FDA, FCC, ONC Release Risk-Based HIT Regulatory Framework

After months of delays, the Food and Drug Administration, Federal Communications Commission, and the Office of the National Coordinator for Health Information Technology today released a proposed strategy and recommendations for a risk-based regulatory framework for health IT meant to "promote innovation, protect patient safety, and avoid regulatory duplication." Mandated under the FDA Safety and Innovation Act (FDASIA), the draft report to Congress was compiled by the FDA in collaboration with the FCC and ONC.

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