Industry groups continue fight over FDA final guidance

The battle between rival industry groups trying to influence the timing of the U.S. Food and Drug Administration's release of its final guidance on mobile medical applications continues to heat up. In the latest salvo, Dan Haley, athenahealth's vice president of government affairs, in an Aug. 13 blog continued the rallying call by 140 healthcare stakeholders asking the FDA to hold off on issuing its final guidance until the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup has completed its congressionally-mandated work.

FDASIA directs the U.S. Department of Health & Human Services (HHS)--acting through the FDA and in consultation with the Office of the National Coordinator (ONC) for Health Information Technology and Federal Communications Commission--to publish a report by January 2014 that will offer a proposed strategy and recommendations for an appropriate risk-based Health IT regulatory framework that includes mobile medical applications. In a June 18 letter to HHS Secretary Kathleen Sebelius and the heads of the FCC, FDA and ONC, a coalition of associations and companies, including athenahealth, urged the delay of the FDA's final guidelines on mobile medical apps until the FDASIA Workgroup completes its tasks.

However, in response, the mHealth Regulatory Coalition (MRC) sent at letter on June 21 to Sebelius warning her that delaying the release of the FDA guidance until after the comprehensive Health IT strategy is finalized would "only perpetuate the confusion that plagues the mHealth industry today" and urged her, through the FDA, to publish the final guidance on mobile medical applications as soon as reasonably possible.

"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," wrote Haley in his Aug. 13 blog. "Others (including athenahealth) disagree emphatically." 

Watertown, Mass.-based athenahealth is a provider of cloud-based services for EHR, practice management, and care coordination. According to Haley, athenahealth in June helped to pull together the broad coalition of more than 140 healthcare stakeholders, including nearly two dozen consumer groups, 18 medical societies and physician groups, six hospitals, and 75 health IT start-ups, that sent the letter to HHS. 

"Emphasizing Congress's clearly-expressed instruction that HHS should avoid unnecessary regulatory duplication, the [June 18] coalition letter argued that final mobile guidance issued before release of the FDASIA-required recommendations for a comprehensive oversight framework, encompassing mHealth IT, would increase rather than alleviate uncertainty in the mhealth marketplace," states Haley in his blog. "This is very much a live issue in Washington this month, 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."

Nevertheless, in an email response to a query from FierceMobileHealthcare, MRC's general counsel Bradley Merrill Thompson strongly disagreed with Haley's arguments for delaying final FDA guidance. "It blows my mind that all of this controversy has erupted in FDA's attempt to explain clearly and cogently what the law already requires," Thompson wrote in his email. "These people who are opposing the guidance are in effect saying that software entrepreneurs should be kept in the dark about what the existing law requires, potentially creating the risk of criminal violations. The FDA laws are, after all, criminal statutes."

"Why should FDA not publish this particular guidance? What harm does it do?," asked Thompson. "It doesn't expand regulation one iota, and indeed it seems that FDA is trying to deregulate some of what it already regulates. These people seem to have an agenda of big picture legislative change for the regulation of health IT.  How exactly would FDA publishing this educational paper even hurt their efforts? It's a free country, they can pursue whatever they want. But in the meantime, they are utterly stifling medical mobile app entrepreneurs by denying them educational materials written in a way that translates complicated legalese into simple language."

Last month, FierceMobileHealthcare interviewed Thompson about the current regulatory environment and his work with MRC and the FDASIA sub-workgroup. 

To learn more:
- read the athenahealth blog post