§1169.3. Definitions

As used in this Subpart, the following terms have the meaning ascribed to them in this Section:

(1) "Eligible patient" means a person to whom all of the following criteria apply:

(a) Has a terminal illness.

(b) As determined by the person's physician, has no comparable or satisfactory treatment options that are approved by the United States Food and Drug Administration and available to diagnose, monitor, or treat the person's disease or condition, and the probable risk to the person from the investigational drug, biological product, or device is not greater than the probable risk from the person's disease or condition.

(c) Has received a prescription or recommendation from his physician for an investigational drug, biological product, or device.

(d)(i) Has given his consent in writing for the use of the investigational drug, biological product, or device; or, if he is a minor or lacks the mental capacity to provide consent, a parent or legal guardian has given consent in writing on his behalf.

(ii) A person who can understand and comprehend spoken English but is physically unable to talk or write may be deemed as meeting the criteria of this Subparagraph if he is competent and able to indicate consent by other means.

(e) Has documentation from his physician indicating that he has met the requirements provided in this Subpart.

(2)(a) "Investigational drug, biological product, or device" means a drug, biological product, or device that has successfully completed phase one of a United States Food and Drug Administration approved clinical trial, but has not been approved for general use by the United States Food and Drug Administration and remains under investigation in a clinical trial.

(b) Notwithstanding Subparagraph (a) of this Paragraph, for purposes of this Subpart, "investigational drug, biological product, or device" shall include any device possessing the following characteristics regardless of whether it has successfully completed phase one of a United States Food and Drug Administration approved clinical trial:

(i)(aa) If of a robotic nature, the device is designed such that any failure in a multitude of continuous tests of its internal subsystems should cause motion to stop, consistent with the Guidelines For Robotics Safety from the Occupational Safety and Health Administration of the United States Department of Labor (Directive Number STD 01-12-002).

(bb) For purposes of this Item, "robotic nature" shall mean capable of independent motion or moving the user.

(ii) The device has all of the following features for intentional control:

(aa) The motion of the device responds to specific controls from the user.

(bb) The device has no machine state in which motion continues without a specific command from the user.

(iii) The device has an emergency stop button which allows an assistant to force the motion of the device to stop.

(3) "Terminal illness" means a disease that, without life-sustaining procedures, will result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely. This diagnosis shall be confirmed by a second independent evaluation by a board-certified physician in an appropriate speciality.

Acts 2014, No. 346, §1; Redesignated from R.S. 40:1300.423 by HCR 84 of 2015 R.S.; Acts 2017, No. 292, §1.