(1) It is not a breach of the applicable standard of care for a physician, other licensed health care provider, or hospital to treat an eligible patient with an investigational drug or investigational device under this chapter.

(2) A physician, other licensed health care provider, or hospital that treats an eligible patient with an investigational drug or investigational device under this chapter may not, for any harm done to the eligible patient by the investigational drug or device, be subject to: (a) civil liability; (b) criminal liability; or (c) licensure sanctions under: (i) for a physician: (A)Title 58, Chapter 67, Utah Medical Practice Act; or (B)Title 58, Chapter 68, Utah Osteopathic Medical Practice Act; (ii) for the other licensed health care provider, the act governing the other licensed health care provider's license; or (iii) for the hospital, Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.

(a) civil liability;

(b) criminal liability; or

(c) licensure sanctions under: (i) for a physician: (A)Title 58, Chapter 67, Utah Medical Practice Act; or (B)Title 58, Chapter 68, Utah Osteopathic Medical Practice Act; (ii) for the other licensed health care provider, the act governing the other licensed health care provider's license; or (iii) for the hospital, Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.

(i) for a physician: (A)Title 58, Chapter 67, Utah Medical Practice Act; or (B)Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;

(A)Title 58, Chapter 67, Utah Medical Practice Act; or

(B)Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;

(ii) for the other licensed health care provider, the act governing the other licensed health care provider's license; or

(iii) for the hospital, Title 26, Chapter 21, Health Care Facility Licensing and Inspection Act.

(3) This chapter does not: (a) require a manufacturer of an investigational drug or investigational device to agree to make an investigational drug or investigational device available to an eligible patient or an eligible patient's physician; (b) require a physician to agree to: (i) administer an investigational drug to an eligible patient under this chapter; or (ii) treat an eligible patient with an investigational device under this chapter; or (c) create a private right of action for an eligible patient: (i) against a physician or hospital, for the physician's or hospital's refusal to: (A) administer an investigational drug to an eligible patient under this chapter; or (B) treat an eligible patient with an investigational device under this chapter; or (ii) against a manufacturer, for the manufacturer's refusal to provide an eligible patient with an investigational drug or an investigational device under this chapter.

(a) require a manufacturer of an investigational drug or investigational device to agree to make an investigational drug or investigational device available to an eligible patient or an eligible patient's physician;

(b) require a physician to agree to: (i) administer an investigational drug to an eligible patient under this chapter; or (ii) treat an eligible patient with an investigational device under this chapter; or

(i) administer an investigational drug to an eligible patient under this chapter; or

(ii) treat an eligible patient with an investigational device under this chapter; or

(c) create a private right of action for an eligible patient: (i) against a physician or hospital, for the physician's or hospital's refusal to: (A) administer an investigational drug to an eligible patient under this chapter; or (B) treat an eligible patient with an investigational device under this chapter; or (ii) against a manufacturer, for the manufacturer's refusal to provide an eligible patient with an investigational drug or an investigational device under this chapter.

(i) against a physician or hospital, for the physician's or hospital's refusal to: (A) administer an investigational drug to an eligible patient under this chapter; or (B) treat an eligible patient with an investigational device under this chapter; or

(A) administer an investigational drug to an eligible patient under this chapter; or

(B) treat an eligible patient with an investigational device under this chapter; or

(ii) against a manufacturer, for the manufacturer's refusal to provide an eligible patient with an investigational drug or an investigational device under this chapter.