ONC issues final rule on health IT certification program oversight and accountability

The Office of the National Coordinator for Health Information Technology today issued a final rule that provides a regulatory framework for the agency to directly review certified health IT products that may present a serious risk to public health or safety, or practical challenges for ONC-authorized certification bodies. For example, a suspected non-conformity may require access to confidential or other information unavailable to the ACB, concurrent or overlapping reviews by multiple certification bodies, or exceed the scope of the ACBs’ resources or expertise, ONC said. The ONC review will be complimentary to surveillance conducted by the ACBs, including whether the reviewed products perform properly when they interact with other capabilities or products. ONC will require the ACBs to publish their surveillance results quarterly on its list of certified health IT products, and work with the Department of Health and Human Services to help identify and make appropriate remedies available to users of terminated products.