ONC changing certification standards

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Two major changes have been announced for the Office of National Coordinator’s (ONC) Health IT Certification Program with the aim of reducing burden for IT vendors and providers using their products.

“Whether it is making certification criteria clarifications clearer and more rapidly accessible through the Certification Companion Guides, or offering more flexible certification options through rulemaking, ONC looks to achieve its mission in the most nimble way possible while still serving the needs of patients, providers, and the health IT community,” wrote ONC policy director Elise Sweeney Anthony and ONC standards and technology director Steven Posnack, MS, MHS in a blog post.

The first change will be making 50 percent of test procedures to be self-declarable. Developers of health IT products will be able to self-declare their products on 30 of the 55 criteria which were intended to support the CMS Quality Payment Program introduced through the Medicare Access and CHIP Reauthorization Act (MACRA) without going through an ONC Authorized Testing Laboratory (ONC-ATL).

“The test procedures for health IT products now designated as “self-declaration” are for functionality-based certification criteria,” Anthony and Posnack wrote. “By making this change, ONC enables ONC-ATLs and health IT developers to devote more of their resources and focus on the remaining interoperability-oriented criteria, aligning with the tenets of the 21st Century Cures Act. In addition, health IT developers are still required to meet certification criteria requirements and maintain their products’ conformance to the full scope of the criteria.”

The second change related to randomized surveillance by ONC’s Authorized Certification Bodies (ONC-ACBs), which had been required for at least two percent of the health IT certifications they issue.

This will no longer be the case, as ONC will exercise “enforcement discretion” and not audit ONC-ACBs for complying with that two percent standard or consider not meeting that threshold as a violence of ACB program requirements.

“This exercise of enforcement discretion will permit ONC-ACBs to prioritize complaint driven, or reactive, surveillance and allow them to devote their resources to certifying health IT to the 2015 Edition,” Anthony and Posnack wrote. “These new actions we are announcing today will support greater availability of certified health IT for providers participating in the CMS's Quality Payment Program.”

ONC under its new chief, Donald Rucker, MD, will likely be expected to reprioritize as it faces a $22 million budget cut for next year. Rucker himself has written he wants to the agency’s focus to shift towards improving interoperability and usability.