Home > EHR, FDA, meaningful use, radiation safety, research > FDA, ONC, and FCC Release Report to Congress on a Risk-Based Approach to Regulating Health IT

FDA, ONC, and FCC Release Report to Congress on a Risk-Based Approach to Regulating Health IT

On April 3, the Food and Drug Administration (FDA), Federal Communications Commission (FCC), and HHS Office of the National Coordinator for HIT (ONC) released their highly anticipated report to Congress on a proposed strategy for a risk-based framework for regulating health information technology, including mobile medical applications. The report, which was mandated by the FDA Safety and Innovation Act (FDASIA) of 2012, has been in development since the FDASIA Working Group approved its final recommendations to the tri-agencies in late 2013.

The report categorizes health IT functionality into three buckets: administrative (scheduling, billing, inventory, etc), health management (most CDS, CPOE, electronic access to results, etc.), and higher-risk medical device functionality (CAD, bedside monitor alarms, radiation treatment software, etc). The focus of FDA regulation will continue to be on the third category. Private sector and ONC-coordinated quality/safety/standards conformity management activities will generally focus on the second category. FDA is seeking public comment on categorizing HIT that straddles the line between the second and third categories, such as certain CDS and EHR functions.

Moving forward, the tri-agencies will solicit public comment on the report and convene a three-day public meeting. The tri-agencies will also report periodically to the ONC HIT Policy Committee regarding implementation efforts.  Additionally, Memorandums of Understanding will need to be developed in the future when and where jurisdictions mesh.

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