Is FDA guidance sidetracked by Health IT regulatory framework?

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There is a tug of war going on in Washington between rival industry groups lobbying the Department of Health and Human Services in an effort to influence the timing of the Food and Drug Administration's release of its final guidance on mobile medical applications. In March, the FDA told Congress that it is committed to issuing final guidance no later than September 30. However, the problem is that the Food and Drug Administration Safety and Innovation Act, or FDASIA, requires the Secretary of HHS to prepare a report by January 2014 that outlines a strategy for a risk-based regulatory framework that governs health information technology (IT), including mobile medical apps. And, therein lies the rub.

To assist in developing this HHS report, the FDA in collaboration with the Office of the National Coordinator for Health IT and the Federal Communications Commission formed a FDASIA Workgroup charged with providing input on issues relevant to the report. On the one hand, the Bipartisan Policy Center (BPC) and a coalition of companies and associations has urged HHS to delay the FDA's final guidelines on mobile medical apps until the FDASIA Workgroup completes its tasks. And, on the other hand, the mHealth Regulatory Coalition (MRC) has encouraged HHS, through the FDA, to publish the final guidance on mobile medical apps as soon as possible. Both of these pleas from the two respective coalitions took the form of letters sent last month to HHS Secretary Kathleen Sebelius.

In a June 18 letter to Sebelius and the heads of the FCC, FDA and ONC, the BPC-affiliated coalition urged the administration to "allow ample time for the FDASIA Workgroup to complete its work and to take into consideration the Administration's final recommendations on a risk-based regulatory framework pertaining to health IT in any future Agency guidance or policy to be released associated with the regulation or oversight of health IT." The organization also encouraged the administration to "consider any Congressional recommendations on a risk-based regulatory framework that emerge following the publication of the Administration's final report and to work with Congress on the development of appropriate oversight mechanisms for health IT, including mobile applications."

Not to be outdone, the MRC sent a June 21 letter to Sebelius letting her know that the organization was aware of discussions recently regarding whether FDA should delay the release of its final guidance on mobile medical apps until after HHS develops the comprehensive regulatory strategy for health IT as required by FDASIA. "We disagree with that view," states a June 19 MRC position paper that was included with the letter to Sebelius. "To delay the release until after the comprehensive Health IT strategy is finalized would only perpetuate the confusion that plagues the mHealth industry today without providing the clarity and direction to enable and accelerate mHealth innovation."

Which organization will prevail in this back and forth contest to determine the publication of the FDA's final guidance? I wouldn't want to predict. Nevertheless, it's worth noting that last month, when I interviewed Jodi Daniel, Director of ONC's Office of Policy and Planning, she made a point of emphasizing that ONC is "working with the FDA as they are developing that guidance to make sure that it aligns with health IT policy more broadly." 

Daniel, by the way, is the official who issued the May 30 HHS notice in the Federal Register requesting "broad input" on what elements should be considered for a risk-based regulatory framework for health IT, including mobile medical apps. Does that mean the FDA guidance has been sidetracked until a comprehensive Health IT regulatory framework has been developed? We'll see. In the meantime, an ONC spokesman insists that "because the mobile medical apps guidance is FDA's, it wouldn't be appropriate for us to comment." That's their story and they're sticking to it. - Greg (@Slabodkin)