Home > FDA > House Energy and Commerce Committee Hearings on mHealth and HIT Innovation

House Energy and Commerce Committee Hearings on mHealth and HIT Innovation

On March 19, the U.S. House of Representatives Energy and Commerce Committee held the first in a series of three planned hearings on HIT innovation.  The first hearing focused on the ongoing efforts to better define the Food and Drug Administration’s (FDA) role in regulating mobile medical applications.  The other two hearings (March 20 and 21) will focus more broadly on the benefits of HIT to patients and the Administration’s perspectives on HIT regulation.

As you may recall, in July 2011, the FDA published for public comment its draft guidance to clarify oversight issues related to mobile medical applications.  FDA’s efforts to finalize the draft guidance were eventually hamstrung by the discussions in Congress leading up to passage of the FDA Safety and Innovation Act of 2012.  FDA’s plans for regulating certain mobile medical applications will remain cloudy until the guidance is finalized and published.

Most committee members and witnesses participating in the hearing seemed to agree that the FDA should expeditiously finalize the draft guidance to address the lack of clarity.  Committee Republicans expressed concern about the potential application of the Affordable Care Act’s medical device excise tax to the mHealth domain.  Democrats on the committee urged Republicans to not use mHealth innovation as a political tool for attacking the medical device excise tax and healthcare reform law in general.

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Categories: FDA
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