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ONC Proposed Rule Calls for New Certified EHR Technology Process

ONC's proposed rule calls for more hands-on assessment, establishment of new certified EHR technology labs, and better health IT transparency.

By Sara Heath

The certified EHR technology process is getting an overhaul, as detailed in a new proposed rule from the Office of the National Coordinator for Health IT (ONC) earlier this week.

In the rule, ONC proposed a new process for certifying EHR technology that would allow the agency a more hands-on role. ONC will theoretically be able to directly review all certified EHR and health IT and call for corrective actions where necessary. If the proposed rule is passed, the agency will also be able to create its own certified test laboratories to examine the health technology.

“The proposed rule proposes to establish processes for ONC to directly review health IT certified under the Program and take action when necessary, including requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules,” ONC wrote in a summary of the proposed rule. “The proposed rule includes processes for ONC to authorize and oversee accredited testing laboratories under the Program.”

ONC’s proposed rule contains three parts. The first entails the role the agency will play in examining health IT, the second describes the testing laboratories the agency may establish, and the last calls for better transparency in health IT testing and development.

When directly reviewing health IT and certified EHR technology (CEHRT), ONC will be able to call for developers to fix any non-conformities, or areas where the technology falls short. This will “promote health IT developer accountability for the performance, reliability, and safety of health IT,” ONC says.

Ideally, these provisions will eliminate ONC’s need to cancel or prohibit any health technology because the agency will play a greater role in helping a developer meet its standards.

The proposed rule also calls for ONC-Authorized Testing Labs (ATLs) that would serve as places for health IT and EHRs to be tested for ONC approval. The agency states that labs that currently volunteer to review health technology under ONC rules should apply to become ATLs. On the flip side, ONC says that it will maintain its right to revoke authorization for ATLs that do not meet its standards.

The oversight process for establishing ATLs would be thoroughly developed by ONC, and be similar to how ONC already authorizes health IT testing labs.

“The proposed approach and processes would create an authorization and oversight paradigm for testing labs that is similar and comparable to the paradigm that currently exists for [ONC-Authorized Certification Bodies],” ONC explained in a fact sheet regarding the rule. “This approach would enable ONC to oversee and address testing and certification performance issues throughout the entire continuum of the Program in an immediate, direct, and precise manner.”

In all, these efforts will go toward creating better transparency regarding health IT. ONC explained that it will make information about health technology and EHRs readily available for entities to consult when adopting new products.

The rule states that ONC will make assessment results available on its website each quarter for healthcare organizations to reference, holding health IT and EHR vendors more accountable.

“This would enhance the transparency and accountability of health IT for customers and users by providing valuable information about the continued performance of certified health IT,” ONC said. “The public availability of identifiable surveillance results would also provide a more complete context of surveillance by making more information about certified products available to purchasers and enabling health IT developers to note their continued compliance with Program requirements.”

Government agencies have been making several moves lately toward making health IT assessment more transparent. Earlier this year the Senate Committee on Health, Education, Labor, and Pensions (HELP) passed legislation that also calls for increased transparency for health IT systems, ideally helping healthcare organizations and providers make more informed decisions regarding the technology they choose to adopt.




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