mHealth Oversight Suggestions Nearing End Of The Beginning

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.