In 2011 the Food and Drug Administration (FDA) released draft guidance seeking to clarify its intentions with regard to regulation of mobile health information technology (“mhealth IT”). The Agency solicited and received public comment. Thereafter began a nearly two-year waiting game that continues to this day and has more than a few mobile health stakeholders clamoring for final guidance to provide “clarity” and, by extension, confidence to potential mobile health investors waiting impatiently on the sidelines.
A lot has happened in those many intervening months. For one thing, the once-rational distinction between “mobile” information technology and everything else has become less and less connected to the reality of the technological world that we live in. Put another way, all communications technology is now “mobile” to one degree or another.
More importantly, in July of last year, via FDA Safety and Innovation Act (“FDASIA”) Congress instructed the Obama Administration to recommend a “risk-based” framework for oversight of health IT with three clearly-stated objectives: (1) to protect patients; (2) to promote innovation; and (3) to avoid unnecessary regulatory duplication. Crucially, Congress explicitly included mhealthIT in its FDASIA mandate.
In April 2013, Health and Human Services (HHS) Secretary Sebelius convened a stakeholder workgroup (the “FDASIA Workgroup”) to inform that recommended framework. The FDASIA Workgroup has solicited public comment, held meetings on a more-than-weekly basis, and is on track to issue its recommendations in September.
Some industry stakeholders have urged the FDA to release its final Mobile Guidance as quickly as possible, despite the clear, intervening Congressional call for a comprehensive framework. Others (including athenahealth) disagree emphatically. That’s why in June we helped to pull together a broad coalition of more than 140 healthcare stakeholders, including nearly two dozen consumer groups, 18 medical societies and physician groups, six hospitals, 75 health IT start-ups, and dozens of other potentially-impacted entities and groups. That coalition sent a letter (read it here) to key Administration figures, including Secretary Sebelius, asking FDA to hold off on issuing final Mobile Guidance until the FDASIA Workgroup has provided its Congressionally-mandated recommendations and the Administration has crafted the required comprehensive oversight framework. Emphasizing Congress’s clearly-expressed instruction that HHS should avoid unnecessary regulatory duplication, the coalition letter argued that final Mobile Guidance issued before release of the FDASIA-required recommendations for a comprehensive oversight framework, encompassing mobile health IT, would increase rather than alleviate uncertainty in the mobile health marketplace.
This is very much a live issue in Washington right now, with the FDASIA workgroup preparing to issue its recommendations, rumors persisting about potential final mobile guidance from FDA, and continued uncertainty about the prospects for and the final form of the Congressionally-mandated comprehensive oversight framework. We continue to believe that true regulatory certainty will be provided not by regulatory haste, but by careful deliberation to produce a clear, non-duplicative, risk-based approach that protects patients while fostering innovation. Congress clearly mandated such a framework. The Administration should honor that mandate and resist well-intentioned but ultimately counter-productive calls for rushed, piecemeal regulation.
(This post first appeared over at athenahealth's blog.)