,,ii  #aac? ,,congress  #b;d ,session   
,s4 #bjjg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,febru>y #aj1          
#bjad,mrs4 ,fis*] 7= h]self1 ,mr4 ,k+1 &
 ,mr4 ,rubio7 introduc$ ! foll[+ bill2  
:i* 0 read twice & ref]r$ to !          
,committee on ,heal?1 ,education1       
,labor1 & ,p5sions  ,a ,,bill  ,to am5d 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
to provide = regulat+ cl9ical & heal?   
s(tw>e1 & = o!r purposes4  #a4 ,%ort    
title ,?is ,act may be cit$ z ! ,prev5t+
 ,regulatory ,ov]rea* ,to ,enhance ,c>e 
,te*nology ,act ( #bjad or ! ,,protect  
,act ( #bjad4  #b4 ,f9d+s2 s5se (       
,congress  7a7 ,f9d+s ,congress f9ds z  
foll[s3 7#a7 ,! mobile heal? & mobile   
application economy 0 creat$ 9 ! ,unit$ 
,/ates & is n[ be+ export$ globally1 ) !
 m>ket expect$ to exce$ #bf1jjj1jjj1jjj 
by #bjag4  7#b7 ,! ,unit$ ,/ates mobile 
application economy is responsible =    
ne>ly #ejj1jjj new jobs 9 ! ,unit$      
,/ates4  7#c7 ,consum] heal? in=mation  
te*nologies1 includ+ sm>t phones &      

tablets1 h ! pot5tial to trans=m heal?  
c>e deliv]y ?r\gh r$uc$ sy/emic co/s1   
improv$ pati5t safety1 & bett] cl9ical  
outcomes4  7#d7 ,cl9ical & heal? s(tw>e 
innovation cycles evolve & move fa/] ?an
 ! exi/+ regulatory approval processes4 
7#e7 ,consum]s & innovators ne$ a new   
risk-bas$ framework = ! ov]sight (      
cl9ical & heal? s(tw>e t improves on !  
framework ( ! ,food & ,drug             
,adm9i/ration4  7#f7 ,a work+ gr\p      
conv5$ jo9tly by ! ,food & ,drug        
,adm9i/ration1 ! ,f$]al ,communications 
,commission1 & ! ,(fice ( ! ,national   
,coord9ator = ,heal? ,in=mation         
,te*nology id5tifi$ 9 a report t !re are
 sev]al major b>ri]s to ! effective     
regulation ( heal? in=mation te*nology t
 _c be alleviat$ )\t *anges to exi/+    
law4  7b7 ,s5se ( ,congress ,x is ! s5se
 ( ,congress t-- 7#a7 ! ,presid5t &     
,congress mu/ int]v5e to facilitate     
int]ag5cy coord9ation across regulators 
t focuses ag5cy ef=ts on fo/]+ heal?    
in=mation te*nology & mobile heal?      

innovation :ile bett] protect+ pati5t   
safety1 improv+ heal? c>e1 & creat+ jobs
 9 ! ,unit$ ,/ates2  7#b7 ! ,presid5t & 
! ,congress %\ld "w toge!r to develop & 
enact legislation t e/abli%es a         
risk-bas$ regulatory framework = su*    
cl9ical s(tw>e & heal? s(tw>e t r$uces  
regulatory burd5s1 fo/]s innovation1 &1 
mo/ importantly1 improves pati5t safety2
  7#c7 ,! ,national ,in/itute ( ,/&>ds &
 ,te*nology %\ld be ! ,f$]al ag5cy t has
 ov]sight ov] te*nical /&>ds us$ by     
cl9ical s(tw>e2 &  7#d7 ,! ,national    
,in/itute ( ,/&>ds & ,te*nology1 9      
collaboration ) ! ,f$]al ,communications
 ,commission1 ! ,national ,pati5t       
,safety ,f\ndation1 & ! ,(fice ( !      
,national ,coord9ator = ,heal?          
,in=mation ,te*nology1 %\ld "w on next  
/eps1 beyond curr5t ov]sight ef=ts1     
reg>d+ heal? in=mation te*nology1 su* z 
collaborat+ ) nongov]nm5tal entities to 
develop c]tification processes & to     
promote be/ practice /&>ds4  #c4        
,cl9ical s(tw>e & heal? s(tw>e  7a7     

,def9itions ,section #bja ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7 is am5d$ by add+ at !   
end ! foll[+3  7ss7 7#a7 ,! t]m cl9ical 
s(tw>e means cl9ical decision support   
s(tw>e or o!r s(tw>e 7includ+ any       
associat$ h>dw>e & process dep5d5cies7  
int5d$ = human or animal use t-- 7,a7   
captures1 analyzes1 *anges1 or pres5ts  
pati5t or population cl9ical data or    
in=mation & may recomm5d c\rses (       
cl9ical action1 b does n directly *ange 
! /ructure or any function ( ! body (   
man or o!r animals2 &  7,b7 is int5d$ to
 be m>ket$ = use only by a heal? c>e    
provid] 9 a heal? c>e sett+4  7#b7 ,!   
t]m heal? s(tw>e means s(tw>e 7includ+  
any associat$ h>dw>e & process          
dep5d5cies7 t is n cl9ical s(tw>e &--   
7,a7 t captures1 analyzes1 *anges1 or   
pres5ts pati5t or population cl9ical    
data or in=mation2  7,b7 t supports     
adm9i/rative or op]ational aspects (    
heal? c>e & is n us$ 9 ! direct deliv]y 
( pati5t c>e2 or  7,c7 ^: prim>y purpose

 is to act z a plat=m = a second>y      
s(tw>e1 to run or act z a me*anism =    
connectivity1 or to /ore data4  7#c7 ,! 
t]ms cl9ical s(tw>e & heal? s(tw>e d n  
include s(tw>e-- 7,a7 t is int5d$ to    
int]pret pati5t-specific device data &  
directly diagnose a pati5t or us] )\t ! 
int]v5tion ( a heal? c>e provid]2  7,b7 
t conducts analysis ( radiological or   
imag+ data 9 ord] to provide            
pati5t-specific diagno/ic & treatm5t    
advice to a heal? c>e provid]2  7,c7 ^: 
prim>y purpose is integral to ! function
 ( a drug or device2 or  7,d7 t is a    
compon5t ( a device4  4  7b7            
,prohibition ,sub*apt] ,a ( *apt] ,v ( !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
7#ba ,u4,s4,c4 #cea et seq47 is am5d$ by
 add+ at ! end ! foll[+3  #ebd;,b4      
,cl9ical s(tw>e & heal? s(tw>e ,cl9ical 
s(tw>e & heal? s(tw>e %all n be subject 
to regulation "u ?is ,act4  4  #d4      
,exclusion f def9ition ( device ,section
 #bja7;h7 ( ! ,f$]al ,food1 ,drug1 &    
,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h77 

is am5d$ by add+ at ! end ,! t]m device 
does n include cl9ical s(tw>e or heal?  
s(tw>e44