The long and winding road to federal regulation or oversight of mHealth still has some ground to cover, but a key Food and Drug Administration Safety Innovation Act sub-workgroup has tentative suggestions that are about three organizational layers removed from the FDA.
After a July 19 meeting, the FDSIA subgroup on regulations is sending a batch of tentative recommendations to the FDSIA 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.
The issues being considered by the regulation subgroup — chaired by Epstein Becker Green attorney Bradley Thompson and Partners HealthCare System’s biomedical engineering director Julian Goldman, MD — have been so complex and potentially impactful to the blossoming mHealth industry, that the exact language of recommendations are still being finalized amid subgroup member debate.
[See also: Sparks fly over mHealth regs.]
Tentatively, though, as Thompson said, 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.
That suggestion is generally following 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.
From a legal perspective, though, some members had qualms about how the “unregulated” and “discretion” portions of the suggestions would be worded.
“That statement maybe creates more problems than it solves. You must acknowledge that FDA already regulates some HIT. This may be perpetuating an ambiguity,” said Meghan Dierks, MD, a Harvard Medical School professor of clinical informatics.
“The concept of enforcement discretion is only for something that’s technically regulated by the entity,” she said.
But, as Thompson said, 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.”
[See also: Who should oversee mHealth regs?]