Lessons Learned from FDA Cleared Mobile Health Devices

Like so many other things the government may start making life more difficult for mHealth companies in the future through regulations.  It really does not surprise me as they like to stick their nose in everything, but there are a few different perspectives at this point.  There is a great article by Brian Dolan at mobihealthnews.com about FDA Cleared Mobile Health Devices.  I have included a few interesting parts of the article below.  It is clear that the FDA will change their involvement the question is now what impact they will have.

“We need to balance our desire for safety with rational risk tolerance and transparency,” the West Wireless Health Institute’s Chief Medical Officer Dr. Joseph Smith said during his presentation at the Institute’s Health Care Innovation day in Washington, DC last week. “And I think — I’ve not shared this with them — but I think we need to get the FDA out of the business of assuring absolute safety and into one of absolutely assuring transparency around risks and making sure decisions are well-informed as opposed to trying to protect all of us from the rare circumstances of failed technology.”At the event FDA officials confirmed that a draft guidance document focused on how the agency might regulate health apps would likely publish in the coming months. Officials acknowledged that apps included just a small sliver of the activity going on in mobile health, but it is a start. The FDA will seek commentary on the draft document from the industry during a 60 or 90 day period, officials said.

“Our intent was to support both patients and healthcare providers in the management of chronic disease,” Sysko said. “As we looked at the regulations as early as 2005 of the software that the FDA had published, it was really clear to us that we were an accessory to a medical device — an accessory to a blood glucose meter… We thought that there were sufficient guidelines from a software perspective to go ahead. Little did we know that it would be a long journey and there were many bumps along the way — many self-inflicted — but we felt that it was absolutely something we would have to do to bring our product to market.”