,,ii  #aahth ,,congress  #ast ,session  
,s4 #bhi  ,,in ,,the ,,senate ,,of ,,the
 ,,united ,,states  ,february #g1       
#bjbc,mr4 ,rubio introduced the         
following bill2 which was read twice and
 referred to the ,committee on ,health1 
,education1 ,labor1 and ,pensions  ,a   
,,bill  ,to improve national security at
 the ,national ,institutes of ,health1  
to address national security issues in  
the licensure of biological products1 to
 address national security              
considerations in research at the       
,department of ,health and ,human       
,services1 and for other purposes4  #a4 
,short title ,this ,act may be cited as 
the ,genomics ,data ,security ,act4  #b4
 ,modernizing the ,national ,institutes 
of ,health's approach to national       
security ,section #djb7m77#b7 of the    
,public ,health ,service ,act 7#db      
,u4,s4,c4 #bhb7m77#b77 is amended-- 7#a7
 in subparagraph 7,e71 by striking 2 and
 and inserting a semicolon2  7#b7 by    
redesignating subparagraph 7,f7 as      

subparagraph 7,g72 and  7#c7 by         
inserting after subparagraph 7,e7 the   
following3  7,f7 address national       
security issues1 including ways in which
 the ,national ,institutes of ,health   
can engage with other ,federal agencies 
to modernize the national security      
strategy of the ,national ,institutes of
 ,health2 and  4  #c4 ,utilization of   
genomic sequencing services by the      
,national ,institutes of ,health        
,notwithstanding any other provision of 
law1 no amounts made available to the   
,national ,institutes of ,health may be 
used with respect to activities carried 
out by any company or its subcontractors
 or subsidiaries-- 7#a7 over which      
control is exercised or exercisable by  
the ,government of the ,people's        
,republic of ,china1 a national of the  
,people's ,republic of ,china1 or an    
entity organized under the laws of the  
,people's ,republic of ,china2 or  7#b7 
in which the ,government of the         
,people's ,republic of ,china has a     

substantial interest4  #d4 ,national    
security considerations through         
licensure ,section #cec of the ,public  
,health ,service ,act 7#db ,u4,s4,c4    
#bfc;a7 is amended-- 7#a7 by            
redesignating subsection 7q7 as         
subsection 7r72 and  7#b7 by inserting  
after subsection 7p7 the following3  7q7
 ,ties to the ,people's ,republic of    
,china  7#a7 ,in general ,each          
certificate issued by the ,secretary    
under this section shall state whether--
 7,a7 the laboratory2  7,b7 the company 
that owns or manages the laboratory2 or 
7,c7 any subcontractors or subsidiaries 
of such a laboratory or company1  is an 
entity described in paragraph 7#b74     
7#b7 ,entity described ,an entity       
described in this paragraph is an       
entity-- 7,a7 7i7 that is engaged in the
 biological1 microbiological1           
serological1 chemical1                  
immuno-hematological1 hematological1    
biophysical1 cytological1 pathological1 
or other examination of materials       

derived from the human body for the     
purpose of providing information for the
 diagnosis1 prevention1 or treatment of 
any disease or impairment of1 or the    
assessment of the health of1 people of  
the ,united ,states2 or  7ii7 that      
handles or has access to any data       
related to people of the ,united ,states
 that is derived from any activity      
described in clause 7i72 and  7,b7 7i7  
over which control is exercised or      
exercisable by the ,government of the   
,people's ,republic of ,china1 a        
national of the ,people's ,republic of  
,china1 or an entity organized under the
 laws of the ,people's ,republic of     
,china2 or  7ii7 in which the           
,government of the ,people's ,republic  
of ,china has a substantial interest4  4
  #e4 ,,nih ,grantee ties to foreign    
governments ,title ,,iv of the ,public  
,health ,service ,act is amended by     
inserting after section #djc;,c 7#db    
,u4,s4,c4 #bhc;a-#b7 the following3     
#djc;,c-#a4 ,annual reporting regarding 

grantee ties to foreign governments  7a7
 ,in general ,on an annual basis1 the   
,director of ,,nih shall submit to the  
,committee on ,health1 ,education1      
,labor1 and ,pensions1 the ,committee on
 ,foreign ,relations1 and the ,select   
,committee on ,intelligence of the      
,senate1 and to the ,committee on       
,energy and ,commerce1 the ,committee on
 ,foreign ,affairs1 and the ,permanent  
,select ,committee on ,intelligence of  
the ,house of ,representatives1 a report
 on any ties to foreign governments that
 researchers funded by grants from the  
,national ,institutes of ,health have   
and that are not properly disclosed1    
vetted1 and approved by the ,national   
,institutes of ,health1 including the   
status of any ongoing ,national         
,institutes of ,health compliance       
reviews related to such ties and all    
administrative actions taken to address 
such concerns4  7b7 ,requirement ,the   
,committees receiving the reports under 
subsection 7a7 shall keep confidential1 

and shall not release1 any provision of 
such a report that is related to an     
ongoing ,national ,institutes of ,health
 compliance review4  4  #f4 ,national   
security considerations in research  7a7
 ,establishment of working group ,not   
later than #abj days after the date of  
enactment of this ,act1 the ,secretary  
of ,health and ,human ,services         
7referred to in this section as the     
,secretary7 shall establish a working   
group 7in this ,act referred to as the  
,working ,group7 in the ,department of  
,health and ,human ,services to make    
recommended updates to the ,national    
,institute of ,health's ,genomic ,data  
,sharing ,policy and to that end1       
develop and disseminate best practices  
on data sharing for use by entities     
engaged in biomedical research and      
international collaboration to enable   
both academic1 public1 and private      
institutions to-- 7#a7 protect          
intellectual property2  7#b7 weigh the  
national security risks of potential    

partnerships where sensitive health     
information 7for purposes of this ,act1 
as defined by the ,health ,,it ,policy  
,committee71 of the people of the       
,united ,states is exchanged2 and  7#c7 
protect the sensitive health information
 of the people of the ,united ,states4  
7b7 ,membership  7#a7 ,composition ,the 
,secretary shall1 after consultation    
with the ,director of the ,national     
,science ,foundation and the ,attorney  
,general1 appoint to the ,working       
,group-- 7,a7 individuals with knowledge
 and expertise in data privacy or       
security1 data-sharing1 national        
security1 or the uses of genomic        
technology and information in clinical  
or non-clinical research2  7,b7         
representatives of national associations
 representing biomedical research       
institutions and academic societies2    
7,c7 representatives of at least #b     
major genomics research organizations   
from the private sector2 and  7,d7      
representatives of any other entities   

the ,secretary determines appropriate   
and necessary to develop the best       
practices described in subsection 7a74  
7#b7 ,representation ,in addition to the
 members described in paragraph 7#a71   
the ,working ,group shall include not   
less than one representative of each of 
the following3 7,a7 ,the ,national      
,institutes of ,health4  7,b7 ,the      
,bureau of ,industry and ,security of   
the ,department of ,commerce4  7,c7 ,the
 ,national ,academies of ,science1      
,engineering1 and ,medicine4  7,d7 ,the 
,department of ,state4  7,e7 ,the       
,department of ,justice4  7,f7 ,the     
,federal ,health ,,it ,coordinating     
,council4  7,g7 ,the ,office of the     
,national ,coordinator for ,health      
,information ,technology4  7,h7 ,the    
,defense ,advanced ,research ,projects  
,agency4  7,i7 ,the ,department of      
,energy4  7#c7 ,date ,the appointments  
of the members of the ,working ,group   
shall be made not later than #ij days   
after the date of enactment of this     

,act4  7c7 ,duties of ,working ,group   
7#a7 ,study ,the ,working ,group shall  
study-- 7,a7 the transfer of data       
between private1 public1 and academic   
institutions that partake in science and
 technology research and their research 
partners1 with a focus on entities of   
the ,people's ,republic of ,china and   
other foreign entities of concern1      
including a review of what circumstances
 would constitute a transfer of data2   
7,b7 best practices regarding data      
protection to help private1 public1 and 
academic institutions that partake in   
biomedical research decide how to weigh 
and factor national security into their 
partnership decisions and1 through      
research collaborations1 what steps the 
institutions can take to safeguard data1
 particularly genomic data2  7,c7       
recommendations regarding areas where   
,federal agencies can coordinate to     
increase education to such private and  
academic research institutions that     
partake in science and technology       

research to ensure the institutions can 
better protect themselves from economic 
threats with a strengthened             
understanding of intellectual property  
rights1 research ethics1 and the risk of
 intellectual property theft1 as well as
 education on how to recognize and      
report such threats2 and  7,d7 other    
risks and best practices related to     
information and data sharing1 as        
identified by the ,working ,group1      
including any gaps in current practice  
that could be addressed by congressional
 action4  7#b7 ,report  7,a7 ,in general
 ,not later than #a year after the date 
of enactment of this ,act1 the ,working 
,group shall submit a report that       
contains a detailed statement of the    
findings and conclusions of the ,working
 ,group1 together with recommendations  
to update the ,national ,institute of   
,health's ,genomic ,data ,sharing       
,policy and subsequent nonbinding       
guidance regarding risks and safeguards 
for data sharing with foreign entities  

for research institutions in the field1 
to-- 7i7 the ,secretary of ,health and  
,human ,services2  7ii7 the ,president2 
7iii7 the ,committee on ,health1        
,education1 ,labor1 and ,pensions1 the  
,committee on ,foreign ,relations1 and  
the ,select ,committee on ,intelligence 
of the ,senate2 and  7iv7 the ,committee
 on ,energy and ,commerce1 the          
,committee on ,foreign ,affairs1 and the
 ,permanent ,select ,committee on       
,intelligence of the ,house of          
,representatives4  7,b7 ,guidance ,the  
guidance provided under subparagraph    
7,a7 shall include non-binding guidance 
for entities that utilize genomic       
technologies1 such as whole genomic     
sequencing1 for use in research or other
 types of sensitive health information1 
as defined by the ,secretary4  7#c7     
,requirements ,in carrying out the      
duties of this subsection1 the ,working 
,group shall consider all existing      
,federal guidance and grant requirements
 7as of the date of consideration71     

particularly with regard to foreign     
influences and research integrity1 and  
ensure that all recommended updates to  
the ,genomic ,data ,sharing ,policy and 
subsequent best practices put forward by
 the working group not duplicate or     
conflict with existing guidance1 as of  
the date of publication4  7d7 ,powers of
 ,working ,group  7#a7 ,hearings ,the   
,working ,group may hold such hearings1 
sit and act at such times and places1   
take such testimony1 and receive such   
evidence as the ,working ,group         
considers advisable to carry out this   
,act4  7#b7 ,information from ,federal  
agencies  7,a7 ,in general ,the ,working
 ,group may secure directly from a      
,federal department or agency such      
information as the ,working ,group      
considers necessary to carry out this   
,act4  7,b7 ,furnishing information ,on 
request of a majority of the members of 
the ,working ,group1 the head of the    
department or agency shall furnish the  
information to the ,working ,group4     

7#c7 ,postal services ,the ,working     
,group may use the ,united ,states mails
 in the same manner and under the same  
conditions as other departments and     
agencies of the ,federal ,government4   
7e7 ,termination of ,working ,group ,the
 ,working ,group shall terminate #ij    
days after the date on which the        
,working ,group submits the report      
required under subsection 7c77#b74