The Office of the National Coordinator today released the final rule for the ONC Health IT Certification Program, which gives the agency more direct oversight of the health IT testing labs.
The rule highlights the importance of protecting public health and safety while also strengthening transparency and accountability in the certification program.
The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” final rule will enable the ONC Health IT Certification Program to better support physicians and hospitals – the vast majority of whom use certified electronic health records – and the rapid pace of innovation in the health information technology market, according to the ONC.
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“We have a very good framework that we’ve been working on for several months and how it’s executed and is triggered, it is a process,” National Coordinator Vindell Washington, MD, said on a call with reporters.
Washington also underscored that the focus of the new rule is around items that affect patient safety and items that are certified by multiple Authorized Certification Bodies.
The rule focuses on three areas: Direct review, consistent authorization and oversight and increased transparency and accountability.
Direct review lays out a regulatory framework for ONC to directly review certified health IT products and take necessary action when public health and safety is at risk, or when issues arise involving multiple certified functionalities or products that have been certified by multiple ONC authorized certification bodies.
Consistent authorization establishes a process for ONC to authorize and oversee accredited testing laboratories, making it easier for ONC to quickly, directly, and precisely address testing and performance issues.
The rule also calls for increased transparency and accountability by making surveillance results and performance results of certified health IT publicly available.
The rule requires ONC to provide surveillance results quarterly to the public on the web-based Certified Health IT Product List.
Washington was also asked about the matter of EHR usability.
“To say that usability is a checkbox that you get from a certifying body is not really a place where you want a strong federal arm,” Washington said. He added that if usability itself were contributing to unsafe situations, then ONC could use some oversight efforts.
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