Montana § 50-12-102 - Definitions

§ 50-12-102. Definitions

Definitions. As used in this part, the following definitions apply: (1) "Experimental treatment" means the provision of a medical intervention by a health care provider involving an investigational drug, biological product, device, or other treatment that has successfully completed phase 1 of a clinical trial but has not yet been approved for general use by the United States food and drug administration and either: (a) remains under investigation in a clinical trial approved by the United States food and drug administration; or (b) has a demonstrated safety record through documented clinical evidence from a qualified medical institution as defined by department rule. (2) "Experimental treatment center" has the same meaning as provided in 50-5-101 . (3) "Health care facility" has the same meaning as provided in 50-5-101 . The term includes an experimental treatment center. (4) "Health care provider" means any of the following individuals licensed pursuant to Title 37: (a) a physician; (b) an advanced practice registered nurse authorized by the board of nursing to prescribe medicine; (c) a physician assistant; and (d) a registered nurse performing services at an experimental treatment center. (5) "Informed consent" means written documentation or digital recordation that meets the requirements of 50-12-105 . (6) "Provider agreement" means a contract authorizing a health care provider to deliver an experimental treatment, or services related to the provision of an experimental treatment, under the supervision of an experimental treatment center's medical director.