October 22, 2012

Do we need a FDA Office of Mobile?

A September 26 2012, article on Kaiser Heath News by Jenny Gold raises the question of Mobile regulation by the FDA. In that article Gold report a Congress member will introduced legislation to create an Office of Mobile Health. I have no idea if the legislation will amount to anything but it does raise an interesting topic of conversation: Should mobile be treated as a unique regulatory process?

Here is a section of the piece:
But a bill set to be introduced in the U.S. House of Representatives later this month aims to smooth the agency’s evaluation process. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would establish a special Office of Mobile Health at the FDA to provide recommendations on mobile health app issues. It would also create a mobile health developer support program at the Department of Health and Human Services to help app developers make sure they are operating within privacy regulations, including the federal law HIPAA that sets privacy standards. 
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," Rep. Mike Honda, D-Calif., who is introducing the bill, said in a statement. “Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the healthcare information technology space?  This bill gets us closer to that space.”
I have written about mobile and diabetes apps a few times ok maybe more than a few.... As Gold's article notes The FDA is expected to issue guidance on mobile soon. 

I think that diabetes care offers some unique challenges for the regulation of apps. The FDA appears to be interested in taking thing one step at a time or more precisely single mobile devices at a time. The FDA draft guidance said, “The FDA plans to address in a separate issuance mobile medical app intended to analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device.” 

Diabetes is managed by patients with multiple devices, meters, cgms, pumps, and logs of food, working out and other life activities. To be meaningful diabetes mobile apps will need to deal with more than one device.  To me that is more relevant than the structure of the regulatory office.

(edited to add) I would suggest that we keep an eye open to closed loop A.P. and to get there maybe a good step is an open loop app where users are involved in the process but supported by an app that integrates information from multiple devices.

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