ONC established the ONC Health IT Certification Program (Certification Program) to certify health information technology (health IT) consistent with the authority granted to the national coordinator for health information technology in the HITECH Act. The following regulations have shaped the current Certification Program.
Regulatory Changes to the Certification Program
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule)
Interim Final Rule with Comment – November 4, 2020
The ONC Cures Act Final Rule calls on the healthcare industry to adopt standardized application programming interfaces (APIs), which will help allow individuals to access structured electronic health information (EHI) securely and easily. The rule includes a provision requiring patients’ electronic access to all of their EHI at no cost and implements the information blocking provisions of the Cures Act.
Health IT Certification Program: Enhanced Oversight and Accountability (EOA Final Rule)
The EOA Final Rule creates a regulatory framework for ONC’s Direct Review of Health IT Modules certified under the Certification Program. This oversight includes, when necessary, requiring the correction of non-conformities found in certified health IT products and suspending and/or terminating certifications issued to Certified Health IT Modules. It sets forth processes for ONC to authorize and oversee accredited testing laboratories under the Certification Program. In addition, it includes provisions for expanded public availability of certified health IT surveillance results.
2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications (2015 Edition)
Corrections and Clarifications – December 11, 2015
Proposed Rule – March 30, 2015
The 2015 Edition builds on past rulemakings to facilitate greater interoperability for several clinical health information purposes and enables health information exchange through new and enhanced certification criteria, standards, and implementation specifications.
2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange (2014 Edition Release 2)
Final Rule – September 11, 2014
Proposed Rule – February 26, 2014
The 2014 Edition Release 2 adopted ten optional certification criteria and two revised certification criteria that provide flexibility and clarity and enhance health information exchange. It also made a few improvements to the Certification Program and removed outdated regulation text from the Code of Federal Regulations.
Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology (2014 Edition)
Final Rule – September 4, 2012
The 2014 Edition adopted certification criteria that established the technical capabilities and specified the related standards and implementation specifications that health IT could be certified to and used to meet the Certified EHR Technology required under the Medicare and Medicaid EHR Incentive Programs.
Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (2011 Edition)
Interim Final Rule – October 13, 2010
Interim Final Rule - January 13, 2010
The 2011 Edition set certification criteria that established the technical capabilities and specified the related standards and implementation specifications that Certified EHR Technology (CEHRT) must include to support the meaningful use of EHRs Stage 1.