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 subse-
quently 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National Patient Safe-
ty Board Act of 2024’’. 
SEC. 2. NATIONAL PATIENT SAFETY BOARD. 
(a) ESTABLISHMENT.—For the purpose of preventing 
and reducing patient safety events, there is hereby estab-
lished, within the Office of the Secretary of Health and 
Human Services, an independent board, to be known as 
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the National Patient Safety Board (in this section referred 
to as the ‘‘Board’’). 
(b) DUTIES.— 
(1) IN GENERAL.—For the purpose stated in 
subsection (a), the Board shall— 
(A) support Federal departments and 
agencies in monitoring and anticipating patient 
safety events; 
(B) provide expertise to study the context 
and causes of patient safety events and pre-
vented patient safety events; and 
(C) formulate recommendations and solu-
tions to prevent patient safety events from oc-
curring. 
(2) AUTHORITY.—The Board shall have the 
sole authority to— 
(A) request changes to, or approve, the pa-
tient safety measures and solutions rec-
ommended by the Patient Safety Research and 
Development Division under subsection (g); 
(B) review each report transmitted to the 
Board under subsection (g)(7) and based on 
such review require the Director of such Divi-
sion— 
(i) to conduct further studies; or 
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(ii) to make revisions to the report; 
and 
(C) make any such report publicly avail-
able. 
(3) TIMELINE FOR PUBLIC AVAILABILITY.—The 
Board shall ensure that each report transmitted to 
the Board under subsection (g)(7) is made publicly 
available not later than one year after commence-
ment of the study that is the subject of the report. 
(4) ANNUAL AUDIT.—The Board shall undergo 
an annual audit. 
(5) ANNUAL REPORTS TO CONGRESS.— 
(A) SUBMISSION.—The Chair of the Board 
shall submit annual reports to the Congress on 
the progress of the Board in achieving the pur-
pose stated in subsection (a). 
(B) 
CONTENTS.—Each 
annual 
report 
under subparagraph (A) shall include— 
(i) input from the director of each di-
vision of the Board; 
(ii) detailed solutions; 
(iii) unaddressed needs; and 
(iv) any other information determined 
by the Chair of the Board to be relevant 
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to achieving the purpose stated in sub-
section (a). 
(c) HEARINGS; REPORTS.— 
(1) IN GENERAL.—The Board may, for the pur-
pose of carrying out this Act, hold hearings, take 
testimony, receive evidence, and issue such reports 
as the Board considers appropriate. 
(2) NO INDIVIDUALLY IDENTIFIABLE INFORMA-
TION IN PUBLICATIONS.—The Board (including any 
division, subdivision, or other component thereof) 
shall not include in any report or other publication 
information that can be used to identify any patient, 
health care provider, or health care setting. 
(d) MEMBERSHIP.— 
(1) IN
GENERAL.—The Board shall be com-
posed of 5 members— 
(A) each appointed by the President; and 
(B) each appointed for a term of 5 years, 
with the option to remain on the Board until 
another person is appointed to fill the position. 
(2) 
STAGGERED
TERMS.—Notwithstanding 
paragraph (1)(B), of the initial 5 members of the 
Board— 
(A) 2 shall be appointed for a term of 3 
years; and 
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(B) 3 shall be appointed for a term of 5 
years. 
(3) QUALIFICATIONS.—Of the 5 members of 
the Board— 
(A) at least 3 shall have expertise specifi-
cally in patient safety, or have demonstrated ex-
perience in increasing the safety of systems in 
complex, high-risk industries; and 
(B) at least 2 shall represent individuals 
who have experienced a patient safety event, or 
who have a family member who experienced a 
patient safety event. 
(4) CONFLICTS OF INTEREST.—Each member 
of the Board shall abide by all relevant conflict of 
interest policies. 
(5) CHAIR; VICE CHAIR.—The Board shall have 
a Chair and Vice Chair who shall each— 
(A) be designated by the President, in con-
sultation with the Senate, from among the 
members of the Board appointed under para-
graph (1); 
(B) serve for a 3-year term; and 
(C) have demonstrated complex, high-risk 
experience in patient safety. 
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(e) STAFFING.—The Chair of the Board may appoint 
such personnel as the Chair considers appropriate to carry 
out this section. 
(f) ORGANIZATION.—The Board shall have— 
(1) an Office of the Chair of the Board; 
(2) a Patient Safety Research and Development 
Division, to be headed by a director appointed by the 
Board; 
(3) a Study Division, to be headed by a director 
appointed by the Board; and 
(4) an Administrative Division, to be headed by 
a director appointed by the Board. 
(g) PATIENT SAFETY RESEARCH
AND DEVELOP-
MENT DIVISION.— 
(1) HEALTH CARE SAFETY TEAM.— 
(A) IN GENERAL.—For the purpose stated 
in subsection (a), the Director of the Patient 
Safety Research and Development Division 
shall establish and maintain a public-private 
team (in this section referred to as the ‘‘Health 
Care Safety Team’’) to identify, develop, review, 
update, prioritize, and recommend patient safe-
ty event measures and solutions, based on the 
precursors and causes of patient safety events, 
for the Board’s approval. 
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(B) DATA
SOURCES.—For each patient 
safety event measure and solution recommended 
under subparagraph (A), the Health Care Safe-
ty Team shall identify the data sources used, 
including survey data, electronic health records 
data, claims data, health information exchange 
data, and reports of patient safety events. 
(C) 
PATIENT
SAFETY
DATA
TECH-
NOLOGIES.—The Health Care Safety Team 
shall recommend to public and private entities 
patient safety data surveillance technologies and 
specifications with the ability to identify and 
anticipate the patient safety measures and solu-
tions. 
(D) MEMBERSHIP.—The membership of 
the Health Care Safety Team shall include— 
(i) representatives with demonstrated 
patient safety expertise from the following 
Federal 
agencies: 
the 
Agency 
for 
Healthcare Research and Quality, the Cen-
ters for Disease Control and Prevention, 
the Centers for Medicare & Medicaid, the 
Department of Veterans Affairs, the Office 
of the National Coordinator for Health In-
formation Technology, the Indian Health 
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Service, the Office of Minority Health of 
the Department of Health and Human 
Services, the Health Resources and Serv-
ices Administration, the Substance Abuse 
and Mental Health Services Administra-
tion, the Food and Drug Administration, 
the National Institutes of Health, and the 
United States Preventive Services Task 
Force; and 
(ii) representatives of the private sec-
tor with demonstrated patient safety exper-
tise, representing providers, including orga-
nized labor, health care organizations, pa-
tients, families, caregivers, payors, sup-
pliers, vendors, manufacturers, measure-
ment developers, and data technology ex-
perts. 
(2) OBTAINING OFFICIAL DATA.—To carry out 
the data analysis under paragraph (5), the Director 
of the Patient Safety Research and Development Di-
vision may secure directly from any office or agency 
of the Department of Health and Human Services 
or the Department of Veterans Affairs longitudinal, 
real-time, de-identified patient-level data relating to 
patient safety event measures and solutions. Upon 
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request of the Director of the Patient Research and 
Development Division, the head of the respective of-
fice or agency shall furnish such data to the Direc-
tor. The Director shall maintain and use such data 
consistent with applicable privacy and confidentiality 
law. 
(3) WEBSITE OR SYSTEM.—The Director of the 
Patient Safety Research and Development Division 
shall create and maintain a website or system, to be 
known as the Patient Safety Reporting System, that 
can be used by patients, health care providers, non-
clinical staff, or any other person— 
(A) to report patient safety events to the 
Division, anonymously or not; and 
(B) to receive a response to any such re-
port from the Board. 
(4) DATA
ACCESS
PORTAL.—The Director of 
the Patient Safety Research and Development Divi-
sion shall— 
(A) enter into agreements with public and 
private entities, including at the State and local 
levels, to enable such entities to opt into allow-
ing the Division to access their longitudinal, 
real-time, de-identified patient-level data relat-
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ing to patient safety event measures and solu-
tions; 
(B) maintain a data access portal to enable 
such entities to submit such data to the Divi-
sion; and 
(C) maintain and use such data, consistent 
with applicable privacy and confidentiality law, 
including— 
(i) the Federal Information Security 
Management Act of 2002 (6 U.S.C. 511 et 
seq.); 
(ii) the Risk Management Framework 
and Artificial Intelligence Risk Manage-
ment Framework of the National Institute 
of Standards and Technology; 
(iii) HIPAA privacy and security law 
(as defined in section 3009(a)(2) of the 
Public Health Service Act (42 U.S.C. 
300jj–19(a)(2))); and 
(iv) the Blueprint for an AI Bill of 
Rights of the White House Office of 
Science Technology Policy. 
(5) ANALYZING DATA.—The Director of the Pa-
tient Safety Event Research and Development Divi-
sion shall— 
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(A) aggregate and analyze the patient-level 
data collected in accordance with this section to 
anticipate and identify patient safety events, in-
cluding the precursors to and outcomes of pa-
tient safety events; and 
(B) analyze such patient-level data by race, 
ethnicity, gender, facility, age, social factors, 
and location to identify disparities in patient 
safety events. 
(6) MONITORING.—The Director of the Patient 
Safety Research and Development Division shall— 
(A) submit to the Health Care Safety 
Team bimonthly briefs on patient safety event 
surveillance; and 
(B) prompt the Study Division to conduct 
a study in accordance with subsection (h)(3) 
when any of the following types of findings are 
identified in a geographic area or health care 
organization: 
(i) The most frequently occurring 
major sources of patient safety events. 
(ii) Abnormal patterns of patient safe-
ty events. 
(iii) Unexpectedly low numbers of pa-
tient safety events. 
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(iv) Persistent patterns of injury or 
harm. 
(v) Emergent risks of patient safety 
events. 
(vi) Racial, ethnic, social, gender, or 
geographic disparities. 
(vii) Unaddressed reoccurring patient 
safety events. 
(7) RECOMMENDING SOLUTIONS.—The Director 
of the Patient Safety Research and Development Di-
vision shall— 
(A) work with the Health Care Safety 
Team to identify, develop, review, update, 
prioritize, and recommend patient safety event 
measures and solutions, based on the precur-
sors and causes of patient safety events, for the 
Board’s approval; 
(B) include the resulting recommendations 
in a report for the Board; and 
(C) transmit such report to the Board, to-
gether with the relevant report of the Study Di-
vision under subsection (h)(4) regarding prob-
able precursors, causes, and outcomes. 
(h) STUDY DIVISION.— 
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(ii) vest such person with authority to 
determine the appropriate type of study, 
assemble a study team of experts, and 
identify the study site or sites. 
(B) STUDY
TEAM.—The Study Lead 
shall— 
(i) assemble a team of multidisci-
plinary experts to conduct the study; 
(ii) include in such team— 
(I) individuals with the ability to 
study and understand the interaction 
of human abilities, expectations, and 
limitations with work environments, 
technologies, and system design; and 
(II) other appropriate experts 
from the public and private sectors; 
(iii) prohibit such team from releasing 
information obtained during the study 
prior to the public release of such informa-
tion by the Board; and 
(iv) ensure that such team receives 
permission from each health care organiza-
tion involved to— 
(I) enter health care facilities 
participating in the study; and 
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(II) 
communicate 
with 
staff, 
health care providers, patients, ven-
dors, suppliers, contractors, equip-
ment manufacturers, and members of 
the Board. 
(C) APPROPRIATE TYPE OF STUDY.—The 
Director of the Study Division shall— 
(i) create guidelines and criteria to de-
termine the appropriate type of study to be 
conducted or supported, including whether 
the study should be virtual, in-person, or a 
special board of inquiry; and 
(ii) in creating such guidelines and 
criteria, take into account the impact of 
the patient safety events to be studied, 
whether such patient safety events may in-
dicate a systemic risk, and what may po-
tentially be learned from the study. 
(D) NOVEL
INFECTION
AND
EMERGING 
PANDEMICS.—In the case of a novel infection 
and emerging pandemic, the Director of the 
Study Division, in coordination with the Direc-
tor of the Centers for Disease Control and Pre-
vention, may establish a special board of in-
quiry— 
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(i) 
to 
provide 
independent 
rec-
ommendations on a coordinated national 
preparedness and response plan; 
(ii) to independently monitor the im-
plementation of the preparedness and re-
sponse plan; and 
(iii) to recommend technologies to 
support logistics and autonomous real-time 
research to inform evidence-based treat-
ment options and decisions. 
(4) REPORTING.—The Director of the Study 
Division shall— 
(A) provide for the submission to the 
Board and the Patient Safety Research and De-
velopment Division of— 
(i) at least one progress report on 
each study under this subsection over the 
course of the study; and 
(ii) a final report upon the conclusion 
of the study to inform the Patient Safety 
Research and Development Division’s rec-
ommendations and solutions to prevent pa-
tient safety events; and 
(B) include in a final report under sub-
paragraph (A)(ii) factual information and anal-
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ysis regarding the probable precursors, causes, 
and outcomes of the factors that prompted the 
study of the patient safety events. 
(5) RESPONSE BY SECRETARY.—Not later than 
90 days after the submission of a final report under 
subsection (g)(7)(C), the Secretary of Health and 
Human Services and the Secretary of Veterans Af-
fairs shall publish a response to the recommenda-
tions in such report. 
(i) ADMINISTRATIVE DIVISION.—The Director of the 
Administrative Division shall support the day-to-day ac-
tivities of the Board, including with respect to communica-
tions, facility coordination, shipping and receiving, supply 
inventory, labor relations, and human resource manage-
ment. 
(j) NONPUNITIVE RESTRICTIONS.— 
(1) INADMISSIBILITY AS EVIDENCE.— 
(A) IN
GENERAL.—Any report or other 
publication of the Board (including any divi-
sion, subdivision, or other component thereof) 
shall not be admissible as evidence of individual 
or organizational liability in a civil action for 
damages resulting from the events mentioned in 
the report. 
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(B) SPECIAL
RULE.—Subparagraph (A) 
does not apply with respect to data collected or 
housed outside of the Board. 
(2) STANDARDS OF CARE.—Nothing in this sec-
tion shall be construed to prohibit the use of reports, 
recommendations, or publications of the Board to 
develop or inform standards of care. 
(3) USE OF INFORMATION BY HHS.—The De-
partment of Health and Human Services shall not 
use data, reports, publications, or work product of 
the Board to impose, implement, or enforce any dis-
ciplinary or other punitive measure with respect to 
a health care provider. 
(4) LIMITATION ON AUTHORITY.—The Board 
and any study team of experts assembled under sub-
section (h)(3)(A)(ii) shall not have authority to de-
termine the rights or liabilities of any person with 
respect to adverse patient safety events. 
(k) PROTECTIONS FOR EMPLOYEES.—Cooperation by 
an employee with the Board shall be treated as an activity 
for which the employee may not be discharged or discrimi-
nated against under section 40 of the Consumer Product 
Safety Act (15 U.S.C. 2087). 
(l) DEFINITIONS.—In this section: 
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(1) The term ‘‘health care setting’’ means a 
hospital, nursing facility, comprehensive outpatient 
rehabilitation facility, home health agency, hospice 
program, renal dialysis facility, ambulatory surgical 
center, pharmacy, physician or other health care 
practitioner’s office, long-term care facility, mental 
health treatment facility, substance use disorder 
treatment facility, clinical laboratory, health center, 
urgent care center, wound clinic, emergency room, or 
any other setting in which health care is delivered. 
(2) The term ‘‘patient safety event’’ means an 
action, interaction, inaction, condition, or outbreak 
occurring in a health care setting or as part of 
health care treatment that— 
(A) leads to patient injury, harm, or death; 
(B) could lead to— 
(i) patient injury, harm, or death; or 
(ii) a precursor or potential precursor 
to patient injury, harm, or death; or 
(C) could have harmed the patient but did 
not cause harm as a result of chance, preven-
tion, mitigation, or other factors. 
Æ 
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