For each capability that a technology

(4) Quality management system. (i) For each capability that a technology includes and for which that capability's certification is sought, the use of a Quality Management System (QMS) in the development, testing, implementation, and maintenance of that capability must be identified that satisfies one of the following ways: (A) The QMS used is established by the Federal government or a standards developing organization. (B) The QMS used is mapped to one or more QMS established by the Federal government or standards developing organization(s). (ii) When a single QMS was used for applicable capabilities, it would only need to be identified once. (iii) When different QMS were applied to specific capabilities, each QMS applied would need to be identified. (5) Accessibility-centered design. For each capability that a Health IT Module includes and for which that capability's certification is sought, the use of a health IT accessibility-centered design standard or law in the development, testing, implementation and maintenance of that capability must be identified. (i) When a single accessibility-centered design standard or law was used for applicable capabilities, it would only need to be identified once. (ii) When different accessibility-centered design standards and laws were applied to specific capabilities, each accessibility-centered design standard or law applied would need to be identified. This would include the application of an accessibility-centered design standard or law to some capabilities and none to others. (iii) When no accessibility-centered design standard or law was applied to all applicable capabilities such a response is acceptable to satisfy this certification criterion. (6) Consolidated CDA creation performance. The following technical and performance outcomes must be demonstrated related to Consolidated CDA creation. The capabilities required under paragraphs (g)(6)(i) through (v) of this section can be demonstrated in tandem and do not need to be individually addressed in isolation or sequentially. (i) This certification criterion's scope includes: (A) The data classes expressed in the standards in 170.213 in accordance with 170.205(a)(4) and (a)(5) and paragraphs (g)(6)(i)(C)(1) through (4) of this section for the time period up to and including December 31, 2025; or (B) The data classes expressed in the standards in 170.213, and in accordance with 170.205(a)(4) and (6) and paragraphs (g)(6)(i)(C)(1) through (3) of this section. (C) The following data classes:

Source

45 CFR § 170.315


Scoping language

in this part
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