The Office of the National Coordinator for Health IT is aiming to allay provider concerns about the performance of some electronic health record systems in the field that do not match their stated performance achieved during certification, according to ONC officials.
The clarification came earlier this month during a joint meeting of the HIT Policy and Standards committee during discussion of a final rule released in late October expanding ONC’s scope of review.
“We recognize that certified health IT not only has to do what it’s supposed to do and what it’s certified to do in the testing environment, but also really has to support the needs of providers once it’s on the ground,” said Elise Sweeney Anthony, director of ONC’s Office of Policy.
According to Sweeney Anthony, the so-called Enhanced Oversight and Accountability Rule has codified modifications and new requirements under the ONC Health IT Certification Program in an effort to better protect public health and safety as well strengthen the accountability and transparency of certified HIT. The provisions of the final rule went into effect on December 19.
“This rule is a continued commitment by ONC to make sure that the process associated with certified health IT and its use, once it’s on the ground, is very transparent—that providers and other users are aware of how the technology is supposed to operate and that this actually is how it operates once it’s out, released and then implemented,” added Sweeney Anthony.
At this month’s HIT Policy-Standards Committee meeting, she defined what the final rule does and does not entail. According to Sweeney Anthony, the Enhanced Oversight and Accountability Rule is designed to:
- Establish a regulatory framework for ONC to directly review already certified health IT products.
- Increase ONC oversight of health IT testing bodies.
- Enhance transparency and accountability by making identifiable surveillance results of certified health IT publicly available.
On the other hand, she said the rule does not:
- Create new certification criteria; or requirements for health IT developers not under direct review.
- Establish new certification/health IT requirements for providers participating in HHS programs.
- Create a means for ONC to directly test and certify health IT (ONC-Authorized Certification Bodies—ONC-ACBs—will continue to test and certify).
- Establish regular or routine auditing of certified health IT by ONC.
Sweeney Anthony said ONC may initiate direct review if it has a reasonable belief that certified health IT may not conform to program requirements because the products may be causing or contributing to conditions that present a serious risk to public health or safety. And, suspension of certified health IT can occur when the agency has a “reasonable belief” that the certified health IT may present a serious risk to public health or safety, she added.
In addition, a certification ban prohibits the certification of health IT, unless it serves to correct the non-conformity, thus incentivizing health IT developers to remedy non-conformities.
A corrective action plan (CAP) process enables developers to work with ONC to address issues that arise. In those cases, a CAP requires health IT developers to: notify all potentially affected customers of the non-conformity and plan for resolution; attest and provide documentation that the non-conformity and all issues were resolved in the specified timeframe; and explain and agree to execute the steps that will prevent the non-conformity from re-occurring.
“If, as required under the regulation, the developer isn’t cooperating despite multiple efforts to get them to cooperate, we can issue a notice of proposed termination,” said Michael Lipinski, director of ONC’s division of federal policy/regulatory affairs and lead drafter of the rule.
According to Lipinski, if a product is suspended or terminated, ONC will make that information publicly available on its Certified Health IT Products List. He added that developers can appeal the regulation decision to suspend or terminate. However, they can’t appeal the notice of non-conformity.
“Our goal is not to terminate products as soon as we find that there’s a problem. What we want to do is make sure that this product is operating as it should for the user community that uses these on a daily basis to provide patient care,” claimed Sweeney Anthony. “We think that to be as effective as possible this rule will require everyone to come to table to address the problem and get it fixed and that involves the vendor community.”
She also pointed out that the rule establishes a process for ONC to authorize and oversee accredited testing laboratories (ONC-ATLs) to align with ONC’s existing oversight of ONC-ACBs, and facilitates ONC’s ability to quickly, directly, and precisely address testing and performance issues.
“In terms of the direct review component, what this rule does is it sets up a regulatory framework for ONC to directly review certified health IT that’s already been certified—that’s the key part there and then it increases oversight around health IT testing bodies; it also increases the transparency and accountability for the surveillance results,” said Sweeney Anthony.
She contends that the Enhanced Oversight and Accountability Rule bolsters transparency and provides customers and users of certified HIT with valuable information about the overall conformity of these products to program requirements.
Specifically, the rule requires ONC-ACBs to make identifiable surveillance results publicly available on the web-based Certified Health IT Product List on a quarterly basis. This information must include: the names of health IT developers; names of products and versions; certification criteria and program requirements surveilled; identification of the type of surveillance (i.e., reactive and randomized); the dates of surveillance was initiated and completed; the number of sites that were used in randomized surveillance; as well as the results of surveillance.
According to Sweeney Anthony, the results will start being posted online no later than early April.
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