Genomics Data Security Act

II 117TH CONGRESS 1ST SESSION S. 1744 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 MAY 20, 2021 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 licen- sure of biological products, to address national security considerations in research at the Department of Health and Human Services, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Genomics Data Secu- 4 rity Act’’. 5 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1744 IS SEC. 2. MODERNIZING THE NATIONAL INSTITUTES OF 1 HEALTH’S APPROACH TO NATIONAL SECU- 2 RITY. 3 Section 402(m)(2) of the Public Health Service Act 4 (42 U.S.C. 282(m)(2)) is amended— 5 (1) in subparagraph (E), by striking ‘‘; and’’ 6 and inserting a semicolon; 7 (2) by redesignating subparagraph (F) as sub- 8 paragraph (G); and 9 (3) by inserting after subparagraph (E) the fol- 10 lowing: 11 ‘‘(F) address national security issues, in- 12 cluding ways in which the National Institutes of 13 Health can engage with other Federal agencies 14 to modernize the national security strategy of 15 the National Institutes of Health; and’’. 16 SEC. 3. UTILIZATION OF GENOMIC SEQUENCING SERVICES 17 BY THE NATIONAL INSTITUTES OF HEALTH. 18 Notwithstanding any other provision of law, no 19 amounts made available to the National Institutes of 20 Health may be used with respect to activities carried out 21 by any company or its subcontractors or subsidiaries— 22 (1) over which control is exercised or exer- 23 cisable by the Government of the People’s Republic 24 of China, a national of the People’s Republic of 25 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1744 IS China, or an entity organized under the laws of the 1 People’s Republic of China; or 2 (2) in which the Government of the People’s 3 Republic of China has a substantial interest. 4 SEC. 4. NATIONAL SECURITY CONSIDERATIONS THROUGH 5 LICENSURE. 6 Section 353 of the Public Health Service Act (42 7 U.S.C. 263a) is amended— 8 (1) by redesignating subsection (q) as sub- 9 section (r); and 10 (2) by inserting after subsection (p) the fol- 11 lowing: 12 ‘‘(q) TIES TO THE PEOPLE’S REPUBLIC OF CHINA.— 13 ‘‘(1) IN GENERAL.—Each certificate issued by 14 the Secretary under this section shall state wheth- 15 er— 16 ‘‘(A) the laboratory; 17 ‘‘(B) the company that owns or manages 18 the laboratory; or 19 ‘‘(C) any subcontractors or subsidiaries of 20 such a laboratory or company, 21 is an entity described in paragraph (2). 22 ‘‘(2) ENTITY DESCRIBED.—An entity described 23 in this paragraph is an entity— 24 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1744 IS ‘‘(A)(i) that is engaged in the biological, 1 microbiological, serological, chemical, immuno- 2 hematological, hematological, biophysical, 3 cytological, pathological, or other examination 4 of materials derived from the human body for 5 the purpose of providing information for the di- 6 agnosis, prevention, or treatment of any disease 7 or impairment of, or the assessment of the 8 health of, people of the United States; or 9 ‘‘(ii) that handles or has access to any 10 data related to people of the United States that 11 is derived from any activity described in clause 12 (i); and 13 ‘‘(B)(i) over which control is exercised or 14 exercisable by the Government of the People’s 15 Republic of China, a national of the People’s 16 Republic of China, or an entity organized under 17 the laws of the People’s Republic of China; or 18 ‘‘(ii) in which the Government of the Peo- 19 ple’s Republic of China has a substantial inter- 20 est.’’. 21 SEC. 5. NIH GRANTEE TIES TO FOREIGN GOVERNMENTS. 22 Title IV of the Public Health Service Act is amended 23 by inserting after section 403C (42 U.S.C. 283a–2) the 24 following: 25 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1744 IS ‘‘SEC. 403C–1. ANNUAL REPORTING REGARDING GRANTEE 1 TIES TO FOREIGN GOVERNMENTS. 2 ‘‘(a) IN GENERAL.—On an annual basis, the Director 3 of NIH shall submit to the Committee on Health, Edu- 4 cation, Labor, and Pensions, the Committee on Foreign 5 Relations, and the Select Committee on Intelligence of the 6 Senate, and to the Committee on Energy and Commerce, 7 the Committee on Foreign Affairs, and the Permanent Se- 8 lect Committee on Intelligence of the House of Represent- 9 atives, a report on any ties to foreign governments that 10 researchers funded by grants from the National Institutes 11 of Health have and that are not properly disclosed, vetted, 12 and approved by the National Institutes of Health, includ- 13 ing the status of any ongoing National Institutes of 14 Health compliance reviews related to such ties and all ad- 15 ministrative actions taken to address such concerns. 16 ‘‘(b) REQUIREMENT.—The Committees receiving the 17 reports under subsection (a) shall keep confidential, and 18 shall not release, any provision of such a report that is 19 related to an ongoing National Institutes of Health com- 20 pliance review.’’. 21 SEC. 6. NATIONAL SECURITY CONSIDERATIONS IN RE- 22 SEARCH. 23 (a) ESTABLISHMENT OF WORKING GROUP.—Not 24 later than 120 days after the date of enactment of this 25 Act, the Secretary of Health and Human Services (re- 26 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1744 IS ferred to in this section as the ‘‘Secretary’’) shall establish 1 a working group (in this Act referred to as the ‘‘Working 2 Group’’) in the Department of Health and Human Serv- 3 ices to make recommended updates to the National Insti- 4 tute of Health’s Genomic Data Sharing Policy and to that 5 end, develop and disseminate best practices on data shar- 6 ing for use by entities engaged in biomedical research and 7 international collaboration to enable both academic, pub- 8 lic, and private institutions to— 9 (1) protect intellectual property; 10 (2) weigh the national security risks of poten- 11 tial partnerships where sensitive health information 12 (for purposes of this Act, as defined by the Health 13 IT Policy Committee), of the people of the United 14 States is exchanged; and 15 (3) protect the sensitive health information of 16 the people of the United States. 17 (b) MEMBERSHIP.— 18 (1) COMPOSITION.—The Secretary shall, after 19 consultation with the Director of the National 20 Science Foundation and the Attorney General, ap- 21 point to the Working Group— 22 (A) individuals with knowledge and exper- 23 tise in data privacy or security, data-sharing, 24 national security, or the uses of genomic tech- 25 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1744 IS nology and information in clinical or non-clin- 1 ical research; 2 (B) representatives of national associations 3 representing biomedical research institutions 4 and academic societies; 5 (C) representatives of at least 2 major 6 genomics research organizations from the pri- 7 vate sector; and 8 (D) representatives of any other entities 9 the Secretary determines appropriate and nec- 10 essary to develop the best practices described in 11 subsection (a). 12 (2) REPRESENTATION.—In addition to the 13 members described in paragraph (1), the Working 14 Group shall include not less than one representative 15 of each of the following: 16 (A) The National Institutes of Health. 17 (B) The Bureau of Industry and Security 18 of the Department of Commerce. 19 (C) The National Academies of Science, 20 Engineering, and Mathematics. 21 (D) The Department of State. 22 (E) The Department of Justice. 23 (F) The Federal Health IT Coordinating 24 Council. 25 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1744 IS (G) The Office of the National Coordinator 1 for Health Information Technology. 2 (H) The Defense Advanced Research 3 Projects Agency. 4 (I) The Department of Energy. 5 (3) DATE.—The appointments of the members 6 of the Working Group shall be made not later than 7 90 days after the date of enactment of this Act. 8 (c) DUTIES OF WORKING GROUP.— 9 (1) STUDY.—The Working Group shall study— 10 (A) the transfer of data between private, 11 public, and academic institutions that partake 12 in science and technology research and their re- 13 search partners, with a focus on entities of the 14 People’s Republic of China and other foreign 15 entities of concern, including a review of what 16 circumstances would constitute a transfer of 17 data; 18 (B) best practices regarding data protec- 19 tion to help private, public, and academic insti- 20 tutions that partake in biomedical research de- 21 cide how to weigh and factor national security 22 into their partnership decisions and, through 23 research collaborations, what steps the institu- 24 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 9 •S 1744 IS tions can take to safeguard data, particularly 1 genomic data; 2 (C) recommendations regarding areas 3 where Federal agencies can coordinate to in- 4 crease education to such private and academic 5 research institutions that partake in science 6 and technology research to ensure the institu- 7 tions can better protect themselves from eco- 8 nomic threats with a strengthened under- 9 standing of intellectual property rights, re- 10 search ethics, and the risk of intellectual prop- 11 erty theft, as well as education on how to recog- 12 nize and report such threats; and 13 (D) other risks and best practices related 14 to information and data sharing, as identified 15 by the Working Group, including any gaps in 16 current practice that could be addressed by con- 17 gressional action. 18 (2) REPORT.— 19 (A) IN GENERAL.—Not later than 1 year 20 after the date of enactment of this Act, the 21 Working Group shall submit a report that con- 22 tains a detailed statement of the findings and 23 conclusions of the Working Group, together 24 with recommendations to update the National 25 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 10 •S 1744 IS Institute of Health’s Genomic Data Sharing 1 Policy and subsequent nonbinding guidance re- 2 garding risks and safeguards for data sharing 3 with foreign entities for research institutions in 4 the field, to— 5 (i) the Secretary of Health and 6 Human Services; 7 (ii) the President; 8 (iii) the Committee on Health, Edu- 9 cation, Labor, and Pensions, the Com- 10 mittee on Foreign Relations, and the Se- 11 lect Committee on Intelligence of the Sen- 12 ate; and 13 (iv) the Committee on Energy and 14 Commerce, the Committee on Foreign Af- 15 fairs, and the Permanent Select Committee 16 on Intelligence of the House of Represent- 17 atives. 18 (B) GUIDANCE.—The guidance provided 19 under subparagraph (A) shall include non-bind- 20 ing guidance for entities that utilize genomic 21 technologies, such as whole genomic sequencing, 22 for use in research or other types of sensitive 23 health information, as defined by the Secretary. 24 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 11 •S 1744 IS (3) REQUIREMENTS.—In carrying out the du- 1 ties of this subsection, the Working Group shall con- 2 sider all existing Federal guidance and grant re- 3 quirements (as of the date of consideration), particu- 4 larly with regard to foreign influences and research 5 integrity, and ensure that all recommended updates 6 to the Genomic Data Sharing Policy and subsequent 7 best practices put forward by the working group not 8 duplicate or conflict with existing guidance, as of the 9 date of publication. 10 (d) POWERS OF WORKING GROUP.— 11 (1) HEARINGS.—The Working Group may hold 12 such hearings, sit and act at such times and places, 13 take such testimony, and receive such evidence as 14 the Working Group considers advisable to carry out 15 this Act. 16 (2) INFORMATION FROM FEDERAL AGENCIES.— 17 (A) IN GENERAL.—The Working Group 18 may secure directly from a Federal department 19 or agency such information as the Working 20 Group considers necessary to carry out this Act. 21 (B) FURNISHING INFORMATION.—On re- 22 quest of a majority of the members of the 23 Working Group, the head of the department or 24 VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS 12 •S 1744 IS agency shall furnish the information to the 1 Working Group. 2 (3) POSTAL SERVICES.—The Working Group 3 may use the United States mails in the same man- 4 ner and under the same conditions as other depart- 5 ments and agencies of the Federal Government. 6 (e) TERMINATION OF WORKING GROUP.—The Work- 7 ing Group shall terminate 90 days after the date on which 8 the Working Group submits the report required under 9 subsection (c)(2). 10 Æ VerDate Sep 11 2014 02:40 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6301 E:\BILLS\S1744.IS S1744 kjohnson on DSK79L0C42PROD with BILLS