Code of Federal Regulations (alpha)

CFR /  Title 45  /  Part 170  /  Sec. 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 by submitting an application for ONC-ACB status to the National Coordinator.

Deployment site means the physical location where a Complete EHR, EHR Module(s) or other type of HIT resides or is being or has been implemented.

Development site means the physical location where a Complete EHR, EHR Module(s) or other type of HIT was developed.

Gap certification means the certification of a previously certified Complete EHR or EHR Module(s) to:

(1) All applicable new and/or revised certification criteria adopted by the Secretary at subpart C of this part based on the test results of a NVLAP-accredited testing laboratory; 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 EHR Module(s).

ONC-Approved Accreditor or ONC-AA means an accreditation organization that the National Coordinator has approved to accredit certification bodies under the ONC HIT 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 Complete EHRs, EHR Module(s), and/or other types of HIT under the ONC HIT Certification Program.

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