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.
"The Agencies strategy and recommendations for a risk-based framework for health management health IT include four key priority areas: promote the use of quality management principles; identify, develop, and adopt standards and best practices; leverage conformity assessment tools; and create an environment of learning and continual improvement," states the draft report. "The Agencies also recommend the creation of a Health IT Safety Center as a public-private entity with broad stakeholder engagement, that includes a governance structure for the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts."
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