Certification of Health IT

CRITERIA

Certification Program Requirements

ONC's Health IT Certification Program is composed of functional requirements known as “certification criteria.” Developers certify their Health IT Modules by demonstrating conformance to these certification criteria, using test procedures (that may have associated test tools and/or test data) approved by the National Coordinator. Additionally, ONC provides clarifications to certification criteria through Certification Companion Guides (CCG) designed to assist with health IT product development.

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2015 Edition Criteria

The 2015 Edition builds on past rulemakings through new and enhanced certification criteria, standards, and implementation specifications.

2015 Edition Cures Update Criteria

Updates to the existing 2015 Edition introduced by the ONC Cures Act Final Rule, including standards-based APIs and the U.S. Core Data for Interoperability (USCDI).

Standards Version Advancement Process

The Standards Version Advancement Process (SVAP) permits developers to voluntarily update Certified Health IT Modules to newer approved versions of adopted standards.

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AT A GLANCE

The Certification Process

ONC’s Health IT Certification Program includes both pre-certification testing and post-certification reporting requirements. ONC works with Authorized Certification Bodies (ONC-ACBs) and Testing Labs (ONC-ATLs), consistent with international governance standards, to ensure that Certified Health IT Developers adhere to technical standards and demonstrate functionality to support HHS programs.

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ONC-Authorized Certification Bodies (ONC-ACBs)

View the ONC-ACBs that have been authorized by ONC to certify health IT in the Certification Program.

ONC-Authorized Testing Laboratories (ONC-ATLs)

View the ONC-ALTs that have been authorized by ONC to perform health IT testing.

ONC-Authorized Testing Partners

ONC welcomes the submission of test procedures, test tools and associated test data that may be used to improve the Certification Program.

ONC Health IT Certification Program Test Tools

Explore the test tools that support the Certification Program, including the Standards Implementation & Testing Environment (SITE) and the testing suite for Standardized API for Patient and Population Services, Inferno.

ONC-ACB Surveillance

ONC-ACBs are required to conduct ongoing surveillance activities to assess whether Certified Health IT Modules not only meet the requirements of certification in a controlled testing environment, but also continue to do so when implemented and used in production environment.

ONC Direct Review

In some cases, ONC may choose to directly review Certified Health IT Modules or a Certified Health IT Developer's actions or practices to determine whether they conform to the requirements of the Certification Program.

Conditions & Maintenance of Certification

The 21st Century Cures Act (Section 4002) requires the Secretary of Health and Humans Services to establish Conditions and Maintenance of Certification requirements for the ONC Health IT Certification Program.

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Certified Health IT Product List (CHPL)

The Certified Health IT Product List (CHPL) is a comprehensive and authoritative listing of all certified health information technologies that have been successfully tested and certified by the Certification program.

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ONC Health IT Certification Program Resources

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2022 SVAP Fact Sheet

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API Resource Guide

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Cures Update Fact Sheet

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Attestation Resource Guide

Certified Health IT Complaint Process

For complaints regarding potential noncompliance with ONC Health IT Certification Program requirements, customers and end-users should first reach out to the developer. If this proves ineffective, the matter may be escalated to the ONC-ACB or ONC.

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We recommend that customers and end-users first work with their Certified Health IT Developers to resolve any issues of potential noncompliance with certification requirements, including the Conditions and Maintenance of Certification.

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If the issue cannot be resolved at Step 1, we then recommend the customer or end-user contact the ONC-Authorized Certification Body (ONC-ACB). You can find the ONC-ACB for a Certified Health IT Module on the CHPL by searching the listing.

ONC-ACB Contact Emails

If neither of the preceding steps resolve the issue, customers and end-users may provide feedback to ONC via the Health IT Feedback and Inquiry Portal. ONC will check to see if the Health IT Module in question is certified. If it is, we will refer the matter to the appropriate ONC-ACB at Step 2.

Health IT Feedback and Inquiry Portal

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Content last reviewed on September 21, 2022