,,ii  #aac? ,,congress  #b;d ,session   
,s4 #bigg  ,,9 ,,! ,,s5ate ,,( ,,!      
,,unit$ ,,/ates  ,decemb] #d1 #bjad ,mr4
 ,b5net 7= himself & ,mr4 ,hat*7        
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 ( pati5t 
records & c]ta9 decision support s(tw>e 
7#a7 ,9 g5]al ,! foll[+ are n devices )9
 ! mean+ ( section #bja7;h73 7,a7       
,s(tw>e t is int5d$ solely =            
adm9i/rative or op]ational support ( a  
heal? c>e facility or ! process+ &      

ma9t5ance ( f9ancial records )9 a heal? 
c>e sett+4  7,b7 ,products t are int5d$ 
= use 9 activities unrelat$ to ! cl9ical
 treatm5t ( a disease or disord] & t are
 = ! purpose ( ma9ta9+ heal? &          
condition+4  7,c7 ,electronic pati5t    
records creat$1 /or$1 transf]r$1 or     
review$ by heal? c>e pr(essionals or    
individuals work+ "u sup]vision ( su*   
pr(essionals t functionally repres5t a  
m$ical *>t1 includ+ pati5t hi/ory       
records1 b exclud+ diagno/ic image data1
 provid$ t s(tw>e design$ = use 9       
ma9ta9+ su* pati5t records is validat$  
prior to m>ket+1 consi/5t ) ! /&>ds =   
s(tw>e validation reli$ ^u by !         
,secret>y 9 review+ prem>ket submissions
 = devices4  7,d7 ,s(tw>e t is int5d$ to
 =mat1 organize1 or o!rwise pres5t      
cl9ical laboratory te/ report data prior
 to analysis1 or to o!rwise organize &  
pres5t cl9ical laboratory te/ report    
f9d+s or data & relat$ pati5t education 
in=mation4  7,e7 ,s(tw>e t is int5d$ to 
analyze & support ! display or pr9t+ (  

pati5t or o!r m$ical in=mation = !      
purpose ( support+ or provid+ prev5tion1
 diagno/ic1 or treatm5t recomm5dations =
 heal? c>e pr(essionals to assi/ 9      
pati5t c>e1 & t enables ! heal? c>e     
pr(essional to indep5d5tly review !     
in=mation on :i* su* recomm5dations are 
bas$ su* t ! int5d$ use ( ! s(tw>e is = 
! heal? c>e pr(essional to n rely solely
 on any specific recomm5dations or      
results provid$ by su* s(tw>e to make a 
cl9ical diagnosis or treatm5t decision1 
except to ! ext5t t any su* s(tw>e or   
sub/antially equival5t product-- 7i7 is 
a compon5t or accessory1 or has ! same  
function z a compon5t or accessory1 ( a 
device subject to regulation "u ?is     
,act2 or  7ii7 z ( ! date ( enactm5t (  
?is subsection1 is regulat$ or subject  
to regulation z a device classifi$ z a  
class ,,ii or class ,,iii device or has 
! same function z a compon5t or         
accessory ( a device subject to         
regulation "u ?is ,act4  7#b7 ,rule (   
con/ruction ,no?+ 9 ?is subsection %all 

be con/ru$ z limit+ ! au?ority ( !      
,secret>y to ex]cise en=cem5t discretion
 z to any device subject to regulation  
"u ?is ,act4  4