AN ACT RELATING TO HEALTH AND SAFETY -- TERMINAL PATIENTS' RIGHT TO TRY ACT (Establishes the terminally ill patients’ right to try act.)

H8329

2026 -- H 8329
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LC006089
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STATE OF RHODE ISLAND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2026
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A N A C T
RELATING TO HEALTH AND SAFETY -- TERMINAL PATIENTS' RIGHT TO TRY ACT

Introduced By:
Representatives Slater, and Diaz

Date Introduced:
March 20, 2026

Referred To:
House Judiciary
It is enacted by the General Assembly as follows:
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SECTION 1. Legislative purpose.
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The general assembly enacts this chapter to promote maximum access by removing barriers
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in state law and indemnifying those involved in providing potentially life-saving treatments and
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treatments to improve the quality of patients' remaining life, to incentivize healthcare facilities,
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healthcare providers, manufacturers of drugs, biologics and devices, and other persons and entities
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involved in the care of patients, to treat terminal illness, whether through company-sponsored
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clinical trial, single-patient protocol, compassionate use protocol, or any other means of access to
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drugs, biologics, and/or devices which gathers information on patient outcomes, and to make Rhode
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Island a jurisdiction that attracts and fosters clinical trials and the development of drugs, biologics,
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and devices intended to monitor, diagnose and treat terminal illness.
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SECTION 2. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby
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amended by adding thereto the following chapter:
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CHAPTER 106
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TERMINAL PATIENTS' RIGHT TO TRY ACT
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23-106-1. Definitions.
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As used in this chapter:
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(1) "Diagnostic use" means the use of an innovative medical device to identify, monitor,
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or characterize a disease or condition, or to determine the safety and effectiveness of treatment
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regimens, in patients with a medically threatening disease or condition.

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(2) "Eligible facility" means an institution that is operating with an “Institutional Review
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Board” established pursuant to the provisions of 42 U.S.C. 289(a) and 45 CFR Part 46.
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(3) "Eligible patient" means a person to whom all of the following apply:
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(i) The person has been diagnosed by the person's physician and a consulting physician
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with a terminal illness or life-threatening disease;
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(ii) The person has already tried or is not a candidate for eligible United States Food and
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Drug Administration (FDA) approved treatment options for the person’s disease or condition;
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(iii) The person is unable to participate in a clinical trial involving the eligible
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investigational drug, biologic or device;
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(iv) The person has provided written informed consent for the use of the investigational
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drug, biological product, or device or, if the patient is a minor or lacks the mental capacity to
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provide informed consent, a parent or legal guardian has provided written informed consent on the
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patient's behalf;
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(v) The physician providing access to an investigational drug, biologic, or device shall not
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be compensated directly by the manufacturer for providing access to this therapy.
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(4) "Individualized investigational treatment" means drugs, biologics, or devices unique to
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and produced exclusively for use for an individual patient, based on their own genetic profile
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including, but not limited to, individualized gene therapy antisense oligonucleotides (ASO),
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individualized neoantigen vaccines, and any other individualized treatment.
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(5) "Innovative medical device" means a device that has successfully completed phase one
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of a clinical trial, as defined in 21CFR 312.21(a), but has not been approved for general use by the
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FDA and remains under investigation in a clinical trial, and may be used for either therapeutic or
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diagnostic purposes by eligible patients.
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(6) "Investigational drug, biologic, or device" means a drug, biologic, or device that has
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successfully completed phase one of a clinical trial as defined in 21CFR 312.21(a), but has not been
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approved for general use by the FDA and remains under investigation in a clinical trial.
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(7) "Medically threatening disease or condition" means a terminal or life-threatening
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disease or conditions, or a disease or condition that is likely to result in significant morbidity or
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mortality, or that significantly impairs quality of life, as determined by the patient's physician.
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(8) "Other protected access" means and includes:
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(i) "Expanded access" whereby the treating physician requests access to an investigational
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drug, biologic, or device from the FDA which is subject to oversight from an Institutional Review
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Board; and
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(ii) "Off-label use" means prescribing an FDA approved drug, biologic, or device for a use

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not approved for that specific indication.
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(9) "Physician" means an allopathic or osteopathic physician licensed pursuant to chapter
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37 of title 5,who is providing medical care, treatment or evaluation to the patient.
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(10) "Remote signing" means the signing of any form, witnessed by a notary public or a
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licensed healthcare provider, providing written informed consent for a person diagnosed by a
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physician with a terminal or condition illness, or medically threatening disease or condition, to
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participate in a clinical trial or receive a drug, biologic, or device, by the patient or, if the patient is
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a minor or lacks the mental capacity to provide consent, by a parent or legal guardian on the patient's
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behalf.
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(11) "Serious or potentially life-threatening disease or condition" means a disease or
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condition that is likely to result in significant morbidity, mortality, or permanent impairment of a
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vital organ function including, but not limited to:
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(i) Cancer at stage three (3) or four (4), including aggressive or high-mortality cancers such
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as pancreatic cancer, glioblastoma, colorectal cancer, ovarian cancer, breast cancer, lung cancer,
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and triple-negative breast cancer;
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(ii) Diseases or conditions that, without intervention, are likely to progress to a life-
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threatening state; and
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(iii) Diseases or conditions that significantly impair quality of life or vital organ function,
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as determined by the patient's physician.
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(12) "Telehealth prescreening" means any remote, real-time discussion intended, in part,
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to determine whether a person may be:
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(i) Ineligible for or not selected to participate in a clinical trial; or
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(ii) Ineligible to receive or not be offered a drug, biologic, or device.
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(13) "Terminal illness" means a disease that, without life-sustaining procedures, shall result
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in death in the near future or a state of permanent unconsciousness from which recovery is unlikely.
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23-106-2. Immunity.
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Notwithstanding any provision of law to the contrary, a manufacturer of a drug, biologic,
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or device, a pharmacist, a healthcare facility, a healthcare provider, or a person or entity involved
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in the care of a patient using a drug, biologic, or device is immune from suit for any harm done to
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a patient resulting from the drug, biologic, or device if:
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(1) The person has a terminal illness as determined by the person's physician and a
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consulting physician;
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(2) The person's physician has determined that the person has no comparable or satisfactory
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United States Food and Drug Administration (FDA) approved treatment options available to treat

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the disease or condition involved;
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(3) The patient has provided written informed consent for the use of the drug, biologic, or
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device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent
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or legal guardian has provided written informed consent on the patient's behalf and, if the patient
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is a legal adult, the consent is not contrary to the prior documented directions or directives of the
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patient;
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(4) The manufacturer, pharmacist, facility, provider, or other person or entity has not
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engaged in willful misconduct or other bad faith conduct. For purpose of this subsection, “willful
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misconduct" means any conduct intended to hasten the death of the patient or conducted in bad
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faith or knowingly conducted as not in the best interest of this patient; and
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(5) If the drug, biologic, or device consists of an individualized investigational treatment,
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it is administered by a healthcare provider in cooperation with an eligible facility.
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23-106-3. Private cause of action.
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(a) Nothing in this chapter shall be construed to create a private cause of action against any
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person or entity except as specified in subsection (b) of this section.
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(b) Notwithstanding any provision of law to the contrary, any patient diagnosed by a
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physician with a terminal illness, and who has been treated, is being treated, or otherwise could be
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treated in this state with a drug, biologic, or device, and is affected by a violation of this chapter,
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or a healthcare facility or a healthcare provider involved in the treatment of the patient, shall be
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entitled to petition the superior court for injunctive relief and reasonable attorneys' fees against any
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regulatory or law enforcement authority that violates this chapter.
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23-106-4. Use of innovative medical devices for diagnostic purposes.
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(a) Notwithstanding any provision of law to the contrary, an eligible patient, as defined in
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§ 23-106-1, may access and use an innovative medical device for diagnostic purposes, in addition
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to treatment; provided that:
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(1) The physician providing access to the innovative medical device for diagnostic
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purposes deems the medical device useful for data collection and diagnostic purposes;
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(2) The patient's physician has determined that the use of the device is necessary to
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diagnose, monitor, or characterize the patient's medically threatening disease or condition;
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(3) The patient has provided written informed consent for the use of the device for
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diagnostic purposes, or, if the patient is a minor or lacks the mental capacity to provide informed
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consent, a parent or legal guardian has provided written informed consent on the patient's behalf;
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(4) The physician providing access to the innovative medical device for diagnostic
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purposes shall not be compensated directly by the manufacturer for such access; and

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(5) The use of the device is conducted in accordance with all applicable federal and state
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laws and regulations.
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(b) The provisions of this chapter regarding liability, telehealth prescreening, and remote
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signing shall apply equally to the use of innovative medical devices for diagnostic purposes.
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23-106-5. Telehealth prescreening.
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(a) Notwithstanding any regulation or provision of law to the contrary, any healthcare
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provider, while physically located in the state, may conduct a telehealth prescreening with any
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patient, in any state or jurisdiction, who has been diagnosed by a physician with a terminal illness,
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a medically threatening disease or conditions or a serious or potentially life-threatening disease or
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condition.
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(b) No regulatory or law enforcement agency or state subdivision shall take action against
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a healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient for
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conducting a telehealth prescreening as defined in § 23-106-1 and pursuant to subsection (a) of this
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section.
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(c) A healthcare facility, a healthcare provider, or a person or entity involved in the care of
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a patient shall be immune from suit to the extent that the suit is based upon a telehealth
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prescreening.
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23-106-6. Remote signing.
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(a) Notwithstanding any regulation or provision of law to the contrary, a manufacturer of
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a drug, biologic, or device, a pharmacist, a healthcare facility, a healthcare provider, or a person or
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entity involved in the care of a patient using a drug, biologic, or device may obtain consent to treat
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a patient using remote signing as defined in § 23-106-1; provided that, the manufacturer,
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pharmacist, facility, provider, or other person or entity has an office in the state and has conducted
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a telehealth prescreening pursuant to § 23-106-5.
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(b) The remote signing shall amount to full and effective consent for treatment under all
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applicable laws and regulations.
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(c) No regulatory or law enforcement agency or state subdivision shall take action against
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a healthcare facility, a healthcare provider, or a person or entity involved in the care of a patient for
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obtaining patient consent through remote signing, as defined in § 23-106-1, if the provider or
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facility has complied with subsection (a) of this section.
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(d) A healthcare facility, a healthcare provider, or a person or entity involved in the care of
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a patient shall be immune from suit to the extent that the suit challenges the validity of a remote
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signing to effect lawful consent; provided that, the person or entity is complying in good faith with
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the terms of this chapter and has not engaged in willful misconduct.

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23-106-7. Rules and regulations.
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The director of the department of health shall promulgate rules and regulations to
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implement, enforce and carry out the purpose of this chapter.
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SECTION 3. This act shall take effect on January 1, 2027.
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EXPLANATION
BY THE LEGISLATIVE COUNCIL
OF
A N A C T
RELATING TO HEALTH AND SAFETY -- TERMINAL PATIENTS' RIGHT TO TRY ACT
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This act would establish the terminally ill patients' right to try act. The act would expand
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upon federal law by streamlining access to innovative treatments, allowing for telehealth and
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remote signing of documents, use of innovative medical devices for diagnostic purposes and
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providing immunity to healthcare providers.
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This act would take effect on January 1, 2027.
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LC006089
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