Posted 27 September 2012
By Alexander Gaffney
Could the US Food and Drug Administration (FDA) stand to benefit from dedicating a department to the development and review of mobile health technologies? At least one legislator thinks so, and is preparing to introduce legislation requiring the agency to do just that, reports Kaiser Health News.
The bill, the Healthcare Innovation and Marketplace Technologies Act (HIMTA), is set to be introduced in the US House of Representatives by Rep. Mike Honda (D-CA) and calls for FDA to establish an Office of Mobile Health to take ownership of mobile health technologies.
Developments in mobile technologies are far from foreign to FDA, which last year issued a guidance document on the issue outlining its intent for enforcement and which devices need to receive agency clearance before being allowed on the market.
While the guidance went a long way in defining what, exactly, mobile medical devices are, it was relatively scant on defining the regulatory requirements for manufacturers, referring them to existing guidances on Class I medical device general controls.
That is well and good for larger, established manufacturers, noted Honda, but not necessarily for smaller application developers who may have no idea of how to receive regulatory approval for a device, or that their application is a medical device to begin with.
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," said Honda in a statement since removed from his website. "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."
As Kaiser notes, a regulation for mobile medical applications is already in the works and speculated to come out within the next year. A new office focused solely on assisting developers, then, could come at just the right time.