The changes affect ONC-Authorized Certification Bodies and ONC-Authorized Testing Laboratories.
Here are the two changes to the ONC Health IT Certification Program.
1. More than 50 percent of the program’s test procedures are now self-declared. ONC revised 30 out of its 55 certification criteria — including some those adopted to support CMS Quality Payment Programs — to be “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-ATL,” they wrote.
2. ONC will exercise discretion for randomized surveillance of certified health IT products. Although ONC-ACBs are required to conduct random surveillance testing at a minimum of 2 percent of the health IT certifications they issue, ONC said it will not audit ONC-ACBs for compliance until further notice.
“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,” they wrote.
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