The U.S. Food and Drug Administration's mHealth regulations still have a ways to go before they are finalized. According to an article in GovernmentHealthIT, a key Food and Drug Administration Safety and Innovation Act (FDASIA) sub-workgroup has some suggestions.
Following a July 19 meeting, a FDASIA subgroup on regulations--co-chaired by Epstein Becker Green attorney Bradley Thompson--is sending tentative recommendations to the FDASIA Workgroup for consideration on the last Friday of July, before those and other ideas go to the ONC's HIT Policy Committee and then the FDA, according to GovHealthIT.
Thompson is quoted in the article as saying that HIT and mHealth "should not be subjected to FDA pre-market requirements," except "those areas where it would potentially justify premarket requirements."
Those exceptions, as most of the subgroup agreed to, would be medical device data systems (which the FDA subjects to low-risk Class 1 regulation requiring mostly just registration and adverse event reporting), medical device accessories that could be added to smartphones say for diagnostic uses, and "certain forms of high risk" clinical decision support software or apps, states the article. That suggestion follows a recommendation by the FDASIA taxonomy subgroup to classify all of mHealth and HIT as "unregulated" by the FDA but subject to "enforcement discretion," with those several exceptions.
Thompson states in the article that the charter of the FDASIA Workgroup and its subgroups is "not to design the regulatory system but to define the objectives that the agencies should consider when they design the regulatory system in the fall." If the legal questions get so murky, it could be the federal courts determining the FDA's regulatory scope of HIT, he said. "But we can determine oversight," Thompson added, per Congress's instructions in FDASIA , enacted last July. "The ultimate question is should the FDA actively oversee HIT?"
FDASIA directs that 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 (HIT) regulatory framework that includes mobile medical applications. To assist in developing this HHS report, the FDA in collaboration with ONC and the FCC formed a FDASIA Workgroup charged with providing input on issues relevant to the report.
On June 21, the mHealth Regulatory Coalition (MRC) sent a letter to HHS Secretary Kathleen Sebelius urging her, through the the FDA, to publish the final guidance on mobile medical applications (MMA) "as soon as reasonably possible." However, according to the MRC, that guidance cannot be finalized fast enough.
"The timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community," states the letter to Sebelius from Thompson, who serves as MRC's general counsel and whose Washington-based law firm, Epstein Becker Green, assists with the development of the organization's policy and government relation strategies.
To learn more:
- read the article in GovernmentHealthIT