If you have been following MobiHealthNews' series of contributed articles penned by Bradley Merrill Thompson, a strategic counsel at EBG Advisors, you know that the regulatory environment facing the mobile health industry is unfortunately about as murky as the Gulf Coast right now.
In order to at least draw a line for those companies that believe they do not fall into an FDA regulated device category, Thompson and Dane Stout, Executive Director of the Anson Group, have formed a "temporary" mHealth Regulatory Coalition that aims to work with the FDA to determine where that line should be drawn and to subsequently make that information readily available. (The group is open to all interested parties and is not an official committee within the FDA, view Thompson's invitation to join here.)
Thompson explained this very well in his most recent and final article in our series on mobile health regulation, here's the relevant passage:
"There are a number of technologies used in mHealth where balancing those factors would lead a reasonable person to conclude that regulation is unnecessary. Because of that, recently several of us got together and announced the formation of a coalition—the mHealth Regulatory Coalition or MRC– to develop a consensus among industry participants regarding the scope of what FDA should and should not regulate in the area of mHealth technologies, and propose that approach to FDA for adoption. Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health of FDA, as the recent annual meeting of FDLI invited industry to propose guidance documents on policy issues of importance to industry. FDA will take those documents, make any changes they feel are necessary, and then propose them for formal adoption. We think this topic is ideal for a proposed guidance.
"The MRC is very narrowly focused on the one task, and indeed is only temporary. It will only continue so long as it takes to complete that task, hopefully within months. We are inviting members of the mHealth industry to participate alongside existing trade groups to be inclusive. We plan to have our first meeting on July 8 in Washington, to get organized.
"Our concern is that there are a variety of companies and investors sitting on the sidelines out of fear they may be regulated. The uncertainty is helping no one. We plan to tackle the scope of FDA regulation head on by developing a proposed list of mHealth technologies and intended uses that FDA should regulate, and a list of those they should not. Our preference is to achieve as much specificity as possible, so we can move closer to the efficient frontier."
Read Thompson's full article on the dynamic future of mHealth regulation here