HHS workgroup could shape mHealth regulation

By: Jonah Comstock | Apr 19, 2013        

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hhs logoThe Department of Health and Human Services has formed a new workgroup, charged with “identifying key considerations to improve patient safety and promote innovation in health information technology (Health IT), including mobile medical applications.” The group has been selected by HHS and the FCC and will report to the Health IT Policy Committee which advises the ONC.

This is the same workgroup we reported about last June, when the FDA Safety and Innovation Act was passed with an amendment stipulating the workgroup’s formation. At the time, MobiHealthNews spoke with Joel White, executive director of the HealthIT Now Coalition.

“I think a critical aspect of this is that we have the externals have input into this process,” White said last summer. “From our coalition’s perspective that is absolutely key. The FDA may have one set of experiences and some expertise in this. The FCC brings another and ONC brings another. There are payors, employers, manufacturers, venture capitalists, patients, and providers who bring a completely different perspective. At the end of the day if you go out and get a good recommendation to Congress on what the regulatory framework should be — [one] that promotes innovation and protects patients’ safety — you better solicit input from all those points of view. From our perspective as an organization we believe that external input is critical.”

The workgroup’s efforts will likely end up affecting the regulation of mobile health and health IT. According to HHS, FDASIA requires Sibelius, with the ONC and the FCC, to “develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.”  The new workgroup’s input will feed into that report.

FDASIA requires HHS to publish the report by January 2014. The workgroup’s first meeting will be April 29th. According to the workgroup’s website, the group will seek insight on “types of risk that may be posed by health IT that impact patient safety, the likelihood that these risks will be realized, and the impact of these considerations on a risk-based approach,” as well as “factors or approaches that could be included in a risk-based regulatory approach for health IT to promote innovation and protect patient safety” and “approaches to avoid duplicative or overlapping regulatory requirements.”

Advised by the FDA’s Bakul Patel, the ONC’s Jody Daniel, and the FCC’s brand new healthcare initiatives director Matthew Quinn, the workgroup is a veritable who’s who of major mobile health players. Prominent health investor Esther Dyson is one of the biggest names on the list. Several of the witnesses from the recent congressional hearings on mobile health regulation will also sit on the group: Qualcomm’s Robert Jarrin, West Health’s Joseph Smith, and lawyer Bradley Thompson, of Epstein Becker Green P.C. and regular MobiHealthNews contributor.

Providers from hospitals like Massachusetts General and Brigham and Women’s and representatives from big companies like Philips, Aetna, and IBM are also in the workgroup. Finally, representatives from startups round out the group: Geoff Clapp of Better, Lauren Fifield of Practice Fusion, Michael Sweirnik of MobileHealthRx, Inc., and, notably, T. Drew Hickerson from Happtique. Happtique’s Ben Chodor was also a witness at the congressional hearings: asked whether Happtique’s app ceritification process could replace federal regulation, Chodor gave an unqualified “No.”

Brian Dolan has described the push and pull in DC over mobile health regulation as a “painfully slow chess game.” This workgroup is the latest move, but with such a great diversity of voices involved, it’s hard to say what the final effect will be on mobile health regulation and the role of the FDA.