SECTION 1. Legislative purpose. The general assembly enacts this chapter to promote maximum access by removing barriers in state law and indemnifying those involved in providing potentially life-saving treatments and treatments to improve the quality of patients' remaining life, to incentivize healthcare facilities, healthcare providers, manufacturers of drugs, biologics and devices, and other persons and entities involved in the care of patients, to treat terminal illness, whether through company-sponsored clinical trial, single-patient protocol, compassionate use protocol, or any other means of access to drugs, biologics, and/or devices which gathers information on patient outcomes, and to make Rhode Island a jurisdiction that attracts and fosters clinical trials and the development of drugs, biologics, and devices intended to monitor, diagnose and treat terminal illness.
SECTION 2. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby amended by adding thereto the following chapter: 23-106-1. Definitions. As used in this chapter:
(1) "Diagnostic use" means the use of an innovative medical device to identify, monitor, or characterize a disease or condition, or to determine the safety and effectiveness of treatment regimens, in patients with a medically threatening disease or condition.
(2) "Eligible facility" means an institution that is operating with an “Institutional Review Board” established pursuant to the provisions of 42 U.S.C. 289(a) and 45 CFR Part 46.
(3) "Eligible patient" means a person to whom all of the following apply:
(i) The person has been diagnosed by the person's physician and a consulting physician with a terminal illness or life-threatening disease;
(ii) The person has already tried or is not a candidate for eligible United States Food and Drug Administration (FDA) approved treatment options for the person’s disease or condition;
(iii) The person is unable to participate in a clinical trial involving the eligible investigational drug, biologic or device;
(iv) The person has provided written informed consent for the use of the investigational drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has provided written informed consent on the patient's behalf;
(v) The physician providing access to an investigational drug, biologic, or device shall not be compensated directly by the manufacturer for providing access to this therapy.
(4) "Individualized investigational treatment" means drugs, biologics, or devices unique to and produced exclusively for use for an individual patient, based on their own genetic profile including, but not limited to, individualized gene therapy antisense oligonucleotides (ASO), individualized neoantigen vaccines, and any other individualized treatment.
(5) "Innovative medical device" means a device that has successfully completed phase one of a clinical trial, as defined in 21CFR 312.21(a), but has not been approved for general use by the FDA and remains under investigation in a clinical trial, and may be used for either therapeutic or diagnostic purposes by eligible patients.
(6) "Investigational drug, biologic, or device" means a drug, biologic, or device that has successfully completed phase one of a clinical trial as defined in 21CFR 312.21(a), but has not been approved for general use by the FDA and remains under investigation in a clinical trial.
(7) "Medically threatening disease or condition" means a terminal or life-threatening disease or conditions, or a disease or condition that is likely to result in significant morbidity or mortality, or that significantly impairs quality of life, as determined by the patient's physician.
(8) "Other protected access" means and includes:
(i) "Expanded access" whereby the treating physician requests access to an investigational drug, biologic, or device from the FDA which is subject to oversight from an Institutional Review Board; and
(ii) "Off-label use" means prescribing an FDA approved drug, biologic, or device for a use not approved for that specific indication.
(9) "Physician" means an allopathic or osteopathic physician licensed pursuant to chapter 37 of title 5,who is providing medical care, treatment or evaluation to the patient.
(10) "Remote signing" means the signing of any form, witnessed by a notary public or a licensed healthcare provider, providing written informed consent for a person diagnosed by a physician with a terminal or condition illness, or medically threatening disease or condition, to participate in a clinical trial or receive a drug, biologic, or device, by the patient or, if the patient is a minor or lacks the mental capacity to provide consent, by a parent or legal guardian on the patient's behalf.
(11) "Serious or potentially life-threatening disease or condition" means a disease or condition that is likely to result in significant morbidity, mortality, or permanent impairment of a vital organ function including, but not limited to:
(i) Cancer at stage three (3) or four (4), including aggressive or high-mortality cancers such as pancreatic cancer, glioblastoma, colorectal cancer, ovarian cancer, breast cancer, lung cancer, and triple-negative breast cancer;
(ii) Diseases or conditions that, without intervention, are likely to progress to a life- threatening state; and
(iii) Diseases or conditions that significantly impair quality of life or vital organ function, as determined by the patient's physician.
(12) "Telehealth prescreening" means any remote, real-time discussion intended, in part, to determine whether a person may be:
(i) Ineligible for or not selected to participate in a clinical trial; or
(ii) Ineligible to receive or not be offered a drug, biologic, or device.
(13) "Terminal illness" means a disease that, without life-sustaining procedures, shall result in death in the near future or a state of permanent unconsciousness from which recovery is unlikely. 23-106-2. Immunity. Notwithstanding any provision of law to the contrary, a manufacturer of a drug, biologic, or device, a pharmacist, a healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient using a drug, biologic, or device is immune from suit for any harm done to a patient resulting from the drug, biologic, or device if:
(1) The person has a terminal illness as determined by the person's physician and a consulting physician;
(2) The person's physician has determined that the person has no comparable or satisfactory United States Food and Drug Administration (FDA) approved treatment options available to treat the disease or condition involved;
(3) The patient has provided written informed consent for the use of the drug, biologic, or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has provided written informed consent on the patient's behalf and, if the patient is a legal adult, the consent is not contrary to the prior documented directions or directives of the patient;
(4) The manufacturer, pharmacist, facility, provider, or other person or entity has not engaged in willful misconduct or other bad faith conduct. For purpose of this subsection, “willful misconduct" means any conduct intended to hasten the death of the patient or conducted in bad faith or knowingly conducted as not in the best interest of this patient; and
(5) If the drug, biologic, or device consists of an individualized investigational treatment, it is administered by a healthcare provider in cooperation with an eligible facility. 23-106-3. Private cause of action.
(a) Nothing in this chapter shall be construed to create a private cause of action against any person or entity except as specified in subsection (b) of this section.
(b) Notwithstanding any provision of law to the contrary, any patient diagnosed by a physician with a terminal illness, and who has been treated, is being treated, or otherwise could be treated in this state with a drug, biologic, or device, and is affected by a violation of this chapter, or a healthcare facility or a healthcare provider involved in the treatment of the patient, shall be entitled to petition the superior court for injunctive relief and reasonable attorneys' fees against any regulatory or law enforcement authority that violates this chapter. 23-106-4. Use of innovative medical devices for diagnostic purposes.
(a) Notwithstanding any provision of law to the contrary, an eligible patient, as defined in § 23-106-1, may access and use an innovative medical device for diagnostic purposes, in addition to treatment; provided that:
(1) The physician providing access to the innovative medical device for diagnostic purposes deems the medical device useful for data collection and diagnostic purposes;
(2) The patient's physician has determined that the use of the device is necessary to diagnose, monitor, or characterize the patient's medically threatening disease or condition;
(3) The patient has provided written informed consent for the use of the device for diagnostic purposes, or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has provided written informed consent on the patient's behalf;
(4) The physician providing access to the innovative medical device for diagnostic purposes shall not be compensated directly by the manufacturer for such access; and
(5) The use of the device is conducted in accordance with all applicable federal and state laws and regulations.
(b) The provisions of this chapter regarding liability, telehealth prescreening, and remote signing shall apply equally to the use of innovative medical devices for diagnostic purposes. 23-106-5. Telehealth prescreening.
(a) Notwithstanding any regulation or provision of law to the contrary, any healthcare provider, while physically located in the state, may conduct a telehealth prescreening with any patient, in any state or jurisdiction, who has been diagnosed by a physician with a terminal illness, a medically threatening disease or conditions or a serious or potentially life-threatening disease or condition.
(b) No regulatory or law enforcement agency or state subdivision shall take action against a healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient for conducting a telehealth prescreening as defined in § 23-106-1 and pursuant to subsection (a) of this section.
(c) A healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient shall be immune from suit to the extent that the suit is based upon a telehealth prescreening. 23-106-6. Remote signing.
(a) Notwithstanding any regulation or provision of law to the contrary, a manufacturer of a drug, biologic, or device, a pharmacist, a healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient using a drug, biologic, or device may obtain consent to treat a patient using remote signing as defined in § 23-106-1; provided that, the manufacturer, pharmacist, facility, provider, or other person or entity has an office in the state and has conducted a telehealth prescreening pursuant to § 23-106-5.
(b) The remote signing shall amount to full and effective consent for treatment under all applicable laws and regulations.
(c) No regulatory or law enforcement agency or state subdivision shall take action against a healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient for obtaining patient consent through remote signing, as defined in § 23-106-1, if the provider or facility has complied with subsection (a) of this section.
(d) A healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient shall be immune from suit to the extent that the suit challenges the validity of a remote signing to effect lawful consent; provided that, the person or entity is complying in good faith with the terms of this chapter and has not engaged in willful misconduct. 23-106-7. Rules and regulations. The director of the department of health shall promulgate rules and regulations to implement, enforce and carry out the purpose of this chapter.
SECTION 3. This act shall take effect on January 1, 2027.
