I 
117TH CONGRESS 
2D SESSION 
H. R. 8865 
To authorize the Secretary of Health and Human Services to establish a 
national sepsis data trust, and to fund State-based pilots and programs 
to establish interoperable State-based sepsis data trusts. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 15, 2022 
Ms. SHERRILL introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To authorize the Secretary of Health and Human Services 
to establish a national sepsis data trust, and to fund 
State-based pilots and programs to establish interoper-
able State-based sepsis data trusts. 
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 Sepsis Data 
Research, Outcomes, and Innovation Act’’ or ‘‘LuLu’s 
Law’’. 
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SEC. 2. TREATING AND ELIMINATING THE BURDEN OF SEP-
SIS. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 399V–7. TREATING AND ELIMINATING THE BURDEN 
OF SEPSIS. 
‘‘(a) DEFINITION; DESIGNATION.— 
‘‘(1) DEFINITION OF SEPSIS.—Not later than 
120 days after the date of the enactment of the Na-
tional Sepsis Data Research, Outcomes, and Innova-
tion Act, the Secretary shall issue a rule specifying 
a definition of sepsis. Such definition may specify 
that sepsis is a life-threatening organ dysfunction 
caused by a dysregulated host response to infection. 
Such definition shall be standardized across depart-
ments, agencies, and other entities within the De-
partment of Health of Human Services. 
‘‘(2) NATIONALLY NOTIFIABLE DISEASE.—The 
Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall take 
such steps as may be necessary to include sepsis on 
the list of nationally notifiable diseases published by 
the Council of State and Territorial Epidemiologists 
and the Centers for Disease Control and Prevention. 
‘‘(b) NATIONAL STRATEGY.— 
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‘‘(1) IN GENERAL.—The Secretary shall develop 
a national strategy— 
‘‘(A) to treat and eliminate the burden of 
sepsis, with the specific goals of, with respect to 
sepsis— 
‘‘(i) 
coordinating 
data 
(including 
through the data trust established under 
subsection (d)); 
‘‘(ii) spurring research; and 
‘‘(iii) developing diagnostic tools and 
treatments; 
‘‘(B) to decrease instances of sepsis and 
mitigate long-term health effects of sepsis; and 
‘‘(C) that includes specific actions to be 
taken to treat and eliminate the burden of sep-
sis among at-risk populations identified pursu-
ant to paragraph (3). 
‘‘(2) COODINATION.—The Secretary may, in de-
veloping the strategy under paragraph (1), coordi-
nate among agencies within the Department of 
Health and Human Services and other Federal 
agencies, academic institutions, and non-profit orga-
nizations. 
‘‘(3) AT-RISK
POPULATIONS.—The Secretary 
shall identify population groups the Secretary deter-
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mines to be at a higher risk for contracting sepsis, 
which shall include— 
‘‘(A) children; 
‘‘(B) pregnant women or women in the one 
year postpartum period; 
‘‘(C) active servicemembers and veterans; 
‘‘(D) disabled and elderly individuals; and 
‘‘(E) individuals residing on federally rec-
ognized tribal lands. 
‘‘(c) STATE-BASED SEPSIS DATA TRUST PILOT PRO-
GRAMS.— 
‘‘(1) IN GENERAL.—Subject to the availability 
of appropriations, the Secretary shall award grants 
to not more than 5 States to establish pilot pro-
grams— 
‘‘(A) to collect into State-based sepsis data 
trusts that use standardized data formats and 
coding (as determined by the Secretary) de- 
identified patient data concerning— 
‘‘(i) demographic information about 
each case of sepsis in each such State; 
‘‘(ii) administrative information with 
respect to each such case, including the 
date of diagnosis and the source of infor-
mation; 
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demonstrate established partnerships with a range of 
public and private stakeholders. The Secretary shall, 
of the States that demonstrate such partnerships, 
select— 
‘‘(A) at least one State that has a death 
rate from septicemia of greater than 15 people 
per 100,000 people per year and 1,500 deaths 
per year for the 5 calendar years preceding the 
declaration of the public health emergency with 
respect to COVID–19; 
‘‘(B) at least one rural State with above 
average sepsis mortality rate; 
‘‘(C) a diverse array of other States in 
such a manor as to ensure diversity of popu-
lation density, geographic location, and general 
healthcare access and infrastructure; and 
‘‘(D) other States in such a matter as to 
10 ensure geographic and population diversity. 
‘‘(4) ALTERNATIVE
CRITERIA.—If no State 
meeting the criteria specified in paragraph (3) estab-
lishes a pilot program in coordination with the Sec-
retary within 36 months after the date of the enact-
ment of this section, the Secretary may identify al-
ternative requirements for such States. 
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‘‘(5) REPORTING.—Not later than 18 months 
after the date on which a State successfully (as de-
termined by the Secretary) establishes a State-based 
sepsis data trust using funds received through a 
grant under this subsection, the State shall submit 
to the Secretary a report. Such report shall include, 
with respect to the State-based sepsis data trust in-
volved— 
‘‘(A) the process by which the State estab-
lished the data trust; 
‘‘(B) the process by which data was col-
lected, de-identified, and standardized across 
multiple data systems; 
‘‘(C) implementation barriers experienced 
and the course of corrective action taken to ad-
dress these barriers; and 
‘‘(D) lessons learned through the establish-
ment of the data trust. 
‘‘(6) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection $5,000,000 for each of fiscal years 
2023 through 2028. 
‘‘(d) NATIONAL SEPSIS DATA TRUST.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a national sepsis data trust to improve research, 
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outcomes, and innovation in support of the national 
strategy developed under subsection (b) (including 
the actions to be taken pursuant to paragraph 
(1)(C) of such subsection). Such national sepsis data 
trust shall— 
‘‘(A) accelerate innovation that seeks to 
improve sepsis prevention, diagnosis, treatment, 
outcomes, and survivor support, including 
through— 
‘‘(i) advancing the pace of academic 
research; and 
‘‘(ii) catalyzing more investment in 
mechanisms that provide promise in the 
early recognition and expeditious treatment 
of sepsis; 
‘‘(B) support public health efforts to im-
prove sepsis care, particularly in underserved 
geographic areas and among at-risk and under-
served communities; 
‘‘(C) improve the targeting of antimicrobial 
drugs and other substances for the treatment of 
sepsis, promoting both better care and improved 
antimicrobial stewardship; 
‘‘(D) coordinate and integrate the develop-
ment of State-based sepsis data trusts, includ-
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ing by defining data elements to be included in 
State-based sepsis data trusts, including self-re-
ported data on age, race, ethnicity, primary lan-
guage, membership in a federally recognized 
tribe, status as a member of the armed services, 
status as a veteran, status as pregnant or re-
cently pregnant, and any other data determined 
to be appropriate by the Secretary; and 
‘‘(E) provide for appropriate privacy and 
security of de-identified data in the data trust 
by— 
‘‘(i) prohibiting any entity partici-
pating in the data trust from sharing pa-
tient data with any entity not participating 
in the data trust; and 
‘‘(ii) ensuring that an entity agrees, 
as a condition on participation in the data 
trust to not share any patient data with 
any entity not participating in the data 
trust; and 
‘‘(F) allow access to data de-identified data 
in the data trust by health care providers and 
other entities participating in the data trust. 
‘‘(2) STATE GRANTS.— 
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‘‘(A) IN GENERAL.—In addition to award-
ing grants under subsection (c), the Secretary 
may make grants directly to States to support 
the development and operation of State-based 
sepsis data trusts (or make grants, or enter 
into contracts with academic or nonprofit orga-
nizations designated by a State to operate the 
State-based sepsis data trust involved) to com-
bine and connect data collected by the State 
concerning— 
‘‘(i) demographic information about 
each case of sepsis in each such State; 
‘‘(ii) administrative information with 
respect to each such case, including the 
date of diagnosis and the source of infor-
mation; 
‘‘(iii) pathological and genetic data 
characterizing each such case; 
‘‘(iv) clinical information, including 
relevant diagnoses, treatment, and patient- 
reported outcomes of the individuals with 
sepsis and sepsis survivors; and 
‘‘(v) other elements determined appro-
priate by the Secretary. 
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‘‘(B) MATCHING
FUNDS.—The Secretary 
may make a grant under paragraph (1) only if 
the State involved (or the academic or nonprofit 
private organization designated by a State to 
operate the State-based sepsis data trust in-
volved) agrees, with respect to the costs of the 
program to be funded through the grant, to 
make available (directly or through donations 
from public or private entities) non-Federal 
contributions toward such costs in an amount 
that is not less than 25 percent of such costs. 
‘‘(C) 
DATA
TRUST
GUIDELINES.—The 
guidelines developed under subsection (c)(2) 
shall apply with respect to State-based sepsis 
data trusts established under this paragraph in 
the same manner and to the same extent as 
such guidelines apply with respect to State- 
based sepsis data trusts established under sub-
section (c) (including the data sharing limita-
tions specified in paragraph (2)(B) of such sub-
section). 
‘‘(3) REPORT ON GOVERNMENT SEPSIS DATA 
ACTIVITIES AND RESOURCES.—Not later than 180 
days after the date of the enactment of this section, 
the Secretary shall submit to the Committee on En-
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ergy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor 
and Pensions of the Senate a report containing the 
following: 
‘‘(A) An outline of existing Federal efforts 
to collect and make available data on sepsis and 
its associated conditions, including existing 
Federal repositories of sepsis-relevant de-identi-
fied patient data. 
‘‘(B) A summary of the use of these sepsis 
data by third parties, including public health 
professionals, physicians and nurses, and re-
searchers. 
‘‘(C) A description of Federal efforts to 
improve care related to sepsis and infection in 
underserved populations and communities that 
experience disproportionately poor health out-
comes. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) DE-IDENTIFIED.—The term ‘de-identified’ 
means, with respect to data in a data trust estab-
lished under or pursuant to this section, information 
that has been de-identified (and remains de-identi-
fied) in accordance with the applicable requirements 
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of section 164.514 of title 45, Code of Federal Reg-
ulations (or any successor regulation). 
‘‘(2) NATIONAL
SEPSIS
DATA
TRUST.—The 
term ‘national sepsis data trust’ means an interoper-
able, de-identified, privacy-protected collection sys-
tem that contains de-identified data from a variety 
of sources established by individual States.’’. 
Æ 
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