FDA draft guidance

By MHN Staff 12:15 pm September 4, 2013
By Bradley Merrill Thompson In response to my prior post on this topic, athenahealth's VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions. As I said in my original...
By MHN Staff 11:59 am 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By Dan Haley, VP of Government Affairs, athenahealth In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”).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 04:30 am 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...