This subtitle does not apply to: 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 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: The federal policy for the protection of human subjects established in 45 C.F.R. Part 46; The Good Clinical Practice Guidelines issued by the International Council for Harmonisation; or The U.S. Food and Drug Administration Protection of Human Subjects under 21 C.F.R. Parts 50 and 56.