Certification Program Regulations
The ONC Health IT Certification Program (Certification Program) certifies 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
HTI-4 Final Rule
The Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization (HTI-4) final rule finalizes new and updated health IT certification criteria for electronic prior authorization, electronic prescribing, and real-time prescription benefit information. It also includes several related criteria for application programming interface (API) functionality and finalizes the adoption of additional standards for HHS that support the exchange of clinical and administrative information with payers. HTI-4 is published as part of the FY2026 CMS Hospital Inpatient Prospective Payment System (IPPS) final rule (CMS-1833-F).
HTI-3 Final Rule
The Health Data, Technology, and Interoperability: Protecting Care Access (HTI-3) final rule finalizes information blocking regulatory enhancements in an effort to improve information sharing while protecting patient privacy.
HTI-2 Final Rule
The Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (HTI-2) final rule amends information blocking regulations and includes corrections and updates to current regulatory provisions of the ONC Health IT Certification Program.
HTI-1 Final Rule
The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule implements provisions of the 21st Century Cures Act and make updates to the Certification Program with new and updated standards, implementation specifications, and certification criteria.
ONC Cures Act Final Rule
The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (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.
Enhanced Oversight and Accountability Final Rule
The Health IT Certification Program: Enhanced Oversight and Accountability (EOA Final Rule) creates a regulatory framework for the 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 ASTP/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
The 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) 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
The 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC Health IT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange (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.
2014 Edition
The 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) 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.
2011 Edition
The Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (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.