As used in this part, unless the context otherwise requires:
(1)"Advanced illness" means a progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of current federal drug administration approved and available treatments, and that, without life-sustaining procedures, will soon result in death;
(2)"Adverse event" means any untoward medical occurrence associated with the use of an investigational drug, biological product, or device in humans, regardless if drug-related;
(3)"Eligible patient" means an individual who meets all of the following conditions:
(A)Has an advanced illness, attested to by the patient's treating physician and confirmed by a second phy
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As used in this part, unless the context otherwise requires: (1) "Advanced illness" means a progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of current federal drug administration approved and available treatments, and that, without life-sustaining procedures, will soon result in death; (2) "Adverse event" means any untoward medical occurrence associated with the use of an investigational drug, biological product, or device in humans, regardless if drug-related; (3) "Eligible patient" means an individual who meets all of the following conditions: (A) Has an advanced illness, attested to by the patient's treating physician and confirmed by a second physician; (B) Has considered all other treatment options currently approved by the United States food and drug administration, and is unable to enter, or be accepted within one (1) week after applying to, a clinical trial within fifty (50) miles of the individual's home; (C) Has received a recommendation from the patient's physician for an investigational drug, biological product, or device; (D) Has given written, informed consent for the use of the investigational drug, biological product, or device; and (E) Has documentation from the patient's physician that the patient meets the requirements of this subdivision (3); (4) "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase 1 of a clinical trial as documented by the National Institutes of Health but has not yet been approved for general use by the federal food and drug administration (FDA) and remains under investigation in a clinical trial that is approved by the FDA; and (5) "Written, informed consent" means a written document that is signed by the patient, the patient's parent, if the patient is a minor, the patient's legal guardian, or the patient's attorney-in-fact designated by the patient under title 34, chapter 6, part 2, and attested to by the patient's physician and a witness, and that, at a minimum, includes all of the following: (A) An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers; (B) An attestation that the patient concurs with the patient's physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life; (C) Clear identification of the specific proposed investigational drug, biological product, or device that the patient is seeking to use; (D) A description of the potentially best and worst outcomes of using the investigational drug, biological product, or device and a realistic description of the most likely outcome. The description shall include the possibility that new, unanticipated, different, or worse symptoms might result and that death could be hastened by the proposed treatment. The description shall be based on the physician's knowledge of the proposed treatment in conjunction with an awareness of the patient's condition; (E) A release of liability relative to the treating physician, licensed healthcare providers, hospital, and manufacturer of the investigational drug, biological product, procedure, or device; (F) A statement that the patient's health plan or third-party administrator and provider are not obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product, or device, unless they are specifically required to do so by law or contract; (G) A statement that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment with the investigational drug, biological product, or device and that care may be reinstated if this treatment ends and the patient meets hospice eligibility requirements; and (H) A statement that the patient understands that the patient is liable for all expenses consequent to the use of the investigational drug, biological product, or device and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the drug, biological product, or device states otherwise.