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Calif. Congressman wants new FDA office to foster mHealth innovation

By Jennifer Bresnick

- US Representative Mike Honda, a Democrat representing California, has introduced a bill to establish an Office of Wireless Health at the FDA.  The Healthcare Innovation and Marketplace Technologies Act would provide market incentives, challenge grants, and workforce retraining opportunities to stimulate innovation in the mHealth space, as well as provide a regulatory framework to govern mobile health technology issues.

“As we continue to improve our health care system, technology can and should play a prominent role in achieving better care for Americans,” said Rep. Honda in a press release. “Investments, development, and adoption of technologies remain stagnant. 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.”

The bill would also establish a developer support program at the Department of Health and Human Services (HHS) to help programmers meet privacy regulations.  A national hotline, an educational website, and an annual report would aid these efforts.  The Wireless Health Office would also sponsor a prize program and innovator challenge grants to attract small businesses, as well as provide low-interest loans to clinics and physicians interested in purchasing mobile health IT systems and other products.  An additional tax incentive would reduce the costs of these investments, as well.

Representative Honda’s initiative comes on the heels of a March 2012 mobile health roundtable conducted by the Office of the National Coordinator, designed to gather public and industry input to develop an effective way of securely integrating emerging mobile technology into standard clinical practices.  “When a device taps into the world’s knowledge and when it’s a platform – it’s not just a device that does one thing.  When you can have a near infinite number of applications that can run on a ubiquitous, connected platform, that’s when disruptive innovation, in the best sense of the word, is unleashed.  The use of these is skyrocketing,” Dr. Farzad Mostashari said during his introductory presentation.  “And it starts on the low-cost side of the market.”

The FCC, FDA, Federal Trade Commission, National Institute of Standards and Technology (NIST), and the Office for Civil Rights, a division of HHS, are all working together to develop mobile health technology in the United States, with security, widespread access, and quality of data as top priorities.  Rep. Honda’s proposed organization would clarify and simplify existing regulations, helping to “translate the wide array of privacy guidelines into common English” so small businesses and other technology developers can create products that adhere to government standards.

To view the bill as presented to Congress under the designation H.R. 6626, please click here.

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