Final rule on certified EHR review, oversight released by ONC

The Office of the National Coordinator for Health IT (ONC) has released the final rule on its Health IT Certification Program, focusing on “reliability, transparency, accountability and safety” of certified electronic health records (EHRs).

“More transparency and accountability in health IT is good for consumers, physicians and hospitals,” National Coordinator for Health IT Vindell Washington, MD, said in a statement. “Today’s final rule strengthens the program by ensuring that certified health IT helps clinicians and individuals use and exchange electronic health information safely and reliably.” 

The rule focuses on three areas:

  • Reviewing products: The rule sets up the review process for certified health IT products and allows ONC to take action when there are potential risks for “public health and safety” or practical challenges for authorized certification bodies are present. The rule does include an appeals process for health IT developers which have their certifications suspended or terminated by ONC.
  • Authorization and oversight: The rule “establishes a process for ONC to authorize and oversee accredited testing laboratories to align with ONC’s existing oversight” of authorized certification bodies. The change should allow the agency “to quickly, directly, and precisely address testing and performance issues.” ONC will also help developers craft corrective action plans to be approved by the agency to “remedy any nonconformities” in their products.
  • Transparency: The surveillance results of certified health IT products will be made available to the public on a quarterly basis through an online certified IT product list.

ONC said the goal of the updates to the certification program is to support physicians and hospitals which use certified EHR technology, as well as deal with the “rapid pace of innovation” in the health IT market.

In its initial reaction to the rule, the College of Healthcare Information Management Executives (CHIME) supported the efforts to make surveillance reports more readily accessible.

“CHIME appreciates that steps that the agency is taking to increase transparency of health IT performance,” the group’s statement said. “Hospitals and clinicians must have confidence that the products they purchase work as intended and do not pose a significant risk to patient safety or public health.”