Donald Rucker, M.D., defended the Office of the National Coordinator for Health IT’s recent restructuring of EHR certification attestation requirements, noting that requirements within the 21st Century Cures Act will ensure transparency among EHR developers.
During a fireside chat on Wednesday at the 11th annual Health 2.0 conference, ONC’s national coordinator riffed on the agency’s delicate touch when it comes to standards and regulations and argued that the ONC’s tweaks to certification will be a net benefit for providers and vendors.
Last month, ONC announced that it would allow EHR vendors to “self-declare” on 30 of its 55 EHR certification criteria rather than undergo testing.
“[Providers] are actually paying for the expense of all that testing,” Rucker said, acknowledging that ONC got some pushback over the certification process changes. “That doesn’t float out into the ether. That’s built into the price of the software.”
Rucker also said it will be immediately apparent if the software is not meeting those criteria.
“You would know very rapidly whether these things are working," he said. "Certainly in the clinical space [you'll know] literally within minutes if there is a problem with the software,” he said.
Providers have expressed concern that scaling back EHR testing requirement will “water down” certification. Michael Roberts, chief information officer at Highlands Health System and Highlands Regional Medical Center, told FierceHealthcare he’s worried changes would “allow vendors who have already been caught cheating more flexibility and make it easier on them to cheat.”
An ONC official told FierceHealthcare that changes to certification attestation will not alter expectations and developers will be held to the same rigorous standards.
Rucker pointed to a provision of the 21st Century Cures Act that mandates ONC establish a standardized process for the public to submit reports of information blocking. ONC recently rolled out a Health IT Feedback Form on its website to report “health IT-related feedback or concerns.”
“ONC is required by law to set up a complaint process,” Rucker said. “Judging from some interactions that I’ve seen, I think there will be people using that and I think having that process alone will push some of that transparency.”
Rucker also touched on the complexities of establishing interoperability standards, nodding to the unique capabilities of Direct and Fast Healthcare Interoperability Resources (FHIR). Although global standards might ease the burden for developers, he said the complexity of information exchange is “massive.”
“As an agency that does regulation, we have to be really careful we’re not preventing future innovation,” he said.