Definitions.

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  • (1) "Eligible patient" means an individual who has been diagnosed with a terminal illness by a physician.
  • (2) "Insurer" means the same as that term is defined in Section 31A-1-301.
  • (3) "Investigational device" means a device that:
    • (a) meets the definition of "investigational device" in 21 C.F.R. Sec. 812.3; and
    • (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.
  • (4) "Investigational drug" means a drug that:
    • (a) meets the definition of "investigational new drug" in 21 C.F.R. Sec. 312.3; and
    • (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.
  • (5) "Medicinal dosage form" means the same as that term is defined in Section 58-37-3.6.
  • (6) "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.
  • (7) "Terminal illness" means a condition of a patient that:
    • (a) as determined by a physician:
      • (i) 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
      • (ii) will inevitably lead to the patient's death; 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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