FDASIA workgroup

By MHN Staff April 8, 2014
By Bradley Merrill Thompson I don’t know about you, but when I read the FDASIA Health IT Report released by HHS on April 3, I found it to be largely quite predictable.  Indeed I’ve been scanning the media coverage of the report and I haven’t seen anyone so far express shock or surprise at what was in the report. How is it that we all pretty much knew what would be in there? Quite simply the three...
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 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 June 25, 2013
In the next few days -- after two years of waiting -- the FDA will publish its final guidelines for mobile medical apps. That was the plan, anyway. News of the imminent publication of the guidelines prompted the Bipartisan Policy Center to make moves to put pressure on HHS to stop it. Last week the group got 129 companies and associations to sign a letter that urges the administration to hold off...