ONC Implements Changes to the Health IT Certification Program

On Thursday, September 21, the Office of the National Coordinator for Health IT (ONC) announced two changes to the Health IT Certification Program in an effort to improve efficiency and reduce burden industry-wide.  

The changes are: 

  • Approving more than 50 percent of test procedures to be self-declaration

ONC revised its ONC-approved test procedures for 30 out of the 55 certification criteria focused on the Centers for Medicare & Medicaid Services’ (CMS) Quality Payment Program to be deemed “self-declaration only.”  ONC explained that this change means that health IT developers will self-declare their product’s conformance to these criteria without having to spend valuable time testing with ONC-Authorized Testing Laboratories (ONC-ATLs).  

  • Exercising discretion for randomized surveillance of certified health IT products

ONC is exercising enforcement discretion when it comes to ONC-ACBs conducting randomized surveillance and will not audit ONC-Authorized Certification Bodies (ONC-ACBs) for compliance with randomized surveillance requirements or otherwise take administrative or other action to enforce such requirements against ONC-ACBs.  ONC had previously required that the agency conduct randomized surveillance for, at a minimum, two percent of the health IT certifications they issue.  Overall, ONC stated that 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.