,,ii ,cal5d> ,no4 #dji #aad? ,,congress 
#b;d ,session  ,s4 #aaja  ,,9 ,,!       
,,s5ate ,,( ,,! ,,unit$ ,,/ates  ,april 
#bg1 #bjae,mr4 ,b5net 7= himself & ,mr4 
,hat*7 introduc$ ! foll[+ bill2 :i* 0   
read twice & ref]r$ to ! ,committee on  
,heal?1 ,education1 ,labor1 & ,p5sions  
,april #d1 #bjaf,report$ by ,mr4        
,alex&]1 ) an am5dm5t & an am5dm5t to ! 
title,strike out all aft] ! enact+      
clause & ins]t ! "p pr9t$ 9 italic  ,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  #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$ical s(tw>e  7a7 ,9 g5]al ,section    
#ebj ( ! ,f$]al ,food1 ,drug1 &         
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 is
 am5d$ by add+ at ! end ! foll[+3  7o7  
,regulation ( m$ical & c]ta9 decisions  
support s(tw>e  7#a7 ,regulation ( c]ta9
 s(tw>e ,! t]m device1 z def9$ 9 section
 #bja7;h71 %all n include a s(tw>e      
function t is int5d$-- 7,a7 =           
adm9i/rative support ( a heal? c>e      
facility1 includ+ ! process+ & ma9t5ance
 ( f9ancial records1 claims or bill+    
in=mation1 appo9tm5t s*$ules1 bus9ess   

analytics1 in=mation ab\t pati5t        
populations1 admissions1 practice &     
inv5tory managem5t1 analysis ( hi/orical
 claims data to pr$ict future           
utilization or co/-effectiv5ess1        
det]m9ation ( heal? b5efit eligibility1 
population heal? managem5t1 & laboratory
 workfl[2  7,b7 = ma9ta9+ or enc\rag+ a 
heal?y life/yle & is unrelat$ to !      
diagnosis1 cure1 mitigation1 prev5tion1 
or treatm5t ( a disease or condition2   
7,c7 to s]ve z electronic pati5t        
records1 includ+ pati5t-provid$         
in=mation1 to ! ext5t t su* records are 
int5d$ to transf]1 /ore1 conv]t =mats1  
or display ! equival5t ( a pap] m$ical  
*>t1 s long z--  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* ,act2
 &  7iii7 su* function is n int5d$ to   
int]pret or analyze pati5t records1     
includ+ m$ical image data1 = ! purpose (
 ! diagnosis1 cure1 mitigation1         
prev5tion1 or treatm5t ( a disease or   
condition2  7,d7 = transf]r+1 /or+1     
conv]t+ =mats1 or display+ cl9ical      
laboratory te/ or o!r device data &     
results1 f9d+s by a heal? c>e           
pr(essional ) respect to su* data &     
results1 g5]al in=mation ab\t su* f9d+s1
 & g5]al backgr\nd in=mation ab\t su*   
laboratory te/ or o!r device1 unless su*
 function is int5d$ to int]pret or      
analyze cl9ical laboratory te/ or o!r   
device data1 results1 & f9d+s2 or  7,e7 
= ! purpose (-- 7i7 display+1 analyz+1  
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 support+ or  
provid+ recomm5dations to a heal? c>e   
pr(essional ab\t prev5tion1 diagnosis1  
or treatm5t ( a disease or condition2 & 

7iii7 enabl+ su* heal? c>e pr(essional  
to indep5d5tly review ! basis = su*     
recomm5dations t su* s(tw>e pres5ts s t 
x is n ! int5t t su* heal? c>e          
pr(essional rely prim>ily on any ( su*  
recomm5dations to make a cl9ical        
diagnosis or treatm5t decision reg>d+ an
 individual pati5t2  unless a function  
describ$ 9 subp>agraph 7,e7 is int5d$ to
 acquire1 process1 or analyze a m$ical  
image or a signal f an 9 vitro diagno/ic
 device or a patt]n or signal f a signal
 acquisition sy/em4  7#b7 ,multiple     
functionality products ,9 ! case ( a    
product ) multiple functions t conta9s--
 7,a7 at lea/ "o s(tw>e function t meets
 ! crit]ia "u p>agraph 7#a7 or t o!rwise
 does n meet ! def9ition ( device "u    
section #bja7;h72 &  7,b7 at lea/ "o    
function t does n meet ! crit]ia "u     
p>agraph 7#a7 & t o!rwise meets !       
def9ition ( a device "u section         
#bja7;h71  ! ,secret>y %all n regulate !
 s(tw>e function ( su* product describ$ 
9 subp>agraph 7,a7 z a device4 ,not)/&+ 

! prec$+ s5t5ce1 :5 assess+ ! safety &  
effectiv5ess ( ! device function or     
functions ( su* product describ$ 9      
subp>agraph 7,b71 ! ,secret>y may assess
 ! impact t ! s(tw>e function or        
functions describ$ 9 subp>agraph 7,a7 h 
on su* device function or functions4    
7#c7 ,exception  7,a7 ,9 g5]al ,not)/&+ 
p>agraph 7#a71 a s(tw>e function %all n 
be exclud$ f ! def9ition ( device "u    
section #bja7;h7 if-- 7i7 ! ,secret>y   
det]m9es t ! s(tw>e function meets !    
crit]ia "u subp>agraph 7,c71 7,d71 or   
7,e7 ( p>agraph 7#a72  7ii7 ! ,secret>y 
makes a f9d+ t use ( su* s(tw>e function
 w\ld be reasonably likely to h s]i\s   
adv]se heal? consequ5ces2 &  7iii7 !    
s(tw>e function has be5 id5tifi$ 9 a    
f9al ord] issu$ by ! ,secret>y "u       
subp>agraph 7,b74  7,b7 ,proc$ures      
,subp>agraph 7,a7 %all apply only if !  
,secret>y-- 7i7 publi%es a notification 
& propos$ ord] 9 ! ,f$]al ,regi/]2  7ii7
 includes 9 su* notification !          
,secret>y's f9d+1 includ+ ! rationale & 

id5tification ( ! evid5ce on :i* su*    
f9d+ 0 bas$1 z describ$ 9 subp>agraph   
7,a77ii72 &  7iii7 provides = a p]iod ( 
n less ?an #cj cal5d> days = public     
comm5ts be=e issu+ a f9al ord] or )draw+
 su* propos$ ord]4  7,c7 ,consid]ations 
,9 mak+ a f9d+ "u subp>agraph 7,a77ii7 )
 respect to a s(tw>e function1 !        
,secret>y %all consid] ! foll[+3  7i7 ,!
 likelihood & sev]ity ( pati5t h>m if ! 
s(tw>e function 7 to n p]=m z int5d$4   
7ii7 ,! ext5t to :i* ! s(tw>e function  
is int5d$ to support ! cl9ical judgm5t (
 a heal? c>e pr(essional4  7iii7 ,:e!r  
!re is a reasonable opportunity = a     
heal? c>e pr(essional to review ! basis 
( ! in=mation or treatm5t recomm5dation 
provid$ by ! s(tw>e function4  7iv7 ,!  
int5d$ us] & us] environm5t1 su* z :e!r 
a heal? c>e pr(essional w use a s(tw>e  
function ( a type describ$ 9 subp>agraph
 7,e7 ( p>agraph 7#a74  7#d7 ,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  7,b7 regulate  
s(tw>e us$ 9 ! manufacture & transfusion
 ( blood & blood compon5ts to assi/ 9 ! 
prev5tion ( disease 9 humans2 or  7,c7  
regulate s(tw>e z a device "u ?is ,act  
if su* s(tw>e meets ! crit]ia 9 section 
#eac7;a77#a77;,c74  4  7b7 ,report ,!   
,secret>y ( ,heal? & ,human ,s]vices    
7ref]r$ to 9 ?is subsection z !         
,secret>y71 aft] consultation ) ag5cies 
& (fices ( ! ,dep>tm5t ( ,heal? & ,human
 ,s]vices involv$ 9 heal? in=mation     
te*nology1 %all publi% a report1 e #b   
ye>s beg9n+ aft] ! date ( enactm5t ( ?is
 ,act1 t--  7#a7 includes input f       
outside exp]ts1 su* z repres5tatives (  
pati5ts1 consum]s1 heal? c>e provid]s1  
/>tup companies1 heal? plans or o!r     
?ird-p>ty pay]s1 v5ture capital         
inve/ors1 in=mation te*nology v5dors1   
heal? in=mation te*nology v5dors1 small 
bus9esses1 pur*as]s1 employ]s1 & o!r    
/akehold]s ) relevant exp]tise1 z       
det]m9$ by ! ,secret>y2  7#b7 exam9es   

in=mation available to ! ,secret>y on   
any risks & b5efits to heal? associat$ )
 s(tw>e functions describ$ 9 section    
#ebj7o77#a7 ( ! ,f$]al ,food1 ,drug1 &  
,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;j7 7z
 am5d$ by subsection 7a7 ( ?is ,act72 & 
7#c7 summ>izes f9d+s reg>d+ ! impact (  
su* s(tw>e functions on pati5t safety1  
includ+ be/ practices to promote safety1
 education1 & compet5cy relat$ to su*   
functions4  7c7 ,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$4  4  7d7 ,con=m+       
am5dm5t ,section #bja7;h7 ( ! ,f$]al    
,food1 ,drug1 & ,cosmetic ,act 7#ba     
,u4,s4,c4 #cba7;h77 is am5d$ by add+ at 
! end ! foll[+3 ,! t]m device does n    
include s(tw>e functions exclud$        

pursuant to section #ebj7o744  ,am5d !  
title s z to read3 ,a bill to am5d !    
,f$]al ,food1 ,drug1 & ,cosmetic ,act to
 provide = ! regulation ( pati5t records
 & c]ta9 decision support s(tw>e44      
,april #d1 #bjaf,report$ ) an am5dm5t & 
an am5dm5t to ! title