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Code · Montana · Title 50 — Health and Safety · Chapter 12 · Part 1

50-12-102. Definitions.

238 words·~1 min read·/mt/title-50/chapter-12/part-1/50-12-102·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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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