,i  #aacth ,,congress  #ast ,session    
,h4 ,r4 #ccjc  ,,in ,,the ,,house ,,of  
,,representatives  ,october #bb1        
#bjac,mrs4 ,blackburn 7for herself1 ,mr4
 ,gene ,green of ,texas1 ,mr4 ,walden1  
,ms4 ,de,gette1 ,mr4 ,butterfield1 and  
,mr4 ,gingrey of ,georgia7 introduced   
the following bill2 which was referred  
to the ,committee on ,energy and        
,commerce  ,a ,,bill  ,to amend the     
,federal ,food1 ,drug1 and ,cosmetic    
,act to provide for regulating medical  
software1 and for other purposes4  #a4  
,short title ,this ,act may be cited as 
the ,sensible ,oversight for ,technology
 which ,advances ,regulatory ,efficiency
 ,act of #bjac or the ,,software ,act of
 #bjac4  #b4 ,medical software  7a7     
,definition of medical software ,section
 #bja of the ,federal ,food1 ,drug1 and 
,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is  
amended by adding at the end the        
following3  7ss7 ,the term medical      
software means software that is intended
 for human or animal use and-- 7#a7 7,a7

 is intended to be marketed to directly 
change the structure or any function of 
the body of man or other animals2 or    
7,b7 is intended to be marketed for use 
by consumers and makes recommendations  
for clinical action that-- 7i7 includes 
the use of a drug1 device1 or procedure 
to cure or treat a disease or other     
condition without requiring the         
involvement of a health care provider2  
and  7ii7 if followed1 would change the 
structure or any function of the body of
 man or other animals2  7#b7 is not     
software whose primary purpose is       
integral to the functioning of a drug or
 device2 and  7#c7 is not a component of
 a device4  4  7b7 ,regulation          
,subchapter ,a of chapter ,v of the     
,federal ,food1 ,drug1 and ,cosmetic    
,act 7#ba ,u4,s4,c4 #cea et seq47 is    
amended by adding at the end the        
following3  #ebd;,b4 ,medical software  
7a7 ,in general ,the provisions of this 
,act shall apply with respect to medical
 software to the same extent and in the 

same manner as such provisions apply    
with respect to devices4  7b7           
,delegation ,the ,secretary shall       
delegate primary jurisdiction for       
regulating medical software to the      
center at the ,food and ,drug           
,administration charged with regulating 
devices4  4  #c4 ,clinical software and 
health software  7a7 ,definitions       
,section #bja of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cba71 as amended by section #b7;a71 is
 further amended by adding at the end   
the following3  7tt7 7#a7 ,the term     
clinical software means clinical        
decision support software or other      
software 7including any associated      
hardware and process dependencies7      
intended for human or animal use that-- 
7,a7 captures1 analyzes1 changes1 or    
presents patient or population clinical 
data or information and may recommend   
courses of clinical action1 but does not
 directly change the structure or any   
function of the body of man or other    

animals2 and  7,b7 is intended to be    
marketed for use only by a health care  
provider in a health care setting4  7#b7
 ,the term health software means        
software 7including any associated      
hardware and process dependencies7 that 
is not medical software or clinical     
software and-- 7,a7 that captures1      
analyzes1 changes1 or presents patient  
or population clinical data or          
information2  7,b7 that supports        
administrative or operational aspects of
 health care and is not used in the     
direct delivery of patient care2 or     
7,c7 whose primary purpose is to act as 
a platform for a secondary software1 to 
run or act as a mechanism for           
connectivity1 or to store data4  4  7b7 
,prohibition ,subchapter ,a of chapter  
,v of the ,federal ,food1 ,drug1 and    
,cosmetic ,act 7#ba ,u4,s4,c4 #cea et   
seq471 as amended by section #b7;b71 is 
further amended by adding at the end the
 following3  #ebd;,c4 ,clinical software
 and health software ,clinical software 

and health software shall not be subject
 to regulation under this ,act4  4  7c7 
,sense of ,congress ,it is the sense of 
the ,congress that-- 7#a7 clinical      
software and health software 7as defined
 in section #bja7tt7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act1 as    
added by subsection 7a77-- 7,a7 advance 
the goals of enhanced patient safety and
 continued innovation2  7,b7 hold much  
promise to lower costs and improve the  
health of patients2 and  7,c7 can       
improve the quality and efficacy of     
health care provider services2 and  7#b7
 the ,president and the ,congress should
 work together to develop and enact     
legislation that establishes a          
risk-based regulatory framework for such
 clinical software and health software  
that reduces regulatory burdens1        
promotes patient safety1 and fosters    
innovation4  #d4 ,exclusion from        
definition of device ,section #bja7;h7  
of the ,federal ,food1 ,drug1 and       
,cosmetic ,act 7#ba ,u4,s4,c4 #cba7 is  

amended-- 7#a7 in paragraph 7#b71 by    
striking or other animals1 or and       
inserting or other animals12  7#b7 in   
paragraph 7#c71 by striking and2 and    
7#c7 by inserting after paragraph 7#c7  
the following new paragraphs3  7#d7 is  
not medical software1 or  7#e7 is not   
clinical software or health software1   
and  4