II 

117TH CONGRESS 

2D SESSION S. 4827 

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 SENATE OF THE UNITED STATES 

SEPTEMBER 13, 2022 

Mr. CASSIDY (for himself and Mr. CASEY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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 interoperable State-based sepsis data trusts. 

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 Sepsis Data 

5 Trust, Outcomes, and Innovation Act’’ or ‘‘LuLu’s Law’’. 


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1 SEC. 2. TREATING AND ELIMINATING THE BURDEN OF SEP2 SIS. 

3 Part P of title III of the Public Health Service Act 

4 (42 U.S.C. 280g et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘SEC. 399V–7. TREATING AND ELIMINATING THE BURDEN 

7 OF SEPSIS. 

8 ‘‘(a) DEFINITION; DESIGNATION.— 

9 ‘‘(1) DEFINITION OF SEPSIS.—Not later than 

10 120 days after the date of enactment of the National 

11 Sepsis Data Trust, Outcomes, and Innovation Act, 

12 the Secretary shall issue a rule specifying a defini13 tion of sepsis. Such definition may specify that sep14 sis is a life-threatening organ dysfunction caused by 

15 a dysregulated host response to infection. Such defi16 nition shall be standardized across departments, 

17 agencies, and other entities within the Department 

18 of Health of Human Services. 

19 ‘‘(2) NATIONALLY NOTIFIABLE DISEASE.—The 

20 Secretary, acting through the Director of the Cen21 ters for Disease Control and Prevention, shall take 

22 such steps as may be necessary to include sepsis on 

23 the list of nationally notifiable diseases published by 

24 the Centers for Disease Control and Prevention. 

25 ‘‘(b) NATIONAL STRATEGY.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall develop 

2 a national strategy— 

3 ‘‘(A) to treat and eliminate the burden of 

4 sepsis, with the specific goals of, with respect to 

5 sepsis— 

6 ‘‘(i) coordinating data (including 

7 through the data trust established under 

8 subsection (d)); 

9 ‘‘(ii) spurring research; and 

10 ‘‘(iii) developing diagnostic tools and 

11 treatments; 

12 ‘‘(B) to decrease instances of sepsis and 

13 mitigate long-term health effects of sepsis; and 

14 ‘‘(C) that includes specific actions to be 

15 taken to treat and eliminate the burden of sep16 sis among at-risk populations identified pursu17 ant to paragraph (3). 

18 ‘‘(2) COORDINATION.—In developing the strat19 egy under paragraph (1), the Secretary may coordi20 nate among agencies within the Department of 

21 Health and Human Services and other Federal 

22 agencies, academic institutions, and non-profit orga23 nizations. 

24 ‘‘(3) AT-RISK POPULATIONS.—The Secretary 

25 shall identify population groups the Secretary deterVerDate Sep 11 2014 02:06 Sep 15, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4827.IS S4827

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1 mines to be at a higher risk for contracting sepsis, 

2 which shall include— 

3 ‘‘(A) children; 

4 ‘‘(B) pregnant women or women in the one 

5 year postpartum period; 

6 ‘‘(C) active members of the Armed Forces 

7 and veterans; 

8 ‘‘(D) disabled and elderly individuals; 

9 ‘‘(E) individuals residing on federally-rec10 ognized Tribal lands; and 

11 ‘‘(F) such other groups as the Secretary 

12 determines to be at higher risk for contracting 

13 sepsis. 

14 ‘‘(c) STATE-BASED SEPSIS DATA TRUST PILOT PRO15 GRAMS.— 

16 ‘‘(1) IN GENERAL.—Subject to the availability 

17 of appropriations, the Secretary shall award grants 

18 to not more than 5 States to establish pilot pro19 grams— 

20 ‘‘(A) to collect into State-based sepsis data 

21 trusts that use standardized data formats and 

22 coding (as determined by the Secretary) de23 identified patient data concerning— 

24 ‘‘(i) demographic information about 

25 each case of sepsis in each such State; 


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1 ‘‘(ii) administrative information with 

2 respect to each such case, including the 

3 date of diagnosis and the source of infor4 mation; 

5 ‘‘(iii) pathological and genetic mate6 rial characterizing each such case (includ7 ing deoxyribonucleic acids (DNA), ribo8 nucleic acids (RNA), single cell RNA, 

9 genes, chromosomes, genotype, alleles, epi10 genetic alteration or modifications to DNA 

11 or RNA, single nucleotide polymorphisms 

12 (SNPs), uninterpreted data that results 

13 from analysis of a biological sample from a 

14 diagnosed sepsis patient or other source, 

15 and any information extrapolated, derived, 

16 or inferred therefrom); 

17 ‘‘(iv) clinical information, including 

18 relevant diagnoses, treatment, and patient19 reported outcomes of the individuals with 

20 sepsis and sepsis survivors; 

21 ‘‘(v) with respect to each case of sep22 sis in each such State, the number of staff 

23 working in the relevant unit of the health 

24 care provider involved; 


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1 ‘‘(vi) provider payments that result 

2 from a sepsis diagnosis; and 

3 ‘‘(vii) other elements determined ap4 propriate by the Secretary; and 

5 ‘‘(B) to combine and connect data so col6 lected among such States. 

7 ‘‘(2) DATA TRUST GUIDELINES.— 

8 ‘‘(A) IN GENERAL.—The Secretary shall 

9 establish governance guidelines, data access re10 quirements, privacy and security protocols, and 

11 other such standards as may be required to 

12 support the establishment of interoperable 

13 State-based sepsis data trusts for purposes of 

14 the national sepsis data trust to be established 

15 under subsection (d). 

16 ‘‘(B) DATA SHARING.—The guidelines es17 tablished under subparagraph (A) shall specify 

18 that— 

19 ‘‘(i) no entity participating in the data 

20 trust may share patient data with any en21 tity not participating in the data trust; and 

22 ‘‘(ii) an entity shall agree, as a condi23 tion on participation in the data trust to 

24 not share any patient data with any entity 

25 not participating in the data trust. 


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1 ‘‘(3) SELECTION CRITERIA.—In reviewing appli2 cations submitted by States for grants under this 

3 section, the Secretary shall consider whether the 

4 States submitting such applications demonstrate es5 tablished partnerships with a range of public and 

6 private stakeholders. Of the States that demonstrate 

7 such partnerships, the Secretary shall select— 

8 ‘‘(A) at least one State that has a death 

9 rate from septicemia of greater than 15 people 

10 per 100,000 people per year and 1,500 deaths 

11 per year for the 5 calendar years preceding the 

12 declaration of the public health emergency with 

13 respect to COVID–19; 

14 ‘‘(B) at least one rural State with above 

15 average sepsis mortality rate; 

16 ‘‘(C) a selection of other States in such a 

17 manner as to ensure diversity of population 

18 density, geographic location, and general health 

19 care access and infrastructure; and 

20 ‘‘(D) other States in such a matter as to 

21 ensure geographic and population diversity. 

22 ‘‘(4) ALTERNATIVE CRITERIA.—If no State 

23 meeting the criteria specified in paragraph (3) estab24 lishes a pilot program in coordination with the Sec25 retary within 3 years of the date of enactment of the 


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1 National Sepsis Data Trust, Outcomes, and Innova2 tion Act, the Secretary may identify alternative re3 quirements for such States. 

4 ‘‘(5) REPORTING.—Not later than 18 months 

5 after the date on which a State successfully (as de6 termined by the Secretary) establishes a State-based 

7 sepsis data trust using funds received through a 

8 grant under this subsection, the State shall submit 

9 to the Secretary a report. Such report shall include, 

10 with respect to the State-based sepsis data trust in11 volved— 

12 ‘‘(A) the process by which the State estab13 lished the data trust, including governance and 

14 data access rules; 

15 ‘‘(B) the process by which data was col16 lected, de-identified, and standardized across 

17 multiple data systems; 

18 ‘‘(C) implementation barriers experienced 

19 and the course of corrective action taken to ad20 dress these barriers; and 

21 ‘‘(D) lessons learned through the establish22 ment of the data trust. 

23 ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.— 

24 There are authorized to be appropriated to carry out 


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1 this subsection $5,000,000 for each of fiscal years 

2 2023 through 2028. 

3 ‘‘(d) NATIONAL SEPSIS DATA TRUST.— 

4 ‘‘(1) IN GENERAL.—The Secretary shall estab5 lish a national sepsis data trust to improve research, 

6 outcomes, and innovation in support of the national 

7 strategy developed under subsection (b) (including 

8 the actions to be taken pursuant to paragraph 

9 (1)(C) of such subsection). Such national sepsis data 

10 trust shall— 

11 ‘‘(A) accelerate innovation that seeks to 

12 improve sepsis prevention, diagnosis, treatment, 

13 outcomes, and survivor support, including 

14 through— 

15 ‘‘(i) advancing the pace of academic 

16 research; and 

17 ‘‘(ii) catalyzing more investment in 

18 mechanisms that provide promise in the 

19 early recognition and expeditious treatment 

20 of sepsis; 

21 ‘‘(B) support public health efforts to im22 prove sepsis care, particularly in underserved 

23 geographic areas and among at-risk and under24 served communities; 


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1 ‘‘(C) improve the targeting of antimicrobial 

2 drugs and other substances for the treatment of 

3 sepsis, promoting both better care and improved 

4 antimicrobial stewardship; 

5 ‘‘(D) coordinate and integrate the develop6 ment of State-based sepsis data trusts, includ7 ing by defining data elements to be included in 

8 State-based sepsis data trusts, including self-re9 ported data on age, race, ethnicity, primary lan10 guage, membership in a federally-recognized 

11 Tribe, status as a member of the Armed 

12 Forces, status as a veteran, status as pregnant 

13 or recently pregnant, and any other data the 

14 Secretary determines appropriate; 

15 ‘‘(E) provide for appropriate privacy and 

16 security of de-identified data in the data trust 

17 by— 

18 ‘‘(i) prohibiting any entity partici19 pating in the data trust from sharing pa20 tient data with any entity not participating 

21 in the data trust; and 

22 ‘‘(ii) ensuring that an entity agrees, 

23 as a condition on participation in the data 

24 trust to not share any patient data with 


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1 any entity not participating in the data 

2 trust; and 

3 ‘‘(F) allow access to data de-identified data 

4 in the data trust by health care providers and 

5 other entities participating in the data trust. 

6 ‘‘(2) STATE GRANTS AND CONTRACTS.— 

7 ‘‘(A) IN GENERAL.—In addition to award8 ing grants under subsection (c), the Secretary 

9 may award grants directly to States to support 

10 the development and operation of State-based 

11 sepsis data trusts (or award grants or contracts 

12 to academic or nonprofit organizations des13 ignated by a State to operate the State-based 

14 sepsis data trust involved) to combine and con15 nect data collected by the State concerning— 

16 ‘‘(i) demographic information about 

17 each case of sepsis in each such State; 

18 ‘‘(ii) administrative information with 

19 respect to each such case, including the 

20 date of diagnosis and the source of infor21 mation; 

22 ‘‘(iii) pathological and genetic data 

23 characterizing each such case; 

24 ‘‘(iv) clinical information, including 

25 relevant diagnoses, treatment, and patientVerDate Sep 11 2014 02:06 Sep 15, 2022 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4827.IS S4827

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1 reported outcomes of the individuals with 

2 sepsis and sepsis survivors; and 

3 ‘‘(v) other elements, as the Secretary 

4 determines appropriate. 

5 ‘‘(B) MATCHING FUNDS.—The Secretary 

6 may award a grant or contract under para7 graph (2) only if the State involved (or the aca8 demic or nonprofit private organization des9 ignated by a State to operate the State-based 

10 sepsis data trust involved) agrees, with respect 

11 to the costs of the program to be funded 

12 through the award, to make available (directly 

13 or through donations from public or private en14 tities) non-Federal contributions toward such 

15 costs in an amount that is not less than 25 per16 cent of such costs. 

17 ‘‘(C) DATA TRUST GUIDELINES.—The 

18 guidelines developed under subsection (c)(2) 

19 shall apply with respect to State-based sepsis 

20 data trusts established under this paragraph in 

21 the same manner and to the same extent as 

22 such guidelines apply with respect to State23 based sepsis data trusts established under sub24 section (c) (including the data sharing limitaVerDate Sep 11 2014 02:06 Sep 15, 2022 Jkt 029200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4827.IS S4827

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1 tions specified in paragraph (2)(B) of such sub2 section). 

3 ‘‘(3) REPORT ON GOVERNMENT SEPSIS DATA

4 ACTIVITIES AND RESOURCES.—Not later than 180 

5 days after the date of enactment of the National 

6 Sepsis Data Trust, Outcomes, and Innovation Act, 

7 the Secretary shall submit to the Committee on 

8 Health, Education, Labor, and Pensions of the Sen9 ate and the Committee on Energy and Commerce of 

10 the House of Representatives a report containing the 

11 following: 

12 ‘‘(A) An outline of existing Federal efforts 

13 to collect and make available data on sepsis and 

14 its associated conditions, including existing 

15 Federal repositories of sepsis-relevant de-identi16 fied patient data. 

17 ‘‘(B) A summary of the use of these sepsis 

18 data by third parties, including public health 

19 professionals, physicians and nurses, and re20 searchers. 

21 ‘‘(C) A description of Federal efforts to 

22 improve care related to sepsis and infection in 

23 underserved populations and communities that 

24 experience disproportionately poor health out25 comes. 


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1 ‘‘(e) DEFINITIONS.—In this section: 

2 ‘‘(1) DE-IDENTIFIED.—The term ‘de-identified’ 

3 means, with respect to data in a data trust estab4 lished under or pursuant to this section, information 

5 that has been de-identified (and remains de-identi6 fied) in accordance with the applicable requirements 

7 of section 164.514 of title 45, Code of Federal Reg8 ulations (or any successor regulation). 

9 ‘‘(2) NATIONAL SEPSIS DATA TRUST.—The 

10 term ‘national sepsis data trust’ means an interoper11 able, de-identified, privacy-protected collection, 

12 curation, and storage system that contains de-identi13 fied data from a variety of sources established by in14 dividual States, with data made available to entities 

15 and individuals approved by the Secretary.’’. 

Æ 


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