Montana § 50-12-102 Definitions

Montana Statutes

§ 50-12-102 — Definitions

Montana·Title 50 HEALTH AND SAFETY·Ch. 12 TREATMENTS FOR CHRONIC OR TERMINAL ILLNESS·Part 1 Right to Try Act

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" ha

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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.

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