The Office of the National Coordinator for Health IT on Friday finalized a rule that clarifies its ability to directly review certified health information technology and hold developers accountable for non-conformity.
Direct reviews, the rule outlines, will focus on two specific areas, National Coordinator for Health IT Vindell Washington said on a press call: where there are risks to public health and safety, and where there are circumstances present that provide challenges for ONC authorized certification bodies (ACBs).
“These may be ones such as when issues arise involving multiple certified functionalities or products that have been certified by multiple ONC ACBs,” Washington said.
He added that, because certified health IT can fail to perform as it should when interacting with either uncertified capabilities within a product or other technologies, ONC’s actions under the direct review process will focus on the certified health IT and not on uncertified capabilities or other tools.
“We recognize that certified health IT often doesn’t operate in a vacuum,” Washington said. “A developer of certified health IT would not be held responsible for non-conformities that are not reasonably within the ability of that agent to influence or control. Specifically, ONC does not intend to review the functioning of uncertified capabilities, except to the extent that an uncertified capability interacts with and affects the performance of a certified capability that is under review.”
Under the rule, ONC will require corrective action for non-conformities and will be able to suspend or terminate a certification issued to a Complete EHR or Health IT Module. Developers will be able to appeal such suspensions or certification terminations.
Additionally, the rule outlines the finalization of a “certification ban” on the future certification of a developer’s technology “when the certification of one or more of the health IT developer’s current Complete EHRs or Health IT Modules” experiences the following:
- Termination by ONC
- Withdrawn by an ONC-ACB because the health IT developer requested it to be withdrawn when the health IT developer’s health IT was the subject of a potential non-conformity or non-conformity as determined by ONC
- Withdrawn by an ONC-ACB because of a non-conformity with any of the certification criteria
- Withdrawn by an ONC-ACB because the health IT developer requested it to be withdrawn when the health IT developer’s health IT was the subject of surveillance for a certification criterion
The rule also updates ONC’s health IT certification program by outlining the agency’s ability to authorize and oversee accredited testing laboratories and by making identifiable surveillance results available.
ONC estimates that the average annual costs associated with this rule will be $6,597,033. However, Washington could not provide specifics of how much of this work will be carried out or if additional staff will be necessary. He did say that ONC has been conducting much of the related tasks. ONC’s budget has remained relatively flat--at around $60 million annually--since its inception.
“Today we already get notification complaints from the field,” Washington said. “Today we have a process that we work through with the ACBs. There have been rarely implemented times where we’ve had to decertify products that are in the field. This is, in my mind, more of a refinement of that activity and the development of some more of the ability to have corrective action planning as opposed to the fact that we’ve not had any insight into this.”
When asked similar questions about increasing staffing and the budget regarding the rule last month, Washington said he hoped the requests made in President Barack Obama’s proposed budget for ONC would be honored. The FY 2017 budget request for ONC is $82 million.