If not FDA to regulate mHealth, then who?

For those looking for alternatives to FDA approval of  mobile health or medical apps, some organizations have been tossed into the Suggestion Box. It’s a veritable alphabet soup of abbreviations, starting with ONC (Office of the National Coordinator for Health Information Technology). There’s the private sector review entity initially created for EHR certification with the formation of CCHIT (Certification Commission for Healthcare Information Technology, part of HHS) or what CCHIT has now become, a private/federally monitored model. There’s also the FTC (Federal Trade Commission) which pulled an acne treatment app of the market, and the ever-popular FCC (Federal Communications Commission) which has been searching for a Director of Health Care Initiatives and after all has millions to dole out in the Health Care Connect Fund. Neil Versel’s latest over at Mobihealthnews focuses in on this (omitting the FCC), considers the suggestion by Thomas Santo, MD in a recent column at KevinMD that medical industry associations (AMA–American Medical Association, ACP–American College of Physicians, etc.) should also be involved with health tech tools, to the extent of a rating system or even endorsement–and argues against it. (This excludes Happtique’s certification program standards/performance requirements.) But since both FDA and the FCC are involved, now separately, in most things mHealthy, and at least one proposed bill (HIMTA) would create an FDA Office of Mobile Health, why not have a joint office as a single point of contact? FDA regs would remain the same, but the review would encompass both medical effectiveness and wireless issues.

FDA regulating medical apps–or not? (US)

The long-drawn out drama on the FDA’s endlessly pending (July 2011) final regulations on the approval procedure of mobile health apps seems to be coming to a crescendo with next week’s US House of Representatives Energy and Commerce Committee hearings. There are missed deadlines, unanswered questions, reports due, an apparent repositioning of mobile apps as ‘health IT’, the involvement of an alphabet soup of agencies–Health and Human Services (HHS), the Federal Communications Commission (FCC) and, most importantly the Office of the National Coordinator for Health Information (ONC) under HHS, which seems to be breaking away and asserting control in the FDA vacuum. Cheering on ONC for dominance are health IT companies such as McKesson and perhaps some members of the Committee. This apparent lassitude on FDA’s part is certainly odd, as according to Mobihealthnews, the FDA has already approved 75 mobile medical apps. Brian Dolan over there has done fine work on sorting out this ‘who’s on first?‘–and why–situation in two articles, Republicans, EHR vendors want ONC to take over medical app regulation (14 Mar) and Congress asks FDA if “actual use” is factor in medical app regulation (6 Mar).

Related TTA: The mHealth road map, as drawn by the FCC and Adding another chef to the government regulation kitchen