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

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