,i  #aad? ,,congress  #b;d ,session  ,h4
 ,r4 #dhje  ,,9 ,,! ,,h\se ,,(          
,,repres5tatives  ,m>* #ag1 #bjaf ,mrs4 
,mc,morris ,rodg]s 7= h]self & ,mr4     
,byrne7 introduc$ ! foll[+ bill2 :i* 0  
ref]r$ to ! ,committee on ,en]gy &      
,comm]ce1 & 9 addition to ! ,committee  
on ,ways & ,means1 = 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 am5d ! ,heal?   
,in=mation ,te*nology = ,economic &     
,cl9ical ,heal? ,act to provide t       
in=mation held by heal? c>e cle>+h\ses  
is subject to privacy protections t are 
equival5t to ! protections t apply to   
in=mation held by o!r types ( cov]$     
entities "u ! ,,hipaa ,privacy ,rule1 & 
= o!r purposes4  #a4 ,%ort title ,?is   
,act may be cit$ z ! ,ensur+ ,pati5t    
,access to ,heal?c>e ,records ,act (    
#bjaf4  #b4 ,f9d+s ,! ,congress f9ds z  
foll[s3  7#a7 ,! ,heal? ,insurance      
,portability & ,acc\ntability ,act (    

#aiif 7,,hipaa71 ?r\gh c]ta9 ( its      
implem5t+ regulations kn[n z ! ,privacy 
,rule1 protects ! heal? in=mation (     
enrollees ( heal? plans & o!r           
individuals 79 ?is section ref]r$ to z  
protect$ heal? in=mation74  7#b7 ,!     
,,hipaa ,privacy ,rule applies to       
protect$ heal? in=mation held by heal?  
c>e provid]s1 plans1 & cle>+h\ses1 :i*  
are kn[n z cov]$ entities4 ,su* ,rule   
also applies to v5dors t p]=m c]ta9     
functions = cov]$ entities & !reby come 
into possession ( protect$ heal?        
in=mation4 ,! ,,hipaa ,privacy ,rule    
ref]s to ^! v5dors z bus9ess associates4
  7#c7 ,! ,,hipaa ,privacy ,rule applies
 bo? to ! int]nal use ( protect$ heal?  
in=mation by cov]$ entities & _! bus9ess
 associates & to ! disclosure ( su*     
in=mation to o!r p>ties4  7#d7 ,cov]$   
entities & _! bus9ess associates are    
subject to sub/antial civil & crim9al   
p5alties if !y use or disclose protect$ 
heal? in=mation 9 violation ( ! ,,hipaa 
,privacy ,rule4  7#e7 ,cle>+h\ses play a

 unique1 c5tral role 9 ! heal? c>e      
sy/em1 int]act+ ) bo? heal? c>e provid]s
 & plans4 ,cle>+h\ses conv]t in=mation f
 provid]s into claims-process+ /&>d     
electronic =mats & !n submit ! claims to
 ! plans & f9ally s5d provid]s ! plan   
paym5ts4  7#f7 ,claims & o!r data held  
by cle>+h\ses c\ld be analyz$           
longitud9ally & geographically1 provid+ 
p[]ful analytical tools t c\ld b5efit ! 
ov]all heal? c>e sy/em & facilitate     
m$ical innovation 9 ! #ba/ ,c5tury4     
7#g7 ,cle>+h\ses are unable to unlock ! 
b5efits ( su* claims & o!r data because 
! ,,hipaa ,privacy ,rule assigns        
cle>+h\ses a dual role4 ,su* cle>+h\ses 
are n only cov]$ entities1 b are also   
bus9ess associates4 ,! latt] role       
sub/antially re/ricts ! ability (       
cle>+h\ses to analyze claims data4  7#h7
 ,cle>+h\ses %\ld n be consid]$ bus9ess 
associates & %\ld in/ead h ! same       
ability to use & disclose heal?-relat$  
data z o!r types ( cov]$ entities4  7#i7
 ,elim9at+ ! bus9ess-associate role (   

cle>+h\ses w\ld n affect ! applicability
 ( ! civil & crim9al p5alties t en=ce ! 
,,hipaa ,privacy ,rule4 ,cle>+h\ses w\ld
 cont9ue to be subject to su* p5alties 9
 _! role z cov]$ entities4  7#aj7 ,9    
addition to ! uses ( heal?-relat$       
in=mation t ! ,,hipaa ,privacy ,rule    
curr5tly au?orizes = cov]$ entities1 !re
 are sev]al p>ticul> analytical uses t  
%\ld be au?oriz$ specifically =         
cle>+h\ses because ( ! unique b5efits t 
w\ld result f au?oriz+ ^? uses4 ,al?\gh 
^! p>ticul> new analytical uses %\ld be 
au?oriz$ = cle>+h\ses1 ! disclosure (   
heal? in=mation pursuant to ^! uses %\ld
 be subject to ! protection pr9ciples   
curr5tly und]ly+ ! ,,hipaa ,privacy     
,rule1 includ+ en=cem5t pr9ciples4  #c4 
,treatm5t ( c]ta9 ,,hipaa-relat$        
activities ( heal? c>e cle>+h\ses  7a7  
,9 g5]al ,subtitle ,d ( ! ,heal?        
,in=mation ,te*nology = ,economic &     
,cl9ical ,heal? ,act 7#db ,u4,s4,c4     
#agiba et seq47 is am5d$ by add+ at !   
end ! foll[+3  #e ,heal? ,c>e           

,cle>+h\ses2 ,analytical ,functions     
,t[>d ,improv+ ! ,heal? ,c>e ,sy/em     
#acdea4 ,au?ority reg>d+ analytical     
functions t[>d improv+ ! heal? c>e sy/em
  7a7 ,9 g5]al ,) respect to ! use &    
disclosure ( protect$ heal? in=mation1 !
 ,secret>y-- 7#a7 %all n consid] heal?  
c>e cle>+h\ses to be bus9ess associates 
"u ?is subtitle1 "p ,c ( title ,,xi ( ! 
,social ,security ,act1 or ! regulations
 promulgat$ pursuant to section #bfd7;c7
 ( ! ,heal? ,insurance ,portability &   
,acc\ntability ,act ( #aiif = purposes (
 c>ry+ out activities describ$ 9 section
 #aaga7b7 ( ! ,social ,security ,act &  
subsections 7b7 & 7c7 ( ?is section2 &  
7#b7 %all consid] su* cle>+h\ses to be  
cov]$ entities "u su* provisions ( law =
 su* purposes4  7b7 ,c]ta9 functions ,! 
functions t may be c>ri$ out by a heal? 
c>e cle>+h\se pursuant to subsection 7a7
 include ! foll[+3  7#a7 ,promptly ^u ! 
reque/ ( individuals1 provid+ su*       
individuals ) access to _! protect$     
heal? in=mation z p]mitt$ by section    

#afd4ejb7;a77#a77;i7 ( title #de1 ,code 
( ,f$]al ,regulations4 ,9 c>ry+ out !   
previ\s s5t5ce1 ! cle>+h\se may *>ge su*
 an individual a fee1 n to exce$ ! fair 
m>ket value1 = prep>+ ! record ( su*    
in=mation involv$4  7#b7 ,promptly ^u ! 
reque/ ( individuals1 provid+ su*       
individuals ) access to _! protect$     
heal? in=mation z requir$ by section    
#afd4ejb7;a77#b77;i7 ( title #de1 ,code 
( ,f$]al ,regulations4 ,9 c>ry+ out !   
previ\s s5t5ce1 ! cle>+h\se may *>ge su*
 an individual a fee1 n to exce$ ! fair 
m>ket value1 = prep>+ ! record ( su*    
in=mation involv$4  7#c7 ,) respect to !
 access ( pati5ts to exp]im5tal         
treatm5ts & diagno/ics1 notify+ pati5ts 
t !y may be appropriate c&idates z      
subjects 9 cl9ical rese>*1 & conduct+   
rese>* to id5tify su* pati5ts1 pursuant 
to ! prep>atory-rese>* provisions (     
section #afd4eab7;i7 ( title #de1 ,code 
( ,f$]al ,regulations1 & pursuant to !  
regulations ref]r$ to 9 p>agraph 7#a7 ( 
?is subsection4  7#d7 ,mak+ public heal?

 disclosures au?oriz$ by sections       
#afd4eab7;b7 or #afd4ead7;e7 ( title    
#de1 ,code ( ,f$]al ,regulations1       
includ+ notify+ manufactur]s ( drugs or 
devices ab\t adv]se ev5ts relat$ to _!  
products pursuant to su* section        
#afd4eab7;b74  7#e7 ,rese>* z au?oriz$  
by sections #afd4eab7;i7 or #afd4ead7;e7
 ( title #de1 ,code ( ,f$]al            
,regulations4  7#f7 ,consi/5t ) !       
applicable requirem5ts ( section        
#afd4ead ( title #de1 ,code ( ,f$]al    
,regulations1 creat+ de-id5tifi$ heal?  
in=mation or a limit$ data set4  7c7    
,additional functions  7#a7 ,9 g5]al ,9 
addition to ! functions t may be c>ri$  
out by a heal? c>e cle>+h\se pursuant to
 subsection 7a71 su* a cle>+h\se may1   
subject only to ! privacy protections "u
 p>agraph 7#b71 aggregate1 use1 &       
disclose data ! cle>+h\se possesses 9   
ord] to c>ry out ! foll[+ functions3    
7,a7 ,prep>e reports1 analyses1 &       
pres5tations on ! quality & co/s ( heal?
 c>e s]vices1 includ+ 9 specific        

geographic areas1 9 ord] to assi/       
individuals select heal? c>e s]vices &  
provid]s4  7,b7 ,prep>e reports1        
analyses1 & pres5tations ( heal?-s]vices
 outcomes data1 includ+ pres5tations    
address+ outcomes ( v>i\s types (       
approa*es to a p>ticul> disease1        
disord]1 or o!r adv]se heal? condition4 
7,c7 ,prep>e reports1 analyses1 &       
pres5tations ( epidemiological data to  
assi/ decisionmak+ 9 developm5t programs
 = new treatm5ts or diagno/ics4  7,d7   
,prep>e reports1 analyses1 &            
pres5tations on co/s & *>ges = heal? c>e
 products & s]vices4  7,e7 ,^u ! reque/ 
( a cov]$ entity1 prep>e reports1       
analyses1 & pres5tations t b5*m>k !     
op]ations ( su* cov]$ entity aga9/ !    
op]ations ( "o or m o!r cov]$ entities t
 h elect$ to p>ticipate 9 su* b5*m>k+4  
7#b7 ,privacy ,a heal? c>e cle>+h\se may
 c>ry out ! functions describ$ 9        
p>agraph 7#a7 )\t obta9+ any            
au?orizations "u section #afd4ejh (     
title #de1 ,code ( ,f$]al ,regulations4 

,= purposes ( su* p>agraph1 ) respect to
 any report1 analysis1 or pres5tation   
provid$ by ! cle>+h\se to a ?ird p>ty1  
su* report1 analysis1 or pres5tation--  
7,a7 %all include only de-id5tifi$ data2
 or  7,b7 if conta9+ protect$ heal?     
in=mation1 %all include su* data t is-- 
7i7 subject to a qualify+ data use      
agreem5t 7z def9$ 9 subsection 7i772 or 
7ii7 provid$ to ! ,food & ,drug         
,adm9i/ration = purposes au?oriz$ by law
 = su* ,adm9i/ration1 subject to        
protect$ heal? in=mation be+ disclos$ to
 su* ,adm9i/ration only to ! ext5t      
necess>y = su* purposes4  7d7 ,relevant 
in=mation ,9 ! case ( a heal? c>e       
cle>+h\se1 ! au?ority "u subsections 7a7
 ?r\gh 7c7 includes applicability )     
respect to protect$ heal? in=mation     
collect$ f o!r cov]$ entities & includes
 applicability ) respect to !           
aggregation ( su* in=mation betwe5 cov]$
 entities4  7e7 ,compreh5sive ,records  
,p] ,reque/ ( ,individual ,= purposes ( 
subsection 7b77#b71 :5 a heal? c>e      

cle>+h\se receives a reque/ f an        
individual = ! protect$ heal? in=mation 
( ! individual1 ! cle>+h\se %all provide
 to ! individual a compreh5sive record (
 su* in=mation 7across heal? c>e        
provid]s & heal? plans71 unless !       
cle>+h\se det]m9es 9 its discretion t   
provid+ a compreh5sive record is n      
te*nologically feasible4 ,9 prep>+ su*  
record = ! individual1 ! cle>+h\se may1 
) ! p]mission ( ! individual1 pur*ase ! 
protect$ heal? c>e in=mation ( !        
individual f "o or m o!r heal? c>e      
cle>+h\ses 7& ! co/ ( su* pur*ase may be
 includ$ 9 ! fee *>g$ to ! individual74 
7f7 ,situations n involv+ direct        
int]action ) individuals ,sections      
#afd4djj ?r\gh #afd4dad1 sections       
#afd4ebj ?r\gh #afd4ebh1 & #afd4ecj (   
title #de1 ,code ( ,f$]al ,regulations1 
apply to a cle>+h\se to ! ext5t t x has 
curr5t contact in=mation pursuant to    
direct int]action ) ! individual4 ,9 !  
case ( ea* o!r individual1 ! cle>+h\se  
%all c>ry out its functions "u ?is      

subtitle1 "p ,c ( title ,,xi ( ! ,social
 ,security ,act1 & ! regulations        
promulgat$ pursuant to section #bfd7;c7 
( ! ,heal? ,insurance ,portability &    
,acc\ntability ,act ( #aiif z if !      
cle>+h\se 7 a bus9ess associate4 ,!     
individuals to :om ! prec$+ s5t5ce      
applies includes individuals ) respect  
to :om ! sole cle>+h\se function is to  
process or facilitate ! process+ (      
non/&>d data elem5ts ( heal? in=mation  
into /&>d data elem5ts4  7g7 ,transition
 ,) respect to agreem5ts ent]$ into by a
 heal? c>e cle>+h\se be=e ! effective   
date ( ?is section1 a provision ( an    
agreem5t t conflicts ) ?is section %all 
n h any legal =ce or effect4 ,! prec$+  
s5t5ce may n be con/ru$ z affect+ any   
provision ( an agreem5t t does n        
conflict ) ?is section4 ,a heal? c>e    
cle>+h\se %all provide notice ( ?is     
subsection to ea* entity ) :i* !        
cle>+h\se has an agreem5t t is affect$  
by ?is subsection4  7h7 ,en=cem5t       
,section #acdaj7;a77#b7 applies to ?is  

"p 9 ! same mann] z su* section applies 
to p>ts #a & #b4  7i7 ,def9itions ,=    
purposes ( ?is "p3 7#a7 ,! t]m          
de-id5tifi$1 ) respect to heal?         
in=mation1 means su* in=mation t is n   
individually id5tifiable z det]m9$ 9    
accordance ) ! /&>ds "u section         
#afd4ead7;b7 ( title #de1 ,code ( ,f$]al
 ,regulations4  7#b7 ,! t]m heal? c>e   
cle>+h\se has ! mean+ giv5 su* t]m 9    
section #aaga ( ! ,social ,security     
,act4  7#c7 ,! t]m individual1 ) respect
 to protect$ heal? in=mation1 has !     
mean+ t applies "u section #afj4ajc (   
title #de1 ,code ( ,f$]al ,regulations4 
7#d7 ,! t]m qualify+ data use agreem5t  
means an agreem5t t e/abli%es ! p]mitt$ 
uses & disclosures ( protect$ heal?     
in=mation by ! recipi5t = "o or m       
functions describ$ 9 subsection 7c77#a7 
& re/ricts ! use & disclosure ( !       
in=mation by ! recipi5t 9 ! same mann] z
 applies "u p>agraphs 7e77#d77;ii77,b7 &
 7e77#d77;ii77,c7 7#a7-7d7 ( section    
#afd4ead ( title #de1 ,code ( ,f$]al    

,regulations1 b )\t reg>d to ! ref]5ces 
to limit$ data sets4  7j7 ,relation to  
o!r laws ,section #acdba applies to ?is 
"p 9 ! same mann] z su* section applies 
to p>ts #a & #b1 except to ! ext5t t su*
 section conc]ns section                
#aagh7;a77#b77;,b7 ( ! ,social ,security
 ,act4  4  7b7 ,regulations ,n lat] ?an 
! expiration ( ! #ij-;day p]iod beg9n+  
on ! date ( ! enactm5t ( ?is ,act1 !    
,secret>y ( ,heal? & ,human ,s]vices    
%all promulgate regulations to c>ry out 
! am5dm5t made by subsection 7a74  7c7  
,con=m+ am5dm5t ,section #aaga7b7 ( !   
,social ,security ,act 7#db ,u4,s4,c4   
#acbj;d7#b77 is am5d$ by ins]t+ be=e !  
p]iod ! foll[+3 1 or t c>ries out su*   
process+ function & 9 addition any ( !  
functions au?oriz$ 9 section #acdea ( ! 
,heal? ,in=mation ,te*nology = ,economic
 & ,cl9ical ,heal? ,act4