Home > EHR, FDA, IOM, radiation safety > ACR Submits Comments to FDA, FCC, and ONC on the FDASIA Health IT Report

ACR Submits Comments to FDA, FCC, and ONC on the FDASIA Health IT Report

On July 3, the American College of Radiology (ACR) submitted comments to the Food and Drug Administration (FDA), Federal Communications Commission (FCC), and Office of the National Coordinator for HIT (ONC) regarding the agencies’ report on a proposed strategy for a risk-based regulatory framework for health IT. The agencies were mandated by a provision in the FDA Safety and Innovation Act of 2012 (FDASIA) to draft recommendations that appropriately balanced HIT safety with innovation and avoided overlapping jurisdictions.

The report called for a risk-based, three tier categorization scheme for HIT functionality. FDA would continue to regulate the highest risk “medical device” IT functionality as before, and would not expand into new areas of oversight. ONC, in collaboration with the private sector and a future public-private HIT Safety Center, would promote HIT safety through non-regulatory activities for the middle tier “health management” IT functionality. Functionality in the lowest risk “administrative” category (billing systems, etc.) would not be a safety concern.

The ACR participated in several federal efforts leading up to the proposed framework, including the FDA’s mobile medical applications guidance activities in previous years and a FDA-FCC-ONC meeting addressing the FDASIA HIT report in May 2014.

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Categories: EHR, FDA, IOM, radiation safety

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