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Note that "alternative" means any test method that is not operated-maintained by ONC or NIST.
Background
On June 9, 2015 the Department of Health and Human Services (HHS) published a notice in the Federal Register titled "Acceptance and Approval of Non-Governmental Developed Test Procedures, Test Tools, and Test Data for Use Under the ONC Health IT Certification Program." This notice informed the public of ONC's policy that permits any person or entity to submit test procedures, test tools, and test data (herein a "test method") to ONC to be considered for approval and use by accredited testing laboratories. The notice reiterated that in determining whether to approve a test method for purposes of the ONC Health IT Certification Program, the National Coordinator will consider whether it is clearly traceable to a certification criterion or criteria; whether it is sufficiently comprehensive for NVLAP-accredited testing laboratories to use in testing health IT's compliance with the certification criterion or criteria; whether an appropriate public comment process was used during the development of the test method; and any other relevant factors (76 FR 1280).
Read the 5-year goal to transition the ONC Health IT Certification Program testing portfolio.
Process
Test Procedure - Tool Approval Worksheet
ONC – Authorized Testing Laboratory Application (ONC-ATL)
Reference: https://www.healthit.gov/topic/certification-ehrs/onc-approved-alternative-test-method
PPT list of the current Program Partners
Step 1 | Step 2 | Step 3 | Step 4 |
---|---|---|---|
Summary proposal is submitted to the ONC.Certification@hhs.gov mailbox | ONC response with a process overview, a customized worksheet is created-sent | Completed worksheet is submitted, ONC reviews- requests demonstrations- information as necessary | ONC prepares analysis recommendation paper, and then a memorandum for the National Coordinator to approve or disapprove based on the analysis |
Step 5 | Step 6 | Step 7 | |
MOU is created- signed defining operational dimensions | Test procedures-artifacts are created by the submitter, reviewed-approved by ONC; CHPL updated | ATL-ACB's are trained in testing method as required |
Engagements
The Sequoia Project