed the letter -- Michael Bennet, Orrin Hatch, Tom Harkin, Lamar Alexander, Mark Warner, and Richard Burr -- stated that they wanted to ensure the agency's oversight over...
By MHN Staff September 30, 2013
by Bradley Merrill Thompson As just about everyone knows, last week the FDA published its final guidance on mobile medical apps. That guidance explains in plain English the types of mHealth apps the agency regulates. Over the coming weeks, many of us will be dissecting that guidance to assess what it really means and how the guidance affects the numerous apps already released, as well as those on...
By Brian Dolan April 1, 2013
The March edition of The MobiHealthNews Podcast went live over the weekend. If you missed the congressional hearings on FDA regulation of mobile medical apps, this 30 minute podcast can bring you up to speed. We condensed the hours and hours of testimony and grandstanding into a digestible series of the most important and representative quotes with a little context from MobiHealthNews. (OK, we...
By Brian Dolan March 19, 2013
We are live blogging old school today: Hit the refresh button every few minutes for updates! (Live blog is now concluded.) 12:24PM: Rep. Ellmers very quickly concludes the hearing. That's a wrap! Next hearing is slated for tomorrow at 10AM ET. 12:22PM: Rep. Ellmers asks if medical device tax will hamper innovation. Thompson, Dagi, and Ford all said yes. Others said unclear. Rep. Ellmers says she...
By Brian Dolan October 2, 2012
In an editorial published in The Wall Street Journal last week, former Senator Evan Bayh, a Democrat from Indiana, argued that at least one provision in the Affordable Care Act "threatens thousands of American jobs and our global competitiveness". Bayh was pointing to the 2.3 percent tax that the law requires medical device companies to tack on to each sale starting in January. For the first half...