Shutdown postpones House hearing on health IT regulation

A scheduled House committee hearing on the Food and Drug Administration's progress toward implementing a federal law requiring it to develop a regulatory strategy for health information technology was postponed Thursday, as the government shutdown continued into its third day.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, was scheduled to testify before the Health Subcommittee of the House Energy and Commerce Committee on the Food and Drug Administration Safety Innovation Act.

The 2012 law requires HHS, through the FDA, and in consultation with the Office of the National Coordinator of Health Information Technology and the Federal Communications Commission, to develop "a proposed strategy and recommendations 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."

In April, a special work group of the federally chartered Health IT Policy Committee was formed with representatives from the FDA, FCC and ONC, among other organizations, to advise all three agencies on “key considerations to improve patient safety and promote innovation in health information technology, including mobile medical applications. In the Safety Innovation Act, Congress mandated the FDA to come up with a plan for a regulatory framework by January 2014.

Last month, the FDA issued a final draft of “"Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff" (PDF),” which is to be part of the overall FDA regulatory strategy. Shuren was the FDA point man at a briefing at the release of the 43-page document.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, was also scheduled to testify at the subcommittee hearing.

Follow Joseph Conn on Twitter: @MHJConn