,,ii  #aae? ,,congress  #a/ ,session    
,s4 #ajfi  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,may #h1 #bjag,mr4     
,casey 7= himself1 ,ms4 ,w>r51 & ,mr4   
,frank57 introduc$ ! foll[+ bill2 :i* 0 
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to e/abli% pilot projects 9 
ord] to provide timely & reliable       
in=mation on ! safety & effectiv5ess (  
cle>$ or approv$ devices4  #a4 ,%ort    
title ,?is ,act may be cit$ z ! ,m$ical 
,device ,safety ,monitor+ ,act4  #b4    
,device pilot projects  7a7 ,po/m>ket   
pilot ,section #eai ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;i7 is am5d$ by add+ at ! end !     
foll[+3  7i7 ,pilot projects  7#a7 ,9   
g5]al ,9 ord] to provide timely &       
reliable in=mation on ! safety &        
effectiv5ess ( cle>$ or approv$ devices1
 includ+ responses to adv]se ev5ts &    
malfunctions1 & to advance ! objectives 
( "p #hjc ( title #ba1 ,code ( ,f$]al   
,regulations 7or successor regulations71

 & advance ! objectives (1 & evaluate   
innovative new me?ods ( compliance )1   
?is section & section #ebb1 ! ,secret>y 
%all1 )9 "o ye> ( ! date ( enactm5t (   
?is subsection1 initiate "o or m pilot  
projects = volunt>y p>ticipation by a   
manufactur] or manufactur]s ( device or 
device type1 or cont9ue exi/+ projects 9
 accordance ) p>agraph 7#c71 t meet all 
( ! foll[+ requirem5ts3  7,a7 ,are      
design$ to effici5tly g5]ate reliable & 
timely safety & active surveillance data
 = use by ! ,secret>y or manufactur]s ( 
! devices t are involv$ 9 ! pilot       
project4  7,b7 ,in=m ! developm5t (     
me?ods1 sy/ems1 data crit]ia1 & programs
 t c\ld be us$ to support safety &      
active surveillance activities = devices
 n includ$ 9 su* project4  7,c7 ,are    
design$ & conduct$ 9 coord9ation ) a    
compreh5sive sy/em = evaluat+ m$ical    
device te*nology t op]ates "u a gov]n+  
bo>d ) appropriate repres5tation (      
/akehold]s1 includ+ consum] gr\ps &     
device manufactur]s4  7,d7 ,use         

electronic heal? data includ+ claims    
data1 pati5t survey data1 & any o!r     
data1 z ! ,secret>y det]m9es            
appropriate4  7,e7 ,prioritize devices &
 device types t meet "o or m ( ! foll[+ 
crit]ia3 7i7 ,devices & device types =  
:i* ! collection & analysis ( real _w   
evid5ce reg>d+ a device's safety &      
effectiv5ess is likely to advance public
 heal?4  7ii7 ,devices & device types t 
are widely us$4  7iii7 ,devices & device
 types1 ! failure ( :i* has significant 
heal? consequ5ces4  7iv7 ,devices &     
device types = :i* ! ,secret>y has      
receiv$ public recomm5dations 9         
accordance ) p>agraph 7#b77;,b7 & has   
det]m9$ to meet "o ( ! crit]ia "u       
clauses 7i7 ?r\gh 7iii7 & is appropriate
 = a project "u ?is subsection4  7#b7   
,p>ticipation ,! ,secret>y %all e/abli% 
! conditions & processes =-- 7,a7       
au?oriz+ volunt>y p>ticipation ( a      
manufactur] ( a device 9 ! pilot project
 describ$ 9 p>agraph 7#a72 &  7,b7      
facilitat+ public recomm5dations =      

devices to be prioritiz$ "u ! pilot     
project describ$ 9 p>agraph 7#a71       
includ+ requirem5ts = ! data necess>y to
 support su* recomm5dation4  7#c7       
,implem5tation ,! ,secret>y may satisfy 
! requirem5ts ( p>agraphs 7#a7 & 7#b7 by
 cont9u+ or exp&+ exi/+ projects1 or by 
beg9n+ new projects1 t meet ! crit]ia ( 
subp>agraphs 7,a7 ?r\gh 7,e7 ( p>agraph 
7#a7 or by ent]+ into contracts1        
coop]ative agreem5ts1 grants1 or o!r    
appropriate agreem5ts ) public or       
private entities t h a significant      
pres5ce 9 ! ,unit$ ,/ates1 & meet !     
foll[+ additional conditions3  7,a7 ,if 
su* public or private entities are a    
compon5t ( ano!r organization1 !        
entities h e/abli%$ appropriate security
 measures to ma9ta9 ! confid5tiality &  
privacy ( ! data describ$ 9 p>agraph    
7#a77;,d7 & ! entity %all n make an     
unau?oriz$ disclosure ( su* data to !   
o!r compon5ts ( ! organization 9 brea* (
 su* confid5tiality & privacy           
requirem5ts4  7,b7 ,9 ! case ( !        

t]m9ation or nonr5ewal ( su* contracts1 
coop]ative agreem5ts1 grants1 or o!r    
appropriate agreem5ts1 ! entities %all  
comply ) ea* ( ! foll[+3  7i7 ,cont9ue  
to comply ) ! confid5tiality & privacy  
requirem5ts "u ?is subsection ) respect 
to all data disclos$ to ! entity4  7ii7 
,return any data disclos$ to su* entity 
"u ?is subsection to :i* x w\ld n       
o!rwise h access or1 if return+ ! data  
is n practicable1 de/roy ! data4  7,c7  
,h at lea/ "o ( ! foll[+ qualifications3
  7i7 ,rese>*1 /ati/ical1 epidemiologic1
 or cl9ical capability & exp]tise to    
conduct & complete ! activities "u ?is  
subsection1 includ+ ! capability &      
exp]tise to provide ! ,secret>y access  
to de-id5tifi$ data consi/5t ) !        
requirem5ts ( ?is subsection4  7ii7 ,an 
in=mation te*nology infra/ructure 9     
place to support electronic data &      
op]ational /&>ds to provide security =  
su* data1 z appropriate4  7iii7         
,exp]i5ce )1 & exp]tise on1 ! developm5t
 ( device safety & effectiv5ess rese>* &

 surveillance us+ electronic heal? data4
  7iv7 ,o!r exp]tise :i* ! ,secret>y    
det]m9es necess>y to fulfill !          
activities "u ?is subsection4  7#d7     
,review ( contract 9 ! ev5t ( a m]g] or 
acquisition ,! ,secret>y %all review a  
contract ) a qualifi$ entity "u ?is     
subsection 9 ! ev5t ( a m]g] or         
acquisition ( ! entity 9 ord] to ensure 
t ! requirem5ts "u ?is subsection w     
cont9ue to be met4  7#e7 ,report to     
,congress ,n lat] ?an #ah mon?s aft] !  
date ( enactm5t ( ?is subsection1 &     
annually !reaft]1 ! ,secret>y %all      
submit to ! ,committee on ,heal?1       
,education1 ,labor1 & ,p5sions ( !      
,s5ate & ! ,committee on ,en]gy &       
,comm]ce ( ! ,h\se ( ,repres5tatives a  
report conta9+ a description ( ! pilot  
projects be+ conduct$ pursuant to ?is   
subsection1 includ+ = ea* pilot         
project--  7,a7 h[ ! project is be+     
implem5t$ 9 accordance ) p>agraph 7#c7 &
 ! contractor or grantee z applicable2  
7,b7 ! numb] ( manufactur]s t h agre$ to

 p>ticipate2  7,c7 ! data s\rces us$2   
7,d7 ! devices or device categories     
involv$2 &  7,e7 ! numb] ( pati5ts      
involv$4  7#f7 ,compliance ) requirem5ts
 = records or reports on devices ,!     
p>ticipation ( a manufactur] 9 a pilot  
project "u ?is subsection %all n affect 
! eligibility ( su* manufactur] to      
p>ticipate 9 any qu>t]ly report+ program
 implem5t$ "u ?is ,act4 ,! ,secret>y may
 det]m9e t1 = ! specifi$ "t p]iod to be 
det]m9$ by ! ,secret>y1 a manufactur]'s 
p>ticipation 9 a pilot project "u ?is   
subsection may meet c]ta9 o!r           
requirem5ts ( ?is section or section    
#ebb if--  7,a7 ! project has demon/rat$
 success 9 captur+ relevant adv]se ev5t 
in=mation2 &  7,b7 ! ,secret>y has      
e/abli%$ proc$ures = mak+ adv]se ev5t & 
safety in=mation collect$ f ! pilot     
public1 to ! ext5t possible1 if collect$
 pursuant to ?is section or section     
#ebb4  7#g7 ,privacy requirem5ts ,)     
respect to ! pilot projects conduct$    
pursuant to ?is subsection-- 7,a7       

individual id5tifiable heal? in=mation  
%all n be disclos$ :5 pres5t+ any       
in=mation f su* project2 &  7,b7 su*    
projects %all comply ) section #bfd7;c7 
( ! ,heal? ,insurance ,portability &    
,acc\ntability ,act ( #aiif 7#db        
,u4,s4,c4 #acbj;d-#b note7 & sections   
#eeb & #eeb;a ( title #e1 ,unit$ ,/ates 
,code4  7#h7 ,o!r compliance ,any pilot 
program und]tak5 9 coord9ation ) !      
compreh5sive sy/em describ$ 9 p>agraph  
7#a77;,c71 includ+ pilot projects "u ?is
 subsection1 t relates to ! use ( real  
_w evid5ce = devices %all comply )      
p>agraph 7#a77;,b71 ! conditions li/$ 9 
subp>agraphs 7,a7 & 7,b7 ( p>agraph     
7#c71 & p>agraphs 7#d71 7#e71 7#f71 &   
7#g74  7#i7 ,sunset ,?is subsection %all
 cease to h =ce or effect on ,octob] #a1
 #bjbb4  4  7b7 ,report ,n lat] ?an     
,janu>y #ca1 #bjba1 ! ,secret>y ( ,heal?
 & ,human ,s]vices1 act+ ?r\gh !        
,commission] ( ,food & ,drugs1 %all     
conduct a review ?r\gh an indep5d5t ?ird
 p>ty to evaluate ! /r5g?s1 limitations1

 & appropriate use ( evid5ce collect$   
pursuant to real _w evid5ce pilot       
projects describ$ 9 ! lett]s describ$ 9 
section #bja7;b7 ( ! ,m$ical ,device    
,us] ,fee ,am5dm5ts ( #bjag & subsection
 7i7 ( section #eai ( ! ,f$]al ,food1   
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;i71 z am5d$ by subsection 7a71 =   
in=m+ prem>ket & po/m>ket decisionmak+ =
 multiple device types1 & to det]m9e    
:e!r ! me?ods1 sy/ems1 & programs 9 su* 
pilot projects effici5tly g5]ate        
reliable & timely evid5ce ab\t !        
effectiv5ess or safety surveillance (   
devices4