,i  #aah? ,,congress  #b;d ,session  ,h4
 ,r4 #geia  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #h1 #bjbd,ms4    
,b>ragn 7= h]self & ,mr4 ,burgess7      
introduc$ ! foll[+ bill2 :i* 0 ref]r$ to
 ! ,committee on ,en]gy & ,comm]ce1 & 9 
addition to ! ,committee on ,vet]ans'   
,affairs1 = a p]iod to be subsequ5tly   
det]m9$ by ! ,speak]1 9 ea* case =      
consid]ation ( su* provisions z fall )9 
! jurisdiction ( ! committee conc]n$  ,a
 ,,bill  ,to e/abli% ! ,national ,pati5t
 ,safety ,bo>d4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,national ,pati5t  
,safety ,bo>d ,act ( #bjbd4  #b4        
,national ,pati5t ,safety ,bo>d  7a7    
,e/abli%m5t ,= ! purpose ( prev5t+ &    
r$uc+ pati5t safety ev5ts1 !re is h]eby 
e/abli%$1 )9 ! ,(fice ( ! ,secret>y (   
,heal? & ,human ,s]vices1 an indep5d5t  
bo>d1 to be kn[n z ! ,national ,pati5t  
,safety ,bo>d 79 ?is section ref]r$ to z
 ! ,bo>d74  7b7 ,duties  7#a7 ,9 g5]al  
,= ! purpose /at$ 9 subsection 7a71 !   
,bo>d %all-- 7,a7 support ,f$]al        

dep>tm5ts & ag5cies 9 monitor+ &        
anticipat+ pati5t safety ev5ts2  7,b7   
provide exp]tise to /udy ! context &    
causes ( pati5t safety ev5ts & prev5t$  
pati5t safety ev5ts2 &  7,c7 =mulate    
recomm5dations & solutions to prev5t    
pati5t safety ev5ts f occurr+4  7#b7    
,au?ority ,! ,bo>d %all h ! sole        
au?ority to-- 7,a7 reque/ *anges to1 or 
approve1 ! pati5t safety measures &     
solutions recomm5d$ by ! ,pati5t ,safety
 ,rese>* & ,developm5t ,division "u     
subsection 7g72  7,b7 review ea* report 
transmitt$ to ! ,bo>d "u subsection     
7g77#g7 & bas$ on su* review require !  
,director ( su* ,division-- 7i7 to      
conduct fur!r /udies2 or  7ii7 to make  
revisions to ! report2 &  7,c7 make any 
su* report publicly available4  7#c7    
,timel9e = public availability ,! ,bo>d 
%all ensure t ea* report transmitt$ to !
 ,bo>d "u subsection 7g77#g7 is made    
publicly available n lat] ?an "o ye>    
aft] comm5cem5t ( ! /udy t is ! subject 
( ! report4  7#d7 ,annual audit ,! ,bo>d

 %all und]go an annual audit4  7#e7     
,annual reports to ,congress  7,a7      
,submission ,! ,*air ( ! ,bo>d %all     
submit annual reports to ! ,congress on 
! progress ( ! ,bo>d 9 a*iev+ ! purpose 
/at$ 9 subsection 7a74  7,b7 ,cont5ts   
,ea* annual report "u subp>agraph 7,a7  
%all include-- 7i7 input f ! director ( 
ea* division ( ! ,bo>d2  7ii7 detail$   
solutions2  7iii7 unaddress$ ne$s2 &    
7iv7 any o!r in=mation det]m9$ by !     
,*air ( ! ,bo>d to be relevant to a*iev+
 ! purpose /at$ 9 subsection 7a74  7c7  
,he>+s2 reports  7#a7 ,9 g5]al ,! ,bo>d 
may1 = ! purpose ( c>ry+ out ?is ,act1  
hold he>+s1 take te/imony1 receive      
evid5ce1 & issue su* reports z ! ,bo>d  
consid]s appropriate4  7#b7 ,no         
individually id5tifiable in=mation 9    
publications ,! ,bo>d 7includ+ any      
division1 subdivision1 or o!r compon5t  
!re(7 %all n include 9 any report or o!r
 publication in=mation t c be us$ to    
id5tify any pati5t1 heal? c>e provid]1  
or heal? c>e sett+4  7d7 ,memb]%ip  7#a7

 ,9 g5]al ,! ,bo>d %all be compos$ ( #e 
memb]s-- 7,a7 ea* appo9t$ by !          
,presid5t2 &  7,b7 ea* appo9t$ = a t]m (
 #e ye>s1 ) ! option to rema9 on ! ,bo>d
 until ano!r p]son is appo9t$ to fill ! 
position4  7#b7 ,/agg]$ t]ms ,not)/&+   
p>agraph 7#a77;,b71 ( ! initial #e      
memb]s ( ! ,bo>d-- 7,a7 #b %all be      
appo9t$ = a t]m ( #c ye>s2 &  7,b7 #c   
%all be appo9t$ = a t]m ( #e ye>s4  7#c7
 ,qualifications ,( ! #e memb]s ( !     
,bo>d-- 7,a7 at lea/ #c %all h exp]tise 
specifically 9 pati5t safety1 or h      
demon/rat$ exp]i5ce 9 increas+ ! safety 
( sy/ems 9 complex1 high-risk indu/ries2
 &  7,b7 at lea/ #b %all repres5t       
individuals :o h exp]i5c$ a pati5t      
safety ev5t1 or :o h a family memb] :o  
exp]i5c$ a pati5t safety ev5t4  7#d7    
,conflicts ( int]e/ ,ea* memb] ( ! ,bo>d
 %all abide by all relevant conflict (  
int]e/ policies4  7#e7 ,*air2 ,vice     
,*air ,! ,bo>d %all h a ,*air & ,vice   
,*air :o %all ea*-- 7,a7 be designat$ by
 ! ,presid5t1 9 consultation ) ! ,s5ate1

 f among ! memb]s ( ! ,bo>d appo9t$ "u  
p>agraph 7#a72  7,b7 s]ve = a #c-ye>    
t]m2 &  7,c7 h demon/rat$ complex1      
high-risk exp]i5ce 9 pati5t safety4  7e7
 ,/aff+ ,! ,*air ( ! ,bo>d may appo9t   
su* p]sonnel z ! ,*air consid]s         
appropriate to c>ry out ?is section4    
7f7 ,organization ,! ,bo>d %all h-- 7#a7
 an ,(fice ( ! ,*air ( ! ,bo>d2  7#b7 a 
,pati5t ,safety ,rese>* & ,developm5t   
,division1 to be head$ by a director    
appo9t$ by ! ,bo>d2  7#c7 a ,/udy       
,division1 to be head$ by a director    
appo9t$ by ! ,bo>d2 &  7#d7 an          
,adm9i/rative ,division1 to be head$ by 
a director appo9t$ by ! ,bo>d4  7g7     
,pati5t ,safety ,rese>* & ,developm5t   
,division  7#a7 ,heal? ,c>e ,safety     
,team  7,a7 ,9 g5]al ,= ! purpose /at$ 9
 subsection 7a71 ! ,director ( ! ,pati5t
 ,safety ,rese>* & ,developm5t ,division
 %all e/abli% & ma9ta9 a public-private 
team 79 ?is section ref]r$ to z ! ,heal?
 ,c>e ,safety ,team7 to id5tify1        
develop1 review1 update1 prioritize1 &  

recomm5d pati5t safety ev5t measures &  
solutions1 bas$ on ! precursors & causes
 ( pati5t safety ev5ts1 = ! ,bo>d's     
approval4  7,b7 ,data s\rces ,= ea*     
pati5t safety ev5t measure & solution   
recomm5d$ "u subp>agraph 7,a71 ! ,heal? 
,c>e ,safety ,team %all id5tify ! data  
s\rces us$1 includ+ survey data1        
electronic heal? records data1 claims   
data1 heal? in=mation ex*ange data1 &   
reports ( pati5t safety ev5ts4  7,c7    
,pati5t safety data te*nologies ,!      
,heal? ,c>e ,safety ,team %all recomm5d 
to public & private entities pati5t     
safety data surveillance te*nologies &  
specifications ) ! ability to id5tify & 
anticipate ! pati5t safety measures &   
solutions4  7,d7 ,memb]%ip ,! memb]%ip (
 ! ,heal? ,c>e ,safety ,team %all       
include-- 7i7 repres5tatives )          
demon/rat$ pati5t safety exp]tise f !   
foll[+ ,f$]al ag5cies3 ! ,ag5cy =       
,heal?c>e ,rese>* & ,quality1 ! ,c5t]s =
 ,disease ,control & ,prev5tion1 !      
,c5t]s = ,m$ic>e  ,m$icaid1 ! ,dep>tm5t 

( ,vet]ans ,affairs1 ! ,(fice ( !       
,national ,coord9ator = ,heal?          
,in=mation ,te*nology1 ! ,indian ,heal? 
,s]vice1 ! ,(fice ( ,m9ority ,heal? ( ! 
,dep>tm5t ( ,heal? & ,human ,s]vices1 ! 
,heal? ,res\rces & ,s]vices             
,adm9i/ration1 ! ,sub/ance ,abuse &     
,m5tal ,heal? ,s]vices ,adm9i/ration1 ! 
,food & ,drug ,adm9i/ration1 ! ,national
 ,in/itutes ( ,heal?1 & ! ,unit$ ,/ates 
,prev5tive ,s]vices ,task ,=ce2 &  7ii7 
repres5tatives ( ! private sector )     
demon/rat$ pati5t safety exp]tise1      
repres5t+ provid]s1 includ+ organiz$    
labor1 heal? c>e organizations1 pati5ts1
 families1 c>egiv]s1 payors1 suppli]s1  
v5dors1 manufactur]s1 measurem5t        
develop]s1 & data te*nology exp]ts4     
7#b7 ,obta9+ (ficial data ,to c>ry out !
 data analysis "u p>agraph 7#e71 !      
,director ( ! ,pati5t ,safety ,rese>* & 
,developm5t ,division may secure        
directly f any (fice or ag5cy ( !       
,dep>tm5t ( ,heal? & ,human ,s]vices or 
! ,dep>tm5t ( ,vet]ans ,affairs         

longitud9al1 real-"t1 de-id5tifi$       
pati5t-level data relat+ to pati5t      
safety ev5t measures & solutions4 ,^u   
reque/ ( ! ,director ( ! ,pati5t ,rese>*
 & ,developm5t ,division1 ! head ( !    
respective (fice or ag5cy %all furni%   
su* data to ! ,director4 ,! ,director   
%all ma9ta9 & use su* data consi/5t )   
applicable privacy & confid5tiality law4
  7#c7 ,website or sy/em ,! ,director ( 
! ,pati5t ,safety ,rese>* & ,developm5t 
,division %all create & ma9ta9 a website
 or sy/em1 to be kn[n z ! ,pati5t       
,safety ,report+ ,sy/em1 t c be us$ by  
pati5ts1 heal? c>e provid]s1 noncl9ical 
/aff1 or any o!r p]son-- 7,a7 to report 
pati5t safety ev5ts to ! ,division1     
anonym\sly or n2 &  7,b7 to receive a   
response to any su* report f ! ,bo>d4   
7#d7 ,data access portal ,! ,director ( 
! ,pati5t ,safety ,rese>* & ,developm5t 
,division %all-- 7,a7 ent] into         
agreem5ts ) public & private entities1  
includ+ at ! ,/ate & local levels1 to   
enable su* entities to opt into all[+ ! 

,division to access _! longitud9al1     
real-"t1 de-id5tifi$ pati5t-level data  
relat+ to pati5t safety ev5t measures & 
solutions2  7,b7 ma9ta9 a data access   
portal to enable su* entities to submit 
su* data to ! ,division2 &  7,c7 ma9ta9 
& use su* data1 consi/5t ) applicable   
privacy & confid5tiality law1 includ+-- 
7i7 ! ,f$]al ,in=mation ,security       
,managem5t ,act ( #bjjb 7#f ,u4,s4,c4   
#eaa et seq472  7ii7 ! ,risk ,managem5t 
,framework & ,artificial ,intellig5ce   
,risk ,managem5t ,framework ( !         
,national ,in/itute ( ,/&>ds &          
,te*nology2  7iii7 ,,hipaa privacy &    
security law 7z def9$ 9 section         
#cjji7;a77#b7 ( ! ,public ,heal? ,s]vice
 ,act 7#db ,u4,s4,c4                    
#cjj;jj-#ai7;a77#b7772 &  7iv7 !        
,bluepr9t = an ,,ai ,bill ( ,rights ( ! 
,:ite ,h\se ,(fice ( ,sci5ce ,te*nology 
,policy4  7#e7 ,analyz+ data ,!         
,director ( ! ,pati5t ,safety ,ev5t     
,rese>* & ,developm5t ,division %all--  
7,a7 aggregate & analyze ! pati5t-level 

data collect$ 9 accordance ) ?is section
 to anticipate & id5tify pati5t safety  
ev5ts1 includ+ ! precursors to &        
outcomes ( pati5t safety ev5ts2 &  7,b7 
analyze su* pati5t-level data by race1  
e?nicity1 g5d]1 facility1 age1 social   
factors1 & location to id5tify          
disp>ities 9 pati5t safety ev5ts4  7#f7 
,monitor+ ,! ,director ( ! ,pati5t      
,safety ,rese>* & ,developm5t ,division 
%all-- 7,a7 submit to ! ,heal? ,c>e     
,safety ,team bimon?ly briefs on pati5t 
safety ev5t surveillance2 &  7,b7 prompt
 ! ,/udy ,division to conduct a /udy 9  
accordance ) subsection 7h77#c7 :5 any (
 ! foll[+ types ( f9d+s are id5tifi$ 9 a
 geographic area or heal? c>e           
organization3 7i7 ,! mo/ frequ5tly      
occurr+ major s\rces ( pati5t safety    
ev5ts4  7ii7 ,abnormal patt]ns ( pati5t 
safety ev5ts4  7iii7 ,unexpect$ly l[    
numb]s ( pati5t safety ev5ts4  7iv7     
,p]si/5t patt]ns ( injury or h>m4  7v7  
,em]g5t risks ( pati5t safety ev5ts4    
7vi7 ,racial1 e?nic1 social1 g5d]1 or   

geographic disp>ities4  7vii7           
,unaddress$ reoccurr+ pati5t safety     
ev5ts4  7#g7 ,recomm5d+ solutions ,!    
,director ( ! ,pati5t ,safety ,rese>* & 
,developm5t ,division %all-- 7,a7 "w ) !
 ,heal? ,c>e ,safety ,team to id5tify1  
develop1 review1 update1 prioritize1 &  
recomm5d pati5t safety ev5t measures &  
solutions1 bas$ on ! precursors & causes
 ( pati5t safety ev5ts1 = ! ,bo>d's     
approval2  7,b7 include ! result+       
recomm5dations 9 a report = ! ,bo>d2 &  
7,c7 transmit su* report to ! ,bo>d1    
toge!r ) ! relevant report ( ! ,/udy    
,division "u subsection 7h77#d7 reg>d+  
probable precursors1 causes1 & outcomes4
  7h7 ,/udy ,division  7#a7 ,9 g5]al ,! 
,director ( ! ,/udy ,division may       
conduct or support /udies ) respect to  
pati5t safety ev5ts4  7#b7 ,data %>+    
7,a7 ,reque/ ,9 conduct+ or support+ a  
/udy "u p>agraph 7#a71 ! ,director ( !  
,/udy ,division may reque/ f ! ,director
 ( ! ,pati5t ,safety ,rese>* &          
,developm5t ,division su* in=mation z   

may be collect$ by ! ,pati5t ,safety    
,rese>* & ,developm5t ,division &       
relevant to ! /udy4  7,b7 ,%>+ ,^u      
receipt ( su* a reque/1 ! ,director ( ! 
,pati5t ,safety ,rese>* & ,developm5t   
,division %all %>e su* in=mation ) !    
,director ( ! ,/udy ,division4  7#c7    
,/udy requirem5ts ,9 conduct+ or        
support+ a /udy "u p>agraph 7#a73 7,a7  
,/udy lead ,! ,director ( ! ,/udy       
,division %all-- 7i7 appo9t an          
individual to s]ve z ! p]son 9 *>ge ( ! 
/udy 79 ?is p>agraph ref]r$ to z ! ,/udy
 ,lead72 &  7ii7 ve/ su* p]son )        
au?ority to det]m9e ! appropriate type (
 /udy1 assemble a /udy team ( exp]ts1 & 
id5tify ! /udy site or sites4  7,b7     
,/udy team ,! ,/udy ,lead %all-- 7i7    
assemble a team ( multidiscipl9>y exp]ts
 to conduct ! /udy2  7ii7 include 9 su* 
team-- 7,i7 individuals ) ! ability to  
/udy & und]/& ! int]action ( human      
abilities1 expectations1 & limitations )
 "w environm5ts1 te*nologies1 & sy/em   
design2 &  7,,ii7 o!r appropriate exp]ts

 f ! public & private sectors2  7iii7   
prohibit su* team f releas+ in=mation   
obta9$ dur+ ! /udy prior to ! public    
release ( su* in=mation by ! ,bo>d2 &   
7iv7 ensure t su* team receives         
p]mission f ea* heal? c>e organization  
involv$ to-- 7,i7 ent] heal? c>e        
facilities p>ticipat+ 9 ! /udy2 &       
7,,ii7 communicate ) /aff1 heal? c>e    
provid]s1 pati5ts1 v5dors1 suppli]s1    
contractors1 equipm5t manufactur]s1 &   
memb]s ( ! ,bo>d4  7,c7 ,appropriate    
type ( /udy ,! ,director ( ! ,/udy      
,division %all-- 7i7 create guidel9es & 
crit]ia to det]m9e ! appropriate type ( 
/udy to be conduct$ or support$1 includ+
 :e!r ! /udy %\ld be virtual1 9-p]son1  
or a special bo>d ( inquiry2 &  7ii7 9  
creat+ su* guidel9es & crit]ia1 take    
into acc\nt ! impact ( ! pati5t safety  
ev5ts to be /udi$1 :e!r su* pati5t      
safety ev5ts may indicate a sy/emic     
risk1 & :at may pot5tially be le>n$ f ! 
/udy4  7,d7 ,novel infection & em]g+    
p&emics ,9 ! case ( a novel infection & 

em]g+ p&emic1 ! ,director ( ! ,/udy     
,division1 9 coord9ation ) ! ,director (
 ! ,c5t]s = ,disease ,control &         
,prev5tion1 may e/abli% a special bo>d (
 inquiry-- 7i7 to provide indep5d5t     
recomm5dations on a coord9at$ national  
prep>$ness & response plan2  7ii7 to    
indep5d5tly monitor ! implem5tation ( ! 
prep>$ness & response plan2 &  7iii7 to 
recomm5d te*nologies to support logi/ics
 & autonom\s real-"t rese>* to in=m     
evid5ce-bas$ treatm5t options &         
decisions4  7#d7 ,report+ ,! ,director (
 ! ,/udy ,division %all-- 7,a7 provide =
 ! submission to ! ,bo>d & ! ,pati5t    
,safety ,rese>* & ,developm5t ,division 
(-- 7i7 at lea/ "o progress report on   
ea* /udy "u ?is subsection ov] ! c\rse (
 ! /udy2 &  7ii7 a f9al report ^u !     
conclusion ( ! /udy to in=m ! ,pati5t   
,safety ,rese>* & ,developm5t           
,division's recomm5dations & solutions  
to prev5t pati5t safety ev5ts2 &  7,b7  
include 9 a f9al report "u subp>agraph  
7,a77ii7 factual in=mation & analysis   

reg>d+ ! probable precursors1 causes1 & 
outcomes ( ! factors t prompt$ ! /udy ( 
! pati5t safety ev5ts4  7#e7 ,response  
by ,secret>y ,n lat] ?an #ij days aft] !
 submission ( a f9al report "u          
subsection 7g77#g77;,c71 ! ,secret>y (  
,heal? & ,human ,s]vices & ! ,secret>y (
 ,vet]ans ,affairs %all publi% a        
response to ! recomm5dations 9 su*      
report4  7i7 ,adm9i/rative ,division ,! 
,director ( ! ,adm9i/rative ,division   
%all support ! day-to-day activities ( !
 ,bo>d1 includ+ ) respect to            
communications1 facility coord9ation1   
%ipp+ & receiv+1 supply inv5tory1 labor 
relations1 & human res\rce managem5t4   
7j7 ,nonpunitive re/rictions  7#a7      
,inadmissibility z evid5ce  7,a7 ,9     
g5]al ,any report or o!r publication ( !
 ,bo>d 7includ+ any division1           
subdivision1 or o!r compon5t !re(7 %all 
n be admissible z evid5ce ( individual  
or organizational liability 9 a civil   
action = damages result+ f ! ev5ts      
m5tion$ 9 ! report4  7,b7 ,special rule 

,subp>agraph 7,a7 does n apply ) respect
 to data collect$ or h\s$ outside ( !   
,bo>d4  7#b7 ,/&>ds ( c>e ,no?+ 9 ?is   
section %all be con/ru$ to prohibit !   
use ( reports1 recomm5dations1 or       
publications ( ! ,bo>d to develop or    
in=m /&>ds ( c>e4  7#c7 ,use ( in=mation
 by ,,hhs ,! ,dep>tm5t ( ,heal? & ,human
 ,s]vices %all n use data1 reports1     
publications1 or "w product ( ! ,bo>d to
 impose1 implem5t1 or en=ce any         
discipl9>y or o!r punitive measure )    
respect to a heal? c>e provid]4  7#d7   
,limitation on au?ority ,! ,bo>d & any  
/udy team ( exp]ts assembl$ "u          
subsection 7h77#c77;,a77ii7 %all n h    
au?ority to det]m9e ! rights or         
liabilities ( any p]son ) respect to    
adv]se pati5t safety ev5ts4  7k7        
,protections = employees ,coop]ation by 
an employee ) ! ,bo>d %all be treat$ z  
an activity = :i* ! employee may n be   
dis*>g$ or discrim9at$ aga9/ "u section 
#dj ( ! ,consum] ,product ,safety ,act  
7#ae ,u4,s4,c4 #bjhg74  7l7 ,def9itions 

,9 ?is section3 7#a7 ,! t]m heal? c>e   
sett+ means a hospital1 nurs+ facility1 
compreh5sive outpati5t rehabilitation   
facility1 home heal? ag5cy1 hospice     
program1 r5al dialysis facility1        
ambulatory surgical c5t]1 ph>macy1      
physician or o!r heal? c>e practition]'s
 (fice1 long-t]m c>e facility1 m5tal    
heal? treatm5t facility1 sub/ance use   
disord] treatm5t facility1 cl9ical      
laboratory1 heal? c5t]1 urg5t c>e c5t]1 
w\nd cl9ic1 em]g5cy room1 or any o!r    
sett+ 9 :i* heal? c>e is deliv]$4  7#b7 
,! t]m pati5t safety ev5t means an      
action1 int]action1 inaction1 condition1
 or outbreak occurr+ 9 a heal? c>e sett+
 or z "p ( heal? c>e treatm5t t-- 7,a7  
leads to pati5t injury1 h>m1 or dea?2   
7,b7 c\ld lead to-- 7i7 pati5t injury1  
h>m1 or dea?2 or  7ii7 a precursor or   
pot5tial precursor to pati5t injury1    
h>m1 or dea?2 or  7,c7 c\ld h h>m$ !    
pati5t b did n cause h>m z a result (   
*ance1 prev5tion1 mitigation1 or o!r    
factors4