Genomics Data Security Act

Subjects: Health, Asia, China, Congressional oversight, Department of Health and Human Services, Executive agency funding and structure, Genetics, Government studies and investigations, Health facilities and institutions, Health information and medical records, Health programs administration and funding, Health promotion and preventive care, Higher education, Intellectual property, International organizations and cooperation, Licensing and registrations, Medical ethics, Medical research, Medical tests and diagnostic methods, National Institutes of Health (NIH), Research administration and funding, Research ethics

Summary:  <p><strong>Genomics Data Security Act</strong></p> <p>This bill establishes requirements and otherwise directs the National Institutes of Health (NIH) to take actions to address national security concerns in genomic and other research.</p> <p>Specifically, the bill prohibits the use of NIH funds by any Chinese company (or its subcontractors or subsidiaries). This includes companies (1) over which the Chinese government, a Chinese national, or an entity organized under Chinese law exercises control; or (2) in which the Chinese government has a substantial interest. It also requires, as a condition of certification, that clinical laboratories that have access to U.S. health data disclose ties to the Chinese government.</p> <p>In addition, the NIH must incorporate national security issues in its strategic plan and report annually on any improperly disclosed, vetted, or approved ties that NIH-funded researchers have to foreign governments.</p> <p>Furthermore, the Department of Health and Human Services must establish a working group to update the NIH's Genomic Data Sharing Policy with respect to intellectual property, national security, and privacy concerns.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 289 Introduced in Senate (IS)]

&lt;DOC&gt;






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Genomics Data Security Act''.

SEC. 2. MODERNIZING THE NATIONAL INSTITUTES OF HEALTH'S APPROACH TO 
              NATIONAL SECURITY.

    Section 402(m)(2) of the Public Health Service Act (42 U.S.C. 
282(m)(2)) is amended--
            (1) in subparagraph (E), by striking ``; and'' and 
        inserting a semicolon;
            (2) by redesignating subparagraph (F) as subparagraph (G); 
        and
            (3) by inserting after subparagraph (E) the following:
                    ``(F) address national security issues, 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 Health; and''.

SEC. 3. UTILIZATION OF GENOMIC SEQUENCING SERVICES BY THE NATIONAL 
              INSTITUTES OF HEALTH.

    Notwithstanding any other provision of law, 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--
            (1) over which control is exercised or exercisable by the 
        Government of the People's Republic of China, a national of the 
        People's Republic of China, or an entity organized under the 
        laws of the People's Republic of China; or
            (2) in which the Government of the People's Republic of 
        China has a substantial interest.

SEC. 4. NATIONAL SECURITY CONSIDERATIONS THROUGH LICENSURE.

    Section 353 of the Public Health Service Act (42 U.S.C. 263a) is 
amended--
            (1) by redesignating subsection (q) as subsection (r); and
            (2) by inserting after subsection (p) the following:
    ``(q) Ties to the People's Republic of China.--
            ``(1) In general.--Each certificate issued by the Secretary 
        under this section shall state whether--
                    ``(A) the laboratory;
                    ``(B) the company that owns or manages the 
                laboratory; or
                    ``(C) any subcontractors or subsidiaries of such a 
                laboratory or company,
        is an entity described in paragraph (2).
            ``(2) Entity described.--An entity described in this 
        paragraph is an entity--
                    ``(A)(i) that is engaged in the biological, 
                microbiological, serological, chemical, immuno-
                hematological, hematological, biophysical, cytological, 
                pathological, or other examination of materials derived 
                from the human body for the purpose of providing 
                information for the diagnosis, prevention, or treatment 
                of any disease or impairment of, or the assessment of 
                the health of, people of the United States; or
                    ``(ii) that handles or has access to any data 
                related to people of the United States that is derived 
                from any activity described in clause (i); and
                    ``(B)(i) over which control is exercised or 
                exercisable by the Government of the People's Republic 
                of China, a national of the People's Republic of China, 
                or an entity organized under the laws of the People's 
                Republic of China; or
                    ``(ii) in which the Government of the People's 
                Republic of China has a substantial interest.''.

SEC. 5. NIH GRANTEE TIES TO FOREIGN GOVERNMENTS.

    Title IV of the Public Health Service Act is amended by inserting 
after section 403C (42 U.S.C. 283a-2) the following:

``SEC. 403C-1. ANNUAL REPORTING REGARDING GRANTEE TIES TO FOREIGN 
              GOVERNMENTS.

    ``(a) In General.--On an annual basis, the Director of NIH shall 
submit to the Committee on Health, Education, Labor, and Pensions, the 
Committee on Foreign Relations, and the Select Committee on 
Intelligence of the Senate, and to the Committee on Energy and 
Commerce, the Committee on Foreign Affairs, and the Permanent Select 
Committee on Intelligence of the House of Representatives, 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 
disclosed, vetted, and approved by the National Institutes of Health, 
including the status of any ongoing National Institutes of Health 
compliance reviews related to such ties and all administrative actions 
taken to address such concerns.
    ``(b) Requirement.--The Committees receiving the reports under 
subsection (a) shall keep confidential, and shall not release, any 
provision of such a report that is related to an ongoing National 
Institutes of Health compliance review.''.

SEC. 6. NATIONAL SECURITY CONSIDERATIONS IN RESEARCH.

    (a) Establishment of Working Group.--Not later than 120 days after 
the date of enactment of this Act, the Secretary of Health and Human 
Services (referred to in this section as the ``Secretary'') shall 
establish a working group (in this Act referred to as the ``Working 
Group'') 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 end, develop and disseminate best practices 
on data sharing for use by entities engaged in biomedical research and 
international collaboration to enable both academic, public, and 
private institutions to--
            (1) protect intellectual property;
            (2) weigh the national security risks of potential 
        partnerships where sensitive health information (for purposes 
        of this Act, as defined by the Health IT Policy Committee), of 
        the people of the United States is exchanged; and
            (3) protect the sensitive health information of the people 
        of the United States.
    (b) Membership.--
            (1) Composition.--The Secretary shall, after consultation 
        with the Director of the National Science Foundation and the 
        Attorney General, appoint to the Working Group--
                    (A) individuals with knowledge and expertise in 
                data privacy or security, data-sharing, national 
                security, or the uses of genomic technology and 
                information in clinical or non-clinical research;
                    (B) representatives of national associations 
                representing biomedical research institutions and 
                academic societies;
                    (C) representatives of at least 2 major genomics 
                research organizations from the private sector; and
                    (D) representatives of any other entities the 
                Secretary determines appropriate and necessary to 
                develop the best practices described in subsection (a).
            (2) Representation.--In addition to the members described 
        in paragraph (1), the Working Group shall include not less than 
        one representative of each of the following:
                    (A) The National Institutes of Health.
                    (B) The Bureau of Industry and Security of the 
                Department of Commerce.
                    (C) The National Academies of Science, Engineering, 
                and Medicine.
                    (D) The Department of State.
                    (E) The Department of Justice.
                    (F) The Federal Health IT Coordinating Council.
                    (G) The Office of the National Coordinator for 
                Health Information Technology.
                    (H) The Defense Advanced Research Projects Agency.
                    (I) The Department of Energy.
            (3) Date.--The appointments of the members of the Working 
        Group shall be made not later than 90 days after the date of 
        enactment of this Act.
    (c) Duties of Working Group.--
            (1) Study.--The Working Group shall study--
                    (A) the transfer of data between private, public, 
                and academic institutions that partake in science and 
                technology research and their research partners, with a 
                focus on entities of the People's Republic of China and 
                other foreign entities of concern, including a review 
                of what circumstances would constitute a transfer of 
                data;
                    (B) best practices regarding data protection to 
                help private, public, and academic institutions that 
                partake in biomedical research decide how to weigh and 
                factor national security into their partnership 
                decisions and, through research collaborations, what 
                steps the institutions can take to safeguard data, 
                particularly genomic data;
                    (C) 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 rights, research ethics, and the 
                risk of intellectual property theft, as well as 
                education on how to recognize and report such threats; 
                and
                    (D) other risks and best practices related to 
                information and data sharing, as identified by the 
                Working Group, including any gaps in current practice 
                that could be addressed by congressional action.
            (2) Report.--
                    (A) In general.--Not later than 1 year after the 
                date of enactment of this Act, the Working Group shall 
                submit a report that contains a detailed statement of 
                the findings and conclusions of the Working Group, 
                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 field, to--
                            (i) the Secretary of Health and Human 
                        Services;
                            (ii) the President;
                            (iii) the Committee on Health, Education, 
                        Labor, and Pensions, the Committee on Foreign 
                        Relations, and the Select Committee on 
                        Intelligence of the Senate; and
                            (iv) the Committee on Energy and Commerce, 
                        the Committee on Foreign Affairs, and the 
                        Permanent Select Committee on Intelligence of 
                        the House of Representatives.
                    (B) Guidance.--The guidance provided under 
                subparagraph (A) shall include non-binding guidance for 
                entities that utilize genomic technologies, such as 
                whole genomic sequencing, for use in research or other 
                types of sensitive health information, as defined by 
                the Secretary.
            (3) Requirements.--In carrying out the duties of this 
        subsection, the Working Group shall consider all existing 
        Federal guidance and grant requirements (as of the date of 
        consideration), particularly with regard to foreign influences 
        and research integrity, 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 guidance, as of the date of publication.
    (d) Powers of Working Group.--
            (1) Hearings.--The Working Group may hold such hearings, 
        sit and act at such times and places, take such testimony, and 
        receive such evidence as the Working Group considers advisable 
        to carry out this Act.
            (2) Information from federal agencies.--
                    (A) 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 Act.
                    (B) Furnishing information.--On request of a 
                majority of the members of the Working Group, the head 
                of the department or agency shall furnish the 
                information to the Working Group.
            (3) 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 Government.
    (e) Termination of Working Group.--The Working Group shall 
terminate 90 days after the date on which the Working Group submits the 
report required under subsection (c)(2).
                                 &lt;all&gt;
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