This subtitle does not apply to:
(1) 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:
(i) Required to comply with:
1. Title V of the federal Gramm–Leach–Bliley Act;
2. The federal Health Information Technology for Economic and Clinical Health Act; or
3. Regulations promulgated under § 264(c) of the Health Insurance Portability and Accountability Act of 1996; and
(ii) In compliance with the information security requirements of applicable statutes or regulations identified in item (i) of this item; or
(2) Information collected as part of a clinical trial subject to the Federal Policy for the Protection of Human Subjects, in accordance with:
(i) Good clinical practice guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; or
(ii) Human subject protection requirements of the U.S. Food and Drug Administration.