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SB2281
THE SENATE
S.B. NO.
2281
THIRTY-THIRD LEGISLATURE, 2026
STATE OF HAWAII
A BILL FOR AN ACT
relating to
The use of
artificial intelligence in
health care
.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:
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SECTION 1.
�
Chapter 321,
Hawaii Revised Statutes, is amended by adding a new part to be appropriately
designated and to read as follows:
"
Part .
�
ARTIFICIAL INTELLIGENCE IN HEALTH CARE
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�321-
�
Definitions.
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For the purposes of this part:
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"Artificial intelligence"
or "artificial
intelligence system"
means an
y
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.
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"Authorized
representative" means:
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(1)
�
An agent, a guardian, or a surrogate of the
patient; or
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(2)
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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.
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"Consequential decision" means a
decision that has a significant effect on the physical or mental health of a
patient or a material legal or similarly significant effect on the provision or
denial to any patient of, or the cost or terms of, health care services.
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"Department" means the department of
health.
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"Health care provider"
and "health care
service"
ha
ve
the same meanings as defined in section 323D-2.
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"Health
information" and "individually identifiable health information"
have the same meanings as defined in section 323B‑2.
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"Patient"
means a person who is under the observation and care of or otherwise receiving
health care services from a health care provider.
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"Personal
data" means any information that is linked or could be reasonably linkable
to an identified or identifiable natural person.
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"Personal data" does not include
de-identified data or publicly available information.
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"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.
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"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.
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"Remote communication" includes telecommunication,
videoconference, and electronic communication, including internet-based
communication and electronic transmission.
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"Substantial
factor"
means a factor that:
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(1)
�
Assists in making a consequential decision;
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(2)
�
Is capable of altering the outcome of a
consequential decision; and
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(3)
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Is generated by an artificial intelligence
system.
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"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.
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Health care providers;
artificial
intelligence; patient interaction;
disclosure.
�
(a)
�
Any
health care provider that
uses
or
makes available
for
use an
artificial intelligence
system intended
to interact with patient
s
by means of remote communication s
hall
disclose
to the
patient
or the patient's authorized representative, as
applicable, that
th
e person is
interacting with artificial
intelligence
.
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(b)
�
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.
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(c)
�
The disclosure shall be clear and conspicuous,
and include:
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(1)
�
A disclaimer that:
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(A)
�
T
he communication was generated by
artificial intelligence;
or
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(B)
�
T
he
communication
was generated by artificial intelligence and reviewed
by a
health care provider who is a natural person or a natural person retained
by the health care provider; and
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(2)
�
Clear
instructions
on how the
patient
can
directly
contact
a
health care provider
who
is a natural person, an employee of the health care provider, or other
appropriate natural person.
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Health care providers;
artificial
intelligence; consequential decisions; notice; statement; opt-out; corrections;
appeal
.
�
(a)
�
Before using an artificial
intelligence system to make
, or be
a s
ubstantial
factor in making
,
a consequential decision, a health
care provider shall
provide the
patient
or the
patient's authorized representative, as applicable, with a written notice that:
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(1)
�
Informs
the recipient that
the
health care
provider
will be
using
an artificial intelligence system to make
,
or
be
a s
ubstantial
factor in
making,
the consequential decision
;
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(
2
)
�
D
iscloses the purpose of the artificial
intelligence system and
the
nature of the consequential
decision;
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(
3
)
�
D
escri
bes the
artificial
intelligence system
in plain language; and
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(4)
�
Allows the patient to opt out of the
processing of the patient's individually identifiable health information or
other personal data for purposes of profiling in furtherance of decisions that have
legal or similarly significant effects concerning the patient.
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(b)
�
Any
health care provider
that
used an artificial intelligence system to make, or be a substantial factor in
making, a consequential decision
shall
provide the
patient
or the
patient's authorized representative, as applicable with:
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(1)
�
A written statement that describes the
consequential decision and the principal reasons for the consequential
decision, including:
���������
(A)
�
The degree to which, and manner in which, the artificial
intelligence system contributed to the consequential decision;
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(B)
�
The type of data that was processed by the artificial
intelligence system in making the consequential decision; and
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(C)
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The sources of the data described in paragraph (B);
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(2)
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An opportunity to correct any incorrect health
information or personal data that the artificial intelligence system processed
in making, or as a substantial factor in making, the consequential decision;
and
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(3)
�
An opportunity to appeal the consequential decision,
including allowing, to the extent technically feasible, human review of all
information relating to the consequential decision; provided that this
paragraph shall not apply if providing the opportunity for appeal is not in the
best interest of the patient, including in instances in which any delay might
pose a risk to the life or safety of the patient.
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(c)
�
The notice and statement required pursuant to subsections
(a) and (b), respectively, shall be provided d
irectly to the patient
or the
patient's authorized representative, as applicable; provided that if the health
care provider is unable to comply with this requirement, the health care
provider shall provide the notice or statement in a manner that is reasonably
calculated to ensure that
the patient
or the patient's
authorized representative, as applicable, receives the notice or statement.
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Health care providers;
artificial
intelligence; consequential decisions; review and validation by qualified oversight
personnel
.
�
(a)
�
Any
health care provider
that
uses an artificial intelligence system to make, or be a substantial factor in
making, a consequential decision
shall
m
aintain a
n
artificial intelligence oversight personnel.
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(b)
�
The artificial intelligence oversight
personnel:
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(1)
�
Shall be a natural person;
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(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 systems in the
field of health care; and
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(3)
�
May be retained by contracting with a
third-party.
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(c)
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The artificial intelligence oversight
personnel shall:
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(1)
�
Monitor
the
artificial intelligence systems used by the
health care provider; and
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(2)
�
B
efore
the health care provider uses
an output generated by an artificial intelligence system to make, or be a
substantial factor in making, a consequential decision:
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(A)
�
Review
and evaluate the output; and
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(B)
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Validate
or override the output.
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Health care providers;
artificial intelligence; consequential decisions;
monitoring;
performance evaluation; record keeping
.
�
Any
health care provider
that
uses an artificial intelligence system to make, or be a substantial factor in
making, a consequential decision
shall:
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(
1
)
�
Monitor the
usage of
artificial intelligence systems to make, or be
a substantial factor in making, consequential decisions;
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(2)
�
Conduct
regular performance evaluations of
the
artificial intelligence systems
, including
the assessment of:
���������
(A)
�
P
otential biases in training data;
���������
(
B
)
�
Risks to
the
safety
and
rights of patients, including the
confidentiality
of personal
data
;
and
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(C)
�
Mitigation
strategies for any identified risks;
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(
3
)
�
Implement procedures to address any
deficiencies
identified
through the monitoring or performance
evaluations,
including the suspension or recalibration of an
y
artificial intelligence system
; and
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(
4
)
�
Maintain:
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����
(
A
)
�
A
n updated inventory of
the
artificial
intelligence systems;
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����
(
B
)
�
Documentation on the s
ystem design,
intended use, and training data of
the
artificial intelligence systems;
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(
C
)
�
Record of
the
monitoring,
performance evaluations
,
and oversight
activities;
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(D)
�
Documentation
of f
indings and actions taken to address any
deficiencies
identified
through the monitoring or performance
evaluations.
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�321
-
�
Reports to the department
.
�
Any health care provider who uses an
artificial intelligence system pursuant to this part shall submit an annual
report to the department relating to the health care provider's compliance with
this part.
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�321
-
�
Rules
.
�
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
intelligence oversight personnel and the frequency of
regular
performance evaluations
of artificial intelligence systems required to
be performed by certain health care providers.
"
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SECTION
2.
�
This Act shall take effect upon its
approval.
INTRODUCED BY:
_____________________________
Report Title:
DOH;
Health
Care
Providers
;
Artificial Intelligence; Patient
Interaction;
Consequential Decisions; Disclosure; Notice;
Oversight; Performance Evaluations
; Recordkeeping; Reports; Rules
Description:
Requires h
ealth care providers
using
artificial intelligence
(AI) in
patient interaction
s to disclose to the patient that
the
patient
is interacting with artificial intelligence.
�
Requires health care providers using AI in
making consequential decisions relating to the patient to provide certain
notice and statements to the patient; maintain a qualified AI oversight
personnel who shall be a natural person that reviews, evaluates, and validates
or overrides AI outputs; monitor and conduct regular performance evaluations of
their AI systems; implement procedures to address identified deficiencies; and
maintain certain records.
�
Requires certain
health care providers using AI to submit annual reports to the Department of
Health.
�
Requires the Department to adopt
rules.
The summary description
of legislation appearing on this page is for informational purposes only and is
not legislation or evidence of legislative intent.