,,ii  #aagth ,,congress  #b;d ,session  
,s4 #dhbg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,september #ac1
 #bjbb,mr4 ,cassidy 7for himself and    
,mr4 ,casey7 introduced the following   
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to authorize the ,secretary of 
,health and ,human ,services to         
establish a national sepsis data trust1 
and to fund ,state-based pilots and     
programs to establish interoperable     
,state-based sepsis data trusts4  #a4   
,short title ,this ,act may be cited as 
the ,national ,sepsis ,data ,trust1     
,outcomes1 and ,innovation ,act or      
,lu,lu's ,law4  #b4 ,treating and       
eliminating the burden of sepsis ,part  
,p of title ,,iii of the ,public ,health
 ,service ,act 7#db ,u4,s4,c4 #bhj;g et 
seq47 is amended by adding at the end   
the following3  #cii,v-#g4 ,treating and
 eliminating the burden of sepsis  7a7  
,definition2 designation  7#a7          

,definition of sepsis ,not later than   
#abj days after the date of enactment of
 the ,national ,sepsis ,data ,trust1    
,outcomes1 and ,innovation ,act1 the    
,secretary shall issue a rule specifying
 a definition of sepsis4 ,such          
definition may specify that sepsis is a 
life-threatening organ dysfunction      
caused by a dysregulated host response  
to infection4 ,such definition shall be 
standardized across departments1        
agencies1 and other entities within the 
,department of ,health of ,human        
,services4  7#b7 ,nationally notifiable 
disease ,the ,secretary1 acting through 
the ,director of the ,centers for       
,disease ,control and ,prevention1 shall
 take such steps as may be necessary to 
include sepsis on the list of nationally
 notifiable diseases published by the   
,centers for ,disease ,control and      
,prevention4  7b7 ,national strategy    
7#a7 ,in general ,the ,secretary shall  
develop a national strategy-- 7,a7 to   
treat and eliminate the burden of       

sepsis1 with the specific goals of1 with
 respect to sepsis-- 7i7 coordinating   
data 7including through the data trust  
established under subsection 7d772  7ii7
 spurring research2 and  7iii7          
developing diagnostic tools and         
treatments2  7,b7 to decrease instances 
of sepsis and mitigate long-term health 
effects of sepsis2 and  7,c7 that       
includes specific actions to be taken to
 treat and eliminate the burden of      
sepsis among at-risk populations        
identified pursuant to paragraph 7#c74  
7#b7 ,coordination ,in developing the   
strategy under paragraph 7#a71 the      
,secretary may coordinate among agencies
 within the ,department of ,health and  
,human ,services and other ,federal     
agencies1 academic institutions1 and    
non-profit organizations4  7#c7 ,at-risk
 populations ,the ,secretary shall      
identify population groups the          
,secretary determines to be at a higher 
risk for contracting sepsis1 which shall
 include-- 7,a7 children2  7,b7 pregnant

 women or women in the one year         
postpartum period2  7,c7 active members 
of the ,armed ,forces and veterans2     
7,d7 disabled and elderly individuals2  
7,e7 individuals residing on            
federally-recognized ,tribal lands2 and 
7,f7 such other groups as the ,secretary
 determines to be at higher risk for    
contracting sepsis4  7c7 ,state-,based  
sepsis data trust pilot programs  7#a7  
,in general ,subject to the availability
 of appropriations1 the ,secretary shall
 award grants to not more than #e       
,states to establish pilot programs--   
7,a7 to collect into ,state-based sepsis
 data trusts that use standardized data 
formats and coding 7as determined by the
 ,secretary7 de-identified patient data 
concerning-- 7i7 demographic information
 about each case of sepsis in each such 
,state2  7ii7 administrative information
 with respect to each such case1        
including the date of diagnosis and the 
source of information2  7iii7           
pathological and genetic material       

characterizing each such case 7including
 deoxyribonucleic acids 7,,dna71        
ribonucleic acids 7,,rna71 single cell  
,,rna1 genes1 chromosomes1 genotype1    
alleles1 epigenetic alteration or       
modifications to ,,dna or ,,rna1 single 
nucleotide polymorphisms 7,s,n,ps71     
uninterpreted data that results from    
analysis of a biological sample from a  
diagnosed sepsis patient or other       
source1 and any information             
extrapolated1 derived1 or inferred      
therefrom72  7iv7 clinical information1 
including relevant diagnoses1 treatment1
 and patient-reported outcomes of the   
individuals with sepsis and sepsis      
survivors2  7v7 with respect to each    
case of sepsis in each such ,state1 the 
number of staff working in the relevant 
unit of the health care provider        
involved2  7vi7 provider payments that  
result from a sepsis diagnosis2 and     
7vii7 other elements determined         
appropriate by the ,secretary2 and  7,b7
 to combine and connect data so         

collected among such ,states4  7#b7     
,data trust guidelines  7,a7 ,in general
 ,the ,secretary shall establish        
governance guidelines1 data access      
requirements1 privacy and security      
protocols1 and other such standards as  
may be required to support the          
establishment of interoperable          
,state-based sepsis data trusts for     
purposes of the national sepsis data    
trust to be established under subsection
 7d74  7,b7 ,data sharing ,the          
guidelines established under            
subparagraph 7,a7 shall specify that--  
7i7 no entity participating in the data 
trust may share patient data with any   
entity not participating in the data    
trust2 and  7ii7 an entity shall agree1 
as a condition on participation in the  
data trust to not share any patient data
 with any entity not participating in   
the data trust4  7#c7 ,selection        
criteria ,in reviewing applications     
submitted by ,states for grants under   
this section1 the ,secretary shall      

consider whether the ,states submitting 
such applications demonstrate           
established partnerships with a range of
 public and private stakeholders4 ,of   
the ,states that demonstrate such       
partnerships1 the ,secretary shall      
select-- 7,a7 at least one ,state that  
has a death rate from septicemia of     
greater than #ae people per #ajj1jjj    
people per year and #a1ejj deaths per   
year for the #e calendar years preceding
 the declaration of the public health   
emergency with respect to ,,covid-#ai2  
7,b7 at least one rural ,state with     
above average sepsis mortality rate2    
7,c7 a selection of other ,states in    
such a manner as to ensure diversity of 
population density1 geographic location1
 and general health care access and     
infrastructure2 and  7,d7 other ,states 
in such a matter as to ensure geographic
 and population diversity4  7#d7        
,alternative criteria ,if no ,state     
meeting the criteria specified in       
paragraph 7#c7 establishes a pilot      

program in coordination with the        
,secretary within #c years of the date  
of enactment of the ,national ,sepsis   
,data ,trust1 ,outcomes1 and ,innovation
 ,act1 the ,secretary may identify      
alternative requirements for such       
,states4  7#e7 ,reporting ,not later    
than #ah months after the date on which 
a ,state successfully 7as determined by 
the ,secretary7 establishes a           
,state-based sepsis data trust using    
funds received through a grant under    
this subsection1 the ,state shall submit
 to the ,secretary a report4 ,such      
report shall include1 with respect to   
the ,state-based sepsis data trust      
involved-- 7,a7 the process by which the
 ,state established the data trust1     
including governance and data access    
rules2  7,b7 the process by which data  
was collected1 de-identified1 and       
standardized across multiple data       
systems2  7,c7 implementation barriers  
experienced and the course of corrective
 action taken to address these barriers2

 and  7,d7 lessons learned through the  
establishment of the data trust4  7#f7  
,authorization of appropriations ,there 
are authorized to be appropriated to    
carry out this subsection #e1jjj1jjj for
 each of fiscal years #bjbc through     
#bjbh4  7d7 ,national ,sepsis ,data     
,trust  7#a7 ,in general ,the ,secretary
 shall establish a national sepsis data 
trust to improve research1 outcomes1 and
 innovation in support of the national  
strategy developed under subsection 7b7 
7including the actions to be taken      
pursuant to paragraph 7#a77;,c7 of such 
subsection74 ,such national sepsis data 
trust shall-- 7,a7 accelerate innovation
 that seeks to improve sepsis           
prevention1 diagnosis1 treatment1       
outcomes1 and survivor support1         
including through-- 7i7 advancing the   
pace of academic research2 and  7ii7    
catalyzing more investment in mechanisms
 that provide promise in the early      
recognition and expeditious treatment of
 sepsis2  7,b7 support public health    

efforts to improve sepsis care1         
particularly in underserved geographic  
areas and among at-risk and underserved 
communities2  7,c7 improve the targeting
 of antimicrobial drugs and other       
substances for the treatment of sepsis1 
promoting both better care and improved 
antimicrobial stewardship2  7,d7        
coordinate and integrate the development
 of ,state-based sepsis data trusts1    
including by defining data elements to  
be included in ,state-based sepsis data 
trusts1 including self-reported data on 
age1 race1 ethnicity1 primary language1 
membership in a federally-recognized    
,tribe1 status as a member of the ,armed
 ,forces1 status as a veteran1 status as
 pregnant or recently pregnant1 and any 
other data the ,secretary determines    
appropriate2  7,e7 provide for          
appropriate privacy and security of     
de-identified data in the data trust    
by-- 7i7 prohibiting any entity         
participating in the data trust from    
sharing patient data with any entity not

 participating in the data trust2 and   
7ii7 ensuring that an entity agrees1 as 
a condition on participation in the data
 trust to not share any patient data    
with any entity not participating in the
 data trust2 and  7,f7 allow access to  
data de-identified data in the data     
trust by health care providers and other
 entities participating in the data     
trust4  7#b7 ,state grants and contracts
  7,a7 ,in general ,in addition to      
awarding grants under subsection 7c71   
the ,secretary may award grants directly
 to ,states to support the development  
and operation of ,state-based sepsis    
data trusts 7or award grants or         
contracts to academic or nonprofit      
organizations designated by a ,state to 
operate the ,state-based sepsis data    
trust involved7 to combine and connect  
data collected by the ,state            
concerning-- 7i7 demographic information
 about each case of sepsis in each such 
,state2  7ii7 administrative information
 with respect to each such case1        

including the date of diagnosis and the 
source of information2  7iii7           
pathological and genetic data           
characterizing each such case2  7iv7    
clinical information1 including relevant
 diagnoses1 treatment1 and              
patient-reported outcomes of the        
individuals with sepsis and sepsis      
survivors2 and  7v7 other elements1 as  
the ,secretary determines appropriate4  
7,b7 ,matching funds ,the ,secretary may
 award a grant or contract under        
paragraph 7#b7 only if the ,state       
involved 7or the academic or nonprofit  
private organization designated by a    
,state to operate the ,state-based      
sepsis data trust involved7 agrees1 with
 respect to the costs of the program to 
be funded through the award1 to make    
available 7directly or through donations
 from public or private entities7       
non-,federal contributions toward such  
costs in an amount that is not less than
 #be percent of such costs4  7,c7 ,data 
trust guidelines ,the guidelines        

developed under subsection 7c77#b7 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    
subsection 7c7 7including the data      
sharing limitations specified in        
paragraph 7#b77;,b7 of such subsection74
  7#c7 ,report on government sepsis data
 activities and resources ,not later    
than #ahj days after the date of        
enactment of the ,national ,sepsis ,data
 ,trust1 ,outcomes1 and ,innovation     
,act1 the ,secretary shall submit to the
 ,committee on ,health1 ,education1     
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives a    
report containing the following3 7,a7   
,an outline of existing ,federal efforts
 to collect and make available data on  
sepsis and its associated conditions1   
including existing ,federal repositories

 of sepsis-relevant de-identified       
patient data4  7,b7 ,a summary of the   
use of these sepsis data by third       
parties1 including public health        
professionals1 physicians and nurses1   
and researchers4  7,c7 ,a description of
 ,federal efforts to improve care       
related to sepsis and infection in      
underserved populations and communities 
that experience disproportionately poor 
health outcomes4  7e7 ,definitions ,in  
this section3 7#a7 ,de-identified ,the  
term de-identified means1 with respect  
to data in a data trust established     
under or pursuant to this section1      
information that has been de-identified 
7and remains de-identified7 in          
accordance with the applicable          
requirements of section #afd4ead of     
title #de1 ,code of ,federal            
,regulations 7or any successor          
regulation74  7#b7 ,national sepsis data
 trust ,the term national sepsis data   
trust means an interoperable1           
de-identified1 privacy-protected        

collection1 curation1 and storage system
 that contains de-identified data from a
 variety of sources established by      
individual ,states1 with data made      
available to entities and individuals   
approved by the ,secretary4  4