What This Bill Does
This bill creates rules to protect national security at the National Institutes of Health (NIH), particularly related to genetic information. It prevents the NIH from using federal money with companies controlled by China or in which China has significant ownership. The bill also requires the Department of Health and Human Services to create a working group that will develop best practices for protecting sensitive health information when researchers share data with international partners.
##
Who It Affects
* The National Institutes of Health and its leadership
* Companies that provide genetic sequencing services to the NIH
* Laboratories that test human samples and issue certificates
* Researchers who receive NIH grant funding
* Academic, public and private biomedical research institutions
* Members of Congress (specific committees that will receive reports)
* Federal agencies including the Department of Commerce, Department of State, and Department of Justice
##
Key Provisions
* The NIH cannot spend federal money with any company or its subsidiaries controlled by China's government or in which China has substantial ownership (Sec. 3)
* Laboratories seeking official certificates must disclose whether they or their parent companies have ties to China's government or substantial Chinese ownership (Sec. 4)
* The NIH Director must submit annual reports to Congress about researchers funded by NIH grants who have undisclosed ties to foreign governments, including details on compliance reviews and actions taken (Sec. 5)
* A working group must be created within 120 days to develop best practices on protecting health information shared during international research partnerships, with special focus on risks involving China and other foreign entities (Sec. 6)
* The working group must study how genetic data moves between research institutions and foreign partners, recommend ways to protect intellectual property and sensitive health information, and provide guidance to research institutions on safeguarding genomic data (Sec. 6)
##
What Changes
If this law passes, the NIH will no longer be allowed to fund genomic sequencing services from Chinese-controlled companies. Laboratories seeking federal certification will have to reveal any connections to China. Congress will receive yearly reports about researchers with foreign government ties that were not properly disclosed to the NIH. Research institutions will receive new guidance on how to protect genetic and health information when working with international partners, particularly those from China. A temporary federal working group will spend one year developing these best practices before dissolving.
##
Important Definitions
* **Sensitive health information:** As defined by the Health IT Policy Committee (the bill does not provide its own definition) (Sec. 6)
* **Genomic data:** Genetic information derived from examination of human biological materials for diagnosing disease, preventing disease, treating disease, or assessing health (Sec. 4)
* **Entity organized under the laws of the People's Republic of China:** A company or organization created according to Chinese law (Sec. 3)
* **Substantial interest:** Not explicitly defined in the bill text
##
Effective Date
Not specified in bill text. The working group must be established within 120 days of when the law is enacted, and the working group must submit its report within one year of enactment.
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 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’’.
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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
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•S 289 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—
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‘‘(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:
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‘‘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
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•S 289 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
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•S 289 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 Medicine.
21
(D) The Department of State.
22
(E) The Department of Justice.
23
(F) The Federal Health IT Coordinating
24
Council.
25
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(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
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•S 289 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
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•S 289 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
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(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
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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
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