This subtitle does not apply to: (1) Protected health information that is collected by a covered entity or business associate as defined in 45 C.F.R. Parts 160 and 164; or (2) Genetic data or biological samples collected for the purpose of research, as defined in 45 C.F.R. 164.501, that is conducted in accordance with: (i) The federal policy for the protection of human subjects established in 45 C.F.R. Part 46; (ii) The Good Clinical Practice Guidelines issued by the International Council for Harmonisation; or (iii) The U.S. Food and Drug Administration Protection of Human Subjects under 21 C.F.R. Parts 50 and 56.
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