- The U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health IT (ONC) issued a final rule Friday that increases oversight provided by the ONC Health IT Certification Program.
- The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” final rule strives to strengthen transparency and accountability around certified health IT.
- The end goal is to better support physicians and hospitals, particularly in the use of EHRs.
The increased oversight has long raised concerns in the health IT world, with opposition having been discussed since the announcement of the proposed rule back in March. Certain vendors and associations were concerned ONC may extend its reviews beyond certified capabilities or could suspend or terminate a vendor's Meaningful Use certification for a product or a quality measure within a product until an issue is fixed.
Concerns remain, with Health IT Now having issued a new statement regarding the finalized rule, in which it asked the administration to reconsider it and Congress to block its implementation and appropriations.
The group argued ONC was never intended by Congress to serve as a regulator like the FDA and that by implementing the new rule it is overstepping its authority. It further argued the FDA, Congress, and other stakeholders have already been working to find a balance between regulation and support of innovation.
"This ONC action has the potential to negatively impact those efforts, create confusion in the marketplace, slow innovation, and adversely affect patient safety by impeding access to health IT products," the group said.
The new rule focuses on three areas, including Direct Review, which provides a regulatory framework for ONC to review certified health IT products and "take necessary action" in the event of risks to public health or certification complications. It also allows for corrective action plans and includes an appeals process for developers.
The second area the rule addresses is a process for ONC to authorize and oversee accredited testing laboratories, and the third area is a process to support increased transparency and accountability by making surveillance results of certified health IT available to the public.