medical device regulations

By Brian Dolan 08:09 am September 23, 2013
PillPhone: One of the first patient-facing mobile apps to get FDA clearance. Last week when departing ONC chief Dr. Farzad Mostashari told MobiHealthNews that he thought the FDA should release its final guidance document for mobile medical apps without delay, he might have known something we didn't. After more than two years since the FDA first published its draft guidance on how it regulates...
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By Dan Haley, VP of Government Affairs, athenahealth In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”).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...