§ 14-4802

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.