Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 45 - Public Welfare |
Subtitle A - Department of Health and Human Services |
SubChapter D - Health Information Technology |
Part 170 - Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology |
Subpart E - ONC Health IT Certification Program |
§ 170.501 - Applicability.
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§ 170.501 Applicability.
(a) This subpart establishes the processes that applicants for ONC-ACB status must follow to be granted ONC-ACB status by the National Coordinator; the processes the National Coordinator will follow when assessing applicants and granting ONC-ACB status; the requirements that ONC-ACBs must follow to maintain ONC-ACB status; and the requirements of ONC-ACBs for certifying Complete EHRs, Health IT Module(s), and other types of health IT in accordance with the applicable certification criteria adopted by the Secretary in subpart C of this part.
(b) This subpart establishes the processes that applicants for ONC-ATL status must follow to be granted ONC-ATL status by the National Coordinator; the processes the National Coordinator will follow when assessing applicants and granting ONC-ATL status; the requirements that ONC-ATLs must follow to maintain ONC-ATL status; and the requirements of ONC-ATLs for testing Complete EHRs and Health IT Modules in accordance with the applicable certification criteria adopted by the Secretary in subpart C of this part.
(c) This subpart establishes the processes accreditation organizations must follow to request approval from the National Coordinator to be an ONC-AA and that the National Coordinator will follow to approve an accreditation organization under the ONC Health IT Certification Program as well as certain ongoing responsibilities for an ONC-AA. [Reserved]
(d) This subpart establishes the processes the National Coordinator will follow when exercising direct review of certified health IT and related requirements for ONC-ACBs, ONC-ATLs, and developers of health IT certified under the ONC Health IT Certification Program.
[81 FR 72464, Oct. 19, 2016, as amended at 85 FR 25950, May 1, 2020]