FDA final guidance

By MHN Staff September 4, 2013
By Dan Haley, VP of Government Affairs, athenahealth In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile...
By MHN Staff August 27, 2013
By Bradley Merrill Thompson I feel like a dissident trying to convince the government to free a political prisoner. That’s a pretty apt description, considering that the FDA’s Mobile Medical App (MMA) guidance document is being held hostage purely on political grounds. Earlier this year, a DC advocacy group decided they wanted Congress to adopt an entirely different approach to health IT. The...
By Brian Dolan May 30, 2013
Following MobiHealthNews' coverage of the rare action that FDA took last week by sending a medical app developer an "It has come to our attention" letter that instructs it to seek 510(k) clearance for its urine analysis app, two readers wrote in to point out that Biosense Technologies, the maker of the app, had indeed already registered it as a Class I medical device with the FDA. The company...
By MHN Staff May 25, 2013
By Bradley Merrill Thompson As MobiHealthNews reported earlier, this week FDA sent an enforcement letter to the developer of a urinalysis app. This might sound weird, but I believe that’s good news for the mobile health industry. Full disclosure, I may have played a part in FDA’s decision to send that letter. Over the last several months, I’ve had four occasions to talk about the app publicly,...
By Brian Dolan March 28, 2013
Coinciding with the second day of congressional hearings on FDA regulation of mobile medical apps last week, McKesson announced the launch of a new app, Medisoft Mobile, for doctors and their staff that aims to make it easier to manage their practice through iPhones or iPads. Between the Medisoft Mobile app and the newest version of Medisoft software, care providers can now use their mobile...
By MHN Staff March 26, 2013
By Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on mHealth, I feel the urge to plan for the regulatory world after FDA publishes its final guidance. FDA testified the...