New Health IT Workgroup Will Address Patient Safety and Innovation

Health IT Workgroup Formed to Address Patient Safety, InnovationHealth IT workgroup to give recommendations for regulatory framework

Members of a newly created health information technology (health IT) workgroup have been selected and announced. The Food and Drug Administration Safety Innovation Act authorized the creation of the group, called the FDASIA Workgroup. The workgroup will focus on identifying key considerations to improve patient safety and promote innovation in health IT and report to the Health IT Policy Committee under the Office of the National Coordinator for Health IT (ONC).

The workgroup will hold its first meeting April 29, 2013. Members selected include agency officials and experts representing patients, consumers, health care providers, startup companies, and health plans or other third-party payers. The workgroup also includes venture capital investors, information technology vendors, health IT technology vendors, small businesses, purchasers, employers, and other stakeholders.

“Patients already benefit from innovative information technology tools such as electronic health records that allow their providers to improve coordination and delivery of care,” said HHS Secretary Kathleen Sebelius in a press release announcing the members. “This workgroup will help the Health IT Policy Committee consider new ways to navigate this rapidly growing industry while promoting innovation and protecting patient safety.”

Up first for the workgroup? Begin development of a report outlining a proposed strategy and recommendations for an “appropriate, risk-based regulatory framework for health IT.”  This would include mobile health apps. The FDA, FCC, HHS and the ONC will review recommendations provided by the Health IT Policy Committee based on input from the new workgroup. The workgroup meetings will provide opportunities for the public to comment. Documents discussed by the workgroup will be available to the public.