Bill would create FDA Office of Mobile Health, HHS support for app developers

By: Neil Versel | Sep 28, 2012        

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iPhone_FDAThough the Food and Drug Administration is developing regulations for mobile medical apps, at least one member of Congress believes the federal agency is not currently equipped to handle the rapid pace of innovation in mobile technology.

Rep. Mike Honda (D-Calif.), whose district covers much of Silicon Valley, is preparing to introduce legislation that would address this perceived shortcoming by establishing an Office of Mobile Health within the FDA. The office, according to Kaiser Health News, would make recommendations to FDA regulators on issues related to mobile health apps.

The planned legislation, reportedly known as the Healthcare Innovation and Marketplace Technologies Act (HIMTA), also would set up a support program within the Department of Health and Human Services to help mobile health technology developers follow HIPAA privacy standards as they design new apps.

“Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry,” Honda says 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.”

Predictably, in this divided political climate, opinions of the forthcoming bill are mixed.

Andrew Rosenthal, chief strategy officer for Massive Health, a startup developer of consumer health apps, tells Kaiser Health News that he is hopeful an FDA Office of Mobile Health could help smaller companies like his navigate the “confusing” and often expensive regulatory process. However, Joel White, executive director of the Health IT Now Coalition, a group of major corporations and the conservative U.S. Chamber of Commerce, would prefer a new agency that works outside the bureaucratic FDA framework so as not to discourage innovation.

Kaiser Health News reports that the bill would be introduced “later this month,” though September ends Sunday. As of Thursday afternoon, no bill had been introduced. Honda’s media spokesman was not immediately available for comment.

  • Rick Valencia

    Since when has the answer to the challenges of dealing with governmental agencies been to create more governmental agencies? What we need is for the FDA to hire software developers from the silicon valley to help build the new regulations now. If the baseline regulations aren’t done right no new agency is going to help.

  • Steve Wallace

    “I’m from the government and I am here to help you.”  Typical – rather than address the actual regulations or problems, let’s make a new office, hire more people, and christen it “progress”. 

    Navigating the bureaucracy is a problem but we don’t need more pilots and more bureaucracy.  If you want more efficiency, start trimming the deadwood.

  • Alan DeRossett

    As someone who knows what an FDA 510k filing costs now (4years and $500k) to get a device registered with FDA. I welcome the Streamlining of the Mobile health apps at least 450 were released into the wild without oversight by Apple ‘s App store. 
    Modern Science will make this process quicker with Rep. Mike Honda’s help