50-12-102: 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.