As used in this chapter: (1) "Eligible illness" means a condition of a patient that: (a) as determined by a physician, presents a substantial and severely debilitating or life- threatening risk to the patient; and (b) presents the patient, after the patient has explored conventional therapy options, with no treatment option that is satisfactory or comparable to treatment with an investigational drug or investigational device. (2) "Eligible patient" means an individual who has been diagnosed with a terminal illness or eligible illness by a physician. (3) "Insurer" means the same as that term is defined in Section 31A-1-301. (4) "Investigational device" means a device that: (a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; (b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational device described in 21 C.F.R. Part 812; and (c) if used to treat an eligible illness, is currently undergoing an investigation, as defined in 21 C.F.R. Sec. 812.3, that complies with all applicable requirements for the investigation in accordance with 21 C.F.R. Part 812. (5) "Investigational drug" means a drug that: (a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; (b) has successfully completed the United States Food and Drug Administration Phase 1 testing for an investigational new drug described in 21 C.F.R. Part 312; and (c) if used to treat an eligible illness, is currently undergoing a clinical investigation, as defined in 21 C.F.R. Sec. 312.3, that complies with all applicable requirements for the clinical investigation in accordance with 21 C.F.R. Part 312. (6) "Medicinal dosage form" means: (a) a tablet; (b) a capsule; (c) a concentrated oil; (d) a liquid formulation; (e) a transdermal preparation; or (f) a sublingual preparation. (7) "Physician" means an individual who is licensed under: (a) Title 58, Chapter 67, Utah Medical Practice Act; or (b) Title 58, Chapter 68, Utah Osteopathic Medical Practice Act. (8) "Terminal illness" means a condition of a patient that: (a) (i) as determined by a physician: (A) is likely to pose a greater risk to the patient than the risk posed to the patient by treatment with an investigational drug or investigational device; and (B) will inevitably lead to the patient's death; or (ii) as determined by a physician who is a board certified oncologist, is cancer; and (b) presents the patient, after the patient has explored conventional therapy options, with no treatment option that is satisfactory or comparable to treatment with an investigational drug or device.
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