Section 1 Short title
This Act may be cited as the “Protecting Americans’ Genomic Information Act of 2021”.
Protecting Americans’ Genomic Information Act of 2021
A BILL
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.
Sec. 2 Securing identifiable, sensitive information
Consideration of national security risks—
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.
Biomedical research described— For purposes of paragraph (1), biomedical research is described in this paragraph if it—
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
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)).
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—
develop a comprehensive framework for assessing and managing national security risks referred to in subsection (a) that includes—
criteria for how and when to conduct risk assessments for projects that may have national security implications;
security controls and training for researchers or entities, including peer reviewers, that manage or have access to such data; and
methods to incorporate risk-reduction in the process for funding such projects that may have national security implications;
not later than 1 year after the risk framework is developed under paragraph (1), develop and implement controls to—
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
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
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.
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).