Healthcare Innovation Bill Establishes Wireless Health Office Within FDA

12-5-2012 10-20-04 PM

Rep. Mike Honda, fifth-term senator representing silicon valley, introduces a bill that establishes an official wireless health office within the Food and Drug Administration. The Health Innovation and Marketplace Technologies Act (H.R. 6626) directs the FDA to work in conjunction with other governmental agencies to solicit feedback on how to develop a consistent regulatory framework for the wireless health industry. The bill does not expand the FDA’s existing authority over the wireless health industry, nor does it limit recent FCC efforts to establish a framework in this space.

“Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry. There is also a lack of an established marketplace for new technologies and a lack of trained workers to handle the implementation and use of these technologies. This bill begins to bridge these gaps.”  – Rep Mike Honda, 15th Congressional District.

The bill also establishes a mHealth developer office within HHS whose mission will be to help application developers produce devices in line with currently regulatory guidance. Furthermore, languages is included which mandates programs aimed at fostering innovation, in a similar fashion to the X-Prize Foundation, by providing prizes for innovator challenges.

Upon introduction, the bill was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Small Business, for further evaluation before a potential roll call.

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