Proposed rule would give ONC power to conduct direct reviews of certified HIT products

Tools

LAS VEGAS -- A newly proposed rule announced by the Office of the National Coordinator for Health IT on Tuesday would enable the agency to conduct direct reviews of certified health IT products.

According to ONC Acting Director for the Office of Policy Elise Sweeney-Anthony, speaking Tuesday to reporters at the Healthcare Information and Management Systems Society's annual conference in Las Vegas, such direct review would also include how certified health IT interacts with other systems.

"Our goal there is to ensure that we have the tools we need to address public health" and other safety issues that might arise, Sweeney-Anthony said.

The rule also increases ONC's oversight of health IT testing bodies to improve alignment and more adequately deal with issues, and seeks to boost transparency associated with the surveillance of certified health IT tools.

"We want to allow not only for negative results in terms of where surveillance uncovers something that should not be the case in terms of certified health IT, but also we want to be able to know where vendors and developers are doing what they're supposed to do with surveillance results coming back positively," Sweeney-Anthony said of the surveillance portion of the rule.

Comments on the rule will be accepted through May 2.

The Department of Health and Human Services, in its announcement of the rule, said it will "empower" consumers by improving availability of certification information.

"Today's proposed rule will help us ensure that health IT products and the health IT marketplace are continuing to meet the needs of the healthcare system," National Coordinator for Health IT Karen DeSalvo said in the announcement. "We look forward to comments on the proposed rule from health IT developers and other stakeholders as we continue to work together to make health information available where and when it is needed safely and reliably."

To learn more:
- here's the ONC announcement
- check out the rule (.pdf)