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Archive for July, 2015

ONC Releases the Health IT Safety Center Roadmap

July 23, 2015 Leave a comment

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

HHS and NIST to Host HIPAA Security Conference

July 16, 2015 Leave a comment

The National Institute of Standards and Technology (NIST) and U.S. Department of Health and Human Services (HHS) Office of Civil Rights will convene the 8th annual conference on “Safeguarding Health Information: Building Assurance through HIPAA Security” September 2-3, 2015 in Washington, DC.

The event will focus on the technology- and electronic health information-related aspects of the Health Insurance Portability and Accountability Act (HIPAA) security requirements, including updates on the Omnibus HIPAA/HITECH final rule, breach management, business associate liability, managing 3rd party risk, securing medical devices, and more.

Online registration is now available.

Categories: EHR