A rule regarding modifications and new requirements to the ONC Health IT Certification Program expanding the ONC's oversight and authority to review health IT has been sent to the Office of Management and Budget for review.
The proposed rule seeks to establish processes for the ONC to directly review health IT certified under the program and, if necessary, take action against those not in compliance with technology requirements by suspending or terminating certifications, among other actions.
The ONC introduced the rule due to concerns with the limited scope of authority authorized certification bodies hold. ONC-ACBs' authority is limited to evaluating vendor conformance with certification criteria but not against other regulatory requirements outside the scope of certification criteria. "ONC-ACBs are not positioned…to address situations that involve non-conformities resulting from the interaction of certified and uncertified capabilities within the certified health IT or the interaction of a certified health IT's capabilities with other products," according to the proposed rule.
As such, the ONC's proposed rule seeks to expand the ONC's role to review and address these types of conformities that are not under the purview of ONC-ACBs.
"ONC would have broad discretion to review certified health IT. However, we anticipate that such review would be relatively infrequent and would focus on situations that pose a risk to public health or safety," according to the proposed rule.
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