II 

118TH CONGRESS 

1ST SESSION S. 289 

To improve national security at the National Institutes of Health, to address 

national security issues in the licensure of biological products, to address 

national security considerations in research at the Department of Health 

and Human Services, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 7, 2023 

Mr. RUBIO introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve national security at the National Institutes of 

Health, to address national security issues in the licensure of biological products, to address national security 

considerations in research at the Department of Health 

and Human Services, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Genomics Data Secu5 rity Act’’. 


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1 SEC. 2. MODERNIZING THE NATIONAL INSTITUTES OF 

2 HEALTH’S APPROACH TO NATIONAL SECU3 RITY. 

4 Section 402(m)(2) of the Public Health Service Act 

5 (42 U.S.C. 282(m)(2)) is amended— 

6 (1) in subparagraph (E), by striking ‘‘; and’’ 

7 and inserting a semicolon; 

8 (2) by redesignating subparagraph (F) as sub9 paragraph (G); and 

10 (3) by inserting after subparagraph (E) the fol11 lowing: 

12 ‘‘(F) address national security issues, in13 cluding ways in which the National Institutes of 

14 Health can engage with other Federal agencies 

15 to modernize the national security strategy of 

16 the National Institutes of Health; and’’. 

17 SEC. 3. UTILIZATION OF GENOMIC SEQUENCING SERVICES 

18 BY THE NATIONAL INSTITUTES OF HEALTH. 

19 Notwithstanding any other provision of law, no 

20 amounts made available to the National Institutes of 

21 Health may be used with respect to activities carried out 

22 by any company or its subcontractors or subsidiaries— 

23 (1) over which control is exercised or exer24 cisable by the Government of the People’s Republic 

25 of China, a national of the People’s Republic of 


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1 China, or an entity organized under the laws of the 

2 People’s Republic of China; or 

3 (2) in which the Government of the People’s 

4 Republic of China has a substantial interest. 

5 SEC. 4. NATIONAL SECURITY CONSIDERATIONS THROUGH 

6 LICENSURE. 

7 Section 353 of the Public Health Service Act (42 

8 U.S.C. 263a) is amended— 

9 (1) by redesignating subsection (q) as sub10 section (r); and 

11 (2) by inserting after subsection (p) the fol12 lowing: 

13 ‘‘(q) TIES TO THE PEOPLE’S REPUBLIC OF CHINA.— 

14 ‘‘(1) IN GENERAL.—Each certificate issued by 

15 the Secretary under this section shall state wheth16 er— 

17 ‘‘(A) the laboratory; 

18 ‘‘(B) the company that owns or manages 

19 the laboratory; or 

20 ‘‘(C) any subcontractors or subsidiaries of 

21 such a laboratory or company, 

22 is an entity described in paragraph (2). 

23 ‘‘(2) ENTITY DESCRIBED.—An entity described 

24 in this paragraph is an entity— 


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1 ‘‘(A)(i) that is engaged in the biological, 

2 microbiological, serological, chemical, immuno3 hematological, hematological, biophysical, 

4 cytological, pathological, or other examination 

5 of materials derived from the human body for 

6 the purpose of providing information for the di7 agnosis, prevention, or treatment of any disease 

8 or impairment of, or the assessment of the 

9 health of, people of the United States; or 

10 ‘‘(ii) that handles or has access to any 

11 data related to people of the United States that 

12 is derived from any activity described in clause 

13 (i); and 

14 ‘‘(B)(i) over which control is exercised or 

15 exercisable by the Government of the People’s 

16 Republic of China, a national of the People’s 

17 Republic of China, or an entity organized under 

18 the laws of the People’s Republic of China; or 

19 ‘‘(ii) in which the Government of the Peo20 ple’s Republic of China has a substantial inter21 est.’’. 

22 SEC. 5. NIH GRANTEE TIES TO FOREIGN GOVERNMENTS. 

23 Title IV of the Public Health Service Act is amended 

24 by inserting after section 403C (42 U.S.C. 283a–2) the 

25 following: 


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1 ‘‘SEC. 403C–1. ANNUAL REPORTING REGARDING GRANTEE 

2 TIES TO FOREIGN GOVERNMENTS. 

3 ‘‘(a) IN GENERAL.—On an annual basis, the Director 

4 of NIH shall submit to the Committee on Health, Edu5 cation, Labor, and Pensions, the Committee on Foreign 

6 Relations, and the Select Committee on Intelligence of the 

7 Senate, and to the Committee on Energy and Commerce, 

8 the Committee on Foreign Affairs, and the Permanent Se9 lect Committee on Intelligence of the House of Represent10 atives, a report on any ties to foreign governments that 

11 researchers funded by grants from the National Institutes 

12 of Health have and that are not properly disclosed, vetted, 

13 and approved by the National Institutes of Health, includ14 ing the status of any ongoing National Institutes of 

15 Health compliance reviews related to such ties and all ad16 ministrative actions taken to address such concerns. 

17 ‘‘(b) REQUIREMENT.—The Committees receiving the 

18 reports under subsection (a) shall keep confidential, and 

19 shall not release, any provision of such a report that is 

20 related to an ongoing National Institutes of Health com21 pliance review.’’. 

22 SEC. 6. NATIONAL SECURITY CONSIDERATIONS IN RE23 SEARCH. 

24 (a) ESTABLISHMENT OF WORKING GROUP.—Not 

25 later than 120 days after the date of enactment of this 

26 Act, the Secretary of Health and Human Services (reVerDate Sep 11 2014 00:59 Feb 17, 2023 Jkt 047007 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S289.IS S289

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1 ferred to in this section as the ‘‘Secretary’’) shall establish 

2 a working group (in this Act referred to as the ‘‘Working 

3 Group’’) in the Department of Health and Human Serv4 ices to make recommended updates to the National Insti5 tute of Health’s Genomic Data Sharing Policy and to that 

6 end, develop and disseminate best practices on data shar7 ing for use by entities engaged in biomedical research and 

8 international collaboration to enable both academic, pub9 lic, and private institutions to— 

10 (1) protect intellectual property; 

11 (2) weigh the national security risks of poten12 tial partnerships where sensitive health information 

13 (for purposes of this Act, as defined by the Health 

14 IT Policy Committee), of the people of the United 

15 States is exchanged; and 

16 (3) protect the sensitive health information of 

17 the people of the United States. 

18 (b) MEMBERSHIP.— 

19 (1) COMPOSITION.—The Secretary shall, after 

20 consultation with the Director of the National 

21 Science Foundation and the Attorney General, ap22 point to the Working Group— 

23 (A) individuals with knowledge and exper24 tise in data privacy or security, data-sharing, 

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1 nology and information in clinical or non-clin2 ical research; 

3 (B) representatives of national associations 

4 representing biomedical research institutions 

5 and academic societies; 

6 (C) representatives of at least 2 major 

7 genomics research organizations from the pri8 vate sector; and 

9 (D) representatives of any other entities 

10 the Secretary determines appropriate and nec11 essary to develop the best practices described in 

12 subsection (a). 

13 (2) REPRESENTATION.—In addition to the 

14 members described in paragraph (1), the Working 

15 Group shall include not less than one representative 

16 of each of the following: 

17 (A) The National Institutes of Health. 

18 (B) The Bureau of Industry and Security 

19 of the Department of Commerce. 

20 (C) The National Academies of Science, 

21 Engineering, and Medicine. 

22 (D) The Department of State. 

23 (E) The Department of Justice. 

24 (F) The Federal Health IT Coordinating 

25 Council. 


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1 (G) The Office of the National Coordinator 

2 for Health Information Technology. 

3 (H) The Defense Advanced Research 

4 Projects Agency. 

5 (I) The Department of Energy. 

6 (3) DATE.—The appointments of the members 

7 of the Working Group shall be made not later than 

8 90 days after the date of enactment of this Act. 

9 (c) DUTIES OF WORKING GROUP.— 

10 (1) STUDY.—The Working Group shall study— 

11 (A) the transfer of data between private, 

12 public, and academic institutions that partake 

13 in science and technology research and their re14 search partners, with a focus on entities of the 

15 People’s Republic of China and other foreign 

16 entities of concern, including a review of what 

17 circumstances would constitute a transfer of 

18 data; 

19 (B) best practices regarding data protec20 tion to help private, public, and academic insti21 tutions that partake in biomedical research de22 cide how to weigh and factor national security 

23 into their partnership decisions and, through 

24 research collaborations, what steps the instituVerDate Sep 11 2014 00:59 Feb 17, 2023 Jkt 047007 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S289.IS S289

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1 tions can take to safeguard data, particularly 

2 genomic data; 

3 (C) recommendations regarding areas 

4 where Federal agencies can coordinate to in5 crease education to such private and academic 

6 research institutions that partake in science 

7 and technology research to ensure the institu8 tions can better protect themselves from eco9 nomic threats with a strengthened under10 standing of intellectual property rights, re11 search ethics, and the risk of intellectual prop12 erty theft, as well as education on how to recog13 nize and report such threats; and 

14 (D) other risks and best practices related 

15 to information and data sharing, as identified 

16 by the Working Group, including any gaps in 

17 current practice that could be addressed by con18 gressional action. 

19 (2) REPORT.— 

20 (A) IN GENERAL.—Not later than 1 year 

21 after the date of enactment of this Act, the 

22 Working Group shall submit a report that con23 tains a detailed statement of the findings and 

24 conclusions of the Working Group, together 

25 with recommendations to update the National 


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1 Institute of Health’s Genomic Data Sharing 

2 Policy and subsequent nonbinding guidance re3 garding risks and safeguards for data sharing 

4 with foreign entities for research institutions in 

5 the field, to— 

6 (i) the Secretary of Health and 

7 Human Services; 

8 (ii) the President; 

9 (iii) the Committee on Health, Edu10 cation, Labor, and Pensions, the Com11 mittee on Foreign Relations, and the Se12 lect Committee on Intelligence of the Sen13 ate; and 

14 (iv) the Committee on Energy and 

15 Commerce, the Committee on Foreign Af16 fairs, and the Permanent Select Committee 

17 on Intelligence of the House of Represent18 atives. 

19 (B) GUIDANCE.—The guidance provided 

20 under subparagraph (A) shall include non-bind21 ing guidance for entities that utilize genomic 

22 technologies, such as whole genomic sequencing, 

23 for use in research or other types of sensitive 

24 health information, as defined by the Secretary. 


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1 (3) REQUIREMENTS.—In carrying out the du2 ties of this subsection, the Working Group shall con3 sider all existing Federal guidance and grant re4 quirements (as of the date of consideration), particu5 larly with regard to foreign influences and research 

6 integrity, and ensure that all recommended updates 

7 to the Genomic Data Sharing Policy and subsequent 

8 best practices put forward by the working group not 

9 duplicate or conflict with existing guidance, as of the 

10 date of publication. 

11 (d) POWERS OF WORKING GROUP.— 

12 (1) HEARINGS.—The Working Group may hold 

13 such hearings, sit and act at such times and places, 

14 take such testimony, and receive such evidence as 

15 the Working Group considers advisable to carry out 

16 this Act. 

17 (2) INFORMATION FROM FEDERAL AGENCIES.— 

18 (A) IN GENERAL.—The Working Group 

19 may secure directly from a Federal department 

20 or agency such information as the Working 

21 Group considers necessary to carry out this Act. 

22 (B) FURNISHING INFORMATION.—On re23 quest of a majority of the members of the 

24 Working Group, the head of the department or 


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1 agency shall furnish the information to the 

2 Working Group. 

3 (3) POSTAL SERVICES.—The Working Group 

4 may use the United States mails in the same man5 ner and under the same conditions as other depart6 ments and agencies of the Federal Government. 

7 (e) TERMINATION OF WORKING GROUP.—The Work8 ing Group shall terminate 90 days after the date on which 

9 the Working Group submits the report required under 

10 subsection (c)(2). 

Æ 


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