FCC sharply elbows up to the mHealth regulatory table

That other three-letter agency, the Federal Communications Commission (FCC), which has shown a distinctly competitive face versus the FDA on Federal healthcare tech policy over the past three years and more, has formed–drum roll–a task force to examine adoption of wireless technologies by health care organizations. Connect2HealthFCC will “identify regulatory barriers and incentives to expand the use of wireless health technologies; and strengthen partnerships with stakeholders in the telehealth and mobile health industries.” If this an accurate statement of the task force’s purpose, the parade not only has gone by, but it’s also three counties away. Yet going back in our files, this Editor notes that the FCC has vigorously fenced not only with the FDA, but also with HHSNIH, NIST and Congress for its place in the Federal HIT regulatory firmament. With issues such as ‘net neutrality’, wireless bandwidth and rural broadband, the FCC has a heaping healthcare helping on its plate just in assuring national access and removing conflicts in frequency demands by devices. However, the task force is headed by Michele Ellison, lately the FCC’s top regulatory enforcer with, as The Hill notes, 6,000 actions under her belt. In Foggy Bottom, things are never what they seem. iHealthBeat

Net neutrality’s end and effect on telehealth (US)

With its recent decision in ending ‘net neutrality’ as directed in the FCC‘s 2010 Open Internet Order, the (Washington) DC Circuit Court of Appeals has changed the playing field for mHealth. The FCC regulation treated internet service providers (ISPs) like telecommunications companies by enforcing telecom ‘common carriage’ requirements that prevented ISPs from blocking or discriminating against types or providers of internet traffic. The current situation is now a double-edged sword for the ISPs: on one edge, ISPs such as Verizon, Comcast or Charter won, because they now can charge fees to, slow down or demand revenue sharing of high-demand content originators (Netflix) which also use a lot of bandwidth; the other edge is that the court affirmed that the FCC regulates the relationship between the two.

The meaning for mHealth? The amount of health data carried over the internet is growing exponentially and dependent on speed. If internet carriage can be held up for small providers to make way for high-paying content, it can and will change the revenue model for mHealth. From clinicians to fitness buffs, everyone wants their data right now. It may impact lower-income people and home health which uses internet tracking for healthcare. But it may also have a stimulative effect on ISPs–more bandwidth and speed means more revenue. How does this compare to UK/Europe/Asia/Oceania regulation? What do you see as the outcome?

More here: mHealth after net neutrality: Innovation drain or gain? (GovernmentHealthIT)Three Dangers of Losing Net Neutrality That Nobody’s Talking About (Wired)Net Neutrality is Dead! Long Live Net Neutrality! (Wall Street Journal)  And an advocate of Congress getting involved (!) is Greg Slabodkin in FierceMobileHealthcareHat tip to Editor Charles Lowe for pointing out the potential effect on mHealth.

An ‘Office of mHealth’ a solution for FDA gridlock? (US)

The ‘FDA Office of mHealth‘ bill (H.R. 6626) as sponsored by Mike Honda, Silicon Valley’s House Representative (California 17th District), which expired with last year’s Congress [TTA 18 Dec] will be revived with revisions, according to MedCityNews. (Rep. Honda will be keynoting on the second day of MedCityNews’ ENGAGE conference in Washington D.C. in June.) Formerly dubbed HIMTA (Healthcare Innovation and Marketplace Technologies Act) will now include how that office will work with the alphabet soup of other agencies: FCC, HHS, ONC, FTC. It struck this Editor in December–and later [TTA 28 Mar]–that this bill does not go far enough. In its good intentions to speed mHealth approvals by creating a framework plus monetary incentives, it is not powerful or independent enough to slice through or bypass various turfs.  What would be revolutionary is simplification. Why not an independent unit that draws from FDA, FCC and HHS, but has priority and license to cut through red tape? But that would require major giving up of ground–and with this Federal Government, that ain’t gonna happen. Add to it that the most innovative work–and usage– is being done at DOD (DARPA, T2) and the VA, and the alphabet soup becomes goulash.  Wall Street Journal’s Venture Capital Dispatch

FCC very quietly names Director of Health Care Initiatives (US)

With no official announcement, the US Federal Communications Commission (FCC) has selected Matthew Quinn from the National Institute of Standards and Technology (NIST) for its first-ever Director of Health Care Initiatives, as reported in FierceMobileHealthcare (via Mobihealthnews). His maiden appearance was at a recent Care Continuum Alliance Capitol Caucus in Washington, D.C. This contrasts with the relative fanfare back in December of the new position and its big scope–administering the Health Care Connect Fund, the health care part of the National Broadband Plan, developing spectrum policy for Medical Body Area Networks (MBANs) and other medical devices as well as expanding broadband to skilled nursing facilities (SNFs). It’s all quite curious as it seems to be a muting of the FCC’s previous aggressive stance in cutting its slice of the pie in health care. FierceMobile’s editor Greg Slabodkin wonders what door the new Director will be using in Welcome, Mr. Quinn, I don’t believe we’ve been introduced.

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