,,ii  #aacth ,,congress  #b;d ,session  
,s4 #bigg  ,,in ,,the ,,senate ,,of     
,,the ,,united ,,states  ,december #d1  
#bjad ,mr4 ,bennet 7for himself and ,mr4
 ,hatch7 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     
patient records and certain decision    
support software  7#a7 ,in general ,the 
following are not devices within the    
meaning of section #bja7;h73 7,a7       

,software that is intended solely for   
administrative or operational support of
 a health care facility or the          
processing and maintenance of financial 
records within a health care setting4   
7,b7 ,products that are intended for use
 in activities unrelated to the clinical
 treatment of a disease or disorder and 
that are for the purpose of maintaining 
health and conditioning4  7,c7          
,electronic patient records created1    
stored1 transferred1 or reviewed by     
health care professionals or individuals
 working under supervision of such      
professionals that functionally         
represent a medical chart1 including    
patient history records1 but excluding  
diagnostic image data1 provided that    
software designed for use in maintaining
 such patient records is validated prior
 to marketing1 consistent with the      
standards for software validation relied
 upon by the ,secretary in reviewing    
premarket submissions for devices4  7,d7
 ,software that is intended to format1  

organize1 or otherwise present clinical 
laboratory test report data prior to    
analysis1 or to otherwise organize and  
present clinical laboratory test report 
findings or data and related patient    
education information4  7,e7 ,software  
that is intended to analyze and support 
the display or printing of patient or   
other medical information for the       
purpose of supporting or providing      
prevention1 diagnostic1 or treatment    
recommendations for health care         
professionals to assist in patient care1
 and that enables the health care       
professional to independently review the
 information on which such              
recommendations are based such that the 
intended use of the software is for the 
health care professional to not rely    
solely on any specific recommendations  
or results provided by such software to 
make a clinical diagnosis or treatment  
decision1 except to the extent that any 
such software or substantially          
equivalent product-- 7i7 is a component 

or accessory1 or has the same function  
as a component or accessory1 of a device
 subject to regulation under this ,act2 
or  7ii7 as of the date of enactment of 
this subsection1 is regulated or subject
 to regulation as a device classified as
 a class ,,ii or class ,,iii device or  
has the same function as a component or 
accessory of a device subject to        
regulation under this ,act4  7#b7 ,rule 
of construction ,nothing in this        
subsection shall be construed as        
limiting the authority of the ,secretary
 to exercise enforcement discretion as  
to any device subject to regulation     
under this ,act4  4