Acceptance and Approval of Non-Governmental Developed Test Procedures, Test Tools, and Test Data for Use Under the ONC Health IT Certification Program, 32477 [2015-13510]
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[FR Doc. 2015–13945 Filed 6–8–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
45 CFR Part 170
Acceptance and Approval of NonGovernmental Developed Test
Procedures, Test Tools, and Test Data
for Use Under the ONC Health IT
Certification Program
Office of the National
Coordinator for Health Information
Technology (ONC), Department of
Health and Human Services.
ACTION: Reissuance.
AGENCY:
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;
SUMMARY:
PO 00000
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32477
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 NVLAPaccredited 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]
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]]>Agencies
[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.
-----------------------------------------------------------------------
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]
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