ONC on EHR certifying bodies: Paradigm shifts ahead

“We’re in a transitional period between what the prior paradigm of testing certification included and what this new paradigm will include for purposes of meaningful use,” stated Steven Posnack, MHS, MS, director of the federal policy division at Office of the National Coordinator for Health IT (ONC) during an informational call for health IT providers on the recently released final rule to establish a temporary certification program for EHR technology.

“We’ve identified complete EHR systems and EHR modules which may vary greatly in terms of the capability they provide while also trying to provide a competitive environment,” said Posnack.

The temporary rule establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify EHR technology. According to Posnack, the temporary certification rule serves two purposes:
  • It establishes the process the National Coordinator will use to authorize organizations to test and certify EHR technology; an open application process; and
  • Sets some of the parameters around the testing and certification of EHR technology.

Out of the application process will come ONC-authorized testing and certification bodies (ONC-ATCBs). Those organizations, once identified and authorized, will be listed on the ONC web site. The process could result in potentially two types of ATCBs, Posnack stated, with the first kind authorized for testing and certifying complete EHRs (ambulatory and inpatient as well as EHR modules) and ATCBs authorized for testing and certifying only EHR modules (whose authorization scope is limited to applied-for EHR modules).

Listening to public comment, Posnack stated that, at a minimum, ONC requires ONC-ATCBs to provide remote testing and certification options for both development and deployment sites to make sure there is flexibility in the market place for what the ATCB could offer to accommodate EHR technology. Additionally, considering updates to EHR technology, Posnack stated that the final rule clarifies that if a system hasn’t been adversely affected the certified capabilities, “we wanted to provide some flexibility for those products to ‘inherit’ certified status.”

Carol Bean, PhD, MPH, ONC’s division director for certification and testing, stated the application process for entities to be authorized to test and certify EHR technology will be in two parts: one as a universal application common to all applicants and a second tailored to the applicant to the scope of authorization they seek. This second part includes general knowledge tests of the programs as well as the methodology, Bean stated. Bean also stated that ONC has 30 days to render a decision on the application.

“We expect to have ATCBs operational before the end of summer [and products to be certified and publicly notified in the fall],” Bean stated. “At that point, they will be in business” where vendors and developers can contact them directly. Bean also stated that a public website called CHPL (Certified Health IT Products List) will provide information on all certified products as provided to ONC by individual ATCBs.

The permanent certification program rules and policies will be finalized later this fall, Posnack stated.

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Trimed Popup
Trimed Popup