Health IT Regulation Heads Back To Capitol Hill

11-13-2013 7-51-09 PM

Over the next week, two significant meetings will take place on Capitol Hill concerning the future of both mHealth and health IT FDA regulation.

This Friday, November 15, Congressman Joe Pitts (PA), chairman of the House Energy & Commerce Committee’s Subcommittee on Health will hold a hearing called “Reviewing FDA’s Implementation of FDASIA". The hearing will cover a number of topics related and unrelated to HIT. FDASIA, or the Food and Drug Administration Safety and Innovation Act, was enacted in 2012 and was initially crafted as a way of authorizing the FDA to collect fees from pharmaceutical and medical device manufacturers in return for an expedited review process. However, the bill also included authorization to form the FDASIA Workgroup, which was tasked with:

“…providing expert input on issues and concepts identified by the Food and Drug Administration (FDA), Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC) to inform the development of a report on an appropriate, risk-based regulatory framework pertaining to health information technology including mobile medical applications that promotes innovation, protects patient safety, and avoids regulatory duplication.”

It was the FDASIA that in September pushed the FDA to release its final guidance of mobile medical applications. Friday’s meeting is expected to cover the overall implementation and effect that the FDASIA has had since its inception.

On Tuesday, November 19 the same group will reconvene in hearings that will zero in closer to home. The “Examining Federal Regulation of Mobile Medical Apps and Other Health Software” hearing is a continuation of the mHealth review hearings that were initiated in March 2013. During this hearing, subcommittee members will consider the testimony it heard from industry in March while reviewing the FDA’s final guidance of medical apps.

The subcommittee will also spend time reviewing Martha Blackburn’s recently proposed SOFTWARE Act, which if enacted would further limit the FDA’s regulatory control over mHealth apps while providing “the FDA the tools it needs to effectively protect consumers from the high-risk technologies.”

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