Protecting Americans’ Genomic Information Act of 2021
Bill: H.R.5515 | Sponsor: Rep. Dunn, Neal P. (R-FL)
Policy area: Health

Summary:
Protecting Americans' Genomic Information Act of 2021
This bill requires the Department of Health and Human Services (HHS) to address national security concerns when conducting or supporting biomedical research that involves human genomic sequencing and sensitive, identifiable information.
Specifically, HHS must implement a risk framework to assess whether such research conducted by the National Institutes of Health or other HHS agencies and offices poses risks to national security and identify approaches to mitigate those risks, including through security controls and training for those that manage or have access to such research.
After the framework is developed, HHS must implement data access controls, ensure that data access committees include members with national security expertise, and update relevant data access and sharing policies.
The bill also requires HHS to brief Congress about these activities.

To direct the Secretary of Health and Human Services to ensure that 
  certain biomedical research is conducted in a manner that considers 
            national security risks, 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 ``Protecting Americans' Genomic 
Information Act of 2021''.

SEC. 2. SECURING IDENTIFIABLE, SENSITIVE INFORMATION.

    (a) Consideration of National Security Risks.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this section as the ``Secretary''), in 
        consultation with the Director of National Intelligence, the 
        Secretary of State, the Secretary of Defense, and other 
        national security experts, as appropriate, shall ensure that 
        biomedical research described in paragraph (2) is conducted in 
        a manner that appropriately considers national security risks, 
        including national security implications related to potential 
        misuse of such data.
            (2) Biomedical research described.--For purposes of 
        paragraph (1), biomedical research is described in this 
        paragraph if it--
                    (A) is conducted or supported, directly or 
                indirectly, including through subgrants, by the 
                National Institutes of Health or other relevant 
                agencies and offices within the Department of Health 
                and Human Services; and
                    (B) involves the sequencing of human genomic 
                information, and collection, analysis, or storage of 
                identifiable, sensitive information, as defined in 
                section 301(d)(4) of the Public Health Service Act (42 
                U.S.C. 241(d)(4)).
    (b) Risk Framework.--Not later than 2 years after the date of 
enactment of this Act, the Secretary shall ensure that the National 
Institutes of Health and other relevant agencies and offices within the 
Department of Health and Human Services, working with the heads of 
agencies and national security experts, including the Office of the 
National Security within the Department of Health and Human Services--
            (1) develop a comprehensive framework for assessing and 
        managing national security risks referred to in subsection (a) 
        that includes--
                    (A) criteria for how and when to conduct risk 
                assessments for projects that may have national 
                security implications;
                    (B) security controls and training for researchers 
                or entities, including peer reviewers, that manage or 
                have access to such data; and
                    (C) methods to incorporate risk-reduction in the 
                process for funding such projects that may have 
                national security implications;
            (2) not later than 1 year after the risk framework is 
        developed under paragraph (1), develop and implement controls 
        to--
                    (A) ensure that researchers or entities that manage 
                or have access to such data have complied with the 
                requirements of paragraph (1) and ongoing requirements 
                with such paragraph; and
                    (B) ensure that data access committees reviewing 
                data access requests for projects that may have 
                national security risks, as appropriate, include 
                members with expertise in current and emerging national 
                security threats, in order to make appropriate 
                decisions related to access to such identifiable, 
                sensitive information; and
            (3) not later than 2 years after the risk framework is 
        developed under paragraph (1), update data access and sharing 
        policies related to human genomic data, as appropriate, based 
        on current and emerging national security threats.
    (c) Congressional Briefing.--Not later than 2 years after the date 
of enactment of this Act, the Secretary shall provide a briefing to the 
Committee on Health, Education, Labor, and Pensions and the Select 
Committee on Intelligence of the Senate and the Committee on Energy and 
Commerce and the Permanent Select Committee on Intelligence of the 
House of Representatives on the activities required under subsections 
(a) and (b).
                                 <all>