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September 22, 2017

ONC updates health IT certification program to ease industry burden

Daily Briefing

The Office of the National Coordinator for Health IT (ONC) on Thursday announced two changes to its health IT certification process intended to improve the program's efficiency and reduce burden on the industry.

The Health IT Certification Program was created in 2010 to provide certification standards for health IT products at a time when eligible professionals and eligible hospitals were beginning to adopt electronic health records under the meaningful use program.

Details on changes to the health IT certification process

The first change is that CMS will make more than 50 percent of test procedures "self-declaration only," meaning health IT developers will no longer have to allocate time to test those procedures with ONC. Instead, health IT developers will "self-declare their product's conformance" with 30 out of ONC's 55 certification criteria, Elise Anthony, ONC's director of policy, and Steven Posnack, ONC's director of office of standards and technology, wrote in a blog post.

The second change will provide ONC's Authorized Certification Bodies (ACBs) more discretion regarding randomized surveillance of certified health IT products, Healthcare IT News reports. Anthony and Posnack wrote, "ONC will not, until further notice, audit ONC-ACBs for compliance with randomized surveillance requirements or otherwise take administrative or other action to enforce such requirements against ONC-ACBs." They explained that the change will allow "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 that by reducing the burden on industry stakeholders, the changes will allow ONC and health IT developers to dedicate additional resources toward the implementation of other measures, such as interoperability efforts and the 21st Century Cures Act (Sullivan, Healthcare IT News, 9/21; Monica, EHRIntelligence, 9/21; ONC blog post, 9/21).

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