This subtitle does not apply to: Data subject to a statute or regulation identified under item (i) of this item that is controlled by a covered entity or service provider that is: Required to comply with: Title V of the federal Gramm–Leach–Bliley Act; The federal Health Information Technology for Economic and Clinical Health Act; or Regulations promulgated under § 264(c) of the Health Insurance Portability and Accountability Act of 1996; and In compliance with the information security requirements of applicable statutes or regulations identified in item (i) of this item; or Information collected as part of a clinical trial subject to the Federal Policy for the Protection of Human Subjects, in accordance with: Good clinical practice guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; or Human subject protection requirements of the U.S. Food and Drug Administration.