2. A New, Temporary Coalition
Nick and I probably share quite a bit of common ground in that I suspect we both believe 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.
IV. Speculations
FDA obviously will regulate at least certain hardware and software used in mHealth, such as the blood glucose meters they already regulate. As to exactly where the line will be drawn around the scope of FDA regulation is yet to be determined, and I suspect will be very much risk-based, and determined by an evaluation of the evidence. FDA doesn’t have to actively regulate everything the statute says is a medical device, and the agency routinely draws lines short of everything it could theoretically regulate. Helping them figure out where to draw that line is industry’s job, subject to all of the other forces being exerted on the process.
The mHealth industry will thrive: it has to. We need it to. But along the way industry will adapt to whatever regulatory scheme ultimately emerges, and likely much of that adaptation will be accomplished through partnerships typical of a network technology industry. So, to ensure mHealth reaches its potential, we need to figure out creative and effective ways to work together. I’m confident we will succeed.
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