First, Do No Digital Harm: Regulating Mobile Health Apps for the 21st Century

July 13, 2016

by John R. Graham

Introduction. Chairman Burgess, Ranking Member Schakowsky, thank you for the opportunity to submit this testimony on the impact of mobile health apps on American Health Care. On a bipartisan basis, the Energy and Commerce Committee has taken the lead in ensuring the United States can take full advantage of innovation in mobile apps to improve cost, quality, and convenience in American health care. The 21st Century Cures Act, passed by the House in 2015 with overwhelming bipartisan support, is forward thinking. If passed into law, the policies it would implement would lead to a responsible and responsive regulatory environment for mobile health apps.

However, misguided policies could also derail the benefits of apps and other digital health technologies. Policies on payment and regulation, well intentioned proposals to move things along quicker, could have the unintended consequence of allowing these digital technologies to be swallowed by an unreformed health system that remains expensive, sluggish, and of uneven quality. The risk of Congress doing too much is at least as great as the risk of doing too little. The principal guiding Congress should be: First, do no digital harm. There are three areas in which Congressional action could have such unintended consequences: State licensing of physicians, interoperability of health data, and Medicare payment for telehealth.

State Licensing of Physicians. Historically, the practice of medicine has been regulated by the states. As telehealth has emerged, this has led some interested parties to conclude state licensing is (to some degree) obsolete. If technology permits a radiologist in Texas to read an image of a patient taken in any state, should that radiologist have to be licensed in every state? A short cut to solve this problem would appear to be to legislate a federal “safe harbor” for Medicare patients. This would comprise federal overreach that would be constitutionally suspect and unnecessary, because states are already solving this problem.

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