Those who were hoping for a new regulatory framework for health information technology products were disappointed by an April 3 draft report released by the federal government. The report, developed by the Food and Drug Administration in coordination with the Office of the National Coordinator for Health IT and the Federal Communications Commission, unequivocally supports a risk-based regulatory framework for health IT products that is subject to FDAs current regulatory framework.
"We are proposing for public comment a limited, narrowly tailored approach that relies primarily on ONC-coordinated activities and private sector capabilities and practices to ensure safe, high quality health IT," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, at a media briefing on the draft report. "We do not believe that new, extensive regulations should be or needs to be the first approach used to reach these outcomes."
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