Test Method for Health Information Technology:
Initial Set of Standards, Implementation Specifications,and Certification Criteria for EHR Technology (45 CFR Part 170 Subpart C)
The American Recovery and Reinvestment Act of 2009 emphasizes the need for the U.S. to move toward the use of electronic health records. To encourage a more widespread adoption of interoperable health information technology, the legislation calls for the Office of the National Coordinator (ONC) for Health IT, in consultation with NIST, to recognize a program for the voluntary certification of health information technology as being in compliance with applicable certification criteria to meet defined meaningful use requirements. In collaboration with ONC, NIST is developing the necessary functional and conformance testing requirements, test cases, and test tools in support of the health IT certification program.
A Final Rule on an initial set of standards, implementation specifications, and certification criteria for adoption by the HHS Secretary was issued on July 13, 2010. NIST has completed its revisions of the draft test procedures to adjust to the Final Rule. These test procedures have been provided to ONC for the National Coordinator's approval for use under the temporary certification program by ONC-ATCBs. The test procedures will retain the "Approval (Pending)" status until formally approved by the National Coordinator.
The Final Rule and related information is found at http://healthit.hhs.gov.
Questions about the applicability of the initial set of standards, implementation specifications, and certification criteria should be directed to ONC at ONC.Certification@hhs.gov. Questions about the test procedures should be directed to NIST at email@example.com. Note that NIST will automatically forward to ONC at the address above any questions regarding the applicability of the standards, implementation specifications, and certification criteria. Questions about functions and activities of the ATCBs should be directed to ONC at ONC.Certification@hhs.gov
Developing the Test Method
In support of the health IT certification program, NIST developed the conformance test method (test procedures, test data, and test tools) to ensure compliance with the meaningful use technical requirements and standards.
To develop the test method, NIST conducted an analysis of the HHS/ONC Interim Final Rule (IFR) published in the Federal Register on January 13,2010 including:
- the functional and interoperable requirements
- the referenced standards
- the test procedures which could be used to validate conformance with the derived test requirements
- the assumptions which may influence the selection of a specific test method or the scope of testing
Beginning in February 2010, NIST released draft test procedures on an incremental basis based on the IFR published on January 13, 2010. The draft test procedures did not take into account considerations from the ONC public comment process. During the rollout of the draft test procedures, NIST received public feedback. This information has been compiled and used in updating the test procedures. The draft test procedures have been archived under Draft Test Procedures (Archive).
A Final Rule on an initial set of standards, implementation specifications, and certification criteria for adoption by the HHS Secretary was issued on July 13, 2010. NIST has completed its revisions of the draft test procedures to adjust to the Final Rule. These test procedures have been approved by the National Coordinator for use under the temporary certification program by ONC-ATCBs. Approved test procedures are located under Approved 2011 Edition Test Procedures.