,,ii  #aad? ,,congress  #a/ ,session    
,s4 #aaja  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,april #bg1 #bjae,mr4  
,b5net introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,a ,,bill  ,to am5d ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act to provide = !  
regulation ( pati5t records & c]ta9     
decision support s(tw>e4  #a4 ,%ort     
title ,?is ,act may be cit$ z ! ,m$ical 
,electronic ,data ,te*nology ,enhancem5t
 = ,consum]s' ,heal? ,act or ! ,,m$te*  
,act4  #b4 ,regulation ( m$ical s(tw>e  
,section #ebj ( ! ,f$]al ,food1 ,drug1 &
 ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7  
is am5d$ by add+ at ! end ! foll[+3  7o7
 ,regulation ( m$ical & c]ta9 decision  
support s(tw>e  7#a7 ,exclusions f !    
category ( devices ,! t]m device1 z     
def9$ 9 section #bja7;h71 %all n include
 ! foll[+3 7,a7 ,s(tw>e t is int5d$ =   
adm9i/rative & op]ational support ( a   
heal? c>e facility or ! process+ &      
ma9t5ance ( f9ancial records1 appo9tm5t 

s*$ules1 bus9ess analytics1             
communication1 in=mation ab\t pati5t    
populations1 & laboratory workfl[       
processes4  7,b7 ,s(tw>e t is int5d$ = !
 purpose ( ma9ta9+ or enc\rag+ a heal?y 
life/yle & are unrelat$ to ! diagnosis1 
cure1 mitigation1 prev5tion1 or treatm5t
 ( a disease or disord]4  7,c7 ,except =
 s(tw>e int5d$ to int]pret or analyze   
m$ical image data = ! purpose (         
diagnosis1 cure1 mitigation1 prev5tion1 
or treatm5t ( a disease or condition1   
electronic pati5t records1 to ! ext5t t 
su* records are int5d$ to transf]1 /ore1
 conv]t =mats1 or display ! equival5t ( 
a pap] m$ical *>t1 :i* may include      
pati5t hi/ory records if--  7i7 su*     
records 7 creat$1 /or$1 transf]r$1 or   
review$ by heal? c>e pr(essionals1 or by
 individuals work+ "u sup]vision ( su*  
pr(essionals2 &  7ii7 su* records are "p
 ( heal? in=mation te*nology t is       
c]tifi$ "u section #cjja7;c77#e7 ( !    
,public ,heal? ,s]vice ,act z be+ 9     
compliance ) applicable c]tification    

crit]ia adopt$ "u subtitle ,a ( title   
,,xxx ( su* ,act4  7,d7 ,except = s(tw>e
 int5d$ to int]pret or analyze cl9ical  
laboratory te/ data1 s(tw>e t is int5d$ 
to transf]1 /ore1 conv]t =mats1 or      
display--  7i7 cl9ical laboratory te/   
report data1 results1 or f9d+s prior to 
analysis or int]pretation by a heal? c>e
 pr(essional2 or  7ii7 cl9ical          
laboratory te/ report data1 results1 or 
f9d+s1 or relat$ pati5t education       
in=mation ) respect to su* data1 to a   
pati5t4  7,e7 ,except = a device        
accessory & s(tw>e t is int5d$ to       
acquire1 process1 or analyze a m$ical   
image or a signal f an 9 vitro diagno/ic
 device or a patt]n or signal f a signal
 acquisition sy/em1 s(tw>e t--  7i7 is  
int5d$ to display1 analyze1 or pr9t     
m$ical in=mation ab\t a pati5t or o!r   
m$ical in=mation 7su* z pe]-review$     
cl9ical /udies & cl9ical practice       
guidel9es72  7ii7 is int5d$ to support  
or provide recomm5dations to a heal? c>e
 pr(essional ab\t prev5tion1 diagnosis1 

or treatm5t2 &  7iii7 enables ! heal?   
c>e pr(essional to indep5d5tly review ! 
basis = ea* recomm5dation t ! s(tw>e    
pres5ts su* t x is n ! int5t t ! heal?  
c>e pr(essional rely solely on any      
specific recomm5dations or results      
provid$ by su* s(tw>e to make a cl9ical 
diagnosis or treatm5t decision4  7#b7   
,multiple functionality products ,9 !   
case ( a product ) multiple             
functionality t conta9s a s(tw>e        
function t is exclud$ "u p>agraph 7#a7 f
 ! def9ition ( a device "u section      
#bja7;h7 & a function t meets !         
def9ition ( device "u section #bja7;h71 
! ,secret>y %all n regulate ! exclud$   
s(tw>e function ( ! product z a device1 
b ! ,secret>y may assess su* s(tw>e     
function = ! purpose ( det]m9+ ! safety 
& effectiv5ess ( ! device function ( !  
product4  7#c7 ,rules ( con/ruction     
,no?+ 9 ?is subsection %all be con/ru$ z
 limit+ ! au?ority ( ! ,secret>y to--   
7,a7 ex]cise en=cem5t discretion z to   
any device subject to regulation "u ?is 

,act2 or  7,b7 regulate s(tw>e devices  
us$ 9 ! manufacture & transfusion (     
blood & blood compon5ts to assi/ 9 !    
prev5tion ( disease 9 humans4  4  #c4   
,quality & /&>ds ,! ,secret>y ( ,heal? &
 ,human ,s]vices %all ensure t s(tw>e   
describ$ 9 subp>agraphs 7,c71 7,d71 &   
7,e7 ( subsection 7o77#a7 ( section #ebj
 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic   
,act 7#ba ,u4,s4,c4 #cfj;j7 7z am5d$ by 
section #c7 is consi/5t ) appropriate   
quality pr9ciples & /&>ds = s(tw>e      
developm5t & validation4  #d4           
,classification ( accessories           
,subsection #eac7;b7 ( ! ,f$]al ,food1  
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#cfj;c7b77 is am5d$ by add+ at ! end !  
foll[+3  7#i7 ,! ,secret>y %all classify
 an accessory "u ?is section bas$ on !  
int5d$ use ( ! accessory1 not)/&+ !     
classification ( any o!r device ) :i*   
su* accessory is int5d$ to be us$4  4   
#e4 ,con=m+ am5dm5t ,section #bja7;h7 ( 
! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 
7#ba ,u4,s4,c4 #cba7;h77 is am5d$ by    

add+ at ! end ,! t]m device does n      
include m$ical & decision support s(tw>e
 describ$ 9 section #ebj7o744