By Rob McCray, on the road in D.C.:
I attended day one (March 19, 2013) of the House Energy & Commerce Committee hearing on wireless health. Multiple topics were addressed but the primary focus was on inter-related issues: is the FDA doing a good job in regulating mobile health; and, will FDA regulation or the medical device tax stifle innovation? The testimony was nuanced and non-controversial, the congressional comments were mostly directed at their peers, and the real issues were not discussed.
The witnesses (three of the six are WLSA members, including Robert Jarrin of Qualcomm, Brad Thompson of Epstein Becker and the mHealth Regulatory Coalition, and Ben Chodor of Happtique) delivered thoughtful and well reasoned testimony. Generally speaking, there was good conversation about some important issues. I personally believe that the medical device tax should be modified to exempt early stage companies that are small and unprofitable. I also personally believe that we need to find a better approach to funding the extension of health care services to the poor.
The hearing did not address the root causes of the problems with which FDA and industry is grappling. It did not address how the line between acceptable and unacceptable risk should be established. It did not address how medical innovation and services are warped by a transactional system that rewards volume over outcome. It did not address the expectations of the public, that regardless of the presence or absence of regulation, all products are safe and reliable for their intended uses (and someone must be liable if this is wrong).
U.S. citizens and our institutions must change the dialogue about health care. I am dedicated to moving the public discussion to be focused on health. In this world view, health care takes its appropriate place as a service that helps people maintain and return to what they really want – good health.