The FDA is the responsible organisation for the regulation of medical devices in the USA. In a proactive move, the FDA published draft guidance (21 July 2011) for what it defined as “mobile medical applications”, and invited comments from industry and staff. Nearly two years on, interested parties are still waiting for formal guidance on what types of apps will be regulated and are therefore subject to FDA approval. Latest indications suggest this guidance will be published by October 2013, but don’t hold your breath.
That’s not to say the FDA have been sitting on their hands in the meantime. During hearings before a House of Representatives committee in March of this year, Christy Foreman, Director of the Office of Device Evaluation, indicated that the FDA had approved some 100 medical apps already (the equivalent figure for the UK’s MHRA could be counted on one hand). Further, in May the FDA made clear it means business by launching its first inquiry into a urinalysis app that the agency said needed, but did not have, FDA approval. We’ve yet to witness such an intervention here in the UK.
However mobile apps aren’t the only area where technology use in healthcare is evolving fast. IT more broadly represents a huge opportunity to improve patient outcomes and make healthcare more efficient. To this end, the Obama administration created a Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup, charged with publishing a report by January 2014 to identify a regulatory framework for “health IT” which includes mobile medical apps. The Workgroup is under oversight of the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC).
Given the potential of mHealth, and health IT more generally, there are clearly many interested parties that want their voice heard, ranging from individual patients, clinicians and developers all the way up to big business. By extension, there are some very different views on what role regulation should play (possibly reflecting the bipartisan views in the USA on the role of government as a whole). And where politics and business interests meet, lobbyists can be found.
Software Advice, a resource for medical software buyers, is currently hosting a poll seeking readers’ opinions on whether or not the FDA should regulate mobile apps. To cast your vote, visit their recent blog which summarises the views of two opposing camps; one urging that mobile medical app regulation isn’t rushed and is considered within the context of the wider FDASIA workgroup remit, the other asking the FDA not to delay in publishing guidelines that will bring further certainty and thus investment to this promising new field.