No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2997 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 2997
To protect the independent judgment of health care professionals acting
in the scope of their practice in overriding AI/CDSS outputs, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 9, 2025
Mr. Markey (for himself and Mr. Blumenthal) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To protect the independent judgment of health care professionals acting
in the scope of their practice in overriding AI/CDSS outputs, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Right to Override Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Definitions.
TITLE I--POLICIES FOR USING AND OVERRIDING AI/CDSS
Sec. 101. Policies with respect to using and overriding AI/CDSS.
Sec. 102. Enforcement.
Sec. 103. Regulations.
TITLE II--ADVERSE EMPLOYMENT ACTIONS; WHISTLEBLOWER PROTECTIONS
Sec. 201. Prohibition on adverse employment actions.
Sec. 202. Whistleblower protections.
Sec. 203. Enforcement.
Sec. 204. Regulations.
TITLE III--GENERAL PROVISIONS
Sec. 301. Educational materials for covered entities and health care
professionals.
Sec. 302. State enforcement.
Sec. 303. Rule of construction.
Sec. 304. Non-preemption.
SEC. 3. DEFINITIONS.
In this Act:
(1) Adverse employment action.--The term ``adverse
employment action'', with respect to a health care
professional, includes--
(A) the termination, suspension, or demotion of the
health care professional from a job;
(B) any disciplinary action or retaliatory
investigation against the health care professional;
(C) the imposition of a work schedule that is more
burdensome to the health care professional;
(D) the failure of the health care professional to
receive, or any adverse adjustment in the ability of
the health care professional to receive, a promotion;
(E) the denial of the health care professional in
receiving or being eligible to receive--
(i) compensation, including the denial of
an increase in compensation; or
(ii) any other job-related benefit or
opportunity, including for telework, training,
or travel;
(F) revocation of admitting privileges;
(G) a reassignment of a duty or the assignment of a
duty inappropriate for the job, skill set, or
experience of the health care professional;
(H) a change in the ability to practice at a
location for which the health care professional would
otherwise be able;
(I) an adverse evaluation or performance review;
(J) any other modification to the terms,
conditions, or privileges of employment or work of the
health care professional that, from the perspective of
a reasonable person, puts the health care professional
in a materially adverse position when compared to the
position of the professional prior to the modification;
and
(K) any other action or inaction that results in
the health care professional being in a materially
adverse position when compared to the position of the
professional prior to the action or inaction.
(2) Artificial intelligence clinical decision support
system; ai/cdss.--The term ``artificial intelligence clinical
decision support system'' or ``AI/CDSS'' means technology
that--
(A) supports decision-making based on algorithms,
or models, based in clinical practice guidelines or
that derive relationships from training data, including
such algorithms or models that are developed using
unsupervised learning models; and
(B) produces an output that results in a
prediction, classification, recommendation, evaluation,
or analysis.
(3) AI/CDSS output.--The term ``AI/CDSS output'' means any
recommendation, decision, or other output of AI/CDSS.
(4) Commerce; industry or activity affecting commerce.--The
terms ``commerce'' and ``industry or activity affecting
commerce'' have the meanings given such terms in section 101 of
the Family and Medical Leave Act of 1993 (29 U.S.C. 2611).
(5) Covered entity.--The term ``covered entity''--
(A) means any individual or entity that--
(i) employs, or otherwise engages in the
performance of work for remuneration, a health
care professional; and
(ii) is engaged in commerce (including
government), or an industry or activity
affecting commerce (including government); and
(B) includes such an individual or entity that is--
(i) a health care facility in any setting,
such as a nurse's office in a school setting;
or
(ii) a health plan or an administrator of a
health plan.
(6) Engaged in the performance of work for remuneration.--
The term ``engaged in the performance of work for
remuneration'', with respect to an individual performing work
for a covered entity, includes the individual having admitting
privileges for the covered entity without regard to whether
such individual is employed by such entity.
(7) Health care professional.--The term ``health care
professional''--
(A) means an individual--
(i) licensed, registered, or certified
under Federal or State laws or regulations to
provide health care services; or
(ii) required to be so licensed,
registered, or certified but that is exempted
by other statute or regulation; and
(B) includes--
(i) an individual described in subparagraph
(A) without regard to whether the individual
works at a health care facility, including a
home health aide or a home care provider; and
(ii) an individual who is employed by, or
otherwise engaged in the performance of work
for remuneration for, a health plan to make
prior authorization determinations or other
determinations regarding coverage under a
health plan.
(8) Health care services.--The term ``health care
services'' means any services that relate to--
(A) the diagnosis, prevention, or treatment of any
human disease or impairment;
(B) the assessment or care of the health of human
beings; or
(C) making prior authorization determinations or
other determinations regarding coverage under a health
plan.
(9) Health plan.--The term ``health plan'' has the meaning
given the term in section 3000 of the Public Health Service Act
(42 U.S.C. 300jj).
(10) Override.--The term ``override'', with respect to an
AI/CDSS output, means making a decision contrary to such
output.
(11) Override data.--The term ``override data''--
(A) means any data related to adherence to or
deviation from AI/CDSS outputs; and
(B) includes--
(i) any such data that is metadata or audit
data; or
(ii) any such data related to a particular
health care professional or group of health
care professionals, or related to a particular
AI/CDSS.
(12) State.--The term ``State'' has the meaning given the
term in section 3000 of the Public Health Service Act.
TITLE I--POLICIES FOR USING AND OVERRIDING AI/CDSS
SEC. 101. POLICIES WITH RESPECT TO USING AND OVERRIDING AI/CDSS.
(a) In General.--A covered entity that uses AI/CDSS shall--
(1) adopt and adhere to a policy with respect to such
usage--
(A) that ensures that AI/CDSS outputs are not
substituted for the independent judgment of a health
care professional employed by, or otherwise engaged in
the performance of work for remuneration for, the
covered entity while such health care professional is
acting in the scope of practice of such health care
professional;
(B) that allows such a health care professional to
override an AI/CDSS output in a timely manner if, at
the time of the override, in the judgment of the health
care professional acting in the scope of practice of
the health care professional, such an override is
appropriate for the patient, or as necessary to comply
with applicable law, including civil rights law;
(C) that allows health care professionals and their
representatives to provide feedback on AI/CDSS,
including incorrect or biased outputs that require
frequent override; and
(D) that prohibits the sharing of override data
on--
(i) a specific health care professional; or
(ii) a group of health care professionals
when the identity of those professionals can be
reasonably inferred;
(2) inform health care professionals employed by, or
otherwise engaged in the performance of work for remuneration
for, the covered entity, and the representatives of such health
care professionals, of the policy under paragraph (1),
including the presence of AI/CDSS in the workplace and the
ability of such health care professionals to override an AI/
CDSS output;
(3) provide training to such health care professionals on--
(A) how to use AI/CDSS;
(B) the circumstances where an AI/CDSS override is
appropriate;
(C) how to override an AI/CDSS output;
(D) AI/CDSS development processes and any data or
other inputs involved in such processes; and
(E) any potential limitations for AI/CDSS,
including any potential areas of bias in the AI/CDSS;
(4) establish and maintain an AI/CDSS committee that
shall--
(A) convene upon the date that is later of--
(i) the date of the adoption of AI/CDSS at
the covered entity; or
(ii) 120 days after the date of enactment
of this Act;
(B) be comprised of at least as many non-managers
as managers;
(C) include membership of any labor organization,
or other authorized representative, of health care
professionals employed by, or otherwise engaged in the
performance of work for remuneration for, the covered
entity;
(D) provide consultation to the covered entity in
developing policies and practices related to the use of
AI/CDSS, including policy required under subparagraphs
(A) through (D) of paragraph (1); and
(E) meet at least quarterly to--
(i) review implementation of policies
adopted by the covered entity with respect to
AI/CDSS; and
(ii) report to the covered entity on
findings and suggestions for improvements; and
(5) review--
(A) all findings and suggestions from the AI/CDSS
committee provided under paragraph (4)(E)(ii); and
(B) any other feedback from health care
professionals employed by, or otherwise engaged in the
performance of work for remuneration for, the covered
entity on the AI/CDSS technology and the policies of
the entity with respect to such technology, including
by reviewing any such feedback on patterns of issues
with the AI/CDSS, such as incorrect or biased outputs
that require frequent override.
(b) Data Sharing Exception.--The prohibition under subsection
(a)(1)(D) shall not apply--
(1) in a case in which a covered entity is informing a
patient or an authorized representative of a patient about a
decision rendered in the administration of the care of such
patient; or
(2) in a case of a civil, criminal, or administrative
action involving medical malpractice, negligence, or violation
of any law.
(c) Oversight Mechanism.--Nothing in this Act shall prohibit a
covered entity from reviewing the performance outcomes of AI/CDSS.
SEC. 102. ENFORCEMENT.
(a) In General.--Except as provided in subsection (c), the
Secretary of Health and Human Services, acting through the Office for
Civil Rights (referred to in this title as the ``Secretary''), shall
receive, investigate, and attempt to resolve, including through
imposing civil monetary penalties, complaints of violations of this
title in the same manner as the Secretary receives, investigates, and
attempts to resolve, including through imposing civil monetary
penalties, complaints of violations of part C of title XI of the Social
Security Act (42 U.S.C. 1320d et seq.).
(b) Civil Monetary Penalties.--The provisions of section 1128A of
the Social Security Act (42 U.S.C. 1320a-7a) (other than subsections
(a) and (b) and the second sentence of subsection (f)) shall apply to
the imposition of a civil monetary penalty under this section in the
same manner as such provisions apply to the imposition of a penalty
under such section 1128A.
(c) Exception.--No complaint of a violation of this title shall be
referred to the Attorney General for investigation as a criminal
violation.
SEC. 103. REGULATIONS.
(a) In General.--The Secretary may prescribe such regulations as
may be necessary to carry out this title.
(b) Consultation.--In prescribing any regulations authorized under
this section, the Secretary--
(1) shall consult with the Secretary of Labor; and
(2) may consult with--
(A) other Federal agencies that have expertise in
artificial intelligence or health care; and
(B) other Federal agencies that have jurisdiction
over labor and employment issues, including the Equal
Employment Opportunity Commission, the Department of
Justice, and the National Labor Relations Board.
TITLE II--ADVERSE EMPLOYMENT ACTIONS; WHISTLEBLOWER PROTECTIONS
SEC. 201. PROHIBITION ON ADVERSE EMPLOYMENT ACTIONS.
No covered entity shall take an adverse employment action against a
health care professional employed by, or otherwise engaged in the
performance of work for remuneration for, the covered entity because
the health care professional overrides an AI/CDSS output in a manner
consistent with the requirements under section 101.
SEC. 202. WHISTLEBLOWER PROTECTIONS.
No covered entity shall discriminate or retaliate (including
through intimidation, threats, coercion, or harassment) against any
individual employed by, or otherwise engaged in the performance of work
for remuneration for, the covered entity--
(1) because the individual exercises, or attempts to
exercise, any right provided under this Act; or
(2) because the individual (or another individual or
representative acting at the request of the individual) has--
(A) filed a written or oral complaint to the
covered entity or a Federal, State, local, or Tribal
government entity of a possible violation of this Act;
(B) sought assistance or intervention with respect
to an AI/CDSS-related concern from the covered entity,
a Federal, State, local, or Tribal government, or any
individual or entity representing workers;
(C) instituted, caused to be instituted, or
otherwise participated in any inquiry or proceeding
under or related to this Act;
(D) given, or is about to give, any information in
connection with any inquiry or proceeding relating to
any right provided under this Act;
(E) testified, or is about to testify, in any
inquiry or proceeding relating to any right provided
under this Act; or
(F) discussed a possible violation of this Act with
a co-worker.
SEC. 203. ENFORCEMENT.
(a) Enforcement by Department of Labor.--
(1) Investigation.--
(A) In general.--To ensure compliance with this
title, the Secretary of Labor (referred to in this
title as the ``Secretary'')--
(i) shall have--
(I) the investigative authority
provided under section 11(a) of the
Fair Labor Standards Act of 1938 (29
U.S.C. 211(a)); and
(II) the subpoena authority
provided under section 9 of such Act
(29 U.S.C. 209); and
(ii) may require, by general or special
orders, a covered entity to file with the
Secretary, in such form as the Secretary may
prescribe, annual or special reports or answers
in writing to specific questions (including
information and records) as the Secretary may
require as to the organization, business,
conduct, practices, management, and relation to
other corporations, partnerships, and
individuals, of the covered entity.
(B) Reports and answers.--A covered entity shall
file any reports and answers (including information and
records) required under subparagraph (A)(ii) in such
manner, including under oath or otherwise, and within
such reasonable time period as the Secretary may
require.
(C) Joint investigations.--The Secretary may
conduct investigations and make requests for
information, as authorized under this Act, on a joint
basis with another Federal agency, a State attorney
general, or a State agency.
(D) Obligation to keep, preserve, and make
available records.--A covered entity shall make, keep,
preserve, and make available to the Secretary records
pertaining to compliance with this title in accordance
with section 11(c) of the Fair Labor Standards Act of
1938 (29 U.S.C. 211(c)) and in accordance with any
regulation or order issued by the Secretary.
(2) Enforcement.--The Secretary shall receive, investigate,
and attempt to resolve complaints of violations of this title
in the same manner that the Secretary receives, investigates,
and attempts to resolve complaints of violations of sections 6
and 7 of the Fair Labor Standards Act of 1938 (29 U.S.C. 206
and 207).
(3) Civil monetary penalties.--Subject to subsection (c),
the Secretary may impose a civil monetary penalty on any person
that violates this title--
(A) in an amount of not more than $76,987 per
violation; or
(B) for repeat violations, in an amount of not more
than $769,870 per violation.
(4) Administrative complaints.--An individual adversely
affected by an alleged violation of this title may--
(A) file a complaint of a violation of this title
with the Secretary; and
(B) designate a representative of a labor
organization, regardless of the relationship between
the individual and the labor organization, to--
(i) file the complaint on behalf of the
individual; or
(ii) represent the individual for purposes
of engagement with the Secretary regarding such
complaint, including being present at worker
interviews and participating in workplace
inspections, conferences, and settlement
negotiations.
(5) Litigation.--The Solicitor of Labor may appear for and
represent the Secretary on any litigation brought under this
subsection. If the Secretary determines that a covered entity
has violated this title, the Secretary may file a civil action
in any appropriate United States district court to obtain
injunctive relief to enforce this title.
(6) Burdens of proof.--All complaints under this subsection
shall be governed by the legal burdens of proof set forth in
section 42121(b) of title 49, United States Code.
(b) Private Right of Action.--
(1) In general.--Notwithstanding any action by the
Secretary under subsection (a), any individual adversely
affected by an alleged violation of this title (or a
representative on behalf of such individual) may commence a
civil action against any covered entity that violates this
title in any Federal court of competent jurisdiction.
(2) Relief.--
(A) In general.--In a civil action brought under
paragraph (1) in which the individual described in such
paragraph prevails, the court may award the
individual--
(i) damages of--
(I) an amount equal to the sum of
any actual damages including back pay
sustained by the individual; or
(II) not more than treble damages;
(ii) statutory damages described in
subparagraph (B);
(iii) injunctive relief;
(iv) equitable relief;
(v) reasonable attorney fees and litigation
costs; and
(vi) while the action is pending, temporary
relief, including temporary reinstatement.
(B) Statutory damages.--
(i) In general.--The court may, in
accordance with clause (ii), award statutory
damages under subparagraph (A)(ii) against a
covered entity in the following amounts:
(I) For each violation of section
201 (regarding adverse employment
actions), the court may award damages
of an amount (subject to subsection
(c)) of not less than $5,000 and not
more than $20,000.
(II) For each violation of section
202 (regarding whistleblower
protections), the court may award
damages of an amount (subject to
subsection (c)) of not less than
$10,000 and not more than $100,000.
(ii) Considerations for statutory
damages.--In determining the amount of
statutory damages assessed under this
subparagraph against a covered entity, the
court shall consider any relevant circumstances
presented by the parties to the action,
including--
(I) the nature and seriousness of
the violation;
(II) the number of violations;
(III) the persistence of the
misconduct;
(IV) the length of time over which
the misconduct occurred;
(V) the willfulness of the
misconduct; and
(VI) the assets, liabilities, and
net worth of the covered entity.
(3) Remedies for state workers.--
(A) Waiver of sovereign immunity.--A State's
receipt or use of Federal financial assistance for any
program or activity of a State shall constitute a
waiver of sovereign immunity, under the 11th Amendment
to the Constitution of the United States or otherwise,
to a suit under this subsection for the relief
described in paragraph (2) authorized under this
subsection brought by an individual employed under, or
otherwise engaged in the performance of work for
remuneration under, that program or activity.
(B) Official capacity.--An official of a State may
be sued in the official capacity of the official by any
individual who has complied with the procedures under
this paragraph, for injunctive relief that is
authorized under this subsection. In such a suit the
court may award to the prevailing party those costs
authorized by section 722 of the Revised Statutes (42
U.S.C. 1988).
(C) Applicability.--With respect to a particular
program or activity, subparagraph (A) applies to
conduct that occurs--
(i) after the date of enactment of this
Act; and
(ii) on or after the day on which a State
first receives or uses Federal financial
assistance for that program or activity.
(4) Definition of program or activity.--In this subsection,
the term ``program or activity'' has the meaning given the term
in section 606 of the Civil Rights Act of 1964 (42 U.S.C.
2000d-4a).
(c) Inflation Adjustment.--
(1) In general.--Subject to paragraphs (2) and (3), the
Secretary, not later than September 1 of each calendar year,
shall adjust the dollar amounts referred to in subsections
(a)(3) and (b)(2)(B)(i) by the percent increase, if any, in the
consumer price index for all urban consumers (United States
city average), or a successor index, as determined by the
Bureau of Labor Statistics, or a successor agency, for the most
recent 12-month period for which data is available.
(2) Rounding.--Any adjustment under paragraph (1) that is
not a multiple of $10 shall be rounded to the nearest multiple
of $10.
(3) Publication.--The Secretary shall publish the adjusted
amounts under paragraph (1) in the Federal Register, and on the
official website of the Department of Labor, not later than
October 1, of the applicable calendar year for the increase
under such paragraph.
(4) Effective date.--Each adjustment under paragraph (1)
shall take effect on January 1 of the first calendar year
beginning after the date of the increase under such paragraph.
(d) Arbitration and Class Action.--Notwithstanding any other
provision of law, no predispute arbitration agreement or predispute
joint-action waiver shall be valid or enforceable with respect to any
alleged violation of this title.
SEC. 204. REGULATIONS.
(a) In General.--The Secretary may prescribe such regulations as
may be necessary to carry out this title.
(b) Consultation.--In prescribing any regulations authorized under
this section, the Secretary--
(1) shall consult with the Secretary of Health and Human
Services; and
(2) may consult with--
(A) other Federal agencies that have expertise in
artificial intelligence or health care; and
(B) other Federal agencies that have jurisdiction
over labor and employment issues, including the Equal
Employment Opportunity Commission, the Department of
Justice, and the National Labor Relations Board.
TITLE III--GENERAL PROVISIONS
SEC. 301. EDUCATIONAL MATERIALS FOR COVERED ENTITIES AND HEALTH CARE
PROFESSIONALS.
Not later than 1 year after the date of enactment of this Act, the
Secretary of Health and Human Services, in consultation with the
Secretary of Labor, shall develop and disseminate education materials
for--
(1) covered entities with respect to the compliance of such
entities with the requirements under this Act; and
(2) health care professionals to inform such professionals
of their rights and protections under this Act.
SEC. 302. STATE ENFORCEMENT.
(a) In General.--In any case in which a State attorney general or a
State privacy regulator has reason to believe that an interest of the
residents of a State has been or is adversely affected by any covered
entity that violates any provision of this Act, the State attorney
general or State privacy regulator, as parens patriae, may bring a
civil action on behalf of the residents of the State in an appropriate
State court or an appropriate district court of the United States to--
(1) enjoin further violation of such provision by the
covered entity;
(2) compel compliance with such provision;
(3) obtain damages, civil penalties, restitution, or other
compensation on behalf of the residents of the State; or
(4) obtain reasonable attorney's fees and other litigation
costs reasonably incurred.
(b) Rights of Agency.--Before initiating a civil action under
subsection (a), the State attorney general or State privacy regulator,
as the case may be, shall notify the Secretary in writing of such civil
action. Upon receiving such notice, the Secretary may--
(1) intervene in such action; and
(2) upon intervening--
(A) be heard on all matters arising in such civil
action; and
(B) file petitions for appeal of a decision in such
action.
(c) Preemptive Action by Agency.--In any case in which a civil
action is instituted by or on behalf of the Secretary for a violation
of this Act, a State attorney general or State privacy regulator may
not, during the pendency of such action, institute a civil action
against any defendant named in the complaint in the action instituted
by or on behalf of the Secretary for a violation that is alleged in
such complaint. In a case brought by the Secretary that affects the
interests of a State, the State attorney general or State privacy
regulator may intervene as of right pursuant to the Federal Rules of
Civil Procedure.
(d) Preservation of State Powers.--Except as provided in subsection
(c), no provision of this Act shall be construed as altering, limiting,
or affecting the authority of a State attorney general or State privacy
regulator to--
(1) bring an action or other regulatory proceeding arising
solely under the laws in effect in that State; or
(2) exercise the powers conferred on the State attorney
general or State privacy regulator by the laws of the State,
including the ability to conduct investigations, administer
oaths or affirmations, or compel the attendance of witnesses or
the production of documentary or other evidence.
(e) Definition of Secretary.--In this section, the term
``Secretary'' means--
(1) with respect to a violation of title I, the Secretary
of Health and Human Services; and
(2) with respect to a violation of title II, the Secretary
of Labor.
SEC. 303. RULE OF CONSTRUCTION.
Nothing in this Act shall protect a health care professional from a
medical malpractice or negligence claim for health care services
provided through overriding an AI/CDSS output.
SEC. 304. NON-PREEMPTION.
Nothing in this Act shall preempt a State law or collective
bargaining agreement.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line