Home > EHR, FDA, IOM > ONC Releases the Health IT Safety Center Roadmap

ONC Releases the Health IT Safety Center Roadmap

The HHS Office of the National Coordinator for Health IT (ONC) recently released a contractor-developed “Health IT Safety Center Roadmap.” This policy document by RTI, International provides a vision of the possible future scope and responsibilities of the Health IT Safety Center.

The center was previously discussed in the Food and Drug Administration (FDA)-Federal Communications Commission (FCC)-ONC joint “Health IT Safety Plan” in 2014. The 2014 tri-agency plan was mandated by the FDA Safety and Innovation Act of 2012 (FDASIA) to delineate agencies’ jurisdiction on health IT safety. The plan categorized which functionality types would be actively regulated by FDA and which would be unregulated and/or subject to non-regulatory safety activities under ONC’s umbrella. Under that plan, the Health IT Safety Center would be a public/private partnership supported by ONC to enhance safety via exclusively non-regulatory/voluntary activities.

The recently released roadmap by RTI, International shares the same vision of the center as a decidedly non-regulatory convener of stakeholders and safety enhancement activities. It includes a startup organizational model (advisory board/executive director-led with its own staff) and funding source recommendations (an initial cooperative agreement with 5 years of ONC or AHRQ seed funding). It suggested that the full cost over five years could be $17.8-$20.6 million, with a sustainability plan kicking in thereafter to eliminate federal funding.

In essence, the center’s infrastructure would appear somewhat similar to the modern Patient Centered Outcomes Research Institute (PCORI), albeit with a different initial funding mechanism and totally different scope.

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Categories: EHR, FDA, IOM
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