[Federal Register Volume 80, Number 110 (Tuesday, June 9, 2015)]
[Rules and Regulations]
[Page 32477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 170


Acceptance and Approval of Non-Governmental Developed Test 
Procedures, Test Tools, and Test Data for Use Under the ONC Health IT 
Certification Program

AGENCY: Office of the National Coordinator for Health Information 
Technology (ONC), Department of Health and Human Services.

ACTION: Reissuance.

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SUMMARY: This document further informs the public of ONC's policy that 
permits any person or entity to submit test procedures, test tools, and 
test data for approval and use under the ONC Health IT Certification 
Program.

DATES: Reissued June 9, 2015.

FOR FURTHER INFORMATION CONTACT: Alicia Morton, Director, ONC Health IT 
Certification Program, Office of the National Coordinator for Health 
Information Technology, 202-549-7851.

SUPPLEMENTARY INFORMATION: On January 7, 2011, the Department of Health 
and Human Services issued a final rule establishing a permanent 
certification program for the purposes of testing and certifying health 
information technology (``Establishment of the Permanent Certification 
Program for Health Information Technology,'' 76 FR 1262) (``Permanent 
Certification Program final rule''). The permanent certification 
program was renamed the ``ONC HIT Certification Program'' in a final 
rule published on September 4, 2012 (77 FR 54163) (``2014 Edition EHR 
Certification Criteria final rule''). In the proposed rule entitled 
``2015 Edition Health Information Technology (Health IT) Certification 
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, 
and ONC Health IT Certification Program Modifications'' (80 FR 16804, 
16806), we propose to further rename the program as the ``ONC Health IT 
Certification Program.''
    In the preamble of the Permanent Certification Program final rule, 
we stated that a person or entity may submit a test procedure or test 
tool (to note, which includes any associated test data) to the National 
Coordinator for Health Information Technology (the National 
Coordinator) to be considered for approval and use by NVLAP accredited 
testing laboratories. ``The submission should identify the developer of 
the test tool and/or test procedure; specify the certification 
criterion or criteria that is/are addressed by the test tool and/or 
test procedure; and explain how the test tool and/or test procedure 
would evaluate a Complete EHR's, EHR Module's, or if the applicable, 
and other type of HIT's compliance with the applicable certification 
criterion or criteria. The submission should also provide information 
describing the process used to develop the test tool and/or test 
procedure, including any opportunity for the public to comment on the 
test tool and/or test procedure and the degree to which public comments 
were considered.'' (76 FR 1280) We also stated that ``[i]n determining 
whether to approve a test tool and/or test procedure for purposes of 
the permanent certification program, the National Coordinator will 
consider whether it is clearly traceable to a certification criterion 
or criteria adopted by the Secretary; whether it is sufficiently 
comprehensive (i.e., assesses all required capabilities) for NVLAP-
accredited testing laboratories to use in testing a Complete EHR's, EHR 
Module's, or other type of HIT's compliance with the certification 
criterion or criteria adopted by the Secretary; whether an appropriate 
public comment process was used during the development of the test tool 
and/or test procedure; and any other relevant factors.'' (76 FR 1280)
    During the time in which the ONC Health IT Certification Program 
has operated, health IT developers have suggested that testing 
efficiencies could be achieved if the ONC Health IT Certification 
Program were to leverage operational testing and certification, such as 
the ePrescribing (eRX) network testing (and certification). As 
indicated by the previously recited ONC policy, the National 
Coordinator is open to approving test procedures, test tools, and test 
data that meet the outlined approval requirements above for an 
applicable adopted certification criterion or criteria. By way of this 
document, we strongly encourage persons or entities to submit such test 
procedures, test tools, and test data to ONC if they believe such 
procedures, tools, and data could be used to meet ONC's certification 
criteria and testing approval requirements. We also note that there is 
no programmatic prohibition on the approval of multiple test 
procedures, test tools, and test data for a certification criterion or 
criteria.

    Dated: May 21, 2015.
Alicia Morton,
Director, ONC Health IT Certification Program, Office of the National 
Coordinator for Health Information Technology.
[FR Doc. 2015-13510 Filed 6-8-15; 8:45 am]
 BILLING CODE 4150-45-P