Digital Health’s Future Calls for New Regulatory Vision

May 12, 2012
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Washington, DC, is an impressive city. But too many times, one leaves our nation’s capital scratching one’s head. Understanding how large, complex agencies deal with equally large, complex issues is puzzling enough, but issues that change on an almost-daily basis—such as optimizing the potential of advances in digital health—call for much faster solutions than our bureaucratic system is designed to address.

Washington, DC, is an impressive city. But too many times, one leaves our nation’s capital scratching one’s head. Understanding how large, complex agencies deal with equally large, complex issues is puzzling enough, but issues that change on an almost-daily basis—such as optimizing the potential of advances in digital health—call for much faster solutions than our bureaucratic system is designed to address.

To discuss ways to resolve the puzzles inherent in regulating digital health opportunities, Paul Sonnier and I met with Keith Studdard, the Legislative Director to U.S. Representative Marsha Blackburn (R-Tenn), who has been advocating a clearer, more streamlined regulatory approach to new developments in digital health.  What was our reaction coming home? Instead of scratching our heads, we were pleasantly surprised by the level of engagement and dedication we found.

Our meeting included an acknowledgement that the Republicans in the U.S. House needed to address digital health regulations in a way that involved Democrats. Despite persistent accusations of partisan gridlock in Congress, I came away sensing a high degree of sincerity, at least judging from the candid remarks coming from Blackburn’s office. One of the biggest problems to legislators and regulators in digital health is uncertainty within the industry, a point Studdard reinforced by citing the old maxim that, while “no” is often an answer that people don’t want to hear, “maybe” is worse, particularly in terms of its impact on business planning. And at the moment, digital health’s regulatory future is replete with “maybes.”

Blackburn has been involved in regulating digital health for at least two years, when a Memorandum of Understanding (MOU) was signed between the Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) to help eliminate the “maybes” and coordinate regulations of mobile health apps, devices and other innovations in digital health. The FDA and FCC agreed that wireless and digital health is a brave new world and admitted they were not equipped to deal with this fast-moving area. The agencies admitted that no policies that existed in 2010 could be written in such a way that comprehends what the mobile health space would mean for consumers or patients. The MOU promised to focus on this.

Blackburn was one of six members of Congress who recently crafted a letter asking for a progress report from the FDA and FCC on this MOU. What should be regulated? How should they determine what gets regulated? What regulations would apply? What’s happened since the signing of the MOU in 2010?

Certainly, patient safety, medical record security, and consumer protection are very important areas to consider from a regulatory perspective. But how much regulation is necessary? And how can these regulations provide safeguards without slowing innovation? What types of regulations do you think are necessary in this area? And how would they keep up with the ever-changing digital health world? Let us know, and we commit to continue engaging with those – like Mr. Studdard – who can help make a difference!