Adding another chef to the government regulation kitchen (US)

The much touted HIMTA (Healthcare Innovation and Marketplace Technologies Act, H.R. Bill 6626) as introduced by Silicon Valley’s Representative Mike Honda, if passed would establish an Office of Wireless Health at the FDA for starters. Then it adds layers, like cake: establish specific mhealth software responsibilities for the Health Information Technology Research Center (new?), ‘Challenge Grants’ and prizes for IT developers, an HHS department supporting mHealth developers on designing in line with privacy regulations, workforce retraining, provider loans and tax incentives. The intent is spelled out in the HealthWorks Collective article–Rep. Honda’s public statement is that it would only seek to clarify current regulations, especially privacy, for mHealth developers and reduce barriers to entry, but read to the bottom which then states the intent is to reshape the mHealth industry. Also see Rep. Honda’s press release.

In Editor Donna’s view, it only serves to add another gaggle of chefs in the mHealth government kitchen, which is already packed with FDA, FCC, HHS and NIH elbowing for burners and oven space.

But…there’s more. The FCC just announced their search for a new Health Care Director to head up their initiatives, involving a lot more than sorting out spectrum policy. There’s delicate maneuvering between more working groups with initials than pumpkin or mince pies at Christmas Eve dinner. There’s doling out the ‘Health Care Connect Fund’ for broadbanding providers including a pilot in SNFs (skilled nursing facilities a/k/a nursing homes), etc. But nothing about better, longer studies that might prove things like ROI and better outcomes necessary to gain adoption in the far bigger, wider private market.

Conclusion: The only companies which will be able to advantageously sort out this tangle are those with batteries of lawyers on call, thus putting paid to Rep. Honda’s stated objective of encouraging startups. The only small saving grace is that H.R. 6626 was introduced in a Congress that is ending in three weeks (thus will die and presumably be reborn next year). And there are far higher ‘cliffs’ that need climbing…out of.

Related: Speaking of cliffs, David Lee Scher, MD approaches the one with the HEALTHCARE sign, looks over the edge, and sees a pile of money tossed over it willy-nilly. The healthcare cliff.

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