The Office of the National Coordinator for Health IT on Thursday revealed two changes to its certification criteria that officials said are designed to reduce the burden on industry and make the meaningful use program more efficient.
The first is making more than half of test procedures self-declarable and the second is more discretion around randomized surveillance of certified health IT products.
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Elise Anthony, director of policy at ONC, and Steven Posnack, director of ONC’s Office of Standards and Technology, wrote on the Health IT Buzz blog that 30 of the 55 criteria were intended to support CMS Quality Payment Program and those are now self-declaration only.
“This means that health IT developers will self-declare their product's conformance to these criteria without having to spend valuable time testing with an ONC-Authorized Testing Laboratory,” Anthony and Posnack added. “The test procedures for health IT products now designated as ‘self-declaration’ are for functionality-based certification criteria.”
The second change ONC made on Thursday relates to randomized surveillance of ONC-Authorized Certification Bodies. The ACBs are required to conduct randomized surveillance for at least two percent of the health IT products they certify.
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“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,” Anthony and Posnack wrote. “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.”
ONC said that these changes are intended to ease the burden on health IT developers and certification bodies so they can focus more on interoperability.
“This change enables ONC-ATLs and health IT developers to devote more of their resources to the remaining interoperability-oriented criteria, aligning with the tenets of the 21st Century Cures Act,” Anthony and Posnack wrote.
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