WHAT THIS BILL REGULATES · 4 REQUIREMENT TYPES
How Is This Bill Enforced
Verbatim statutory text on the left; plain-language analysis and a per-section checklist on the right. Numbered markers cross-link to the matching checklist row.
As used in this part: "Artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions)" or "artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions)" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments. "Authorized representativeAuthorized representative"Authorized representative" means: (1) An agent, a guardian, or a surrogate of the patient; or (2) A person who is given a written individual instruction or power of attorney for health care in the patient's advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2.HRS § 321-__ (Definitions)" means: (1) An agent, a guardian, or a surrogate of the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions); or (2) A person who is given a written individual instruction or power of attorney for health care in the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2. "Consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions)" means a decision that has a significant effect on the physical or mental health of a patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions). "DepartmentDepartment"Department" means the department of health.HRS § 321-__ (Definitions)" means the department of health. "Health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions)" and "health care service" have the same meanings as those terms are defined in section 323D-2. "Health informationHealth information"Health information" and "individually identifiable health information" have the same meanings as those terms are defined in section 323B-2.HRS § 321-__ (Definitions)" and "individually identifiable health informationHealth information"Health information" and "individually identifiable health information" have the same meanings as those terms are defined in section 323B-2.HRS § 321-__ (Definitions)" have the same meanings as those terms are defined in section 323B-2. "PatientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)" means a person who is under the observation and care of or otherwise receiving health care services from a health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions). "Personal dataPersonal data"Personal data" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal data" does not include de-identified data or publicly available information.HRS § 321-__ (Definitions)" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal dataPersonal data"Personal data" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal data" does not include de-identified data or publicly available information.HRS § 321-__ (Definitions)" does not include de-identified data or publicly available information. "ProfilingProfiling"Profiling" means any form of automated processing performed on personal data to evaluate, analyze, or predict personal aspects related to an identified or identifiable individual's economic situation, health, personal preferences, interests, reliability, behavior, location, or movements.HRS § 321-__ (Definitions)" means any form of automated processing performed on personal dataPersonal data"Personal data" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal data" does not include de-identified data or publicly available information.HRS § 321-__ (Definitions) to evaluate, analyze, or predict personal aspects related to an identified or identifiable individual's economic situation, health, personal preferences, interests, reliability, behavior, location, or movements. "Remote communicationRemote communication"Remote communication" means communication through means by which a person who is not physically present in the same location as a health care provider may communicate with the health care provider on a substantially simultaneous basis. "Remote communication" includes telecommunication, videoconference, and electronic communication, including internet-based communication and electronic transmission.HRS § 321-__ (Definitions)" means communication through means by which a person who is not physically present in the same location as a health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) may communicate with the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) on a substantially simultaneous basis. "Remote communicationRemote communication"Remote communication" means communication through means by which a person who is not physically present in the same location as a health care provider may communicate with the health care provider on a substantially simultaneous basis. "Remote communication" includes telecommunication, videoconference, and electronic communication, including internet-based communication and electronic transmission.HRS § 321-__ (Definitions)" includes telecommunication, videoconference, and electronic communication, including internet-based communication and electronic transmission. "Substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions)" means a factor that: (1) Assists in making a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); (2) Is capable of altering the outcome of a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); and (3) Is generated by an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions). "Substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions)" includes any use of an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to generate any content, decision, prediction, or recommendation concerning a patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) that is used as a basis to make a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions) concerning the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions).
This section establishes the defined terms for the new part governing artificial intelligence in health care. Key definitions include consequential decision (a decision with a significant effect on a patient's physical or mental health), substantial factor (an AI-generated factor that assists in making or is capable of altering the outcome of a consequential decision), and profiling (automated processing of personal data to evaluate or predict personal aspects). The definitions of health care provider and health care service are incorporated by reference to existing HRS § 323D-2.
(a) 1 Any health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) that uses or makes available for use an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) intended to interact with patientsPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) by means of remote communicationRemote communication"Remote communication" means communication through means by which a person who is not physically present in the same location as a health care provider may communicate with the health care provider on a substantially simultaneous basis. "Remote communication" includes telecommunication, videoconference, and electronic communication, including internet-based communication and electronic transmission.HRS § 321-__ (Definitions) shall disclose to the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) or the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s authorized representativeAuthorized representative"Authorized representative" means: (1) An agent, a guardian, or a surrogate of the patient; or (2) A person who is given a written individual instruction or power of attorney for health care in the patient's advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2.HRS § 321-__ (Definitions), as applicable, that the person is interacting with artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions).
(b)–(c) 1 The disclosure shall be made before or at the time of the interaction; provided that in the case of an emergency, the disclosure shall be made as soon as reasonably possible. (c) The disclosure shall be clear and conspicuous, and include: (1) A disclaimer that: (A) The communication was generated by artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions); or (B) The communication was generated by artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) and reviewed by a health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) who is a natural person or a natural person retained by the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions); and (2) Clear instructions on how the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) can directly contact a health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) who is a natural person, an employee of the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions), or other appropriate natural person.
This section requires health care providers using AI systems that interact with patients by remote communication to disclose AI involvement to the patient or authorized representative. The disclosure must be made before or at the time of interaction (or as soon as reasonably possible in emergencies) and must be clear and conspicuous.
The required disclosure has two components: (1) a disclaimer stating either that the communication was AI-generated, or that it was AI-generated and reviewed by a human health care provider; and (2) clear instructions on how the patient can directly contact a human health care provider or appropriate natural person.
(a) 2 Before using an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions), a health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) shall provide the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) or the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s authorized representativeAuthorized representative"Authorized representative" means: (1) An agent, a guardian, or a surrogate of the patient; or (2) A person who is given a written individual instruction or power of attorney for health care in the patient's advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2.HRS § 321-__ (Definitions), as applicable, with a written notice that: (1) Informs the recipient that the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) will be using an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); (2) Discloses the purpose of the artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) and the nature of the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); (3) Describes the artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) in plain language; and (4) Allows the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) to opt out of the processing of the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s individually identifiable health informationHealth information"Health information" and "individually identifiable health information" have the same meanings as those terms are defined in section 323B-2.HRS § 321-__ (Definitions) or other personal dataPersonal data"Personal data" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal data" does not include de-identified data or publicly available information.HRS § 321-__ (Definitions) for purposes of profilingProfiling"Profiling" means any form of automated processing performed on personal data to evaluate, analyze, or predict personal aspects related to an identified or identifiable individual's economic situation, health, personal preferences, interests, reliability, behavior, location, or movements.HRS § 321-__ (Definitions) in furtherance of decisions that have legal or similarly significant effects concerning the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions).
(b) 3 Any health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) that used an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions) shall provide the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) or the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s authorized representativeAuthorized representative"Authorized representative" means: (1) An agent, a guardian, or a surrogate of the patient; or (2) A person who is given a written individual instruction or power of attorney for health care in the patient's advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2.HRS § 321-__ (Definitions), as applicable, with: (1) A written statement that describes the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions) and the principal reasons for the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions), including: (A) The degree to which, and manner in which, the artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) contributed to the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); (B) The type of data that was processed by the artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) in making the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); and (C) The sources of the data described in paragraph (B); (2) An opportunity to correct any incorrect health informationHealth information"Health information" and "individually identifiable health information" have the same meanings as those terms are defined in section 323B-2.HRS § 321-__ (Definitions) or personal dataPersonal data"Personal data" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal data" does not include de-identified data or publicly available information.HRS § 321-__ (Definitions) that the artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) processed in making, or as a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); and (3) An opportunity to appeal the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions), including allowing, to the extent technically feasible, human review of all information relating to the consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); provided that this paragraph shall not apply if providing the opportunity for appeal is not in the best interest of the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions), including in instances in which any delay might pose a risk to the life or safety of the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions).
(c) 2 The notice and statement required pursuant to subsections (a) and (b), respectively, shall be provided directly to the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) or the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s authorized representativeAuthorized representative"Authorized representative" means: (1) An agent, a guardian, or a surrogate of the patient; or (2) A person who is given a written individual instruction or power of attorney for health care in the patient's advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2.HRS § 321-__ (Definitions), as applicable; provided that if the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) is unable to comply with this requirement, the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) shall provide the notice or statement in a manner that is reasonably calculated to ensure that the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions) or the patientPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions)'s authorized representativeAuthorized representative"Authorized representative" means: (1) An agent, a guardian, or a surrogate of the patient; or (2) A person who is given a written individual instruction or power of attorney for health care in the patient's advance health-care directive pursuant to chapter 327E. For the purposes of this definition, "advance health-care directive", "agent", "guardian", "power of attorney for health care", and "surrogate" have the same meanings as defined in section 327E-2.HRS § 321-__ (Definitions), as applicable, receives the notice or statement.
This section creates a comprehensive set of patient rights when health care providers use AI to make or substantially factor into consequential decisions. It operates in two phases: a pre-decision notice (subsection (a)) and a post-decision statement and rights (subsection (b)).
The pre-decision notice must inform the patient that AI will be used, disclose the purpose of the AI system and the nature of the consequential decision, describe the AI system in plain language, and allow the patient to opt out of profiling that has legal or similarly significant effects. The post-decision statement must explain the decision, including the degree and manner of AI contribution, the data types processed, and data sources. Patients must also be given the opportunity to correct incorrect health information or personal data and to appeal the decision with human review (subject to a patient-safety exception). All notices and statements must be provided directly to the patient or authorized representative.
(a)–(b) 4 Any health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) that uses an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions) shall maintain an artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) oversight personnel. (b) The artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) oversight personnel: (1) Shall be a natural person; (2) Shall have the qualifications, experience, and expertise necessary to effectively evaluate outputs, including but not limited to any information, data, assumptions, predictions, scoring, recommendations, decisions, or conclusions generated by artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) in the field of health care; and (3) May be retained by contracting with a third-party.
(c) 4 The artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) oversight personnel shall: (1) Monitor the artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) used by the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions); and (2) Before the health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) uses an output generated by an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions): (A) Review and evaluate the output; and (B) Validate or override the output.
This section mandates that health care providers using AI in consequential decisions must maintain AI oversight personnel — a qualified natural person who monitors the provider's AI systems, and who reviews, evaluates, and validates or overrides every AI output before it is used in or as a substantial factor in a consequential decision. The oversight personnel must have qualifications, experience, and expertise necessary to evaluate AI outputs in health care. The personnel may be a third-party contractor.
This is a strong human-in-the-loop requirement: the oversight personnel must act before an AI output is used in a consequential decision, and must have authority to override the output — not merely ratify it.
(1)–(3) 5 Any health care providerHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions) that uses an artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, a consequential decisionConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions) shall: (1) Monitor the usage of artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) to make, or be a substantial factorSubstantial factor"Substantial factor" means a factor that: (1) Assists in making a consequential decision; (2) Is capable of altering the outcome of a consequential decision; and (3) Is generated by an artificial intelligence system. "Substantial factor" includes any use of an artificial intelligence system to generate any content, decision, prediction, or recommendation concerning a patient that is used as a basis to make a consequential decision concerning the patient.HRS § 321-__ (Definitions) in making, consequential decisionsConsequential decision"Consequential decision" means a decision that has a significant effect on the physical or mental health of a patient.HRS § 321-__ (Definitions); (2) Conduct regular performance evaluations of the artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions), including the assessment of: (A) Potential biases; (B) Risks to the safety and rights of patientsPatient"Patient" means a person who is under the observation and care of or otherwise receiving health care services from a health care provider.HRS § 321-__ (Definitions), including the confidentiality of personal dataPersonal data"Personal data" means any information that is linked or could be reasonably linkable to an identified or identifiable natural person. "Personal data" does not include de-identified data or publicly available information.HRS § 321-__ (Definitions); and (C) Mitigation strategies for any identified risks; (3) Implement procedures to address any deficiencies identified through the monitoring or performance evaluations, including the suspension or recalibration of any artificial intelligence systemArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions);
(4) 6 (4) Maintain: (A) An updated inventory of the artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions); (B) Documentation on the system design, intended use, and training data of the artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions); (C) Record of the monitoring, performance evaluations, and oversight activities; and (D) Documentation of findings and actions taken to address any deficiencies identified through the monitoring or performance evaluations.
This section imposes ongoing operational obligations on health care providers using AI in consequential decisions. Providers must monitor AI usage, conduct regular performance evaluations covering potential biases, patient safety and privacy risks, and mitigation strategies, implement procedures to address identified deficiencies (including suspension or recalibration), and maintain records including an AI system inventory, design documentation, evaluation records, and documentation of corrective actions.
The performance evaluation requirement is notable for its breadth: it requires assessment of biases, risks to safety and rights (including data confidentiality), and mitigation strategies — essentially a periodic impact assessment obligation.
7 The department of health, in coordination with the department of business, economic development, and tourism, shall adopt rules pursuant to chapter 91 to implement this part. The rules shall include but not be limited to the qualifications, experience, and expertise required for an artificial intelligenceArtificial intelligence"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) oversight personnel and the frequency of regular performance evaluations of artificial intelligence systemsArtificial intelligence system"Artificial intelligence" or "artificial intelligence system" means any engineered or machine-based system that varies in its level of autonomy and that can, for explicit or implicit objectives, infer from the input it receives how to generate outputs that can influence physical or virtual environments.HRS § 321-__ (Definitions) required to be performed by certain health care providersHealth care provider"Health care provider" and "health care service" have the same meanings as those terms are defined in section 323D-2.HRS § 321-__ (Definitions).
This section delegates rulemaking authority to the Department of Health, in coordination with the Department of Business, Economic Development, and Tourism, to implement the new part. The rules must include, at minimum, the qualifications, experience, and expertise required for AI oversight personnel and the frequency of regular performance evaluations of AI systems.
This Act shall take effect on January 30, 2050; provided that section 1 shall take effect on July 1, 2028.
Section 2 provides a bifurcated effective date: Section 1 (the new part added to Chapter 321) takes effect on July 1, 2028, while the Act itself takes effect on January 30, 2050. This unusual structure may reflect a conditional mechanism or placeholder common in Hawaii legislative drafting where the later date is a backstop subject to amendment.