Standard

Standard means a rule, condition, or requirement:
(1) Describing the following information for products, systems, services, or practices:
(i) Classification of components;
(ii) Specification of materials, performance, or operations; or
(iii) Delineation of procedures; or
(2) With respect to the privacy of protected health information.

Source

45 CFR § 160.103

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Scoping language

Except as otherwise provided, the following definitions apply to this subchapter:

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