FDASIA

By Jonah Comstock April 4, 2014
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the...
By MHN Staff March 3, 2014
By Bradley Merrill Thompson This seems like an appropriate time to talk about what can be done to improve FDA regulation so that mobile app development can flourish. First I’ll tackle current events that make this a good time to have this discussion, and then I’ll get into the recommendations that the so-called “FDASIA working group” made with regard to how to improve FDA regulation. Current...
By Brian Dolan November 26, 2013
There are now more than 100 mobile medical apps registered with or cleared by the FDA as medical devices, according to MobiHealthNews' just-updated report, aptly named: The 103 FDA Regulated Mobile Medical Apps. When we first published our extensive round-up of FDA regulated mobile medical apps in December 2012, we found 75 apps in FDA's databases. This time around we added those that received...
By Brian Dolan November 21, 2013
Rep. Joseph Pitts (R-PA) This week the US House of Representatives' Energy and Commerce Committee's subcommittee on Health held a hearing to discuss the "Federal Regulation of Mobile Medical Apps and Other Health Software", which ended up being a partial re-run of the committee's FDA-apps hearings back in March. This time around, however, the committee stacked the witness table with supporters...
By MHN Staff 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 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By Dan Haley, VP of Government Affairs, athenahealth In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”).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 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...
By Jonah Comstock April 19, 2013
The Department of Health and Human Services has formed a new workgroup, charged with "identifying key considerations to improve patient safety and promote innovation in health information technology (Health IT), including mobile medical applications." The group has been selected by HHS and the FCC and will report to the Health IT Policy Committee which advises the ONC. This is the same workgroup...