35 P.S. § 10232.3 Definitions

• Library: Pennsylvania Statutes
• Edition: 2023
• Currency: Current through P.A. Acts 2023-27
• Year: 2023
• Citation: 35 P.S. § 10232.3

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:

"Eligible patient." As follows:

(1) An individual who has:

(i) a terminal illness, attested to by the patient's treating physician;

(ii) carefully considered all other treatment options approved by the Federal Food and Drug Administration;

(iii) been unable to participate in a clinical trial for the terminal illness that is located within 100 miles of the patient's home address or has not been accepted to the clinical trial within one week of completion of the clinical trial application process;

(iv) received a recommendation from the patient's treating physician for an investigational drug, biological product or medical device;

(v) given written, informed consent for the use of the investigational drug, biological product or medical device, or, if the patient is either a minor or lacks the mental capacity to provide informed consent, a parent or legally authorized representative has given written, informed consent on the patient's behalf; and

(vi) documentation from the patient's treating physician that the patient meets the requirements of this paragraph.

(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.