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Final rule issued on ONC Health IT Certification Program

October 22, 2016

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule on its Health IT Certification Program which focuses on three broad topics: direct review, oversight authority, and transparency. In terms of direct review, the rule provides a regulatory framework for ONC to review certified health IT products independent of the current accredited testing laboratories and "take necessary action" should there exist risks to public health or complications with the current certification. It also includes a vendor appeals process and permits ONC to demand vendor corrective action plans. Second, the rule outlines a process for ONC to authorize and oversee accredited testing laboratories. Finally, the rule establishes a process to encourage and support increased transparency and public availability of information related to certified health IT. According to the ONC, vendor accountability will be improved by making surveillance results of certified products, both positive and negative, available to physician practices and other technology purchasers.

Final Rule

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