,,ii #aaith ,,congress #ast ,session ,s4 #biig ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #i1 #bjbe ,mr4 ,markey 7for himself and ,mr4 ,blumenthal7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to protect the independent judgment of health care professionals acting in the scope of their practice in overriding ,,ai_/,,cdss outputs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,right to ,override ,act4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,table of contents4 ,sec4 #c4 ,definitions4 ,,title ,i--,policies for using and overriding ,,ai_/,,cdss ,sec4 #aja4 ,policies with respect to using and overriding ,,ai_/,,cdss4 ,sec4 #ajb4 ,enforcement4 ,sec4 #ajc4 ,regulations4 ,,title ,,ii--,adverse employment actions2 whistleblower protections ,sec4 #bja4 ,prohibition on adverse employment actions4 ,sec4 #bjb4 ,whistleblower protections4 ,sec4 #bjc4 ,enforcement4 ,sec4 #bjd4 ,regulations4 ,,title ,,iii--,general provisions ,sec4 #cja4 ,educational materials for covered entities and health care professionals4 ,sec4 #cjb4 ,state enforcement4 ,sec4 #cjc4 ,rule of construction4 ,sec4 #cjd4 ,non-preemption4 #c4 ,definitions ,in this ,act3 7#a7 ,adverse employment action ,the term adverse employment action1 with respect to a health care professional1 includes-- 7,a7 the termination1 suspension1 or demotion of the health care professional from a job2 7,b7 any disciplinary action or retaliatory investigation against the health care professional2 7,c7 the imposition of a work schedule that is more burdensome to the health care professional2 7,d7 the failure of the health care professional to receive1 or any adverse adjustment in the ability of the health care professional to receive1 a promotion2 7,e7 the denial of the health care professional in receiving or being eligible to receive-- 7i7 compensation1 including the denial of an increase in compensation2 or 7ii7 any other job-related benefit or opportunity1 including for telework1 training1 or travel2 7,f7 revocation of admitting privileges2 7,g7 a reassignment of a duty or the assignment of a duty inappropriate for the job1 skill set1 or experience of the health care professional2 7,h7 a change in the ability to practice at a location for which the health care professional would otherwise be able2 7,i7 an adverse evaluation or performance review2 7,j7 any other modification to the terms1 conditions1 or privileges of employment or work of the health care professional that1 from the perspective of a reasonable person1 puts the health care professional in a materially adverse position when compared to the position of the professional prior to the modification2 and 7,k7 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 inaction4 7#b7 ,artificial intelligence clinical decision support system2 ,,ai_/,,cdss ,the term artificial intelligence clinical decision support system or ,,ai_/,,cdss means technology that-- 7,a7 supports decision-making based on algorithms1 or models1 based in clinical practice guidelines or that derive relationships from training data1 including such algorithms or models that are developed using unsupervised learning models2 and 7,b7 produces an output that results in a prediction1 classification1 recommendation1 evaluation1 or analysis4 7#c7 ,,ai_/,,cdss output ,the term ,,ai_/,,cdss output means any recommendation1 decision1 or other output of ,,ai_/,,cdss4 7#d7 ,commerce2 industry or activity affecting commerce ,the terms commerce and industry or activity affecting commerce have the meanings given such terms in section #aja of the ,family and ,medical ,leave ,act of #aiic 7#bi ,u4,s4,c4 #bfaa74 7#e7 ,covered entity ,the term covered entity-- 7,a7 means any individual or entity that-- 7i7 employs1 or otherwise engages in the performance of work for remuneration1 a health care professional2 and 7ii7 is engaged in commerce 7including government71 or an industry or activity affecting commerce 7including government72 and 7,b7 includes such an individual or entity that is-- 7i7 a health care facility in any setting1 such as a nurse's office in a school setting2 or 7ii7 a health plan or an administrator of a health plan4 7#f7 ,engaged in the performance of work for remuneration ,the term engaged in the performance of work for remuneration1 with respect to an individual performing work for a covered entity1 includes the individual having admitting privileges for the covered entity without regard to whether such individual is employed by such entity4 7#g7 ,health care professional ,the term health care professional-- 7,a7 means an individual-- 7i7 licensed1 registered1 or certified under ,federal or ,state laws or regulations to provide health care services2 or 7ii7 required to be so licensed1 registered1 or certified but that is exempted by other statute or regulation2 and 7,b7 includes-- 7i7 an individual described in subparagraph 7,a7 without regard to whether the individual works at a health care facility1 including a home health aide or a home care provider2 and 7ii7 an individual who is employed by1 or otherwise engaged in the performance of work for remuneration for1 a health plan to make prior authorization determinations or other determinations regarding coverage under a health plan4 7#h7 ,health care services ,the term health care services means any services that relate to-- 7,a7 the diagnosis1 prevention1 or treatment of any human disease or impairment2 7,b7 the assessment or care of the health of human beings2 or 7,c7 making prior authorization determinations or other determinations regarding coverage under a health plan4 7#i7 ,health plan ,the term health plan has the meaning given the term in section #cjjj of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj74 7#aj7 ,override ,the term override1 with respect to an ,,ai_/,,cdss output1 means making a decision contrary to such output4 7#aa7 ,override data ,the term override data-- 7,a7 means any data related to adherence to or deviation from ,,ai_/,,cdss outputs2 and 7,b7 includes-- 7i7 any such data that is metadata or audit data2 or 7ii7 any such data related to a particular health care professional or group of health care professionals1 or related to a particular ,,ai_/,,cdss4 7#ab7 ,state ,the term ,state has the meaning given the term in section #cjjj of the ,public ,health ,service ,act4 ,i ,policies for using and overriding ,,ai_/,,cdss #aja4 ,policies with respect to using and overriding ,,ai_/,,cdss 7a7 ,in general ,a covered entity that uses ,,ai_/,,cdss shall-- 7#a7 adopt and adhere to a policy with respect to such usage-- 7,a7 that ensures that ,,ai_/,,cdss outputs are not substituted for the independent judgment of a health care professional employed by1 or otherwise engaged in the performance of work for remuneration for1 the covered entity while such health care professional is acting in the scope of practice of such health care professional2 7,b7 that allows such a health care professional to override an ,,ai_/,,cdss output in a timely manner if1 at the time of the override1 in the judgment of the health care professional acting in the scope of practice of the health care professional1 such an override is appropriate for the patient1 or as necessary to comply with applicable law1 including civil rights law2 7,c7 that allows health care professionals and their representatives to provide feedback on ,,ai_/,,cdss1 including incorrect or biased outputs that require frequent override2 and 7,d7 that prohibits the sharing of override data on-- 7i7 a specific health care professional2 or 7ii7 a group of health care professionals when the identity of those professionals can be reasonably inferred2 7#b7 inform health care professionals employed by1 or otherwise engaged in the performance of work for remuneration for1 the covered entity1 and the representatives of such health care professionals1 of the policy under paragraph 7#a71 including the presence of ,,ai_/,,cdss in the workplace and the ability of such health care professionals to override an ,,ai_/,,cdss output2 7#c7 provide training to such health care professionals on-- 7,a7 how to use ,,ai_/,,cdss2 7,b7 the circumstances where an ,,ai_/,,cdss override is appropriate2 7,c7 how to override an ,,ai_/,,cdss output2 7,d7 ,,ai_/,,cdss development processes and any data or other inputs involved in such processes2 and 7,e7 any potential limitations for ,,ai_/,,cdss1 including any potential areas of bias in the ,,ai_/,,cdss2 7#d7 establish and maintain an ,,ai_/,,cdss committee that shall-- 7,a7 convene upon the date that is later of-- 7i7 the date of the adoption of ,,ai_/,,cdss at the covered entity2 or 7ii7 #abj days after the date of enactment of this ,act2 7,b7 be comprised of at least as many non-managers as managers2 7,c7 include membership of any labor organization1 or other authorized representative1 of health care professionals employed by1 or otherwise engaged in the performance of work for remuneration for1 the covered entity2 7,d7 provide consultation to the covered entity in developing policies and practices related to the use of ,,ai_/,,cdss1 including policy required under subparagraphs 7,a7 through 7,d7 of paragraph 7#a72 and 7,e7 meet at least quarterly to-- 7i7 review implementation of policies adopted by the covered entity with respect to ,,ai_/,,cdss2 and 7ii7 report to the covered entity on findings and suggestions for improvements2 and 7#e7 review-- 7,a7 all findings and suggestions from the ,,ai_/,,cdss committee provided under paragraph 7#d77;,e77ii72 and 7,b7 any other feedback from health care professionals employed by1 or otherwise engaged in the performance of work for remuneration for1 the covered entity on the ,,ai_/,,cdss technology and the policies of the entity with respect to such technology1 including by reviewing any such feedback on patterns of issues with the ,,ai_/,,cdss1 such as incorrect or biased outputs that require frequent override4 7b7 ,data sharing exception ,the prohibition under subsection 7a77#a77;,d7 shall not apply-- 7#a7 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 patient2 or 7#b7 in a case of a civil1 criminal1 or administrative action involving medical malpractice1 negligence1 or violation of any law4 7c7 ,oversight mechanism ,nothing in this ,act shall prohibit a covered entity from reviewing the performance outcomes of ,,ai_/,,cdss4 #ajb4 ,enforcement 7a7 ,in general ,except as provided in subsection 7c71 the ,secretary of ,health and ,human ,services1 acting through the ,office for ,civil ,rights 7referred to in this title as the ,secretary71 shall receive1 investigate1 and attempt to resolve1 including through imposing civil monetary penalties1 complaints of violations of this title in the same manner as the ,secretary receives1 investigates1 and attempts to resolve1 including through imposing civil monetary penalties1 complaints of violations of part ,c of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq474 7b7 ,civil monetary penalties ,the provisions of section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7 7other than subsections 7a7 and 7b7 and the second sentence of subsection 7f77 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 #aabh;,a4 7c7 ,exception ,no complaint of a violation of this title shall be referred to the ,attorney ,general for investigation as a criminal violation4 #ajc4 ,regulations 7a7 ,in general ,the ,secretary may prescribe such regulations as may be necessary to carry out this title4 7b7 ,consultation ,in prescribing any regulations authorized under this section1 the ,secretary-- 7#a7 shall consult with the ,secretary of ,labor2 and 7#b7 may consult with-- 7,a7 other ,federal agencies that have expertise in artificial intelligence or health care2 and 7,b7 other ,federal agencies that have jurisdiction over labor and employment issues1 including the ,equal ,employment ,opportunity ,commission1 the ,department of ,justice1 and the ,national ,labor ,relations ,board4 ,,ii ,adverse employment actions2 whistleblower protections #bja4 ,prohibition on adverse employment actions ,no covered entity shall take an adverse employment action against a health care professional employed by1 or otherwise engaged in the performance of work for remuneration for1 the covered entity because the health care professional overrides an ,,ai_/,,cdss output in a manner consistent with the requirements under section #aja4 #bjb4 ,whistleblower protections ,no covered entity shall discriminate or retaliate 7including through intimidation1 threats1 coercion1 or harassment7 against any individual employed by1 or otherwise engaged in the performance of work for remuneration for1 the covered entity-- 7#a7 because the individual exercises1 or attempts to exercise1 any right provided under this ,act2 or 7#b7 because the individual 7or another individual or representative acting at the request of the individual7 has-- 7,a7 filed a written or oral complaint to the covered entity or a ,federal1 ,state1 local1 or ,tribal government entity of a possible violation of this ,act2 7,b7 sought assistance or intervention with respect to an ,,ai_/,,cdss-related concern from the covered entity1 a ,federal1 ,state1 local1 or ,tribal government1 or any individual or entity representing workers2 7,c7 instituted1 caused to be instituted1 or otherwise participated in any inquiry or proceeding under or related to this ,act2 7,d7 given1 or is about to give1 any information in connection with any inquiry or proceeding relating to any right provided under this ,act2 7,e7 testified1 or is about to testify1 in any inquiry or proceeding relating to any right provided under this ,act2 or 7,f7 discussed a possible violation of this ,act with a co-worker4 #bjc4 ,enforcement 7a7 ,enforcement by ,department of ,labor 7#a7 ,investigation 7,a7 ,in general ,to ensure compliance with this title1 the ,secretary of ,labor 7referred to in this title as the ,secretary7-- 7i7 shall have-- 7,i7 the investigative authority provided under section #aa7;a7 of the ,fair ,labor ,standards ,act of #aich 7#bi ,u4,s4,c4 #baa7;a772 and 7,,ii7 the subpoena authority provided under section #i of such ,act 7#bi ,u4,s4,c4 #bji72 and 7ii7 may require1 by general or special orders1 a covered entity to file with the ,secretary1 in such form as the ,secretary may prescribe1 annual or special reports or answers in writing to specific questions 7including information and records7 as the ,secretary may require as to the organization1 business1 conduct1 practices1 management1 and relation to other corporations1 partnerships1 and individuals1 of the covered entity4 7,b7 ,reports and answers ,a covered entity shall file any reports and answers 7including information and records7 required under subparagraph 7,a77ii7 in such manner1 including under oath or otherwise1 and within such reasonable time period as the ,secretary may require4 7,c7 ,joint investigations ,the ,secretary may conduct investigations and make requests for information1 as authorized under this ,act1 on a joint basis with another ,federal agency1 a ,state attorney general1 or a ,state agency4 7,d7 ,obligation to keep1 preserve1 and make available records ,a covered entity shall make1 keep1 preserve1 and make available to the ,secretary records pertaining to compliance with this title in accordance with section #aa7;c7 of the ,fair ,labor ,standards ,act of #aich 7#bi ,u4,s4,c4 #baa7;c77 and in accordance with any regulation or order issued by the ,secretary4 7#b7 ,enforcement ,the ,secretary shall receive1 investigate1 and attempt to resolve complaints of violations of this title in the same manner that the ,secretary receives1 investigates1 and attempts to resolve complaints of violations of sections #f and #g of the ,fair ,labor ,standards ,act of #aich 7#bi ,u4,s4,c4 #bjf and #bjg74 7#c7 ,civil monetary penalties ,subject to subsection 7c71 the ,secretary may impose a civil monetary penalty on any person that violates this title-- 7,a7 in an amount of not more than #gf1ihg per violation2 or 7,b7 for repeat violations1 in an amount of not more than #gfi1hgj per violation4 7#d7 ,administrative complaints ,an individual adversely affected by an alleged violation of this title may-- 7,a7 file a complaint of a violation of this title with the ,secretary2 and 7,b7 designate a representative of a labor organization1 regardless of the relationship between the individual and the labor organization1 to-- 7i7 file the complaint on behalf of the individual2 or 7ii7 represent the individual for purposes of engagement with the ,secretary regarding such complaint1 including being present at worker interviews and participating in workplace inspections1 conferences1 and settlement negotiations4 7#e7 ,litigation ,the ,solicitor of ,labor may appear for and represent the ,secretary on any litigation brought under this subsection4 ,if the ,secretary determines that a covered entity has violated this title1 the ,secretary may file a civil action in any appropriate ,united ,states district court to obtain injunctive relief to enforce this title4 7#f7 ,burdens of proof ,all complaints under this subsection shall be governed by the legal burdens of proof set forth in section #dbaba7;b7 of title #di1 ,united ,states ,code4 7b7 ,private right of action 7#a7 ,in general ,notwithstanding any action by the ,secretary under subsection 7a71 any individual adversely affected by an alleged violation of this title 7or a representative on behalf of such individual7 may commence a civil action against any covered entity that violates this title in any ,federal court of competent jurisdiction4 7#b7 ,relief 7,a7 ,in general ,in a civil action brought under paragraph 7#a7 in which the individual described in such paragraph prevails1 the court may award the individual-- 7i7 damages of-- 7,i7 an amount equal to the sum of any actual damages including back pay sustained by the individual2 or 7,,ii7 not more than treble damages2 7ii7 statutory damages described in subparagraph 7,b72 7iii7 injunctive relief2 7iv7 equitable relief2 7v7 reasonable attorney fees and litigation costs2 and 7vi7 while the action is pending1 temporary relief1 including temporary reinstatement4 7,b7 ,statutory damages 7i7 ,in general ,the court may1 in accordance with clause 7ii71 award statutory damages under subparagraph 7,a77ii7 against a covered entity in the following amounts3 7,i7 ,for each violation of section #bja 7regarding adverse employment actions71 the court may award damages of an amount 7subject to subsection 7c77 of not less than #e1jjj and not more than #bj1jjj4 7,,ii7 ,for each violation of section #bjb 7regarding whistleblower protections71 the court may award damages of an amount 7subject to subsection 7c77 of not less than #aj1jjj and not more than #ajj1jjj4 7ii7 ,considerations for statutory damages ,in determining the amount of statutory damages assessed under this subparagraph against a covered entity1 the court shall consider any relevant circumstances presented by the parties to the action1 including-- 7,i7 the nature and seriousness of the violation2 7,,ii7 the number of violations2 7,,iii7 the persistence of the misconduct2 7,,iv7 the length of time over which the misconduct occurred2 7,v7 the willfulness of the misconduct2 and 7,,vi7 the assets1 liabilities1 and net worth of the covered entity4 7#c7 ,remedies for ,state workers 7,a7 ,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 immunity1 under the #aath ,amendment to the ,constitution of the ,united ,states or otherwise1 to a suit under this subsection for the relief described in paragraph 7#b7 authorized under this subsection brought by an individual employed under1 or otherwise engaged in the performance of work for remuneration under1 that program or activity4 7,b7 ,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 paragraph1 for injunctive relief that is authorized under this subsection4 ,in such a suit the court may award to the prevailing party those costs authorized by section #gbb of the ,revised ,statutes 7#db ,u4,s4,c4 #aihh74 7,c7 ,applicability ,with respect to a particular program or activity1 subparagraph 7,a7 applies to conduct that occurs-- 7i7 after the date of enactment of this ,act2 and 7ii7 on or after the day on which a ,state first receives or uses ,federal financial assistance for that program or activity4 7#d7 ,definition of program or activity ,in this subsection1 the term program or activity has the meaning given the term in section #fjf of the ,civil ,rights ,act of #aifd 7#db ,u4,s4,c4 #bjjj;d-#d;a74 7c7 ,inflation adjustment 7#a7 ,in general ,subject to paragraphs 7#b7 and 7#c71 the ,secretary1 not later than ,september #a of each calendar year1 shall adjust the dollar amounts referred to in subsections 7a77#c7 and 7b77#b77;,b77i7 by the percent increase1 if any1 in the consumer price index for all urban consumers 7,united ,states city average71 or a successor index1 as determined by the ,bureau of ,labor ,statistics1 or a successor agency1 for the most recent #ab-month period for which data is available4 7#b7 ,rounding ,any adjustment under paragraph 7#a7 that is not a multiple of #aj shall be rounded to the nearest multiple of #aj4 7#c7 ,publication ,the ,secretary shall publish the adjusted amounts under paragraph 7#a7 in the ,federal ,register1 and on the official website of the ,department of ,labor1 not later than ,october #a1 of the applicable calendar year for the increase under such paragraph4 7#d7 ,effective date ,each adjustment under paragraph 7#a7 shall take effect on ,january #a of the first calendar year beginning after the date of the increase under such paragraph4 7d7 ,arbitration and class action ,notwithstanding any other provision of law1 no predispute arbitration agreement or predispute joint-action waiver shall be valid or enforceable with respect to any alleged violation of this title4 #bjd4 ,regulations 7a7 ,in general ,the ,secretary may prescribe such regulations as may be necessary to carry out this title4 7b7 ,consultation ,in prescribing any regulations authorized under this section1 the ,secretary-- 7#a7 shall consult with the ,secretary of ,health and ,human ,services2 and 7#b7 may consult with-- 7,a7 other ,federal agencies that have expertise in artificial intelligence or health care2 and 7,b7 other ,federal agencies that have jurisdiction over labor and employment issues1 including the ,equal ,employment ,opportunity ,commission1 the ,department of ,justice1 and the ,national ,labor ,relations ,board4 ,,iii ,general provisions #cja4 ,educational materials for covered entities and health care professionals ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 in consultation with the ,secretary of ,labor1 shall develop and disseminate education materials for-- 7#a7 covered entities with respect to the compliance of such entities with the requirements under this ,act2 and 7#b7 health care professionals to inform such professionals of their rights and protections under this ,act4 #cjb4 ,state enforcement 7a7 ,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 ,act1 the ,state attorney general or ,state privacy regulator1 as parens patriae1 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-- 7#a7 enjoin further violation of such provision by the covered entity2 7#b7 compel compliance with such provision2 7#c7 obtain damages1 civil penalties1 restitution1 or other compensation on behalf of the residents of the ,state2 or 7#d7 obtain reasonable attorney's fees and other litigation costs reasonably incurred4 7b7 ,rights of agency ,before initiating a civil action under subsection 7a71 the ,state attorney general or ,state privacy regulator1 as the case may be1 shall notify the ,secretary in writing of such civil action4 ,upon receiving such notice1 the ,secretary may-- 7#a7 intervene in such action2 and 7#b7 upon intervening-- 7,a7 be heard on all matters arising in such civil action2 and 7,b7 file petitions for appeal of a decision in such action4 7c7 ,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 ,act1 a ,state attorney general or ,state privacy regulator may not1 during the pendency of such action1 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 complaint4 ,in a case brought by the ,secretary that affects the interests of a ,state1 the ,state attorney general or ,state privacy regulator may intervene as of right pursuant to the ,federal ,rules of ,civil ,procedure4 7d7 ,preservation of ,state powers ,except as provided in subsection 7c71 no provision of this ,act shall be construed as altering1 limiting1 or affecting the authority of a ,state attorney general or ,state privacy regulator to-- 7#a7 bring an action or other regulatory proceeding arising solely under the laws in effect in that ,state2 or 7#b7 exercise the powers conferred on the ,state attorney general or ,state privacy regulator by the laws of the ,state1 including the ability to conduct investigations1 administer oaths or affirmations1 or compel the attendance of witnesses or the production of documentary or other evidence4 7e7 ,definition of ,secretary ,in this section1 the term ,secretary means-- 7#a7 with respect to a violation of title ,i1 the ,secretary of ,health and ,human ,services2 and 7#b7 with respect to a violation of title ,,ii1 the ,secretary of ,labor4 #cjc4 ,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 output4 #cjd4 ,non-preemption ,nothing in this ,act shall preempt a ,state law or collective bargaining agreement4