The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise:
(2) The term does not include an individual being treated as an inpatient in any hospital. "Health care provider." A licensed health care facility, as defined in section 802.1 of the act of July 19, 1979 ( P.L. 130, No.48), known as the Health Care Facilities Act, or a person who is licensed, certified or otherwise regulated to provide health care services under the laws of this Commonwealth, including, but not limited to, as a physician, a certified nurse practitioner or a physician's assistant.
"Investigational drug, biological product or medical device." A drug, biological product or medical device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the Federal Food and Drug Administration and remains under investigation in a clinical trial approved by the Federal Food and Drug Administration.
"Physician." As defined in section 2 of the act of December 20, 1985 ( P.L. 457, No.112), known as the Medical Practice Act of 1985.
"Terminal illness." A disease or condition that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.
"Written, informed consent." A written document placed in the patient's medical record signed by the patient and attested to by the patient's treating physician and a witness that, at a minimum:
(1) Explains the currently approved products and treatments for the disease or condition from which the patient suffers.(2) Attests to the fact that the patient concurs with the patient's treating physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient's life.(3) Identifies clearly the specific proposed investigational drug, biological product or medical device that the patient is seeking to use.(4) Describes the potentially best and worst outcomes of using the investigational drug, biological product or medical device with a realistic description of the most likely outcome, including the possibility that new, unanticipated, different or worse symptoms might result, and that death could be hastened by the proposed treatment, based on the treating physician's knowledge of the proposed treatment and the patient's condition.(5) Makes clear that the patient's health insurer and health care provider are not obligated to pay for the use of the investigational drug, biological product or medical device or any care or treatments consequent to the use of the investigational drug, biological product or medical device.(6) Makes clear that the patient's eligibility for hospice care may be withdrawn if the patient begins curative treatment and care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements.(7) Makes clear that in-home health care may be denied if treatment begins.(8) States that the patient understands that the patient is liable for all expenses consequent to the use of the investigational drug, biological product or medical device, and that this liability extends to the patient's estate, unless a contract between the patient and the manufacturer of the investigational drug, biological product or medical device states otherwise.