The Office of the National Coordinator for Health Information Technology’s (ONC) Health IT Certification Program (Certification Program) is a voluntary program established by ONC to provide for the certification of health IT. ONC establishes the Certification Program requirements as well as outcome-focused requirements known as “certification criteria” for health IT developers and Health IT Modules. Based on these certification criteria, ONC develops a test method (to include test procedures and may include test tools (including associated test data) that is approved by the National Coordinator for Health Information Technology (National Coordinator). In addition, ONC has developed a Certification Companion Guide for each criterion to provide additional clarifications to the test method. Health IT certified under the Certification Program must conform to the full scope of the product’s required capabilities, including regulatory/conformance expectation clarifications and interpretations set forth in the applicable Certification Companion Guides.
ONC has established certification criteria under the following regulations:
- 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Final Rule, hereafter referred to as the 2015 Edition, published in the Federal Register on October 16, 2015.
- The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule made several changes to the existing 2015 Edition Health IT Certification Criteria. The final rule introduced a small number of new certification criteria, revised several existing certification criteria, and it removed several certification criteria (some immediately and others on a time-limited schedule). These changes constitute the 2015 Edition Cures Update.
- The Information Blocking and the ONC Health IT Certification Program: Extension of Compliance Dates and Timeframes in Response to the COVID-19 Public Health Emergency Interim Final Rule with Comment Period
- The Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition Final Rule was formally approved on December 14, 2012, by the National Coordinator. Per the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule, the 2014 Edition certification criteria and related standards, terms and requirements have been removed from the Code of Federal Regulations (CFR) (77 FR 54163, 79 FR 54429).ONC provided guidance for the removal of the 2014 requirements, similar to guidance created to support the removal of the 2011 Edition EHR certification criteria and related standards, terms and requirements from the Code of Federal Regulations (CFR) (77 FR 54430, 54447).