I 

118TH CONGRESS 

2D SESSION H. R. 7591 

To establish the National Patient Safety Board. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 8, 2024 

Ms. BARRAGA ́N (for herself and Mr. BURGESS) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Veterans’ Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To establish the National Patient Safety Board. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Patient Safe5 ty Board Act of 2024’’. 

6 SEC. 2. NATIONAL PATIENT SAFETY BOARD. 

7 (a) ESTABLISHMENT.—For the purpose of preventing 

8 and reducing patient safety events, there is hereby estab9 lished, within the Office of the Secretary of Health and 

10 Human Services, an independent board, to be known as 


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1 the National Patient Safety Board (in this section referred 

2 to as the ‘‘Board’’). 

3 (b) DUTIES.— 

4 (1) IN GENERAL.—For the purpose stated in 

5 subsection (a), the Board shall— 

6 (A) support Federal departments and 

7 agencies in monitoring and anticipating patient 

8 safety events; 

9 (B) provide expertise to study the context 

10 and causes of patient safety events and pre11 vented patient safety events; and 

12 (C) formulate recommendations and solu13 tions to prevent patient safety events from oc14 curring. 

15 (2) AUTHORITY.—The Board shall have the 

16 sole authority to— 

17 (A) request changes to, or approve, the pa18 tient safety measures and solutions rec19 ommended by the Patient Safety Research and 

20 Development Division under subsection (g); 

21 (B) review each report transmitted to the 

22 Board under subsection (g)(7) and based on 

23 such review require the Director of such Divi24 sion— 

25 (i) to conduct further studies; or 


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1 (ii) to make revisions to the report; 

2 and 

3 (C) make any such report publicly avail4 able. 

5 (3) TIMELINE FOR PUBLIC AVAILABILITY.—The 

6 Board shall ensure that each report transmitted to 

7 the Board under subsection (g)(7) is made publicly 

8 available not later than one year after commence9 ment of the study that is the subject of the report. 

10 (4) ANNUAL AUDIT.—The Board shall undergo 

11 an annual audit. 

12 (5) ANNUAL REPORTS TO CONGRESS.— 

13 (A) SUBMISSION.—The Chair of the Board 

14 shall submit annual reports to the Congress on 

15 the progress of the Board in achieving the pur16 pose stated in subsection (a). 

17 (B) CONTENTS.—Each annual report 

18 under subparagraph (A) shall include— 

19 (i) input from the director of each di20 vision of the Board; 

21 (ii) detailed solutions; 

22 (iii) unaddressed needs; and 

23 (iv) any other information determined 

24 by the Chair of the Board to be relevant 


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1 to achieving the purpose stated in sub2 section (a). 

3 (c) HEARINGS; REPORTS.— 

4 (1) IN GENERAL.—The Board may, for the pur5 pose of carrying out this Act, hold hearings, take 

6 testimony, receive evidence, and issue such reports 

7 as the Board considers appropriate. 

8 (2) NO INDIVIDUALLY IDENTIFIABLE INFORMA9 TION IN PUBLICATIONS.—The Board (including any 

10 division, subdivision, or other component thereof) 

11 shall not include in any report or other publication 

12 information that can be used to identify any patient, 

13 health care provider, or health care setting. 

14 (d) MEMBERSHIP.— 

15 (1) IN GENERAL.—The Board shall be com16 posed of 5 members— 

17 (A) each appointed by the President; and 

18 (B) each appointed for a term of 5 years, 

19 with the option to remain on the Board until 

20 another person is appointed to fill the position. 

21 (2) STAGGERED TERMS.—Notwithstanding 

22 paragraph (1)(B), of the initial 5 members of the 

23 Board— 

24 (A) 2 shall be appointed for a term of 3 

25 years; and 


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1 (B) 3 shall be appointed for a term of 5 

2 years. 

3 (3) QUALIFICATIONS.—Of the 5 members of 

4 the Board— 

5 (A) at least 3 shall have expertise specifi6 cally in patient safety, or have demonstrated ex7 perience in increasing the safety of systems in 

8 complex, high-risk industries; and 

9 (B) at least 2 shall represent individuals 

10 who have experienced a patient safety event, or 

11 who have a family member who experienced a 

12 patient safety event. 

13 (4) CONFLICTS OF INTEREST.—Each member 

14 of the Board shall abide by all relevant conflict of 

15 interest policies. 

16 (5) CHAIR; VICE CHAIR.—The Board shall have 

17 a Chair and Vice Chair who shall each— 

18 (A) be designated by the President, in con19 sultation with the Senate, from among the 

20 members of the Board appointed under para21 graph (1); 

22 (B) serve for a 3-year term; and 

23 (C) have demonstrated complex, high-risk 

24 experience in patient safety. 


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1 (e) STAFFING.—The Chair of the Board may appoint 

2 such personnel as the Chair considers appropriate to carry 

3 out this section. 

4 (f) ORGANIZATION.—The Board shall have— 

5 (1) an Office of the Chair of the Board; 

6 (2) a Patient Safety Research and Development 

7 Division, to be headed by a director appointed by the 

8 Board; 

9 (3) a Study Division, to be headed by a director 

10 appointed by the Board; and 

11 (4) an Administrative Division, to be headed by 

12 a director appointed by the Board. 

13 (g) PATIENT SAFETY RESEARCH AND DEVELOP14 MENT DIVISION.— 

15 (1) HEALTH CARE SAFETY TEAM.— 

16 (A) IN GENERAL.—For the purpose stated 

17 in subsection (a), the Director of the Patient 

18 Safety Research and Development Division 

19 shall establish and maintain a public-private 

20 team (in this section referred to as the ‘‘Health 

21 Care Safety Team’’) to identify, develop, review, 

22 update, prioritize, and recommend patient safe23 ty event measures and solutions, based on the 

24 precursors and causes of patient safety events, 

25 for the Board’s approval. 


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1 (B) DATA SOURCES.—For each patient 

2 safety event measure and solution recommended 

3 under subparagraph (A), the Health Care Safe4 ty Team shall identify the data sources used, 

5 including survey data, electronic health records 

6 data, claims data, health information exchange 

7 data, and reports of patient safety events. 

8 (C) PATIENT SAFETY DATA TECH9 NOLOGIES.—The Health Care Safety Team 

10 shall recommend to public and private entities 

11 patient safety data surveillance technologies and 

12 specifications with the ability to identify and 

13 anticipate the patient safety measures and solu14 tions. 

15 (D) MEMBERSHIP.—The membership of 

16 the Health Care Safety Team shall include— 

17 (i) representatives with demonstrated 

18 patient safety expertise from the following 

19 Federal agencies: the Agency for 

20 Healthcare Research and Quality, the Cen21 ters for Disease Control and Prevention, 

22 the Centers for Medicare & Medicaid, the 

23 Department of Veterans Affairs, the Office 

24 of the National Coordinator for Health In25 formation Technology, the Indian Health 


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1 Service, the Office of Minority Health of 

2 the Department of Health and Human 

3 Services, the Health Resources and Serv4 ices Administration, the Substance Abuse 

5 and Mental Health Services Administra6 tion, the Food and Drug Administration, 

7 the National Institutes of Health, and the 

8 United States Preventive Services Task 

9 Force; and 

10 (ii) representatives of the private sec11 tor with demonstrated patient safety exper12 tise, representing providers, including orga13 nized labor, health care organizations, pa14 tients, families, caregivers, payors, sup15 pliers, vendors, manufacturers, measure16 ment developers, and data technology ex17 perts. 

18 (2) OBTAINING OFFICIAL DATA.—To carry out 

19 the data analysis under paragraph (5), the Director 

20 of the Patient Safety Research and Development Di21 vision may secure directly from any office or agency 

22 of the Department of Health and Human Services 

23 or the Department of Veterans Affairs longitudinal, 

24 real-time, de-identified patient-level data relating to 

25 patient safety event measures and solutions. Upon 


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1 request of the Director of the Patient Research and 

2 Development Division, the head of the respective of3 fice or agency shall furnish such data to the Direc4 tor. The Director shall maintain and use such data 

5 consistent with applicable privacy and confidentiality 

6 law. 

7 (3) WEBSITE OR SYSTEM.—The Director of the 

8 Patient Safety Research and Development Division 

9 shall create and maintain a website or system, to be 

10 known as the Patient Safety Reporting System, that 

11 can be used by patients, health care providers, non12 clinical staff, or any other person— 

13 (A) to report patient safety events to the 

14 Division, anonymously or not; and 

15 (B) to receive a response to any such re16 port from the Board. 

17 (4) DATA ACCESS PORTAL.—The Director of 

18 the Patient Safety Research and Development Divi19 sion shall— 

20 (A) enter into agreements with public and 

21 private entities, including at the State and local 

22 levels, to enable such entities to opt into allow23 ing the Division to access their longitudinal, 

24 real-time, de-identified patient-level data relatVerDate Sep 11 2014 16:00 Mar 17, 2024 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H7591.IH H7591

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1 ing to patient safety event measures and solu2 tions; 

3 (B) maintain a data access portal to enable 

4 such entities to submit such data to the Divi5 sion; and 

6 (C) maintain and use such data, consistent 

7 with applicable privacy and confidentiality law, 

8 including— 

9 (i) the Federal Information Security 

10 Management Act of 2002 (6 U.S.C. 511 et 

11 seq.); 

12 (ii) the Risk Management Framework 

13 and Artificial Intelligence Risk Manage14 ment Framework of the National Institute 

15 of Standards and Technology; 

16 (iii) HIPAA privacy and security law 

17 (as defined in section 3009(a)(2) of the 

18 Public Health Service Act (42 U.S.C. 

19 300jj–19(a)(2))); and 

20 (iv) the Blueprint for an AI Bill of 

21 Rights of the White House Office of 

22 Science Technology Policy. 

23 (5) ANALYZING DATA.—The Director of the Pa24 tient Safety Event Research and Development Divi25 sion shall— 


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1 (A) aggregate and analyze the patient-level 

2 data collected in accordance with this section to 

3 anticipate and identify patient safety events, in4 cluding the precursors to and outcomes of pa5 tient safety events; and 

6 (B) analyze such patient-level data by race, 

7 ethnicity, gender, facility, age, social factors, 

8 and location to identify disparities in patient 

9 safety events. 

10 (6) MONITORING.—The Director of the Patient 

11 Safety Research and Development Division shall— 

12 (A) submit to the Health Care Safety 

13 Team bimonthly briefs on patient safety event 

14 surveillance; and 

15 (B) prompt the Study Division to conduct 

16 a study in accordance with subsection (h)(3) 

17 when any of the following types of findings are 

18 identified in a geographic area or health care 

19 organization: 

20 (i) The most frequently occurring 

21 major sources of patient safety events. 

22 (ii) Abnormal patterns of patient safe23 ty events. 

24 (iii) Unexpectedly low numbers of pa25 tient safety events. 


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1 (iv) Persistent patterns of injury or 

2 harm. 

3 (v) Emergent risks of patient safety 

4 events. 

5 (vi) Racial, ethnic, social, gender, or 

6 geographic disparities. 

7 (vii) Unaddressed reoccurring patient 

8 safety events. 

9 (7) RECOMMENDING SOLUTIONS.—The Director 

10 of the Patient Safety Research and Development Di11 vision shall— 

12 (A) work with the Health Care Safety 

13 Team to identify, develop, review, update, 

14 prioritize, and recommend patient safety event 

15 measures and solutions, based on the precur16 sors and causes of patient safety events, for the 

17 Board’s approval; 

18 (B) include the resulting recommendations 

19 in a report for the Board; and 

20 (C) transmit such report to the Board, to21 gether with the relevant report of the Study Di22 vision under subsection (h)(4) regarding prob23 able precursors, causes, and outcomes. 

24 (h) STUDY DIVISION.— 


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1 (1) IN GENERAL.—The Director of the Study 

2 Division may conduct or support studies with re3 spect to patient safety events. 

4 (2) DATA SHARING.— 

5 (A) REQUEST.—In conducting or sup6 porting a study under paragraph (1), the Direc7 tor of the Study Division may request from the 

8 Director of the Patient Safety Research and 

9 Development Division such information as may 

10 be collected by the Patient Safety Research and 

11 Development Division and relevant to the study. 

12 (B) SHARING.—Upon receipt of such a re13 quest, the Director of the Patient Safety Re14 search and Development Division shall share 

15 such information with the Director of the Study 

16 Division. 

17 (3) STUDY REQUIREMENTS.—In conducting or 

18 supporting a study under paragraph (1): 

19 (A) STUDY LEAD.—The Director of the 

20 Study Division shall— 

21 (i) appoint an individual to serve as 

22 the person in charge of the study (in this 

23 paragraph referred to as the ‘‘Study 

24 Lead’’); and 


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1 (ii) vest such person with authority to 

2 determine the appropriate type of study, 

3 assemble a study team of experts, and 

4 identify the study site or sites. 

5 (B) STUDY TEAM.—The Study Lead 

6 shall— 

7 (i) assemble a team of multidisci8 plinary experts to conduct the study; 

9 (ii) include in such team— 

10 (I) individuals with the ability to 

11 study and understand the interaction 

12 of human abilities, expectations, and 

13 limitations with work environments, 

14 technologies, and system design; and 

15 (II) other appropriate experts 

16 from the public and private sectors; 

17 (iii) prohibit such team from releasing 

18 information obtained during the study 

19 prior to the public release of such informa20 tion by the Board; and 

21 (iv) ensure that such team receives 

22 permission from each health care organiza23 tion involved to— 

24 (I) enter health care facilities 

25 participating in the study; and 


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1 (II) communicate with staff, 

2 health care providers, patients, ven3 dors, suppliers, contractors, equip4 ment manufacturers, and members of 

5 the Board. 

6 (C) APPROPRIATE TYPE OF STUDY.—The 

7 Director of the Study Division shall— 

8 (i) create guidelines and criteria to de9 termine the appropriate type of study to be 

10 conducted or supported, including whether 

11 the study should be virtual, in-person, or a 

12 special board of inquiry; and 

13 (ii) in creating such guidelines and 

14 criteria, take into account the impact of 

15 the patient safety events to be studied, 

16 whether such patient safety events may in17 dicate a systemic risk, and what may po18 tentially be learned from the study. 

19 (D) NOVEL INFECTION AND EMERGING

20 PANDEMICS.—In the case of a novel infection 

21 and emerging pandemic, the Director of the 

22 Study Division, in coordination with the Direc23 tor of the Centers for Disease Control and Pre24 vention, may establish a special board of in25 quiry— 


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1 (i) to provide independent rec2 ommendations on a coordinated national 

3 preparedness and response plan; 

4 (ii) to independently monitor the im5 plementation of the preparedness and re6 sponse plan; and 

7 (iii) to recommend technologies to 

8 support logistics and autonomous real-time 

9 research to inform evidence-based treat10 ment options and decisions. 

11 (4) REPORTING.—The Director of the Study 

12 Division shall— 

13 (A) provide for the submission to the 

14 Board and the Patient Safety Research and De15 velopment Division of— 

16 (i) at least one progress report on 

17 each study under this subsection over the 

18 course of the study; and 

19 (ii) a final report upon the conclusion 

20 of the study to inform the Patient Safety 

21 Research and Development Division’s rec22 ommendations and solutions to prevent pa23 tient safety events; and 

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1 ysis regarding the probable precursors, causes, 

2 and outcomes of the factors that prompted the 

3 study of the patient safety events. 

4 (5) RESPONSE BY SECRETARY.—Not later than 

5 90 days after the submission of a final report under 

6 subsection (g)(7)(C), the Secretary of Health and 

7 Human Services and the Secretary of Veterans Af8 fairs shall publish a response to the recommenda9 tions in such report. 

10 (i) ADMINISTRATIVE DIVISION.—The Director of the 

11 Administrative Division shall support the day-to-day ac12 tivities of the Board, including with respect to communica13 tions, facility coordination, shipping and receiving, supply 

14 inventory, labor relations, and human resource manage15 ment. 

16 (j) NONPUNITIVE RESTRICTIONS.— 

17 (1) INADMISSIBILITY AS EVIDENCE.— 

18 (A) IN GENERAL.—Any report or other 

19 publication of the Board (including any divi20 sion, subdivision, or other component thereof) 

21 shall not be admissible as evidence of individual 

22 or organizational liability in a civil action for 

23 damages resulting from the events mentioned in 

24 the report. 


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1 (B) SPECIAL RULE.—Subparagraph (A) 

2 does not apply with respect to data collected or 

3 housed outside of the Board. 

4 (2) STANDARDS OF CARE.—Nothing in this sec5 tion shall be construed to prohibit the use of reports, 

6 recommendations, or publications of the Board to 

7 develop or inform standards of care. 

8 (3) USE OF INFORMATION BY HHS.—The De9 partment of Health and Human Services shall not 

10 use data, reports, publications, or work product of 

11 the Board to impose, implement, or enforce any dis12 ciplinary or other punitive measure with respect to 

13 a health care provider. 

14 (4) LIMITATION ON AUTHORITY.—The Board 

15 and any study team of experts assembled under sub16 section (h)(3)(A)(ii) shall not have authority to de17 termine the rights or liabilities of any person with 

18 respect to adverse patient safety events. 

19 (k) PROTECTIONS FOR EMPLOYEES.—Cooperation by 

20 an employee with the Board shall be treated as an activity 

21 for which the employee may not be discharged or discrimi22 nated against under section 40 of the Consumer Product 

23 Safety Act (15 U.S.C. 2087). 

24 (l) DEFINITIONS.—In this section: 


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1 (1) The term ‘‘health care setting’’ means a 

2 hospital, nursing facility, comprehensive outpatient 

3 rehabilitation facility, home health agency, hospice 

4 program, renal dialysis facility, ambulatory surgical 

5 center, pharmacy, physician or other health care 

6 practitioner’s office, long-term care facility, mental 

7 health treatment facility, substance use disorder 

8 treatment facility, clinical laboratory, health center, 

9 urgent care center, wound clinic, emergency room, or 

10 any other setting in which health care is delivered. 

11 (2) The term ‘‘patient safety event’’ means an 

12 action, interaction, inaction, condition, or outbreak 

13 occurring in a health care setting or as part of 

14 health care treatment that— 

15 (A) leads to patient injury, harm, or death; 

16 (B) could lead to— 

17 (i) patient injury, harm, or death; or 

18 (ii) a precursor or potential precursor 

19 to patient injury, harm, or death; or 

20 (C) could have harmed the patient but did 

21 not cause harm as a result of chance, preven22 tion, mitigation, or other factors. 

Æ 


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