§ 10232.3. Definitions
Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: December 11, 2017
Effective: December 11, 2017
35 P.S. § 10232.3
§ 10232.3. Definitions
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:
(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
“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),1 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 Food and Drug Administration and remains under investigation in a clinical trial approved by the Food and Drug Administration.
“Physician.” As defined in section 2 of the act of December 20, 1985 (P.L. 457, No.112),2 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 eligible patient's medical record signed by the eligible patient and attested to by the eligible patient's treating physician and a witness that, at a minimum:
(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 eligible 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.
(8) States that the eligible patient understands that the eligible 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 eligible patient's estate, unless a contract between the eligible patient and the manufacturer of the investigational drug, biological product or medical device states otherwise.
2017, Oct. 11, P.L. 347, No. 33, § 3, effective in 60 days [Dec. 11, 2017].
35 P.S. § 10232.3, PA ST 35 P.S. § 10232.3
Current through 2023 Regular Session Act 1. Some statute sections may be more current, see credits for details.
|End of Document|