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FDA Mobile Medical Apps Regulation – What Does it Mean For You?
Executive Speaker Interview - Bradley Merrill Thompson, Counsel to the mHealth Regulatory Coalition and the Continua Health Alliance, and Member of the Firm in the Health Care and Life Sciences Practice and Strategic Counsel with EBG Advisors, Inc
For the folks in Europe what is your role in the Mhealth ecosystem, and the legacy of your work in mHealth?
I serve as counsel to the mHealth Regulatory Coalition and to the Continua Health Alliance. In both of those roles, I'm responsible for helping to develop an industry proposal for how FDA ought to regulate mHealth. More specifically, we are trying to help FDA decide what parts of the mHealth ecosystem to regulate, and to what level. MHealth covers a lot of ground, and much of it need not be subjected to FDA scrutiny. Unfortunately, the laws were written decades ago, and simply don't explain very clearly which mHealth software and hardware gets swept into FDA's jurisdiction.
In the US, the FDA recently released draft guidance on the regulation of ‘mobile medical apps’ – what do you make of this regulation? How will it affect/impact/enhance innovations in mobile healthcare?
Generally, we are glad that the proposal is out there. Now the discussion can become much more specific. Much of what FDA wrote is consistent with the industry proposals, but the agency's version leaves many questions unanswered. For example, we need to understand the difference between apps used to diagnose or treat disease, and those used to manage a person's overall health and wellness. These days we have a much better understanding of how ordinary decisions made throughout the day with regard to what we eat, how much exercise they get, how much sleep we get and how we manage our blood pressure all impact not just our general wellness but also our risk for certain specific diseases such as diabetes and heart disease. Ordinarily, marketers would explain both the general advantages of managing health, as well as advantages of reducing the risk of specific diseases, but those specific advantages might well trigger FDA jurisdiction. We need to know where that line is.
Is it likely that the EU will now release similar regulatory advice? Or will things be slower here?
Many of these discussions are just now getting started in the EU. We have less understanding of where the EU is heading. Our hope is to be involved in that evolution through organizations like Continua, which has many EU-based companies as well as global organizations among its membership.
What is the mHealth Regulatory Coalition (MRC) and how is it moving forward mHealth business?
The coalition is comprised of both for-profit companies and nonprofits. The companies, which pay dues, are from the full spectrum of mHealth related organizations including traditional medical device companies, manufacturers of communication technologies such as chips and handsets, telecommunications carriers, and a wide variety of software developers. The nonprofits tend to be associations themselves, which have as members many providers of healthcare services as well as technology developers.
The coalition has been working diligently over the last nine months to develop an approach to FDA regulation. The coalition plans to take its work product and submit it to the FDA in the form of a comment on the agency's proposal. In that comment, we will go through the areas of the proposal with which we agree, and we will point out where we differ, and where we want to see a more detailed approach.
What are the main issues around mobile healthcare which are slowing business? What solutions do you see happening to ensure mobile healthcare business can continue and grow?
The lack of clarity around the regulatory issues has been scaring away investors from the mHealth space. It is very important that we achieve a level of certainty that will allow investors to decide upon the needed investment to bring new products to market. Without that clarity, capital will continue to sit on the sidelines.
Beyond that, particularly in the states, we need a reimbursement model that will foster the utilization of mHealth technology. Right now, unfortunately, most of it must be paid out of the consumer's pocket. We need to move to a model where this technology is embraced by the healthcare reimbursement system.
Are you looking forward to taking part in the Mobile Healthcare Industry Summit 2011? Which people are you most looking forward to connecting with? What do you think will be the hot topics in the mature markets space for health innovation?
I am quite excited about participating in the summit because I think the issues that we've been confronting in the United States are ripe for consideration around the world, and particularly in the EU. We've been studying the EU, trying to understand exactly what the rules are presently, with an eye toward identifying issues that need to be addressed. Talking with EU-based companies as well as regulators represents a wonderful opportunity to advance the field.
