,,ii ,calendar ,no4 #dbh #aadth         
,,congress  #b;d ,session  ,s4 #bgac    
,,in ,,the ,,senate ,,of ,,the ,,united 
,,states  ,march #ag1 #bjaf,mr4         
,alexander introduced the following     
bill2 which was read twice and referred 
to the ,committee on ,health1           
,education1 ,labor1 and ,pensions       
,april #ah1 #bjaf,reported by ,mr4      
,alexander1 with an amendment,strike out
 all after the enacting clause and      
insert the part printed in italic  ,a   
,,bill  ,to provide for the             
implementation of a ,precision ,medicine
 ,initiative4  #a4 ,short title ,this   
,act may be cited as the ,advancing     
,precision ,medicine ,act of #bjaf4  #b4
 ,precision medicine initiative  7a7 ,in
 general ,the ,secretary of ,health and 
,human ,services 7referred to in this   
section as the ,secretary7 is encouraged
 to establish and carry out an          
initiative1 to be known as the          
,precision ,medicine ,initiative1 to    
augment efforts to address disease      

prevention1 diagnosis1 and treatment4   
7b7 ,components ,the ,initiative        
described under subsection 7a7 may      
include--  7#a7 developing a network of 
scientists to assist in carrying out the
 purposes of the ,initiative2  7#b7     
developing new approaches for addressing
 scientific1 medical1 public health1 and
 regulatory science issues2  7#c7       
applying genomic technologies to provide
 data on the molecular basis of disease2
  7#d7 collecting information           
voluntarily provided by a diverse cohort
 of individuals that can be used to     
better understand health and disease2   
and  7#e7 other activities determined   
appropriate by the ,secretary to advance
 the goals of the ,initiative4  7c7     
,authority of the ,secretary ,in        
carrying out this section1 the          
,secretary may--  7#a7 coordinate with  
the ,secretary of ,energy1 private      
industry1 and others determined         
appropriate by the ,secretary to        
identify and address the advanced       

supercomputing needs for the ,initiative
 described under subsection 7a72  7#b7  
develop and utilize public-private      
partnerships2 and  7#c7 leverage        
existing data sources4  7d7             
,requirements ,in the implementation of 
the ,initiative under subsection 7a71   
the ,secretary shall--  7#a7 ensure the 
collaboration of the ,national          
,institutes of ,health1 the ,food and   
,drug ,administration1 and the ,office  
of the ,national ,coordinator for       
,health ,information ,technology2  7#b7 
comply with existing laws and           
regulations for the protection of human 
subjects involved in research1 including
 the protection of participant privacy2 
7#c7 implement policies and mechanisms  
for appropriate secure data sharing     
across systems that include protections 
for privacy and security of data2 and   
7#d7 consider the diversity of the      
cohort to ensure inclusion of a broad   
range of participants1 including        
consideration of biological1 social1 and

 other determinants of health that      
contribute to health disparities4  #a4  
,short title ,this ,act may be cited as 
the ,advancing ,precision ,medicine ,act
 of #bjaf4  #b4 ,precision medicine     
initiative  7a7 ,in general ,the        
,secretary of ,health and ,human        
,services 7referred to in this section  
as the ,secretary7 is encouraged to     
establish and carry out an initiative1  
to be known as the ,precision ,medicine 
,initiative1 to augment efforts to      
address disease prevention1 diagnosis1  
and treatment4  7b7 ,components ,the    
,initiative described under subsection  
7a7 may include--  7#a7 developing a    
network of scientists to assist in      
carrying out the purposes of the        
,initiative2  7#b7 developing new       
approaches for addressing scientific1   
medical1 public health1 and regulatory  
science issues2  7#c7 applying genomic  
technologies1 such as whole genomic     
sequencing1 to provide data on the      
molecular basis of disease2  7#d7       

collecting information voluntarily      
provided by a diverse cohort of         
individuals that can be used to better  
understand health and disease2 and  7#e7
 other activities determined appropriate
 by the ,secretary to advance the goals 
of the ,initiative4  7c7 ,authority of  
the ,secretary ,in carrying out this    
section1 the ,secretary may--  7#a7     
coordinate with the ,secretary of       
,energy1 private industry1 and others   
determined appropriate by the ,secretary
 to identify and address the advanced   
supercomputing needs for the ,initiative
 described under subsection 7a72  7#b7  
develop and utilize public-private      
partnerships2 and  7#c7 leverage        
existing data sources4  7d7             
,requirements ,in the implementation of 
the ,initiative under subsection 7a71   
the ,secretary shall--  7#a7 ensure the 
collaboration of the ,national          
,institutes of ,health1 the ,food and   
,drug ,administration1 and the ,office  
of the ,national ,coordinator for       

,health ,information ,technology2  7#b7 
comply with existing laws and           
regulations for the protection of human 
subjects involved in research1 including
 the protection of participant privacy2 
7#c7 implement policies and mechanisms  
for appropriate secure data sharing     
across systems that include protections 
for privacy and security of data2 and   
7#d7 consider the diversity of the      
cohort to ensure inclusion of a broad   
range of participants1 including        
consideration of biological1 social1 and
 other determinants of health that      
contribute to health disparities4  #c4  
,protection of privacy of individuals   
who are research subjects  7a7 ,in      
general ,subsection 7d7 of section #cja 
of the ,public ,health ,service ,act    
7#db ,u4,s4,c4 #bda7 is amended to read 
as follows3  7d7 ,protection of privacy 
of individuals who are research subjects
  7#a7 ,issuance of certificate  7,a7   
,in general ,if a person is engaged in  
biomedical1 behavioral1 clinical1 or    

other research1 in which identifiable1  
sensitive information is collected      
7including research on mental health and
 research on the use and effect of      
alcohol and other psychoactive drugs71  
the ,secretary1 in coordination with    
other ,departments1 as applicable--  7i7
 shall issue to such person a           
certificate of confidentiality to       
protect the privacy of individuals who  
are the subjects of such research if the
 research is funded wholly or in part by
 the ,federal ,government2 and  7ii7    
may1 upon application by a person       
engaged in research1 issue to such      
person a certificate of confidentiality 
to protect the privacy of such          
individuals if the research is not so   
funded4  7,b7 ,result of certificate    
,except as provided in subparagraph     
7,c71 any person to whom a certificate  
is issued under subparagraph 7,a7 to    
protect the privacy of individuals      
described in such subparagraph shall not
 disclose or provide to any other person

 not connected with the research the    
name of such an individual or any       
information1 document1 or biospecimen   
that contains identifiable1 sensitive   
information about such an individual and
 that was created or compiled for       
purposes of the research4  7,c7         
,exceptions ,the disclosure prohibition 
in subparagraph 7,b7 shall not apply to 
disclosure or use that is-- 7i7 required
 by ,federal1 ,state1 or local laws1    
excluding instances described in        
subparagraph 7,d72  7ii7 necessary for  
the medical treatment of the individual 
to whom the information1 document1 or   
biospecimen pertains2  7iii7 made with  
the consent of the individual to whom   
the information1 document1 or           
biospecimen pertains2 or  7iv7 made for 
the purposes of other scientific        
research that is in compliance with     
applicable ,federal regulations         
governing the protection of human       
subjects in research4  7,d7 ,prohibition
 on compelling disclosure ,any person to

 whom a certificate is issued under     
subparagraph 7,a7 to protect the privacy
 of an individual described in such     
subparagraph shall not1 in any ,federal1
 ,state1 or local civil1 criminal1      
administrative1 legislative1 or other   
proceeding1 disclose or provide the name
 of such individual or any such         
information1 document1 or biospecimen   
that contains identifiable1 sensitive   
information about the individual and    
that was created or compiled for        
purposes of the research4  7,e7         
,immunity ,identifiable1 sensitive      
information protected under subparagraph
 7,a71 and all copies thereof1 shall be 
immune from the legal process1 and shall
 not1 without the consent of the        
individual to whom the information      
pertains1 be admissible as evidence or  
used for any purpose in any action1     
suit1 or other judicial1 legislative1 or
 administrative proceeding4  7,f7 ,terms
 of protection ,identifiable1 sensitive 
information collected by a person to    

whom a certificate has been issued under
 subparagraph 7,a71 and all copies      
thereof1 shall be subject to the        
protections afforded by this section for
 perpetuity4  7,g7 ,minimizing          
administrative burden ,the ,secretary   
shall take steps to minimize the burden 
to researchers1 streamline the process1 
and reduce the time it takes to comply  
with the requirements of this           
subsection4  7#b7 ,rule of construction 
,nothing in this subsection shall be    
construed to limit the access of an     
individual who is a subject of research 
to information about himself or herself 
collected during such individual's      
participation in the research4  7#c7    
,definitions ,for purposes of this      
subsection1 the term identifiable1      
sensitive information means information 
that is about an individual and that is 
gathered or used during the course of   
research described in paragraph         
7#a77;,a7 and--  7,a7 through which an  
individual is identified2 or  7,b7 for  

which there is a risk1 as determined by 
current scientific practices or         
statistical methods1 that some          
combination of the information1 the     
request1 and other available data       
sources could be used to deduce the     
identity of an individual4  4  7b7      
,applicability ,beginning on the date of
 enactment of this ,act1 all persons    
engaged in research and authorized by   
the ,secretary of ,health and ,human    
,services to protect information under  
section #cja7;d7 of the ,public ,health 
,service ,act 7#db ,u4,s4,c4 #bda7;d77  
prior to the date of enactment of this  
,act shall be subject to the            
requirements of such section 7as amended
 by this ,act74  #d4 ,protection of     
identifiable1 sensitive information     
,section #cja of the ,public ,health    
,service ,act 7#db ,u4,s4,c4 #bda7 is   
amended by adding at the end the        
following3  7f7 7#a7 ,the ,secretary may
 exempt from disclosure under section   
#eeb7;b77#c7 of title #e1 ,united       

,states ,code1 biomedical information   
that is about an individual and that is 
gathered or used during the course of   
biomedical research if--  7,a7 an       
individual is identified2 or  7,b7 there
 is a risk1 as determined by current    
scientific practices or statistical     
methods1 that some combination of the   
information1 the request1 and other     
available data sources could be used to 
deduce the identity of an individual4   
7#b7 7,a7 ,each determination of the    
,secretary under paragraph 7#a7 to      
exempt information from disclosure shall
 be made in writing and accompanied by a
 statement of the basis for the         
determination4  7,b7 ,each such         
determination and statement of basis    
shall be available to the public1 upon  
request1 through the ,office of the     
,chief ,,foia ,officer of the           
,department of ,health and ,human       
,services4  7#c7 ,nothing in this       
subsection shall be construed to limit a
 research participant's access to       

information about such participant      
collected during the participant's      
participation in the research4  4  #e4  
,data sharing ,section #djb7;b7 of the  
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhb7;b77 is amended-- 7#a7 in
 paragraph 7#bc71 by striking and at the
 end2  7#b7 in paragraph 7#bd71 by      
striking the period and inserting 2 and2
 and  7#c7 by inserting after paragraph 
7#bd7 the following3  7#be7 may require 
recipients of ,,nih grants or           
cooperative agreements to share         
scientific data1 to the extent feasible1
 generated from such ,,nih grants or    
cooperative agreements in a manner that 
is consistent with all applicable       
,federal laws and regulations1 including
 such laws and regulations for the      
protection of--  7,a7 human research    
participants1 including with respect to 
privacy1 security1 informed consent1 and
 protected health information2  7,b7    
proprietary interests1 confidential     
commercial information1 and the         

intellectual property rights of the     
funding recipient2 and  7,c7 national1  
homeland1 and economic security         
interests4  4  #f4 ,high-risk1          
high-reward research  7a7 ,in general   
,section #djb of the ,public ,health    
,service ,act 7#db ,u4,s4,c4 #bhb7 is   
amended by adding at the end the        
following3  7m7 ,high-risk1 high-reward 
research  7#a7 ,in general ,the         
,director of ,,nih may approve1 after   
consideration of a proposal under       
paragraph 7#b77;,a71 requests by the    
national research institutes and        
centers1 or program offices within the  
,office of the ,director1 to engage in  
transactions other than a contract1     
grant1 or cooperative agreement with    
respect to projects for high-impact1    
cutting-edge research that fosters      
scientific creativity and increases     
fundamental biological understanding    
leading to the prevention1 diagnosis1 or
 treatment of diseases and disorders4   
7#b7 ,requirements ,the authority       

provided under this subsection may be   
used to conduct or support high-impact1 
cutting-edge research described in      
paragraph 7#a7 using the other          
transactions authority described in such
 paragraph if the institute1 center1 or 
office--  7,a7 submits a proposal to the
 ,director of ,,nih for the use of such 
authority before conducting or          
supporting the research1 including why  
the use of such authority is essential  
to promoting the success of the project2
  7,b7 receives approval for the use of 
such authority from the ,director of    
,,nih2 and  7,c7 for each year in which 
the institute1 center1 or office has    
used such authority in accordance with  
this subsection1 submits a report to the
 ,director of ,,nih on the activities of
 the institute1 center1 or office       
relating to such research4  4  7b7      
,report to ,congress ,not later than    
,september #cj1 #bjbj1 the ,secretary of
 ,health and ,human ,services1 acting   
through the ,director of the ,national  

,institutes of ,health1 shall conduct an
 evaluation of the activities under     
subsection 7m7 of section #djb of the   
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhb71 as added by subsection 
7a71 and submit a report to the         
,committee on ,health1 ,education1      
,labor1 and ,pensions of the ,senate and
 the ,committee on ,energy and ,commerce
 of the ,house of ,representatives on   
the results of such evaluation4  7c7    
,duties of directors of institutes      
,section #dje7;b77#a7 of the ,public    
,health ,service ,act 7#db ,u4,s4,c4    
#bhd7;b77#a77 is amended-- 7#a7 by      
redesignating subparagraphs 7,c7 through
 7,l7 as subparagraphs 7,d7 through     
7,m71 respectively2 and  7#b7 by        
inserting after subparagraph 7,b71 the  
following3  7,c7 shall1 as appropriate1 
conduct and support research that has   
the potential to transform the          
scientific field1 has inherently higher 
risk1 and that seeks to address major   
current challenges2  4  ,april #ah1     

#bjaf,reported with an amendment