,i  #aai? ,,congress  #a/ ,session  ,h4 
,r4 #faag  ,,9 ,,! ,,h\se ,,(           
,,repres5tatives  ,novemb] #ah1         
#bjbe,ms4 ,%]rill introduc$ ! foll[+    
bill2 :i* 0 ref]r$ to ! ,committee on   
,en]gy & ,comm]ce  ,a ,,bill  ,to am5d !
 ,f$]al ,food1 ,drug1 & ,cosmetic ,act  
to au?orize requir+ ! manufactur]s ( a  
cov]$ device to disclose to a pati5t all
 pati5t-specific data t is record$ or   
transmitt$ by ! device & accessible to !
 manufactur]1 & = o!r purposes4  #a4    
,%ort title ,?is ,act may be cit$ z !   
,pati5t ,device ,data ,access ,act (    
#bjbe4  #b4 ,%>+ ( pati5t-specific data 
by device manufactur]s  7a7 ,9 g5]al    
,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;,c4 ,%>+ (    
pati5t-specific data by device          
manufactur]s  7a7 ,requirem5t au?oriz$  
,! ,secret>y may require ! manufactur] (
 a cov]$ device1 at ! reque/ ( a pati5t 
:o is us+ or has us$ su* cov]$ device1  

to disclose all pati5t-specific data t  
is-- 7#a7 record$ or transmitt$ by su*  
device2 &  7#b7 accessible to !         
manufactur]4  7b7 ,regulations  7#a7    
,issuance ,any requirem5t impos$ on     
manufactur]s "u subsection 7a7 %all be  
by regulation4  7#b7 ,applicability to  
all manufactur]s ( cov]$ devices ,any   
requirem5t impos$ "u subsection 7a7 %all
 be applicable ) respect to all         
manufactur]s ( cov]$ devices4  7#c7     
,consid]ation ,9 issu+ any regulation "u
 p>agraph 7#a71 ! ,secret>y %all take   
into consid]ation ! guidance issu$ 9    
,octob] #bjag by ! ,food & ,drug        
,adm9i/ration titl$ ,manufactur]s ,%>+  
,pati5t-,specific ,in=mation f ,m$ical  
,devices ) ,pati5ts ,^u ,reque/4  7#d7  
,cont5ts ,if ! ,secret>y issues         
regulations "u p>agraph 7#a71 !         
,secret>y may include 9 su* regulations 
provisions requir+ ! manufactur] ( a    
cov]$ device to d ! foll[+3 7,a7 ,at !  
reque/ ( a pati5t1 disclose             
pati5t-specific data ref]r$ to 9        

subsection 7a71 :]e possible-- 7i7 9 a  
=mat t is und]/&able to ! pati5t2 &     
7ii7 to ! ext5t practicable1 9 a =mat   
pref]r$ by ! pati5t4  7,b7 ,publi% on ! 
public website ( ! manufactur] ( a cov]$
 device-- 7i7 an indication t su* device
 is a cov]$ device subject to regulation
 "u ?is section2  7ii7 :at types (      
pati5t-specific data1 if any1 are-- 7,i7
 be+ record$ or transmitt$ by ! cov]$   
device2 &  7,,ii7 accessible to !       
manufactur]2 &  7iii7 :e!r & h[ !       
manufactur] utilizes pati5t data1 n     
includ+ any propriet>y in=mation ( !    
manufactur]4  7,c7 ,make publicly       
available1 by po/+ on ! manufactur]'s   
website1 ! me?od by :i* pati5ts :o are  
us+ or h us$ ! cov]$ device may reque/  
_! own pati5t-specific data describ$ 9  
subsection 7a74  7,d7 ,notify1 :]e      
possible1 pati5ts :o are us+ or h us$ ! 
cov]$ device ab\t h[ !y c access        
pati5t-specific data describ$ 9         
subsection 7a74  7,e7 ,notify pati5ts if
 _! cov]$ device is subject to a recall1

 has a s(tw>e update1 or has g5]at$ an  
error message4  7c7 ,exceptions ,?is    
section does n au?orize ! ,secret>y to  
require ! manufactur] ( a cov]$ device--
 7#a7 to disclose data t is-- 7,a7      
record$1 transmitt$1 & reta9$ 9 a clos$ 
sy/em2 &  7,b7 inaccessible to !        
manufactur]2  7#b7 to r$esign ! cov]$   
device to enable disclosure (           
pati5t-specific data2 or  7#c7 to       
disclose pati5t-specific data t is      
inaccessible to ! manufactur]4  7d7     
,def9itions ,9 ?is section3 7#a7 ,! t]m 
cov]$ device means any electronic device
 t is-- 7,a7 int5d$ = use 9 ! diagnosis1
 cure1 mitigation1 treatm5t1 or         
prev5tion ( disease2  7,b7 implant$ into
 a pati5t's body2  7,c7 us$ = ! purposes
 ( remote monitor+2 &  7,d7 capable (   
record+ or transmitt+ pati5t data4  7#b7
 ,! t]m pati5t-specific data-- 7,a7     
means data unique to an individual      
pati5t or unique to ! pati5t's treatm5t 
or diagnosis t is record$ or transmitt$ 
by a cov]$ device2  7,b7 includes data  

describ$ 9 subp>agraph 7,a7 irrespective
 ( :e!r su* data1 abs5t regulation "u   
?is section1 w\ld o!rwise be requir$ by 
law to be disclos$ to ! pati5t or _!    
physician2 &  7,c7 %all include-- 7i7   
in=mation record$ by a cov]$ device     
reg>d+ usage1 al>ms1 or outputs2 &  7ii7
 pulse oximetry data1 he>t electrical   
activity data1 & data on rhy?ms z       
monitor$ by a pace mak]4  7#c7 ,! t]m   
inaccessible to ! manufactur] means data
 t is n reasonably accessible4  4  7b7  
,civil p5alties ,section                
#cjc7;f77#a77;,a7 ( ! ,f$]al ,food1     
,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4  
#ccc7;f77#a77;,a77 is am5d$ by ins]t+ 1 
includ+ any su* requirem5t "u section   
#ebd;,c1 aft] a requirem5t ( ?is ,act   
:i* relates to devices4