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Title 45

Displaying title 45, up to date as of 9/16/2021. Title 45 was last amended 9/13/2021.

Title 45

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§ 170.502 Definitions.

For the purposes of this subpart:

Applicant means a single organization or a consortium of organizations that seeks to become an ONC-ACB or ONC-ATL by submitting an application to the National Coordinator for such status.

Deployment site means the physical location where a Health IT Module(s) or other type of health IT resides or is being or has been implemented.

Development site means the physical location where a Health IT Module(s) or other type of health IT was developed.

Gap certification means the certification of a previously certified Health IT Module(s) to:

(1) All applicable new and/or revised certification criteria adopted by the Secretary at subpart C of this part based on test results issued by a NVLAP-accredited testing laboratory under the ONC Health IT Certification Program or an ONC-ATL; and

(2) All other applicable certification criteria adopted by the Secretary at subpart C of this part based on the test results used to previously certify the Complete EHR or Health IT Module(s) under the ONC Health IT Certification Program.

ONC-Authorized Certification Body or ONC-ACB means an organization or a consortium of organizations that has applied to and been authorized by the National Coordinator pursuant to this subpart to perform the certification of Health IT Module(s), and/or other types of health IT under the ONC Health IT Certification Program.

ONC-Authorized Testing Lab or ONC-ATL means an organization or a consortium of organizations that has applied to and been authorized by the National Coordinator pursuant to this subpart to perform the testing of Health IT Modules to certification criteria adopted by the Secretary at subpart C of this part.

Providing or provide an updated certification means the action taken by an ONC-ACB to ensure that the developer of a previously certified Health IT Module(s) shall update the information required by § 170.523(k)(1)(i), after the ONC-ACB has verified that the certification criterion or criteria to which the Health IT Module(s) was previously certified have not been revised and that no new certification criteria are applicable to the Health IT Module(s).

Remote certification means the use of methods, including the use of web-based tools or secured electronic transmissions, that do not require an ONC-ACB to be physically present at the development or deployment site to conduct certification.

[76 FR 1325, Dec. 7, 2011, as amended at 77 FR 54291, Sept. 4, 2012; 81 FR 72464, Oct. 19, 2016; 85 FR 25950, May 1, 2020]