Critics of Federal HIT Strategy Challenge 'Status Quo' FDA Oversight

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.

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