ONC offers more details about enhanced certification proposed rule

During the most recent Health IT Joint Committee meeting, the Office of the National Coordinator for Health IT (ONC) took the opportunity to clear up confusion about the proposed rule regarding enhanced health IT oversight and accountability.

“The goal is enhanced oversight,” said Elise Sweeney Anthony, acting director of ONC’s Office of Policy Planning.

The rule would not create new certification requirements for health IT developers or new certification requirements for providers participating in Department of Health and Human Services programs. It also would not establish a means for ONC to directly test and certify health IT and would not establish regular or routine auditing of certified health IT by ONC. ONC’s authorized certification bodies (ACBs) will continue to test and certify health IT.

The proposed rule would:

• Enable ONC to directly review already certified health IT products.
• Enable increased ONC oversight of health IT testing bodies
• Enable increased transparency and accountability by making identifiable surveillance results of certified health IT publicly available.

Anthony offered examples of what might warrant ONC direct review. If a developer has products certified by two different certification bodies and ONC receives a complaint, “it might make sense for ONC to engage in a review rather than have multiple ACBs review.”

She also noted that ONC could step in if there is a risk to public health or safety or something could compromise the security or protection of patients’ health information.

Suspension can occur anywhere in the process “because we want to be able to step in quickly.” There are opportunities for appeal and correction action is key. “We really hope and intend to work with developers on how to address the problem.”