,,ii  #aadth ,,congress  #ast ,session  
,s4 #aaja  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,april #bg1    
#bjae,mr4 ,bennet introduced the        
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to amend the ,federal ,food1   
,drug1 and ,cosmetic ,act to provide for
 the regulation of patient records and  
certain decision support software4  #a4 
,short title ,this ,act may be cited as 
the ,medical ,electronic ,data          
,technology ,enhancement for ,consumers'
 ,health ,act or the ,,medtech ,act4    
#b4 ,regulation of medical software     
,section #ebj of the ,federal ,food1    
,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4
 #cfj;j7 is amended by adding at the end
 the following3  7o7 ,regulation of     
medical and certain decision support    
software  7#a7 ,exclusions from the     
category of devices ,the term device1 as
 defined in section #bja7;h71 shall not 
include the following3 7,a7 ,software   

that is intended for administrative and 
operational support of a health care    
facility or the processing and          
maintenance of financial records1       
appointment schedules1 business         
analytics1 communication1 information   
about patient populations1 and          
laboratory workflow processes4  7,b7    
,software that is intended for the      
purpose of maintaining or encouraging a 
healthy lifestyle and are unrelated to  
the diagnosis1 cure1 mitigation1        
prevention1 or treatment of a disease or
 disorder4  7,c7 ,except for software   
intended to interpret or analyze medical
 image data for the purpose of          
diagnosis1 cure1 mitigation1 prevention1
 or treatment of a disease or condition1
 electronic patient records1 to the     
extent that such records are intended to
 transfer1 store1 convert formats1 or   
display the equivalent of a paper       
medical chart1 which may include patient
 history records if--  7i7 such records 
were created1 stored1 transferred1 or   

reviewed by health care professionals1  
or by individuals working under         
supervision of such professionals2 and  
7ii7 such records are part of health    
information technology that is certified
 under section #cjja7;c77#e7 of the     
,public ,health ,service ,act as being  
in compliance with applicable           
certification criteria adopted under    
subtitle ,a of title ,,xxx of such ,act4
  7,d7 ,except for software intended to 
interpret or analyze clinical laboratory
 test data1 software that is intended to
 transfer1 store1 convert formats1 or   
display--  7i7 clinical laboratory test 
report data1 results1 or findings prior 
to analysis or interpretation by a      
health care professional2 or  7ii7      
clinical laboratory test report data1   
results1 or findings1 or related patient
 education information with respect to  
such data1 to a patient4  7,e7 ,except  
for a device accessory and software that
 is intended to acquire1 process1 or    
analyze a medical image or a signal from

 an in vitro diagnostic device or a     
pattern or signal from a signal         
acquisition system1 software that--  7i7
 is intended to display1 analyze1 or    
print medical information about a       
patient or other medical information    
7such as peer-reviewed clinical studies 
and clinical practice guidelines72  7ii7
 is intended to support or provide      
recommendations to a health care        
professional about prevention1          
diagnosis1 or treatment2 and  7iii7     
enables the health care professional to 
independently review the basis for each 
recommendation that the software        
presents such that it is not the intent 
that the health care professional rely  
solely on any specific recommendations  
or results provided by such software to 
make a clinical diagnosis or treatment  
decision4  7#b7 ,multiple functionality 
products ,in the case of a product with 
multiple functionality that contains a  
software function that is excluded under
 paragraph 7#a7 from the definition of a

 device under section #bja7;h7 and a    
function that meets the definition of   
device under section #bja7;h71 the      
,secretary shall not regulate the       
excluded software function of the       
product as a device1 but the ,secretary 
may assess such software function for   
the purpose of determining the safety   
and effectiveness of the device function
 of the product4  7#c7 ,rules of        
construction ,nothing in this subsection
 shall be construed as limiting the     
authority of the ,secretary to-- 7,a7   
exercise enforcement discretion as to   
any device subject to regulation under  
this ,act2 or  7,b7 regulate software   
devices used in the manufacture and     
transfusion of blood and blood          
components to assist in the prevention  
of disease in humans4  4  #c4 ,quality  
and standards ,the ,secretary of ,health
 and ,human ,services shall ensure that 
software described in subparagraphs     
7,c71 7,d71 and 7,e7 of subsection      
7o77#a7 of section #ebj of the ,federal 

,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;j7 7as amended by section
 #c7 is consistent with appropriate     
quality principles and standards for    
software development and validation4    
#d4 ,classification of accessories      
,subsection #eac7;b7 of the ,federal    
,food1 ,drug1 and ,cosmetic ,act 7#ba   
,u4,s4,c4 #cfj;c7b77 is amended by      
adding at the end the following3  7#i7  
,the ,secretary shall classify an       
accessory under this section based on   
the intended use of the accessory1      
notwithstanding the classification of   
any other device with which such        
accessory is intended to be used4  4    
#e4 ,conforming amendment ,section      
#bja7;h7 of the ,federal ,food1 ,drug1  
and ,cosmetic ,act 7#ba ,u4,s4,c4       
#cba7;h77 is amended by adding at the   
end ,the term device does not include   
medical and decision support software   
described in section #ebj7o744