Diversifying investigations via equitable research studies for everyone trials Act

(a) Encouragement of clinical trial enrollment by racially and ethnically diverse populations (1) No cost provision of digital health technologies The free provision of digital health technologies by drug or device manufacturers to their clinical trial participants shall not be considered a violation of section 1128A of the Social Security Act (commonly known as the Civil Monetary Penalties Law) (42 U.S.C. 1320a–7a), section 1128B of the Social Security Act (42 U.S.C. 1320a–7b), or sections 3729 through 3733 of title 31, United States Code (commonly known as the False Claims Act), provided that— (A) the use of digital health technologies will facilitate in any phase of clinical development the inclusion of diversity of patient populations, such as underrepresented racial and ethnic minorities, low-income populations, and the elderly; (B) the digital health technologies will facilitate individuals’ participation, or are necessary to such participation; (C) all features of the digital health technologies that are unrelated to use in the clinical trial are disabled or only allowed to remain activated to model real-world usage of the digital technology; and (D) the clinical trial sponsor requires participants to return, purchase, or disable the digital health technologies by the conclusion of the trial. (2) Grants and contracts (A) In general The Secretary of Health and Human Services (in this section referred to as the Secretary) may issue grants to, and enter into contracts with, entities to support community education, outreach, and recruitment activities for clinical trials with respect to drugs, including vaccines for diseases or conditions which have a disproportionate impact on underrepresented populations (including on racial and ethnic minority populations), including for the diagnosis, prevention, or treatment of COVID–19. Such activities may include— (i) working with community clinical trial sites, including community health centers, academic health centers, and other facilities; (ii) training health care personnel including potential clinical trial investigators, with a focus on significantly increasing the number of underrepresented racial and ethnic minority health care personnel who are clinical trial investigators at the community sites for ongoing clinical trials; (iii) engaging community stakeholders to encourage participation in clinical trials, especially in underrepresented racial and ethnic minority communities; and (iv) fostering partnerships with community-based organizations serving underrepresented racial and ethnic minority populations, including labor organizations and frontline health care workers. (B) Priority for grant and contract awards In awarding grants and contracts under this paragraph, the Secretary shall prioritize entities that— (i) develop educational, recruitment, and training materials in multiple languages; or (ii) undertake clinical trial outreach efforts in more diverse racial and ethnic communities that are traditionally underrepresented in clinical trials, such as Tribal areas. (C) Authorization of appropriations There is authorized to be appropriated for fiscal years 2027 and 2028 such sums as may be necessary to carry out this paragraph. (b) Clarification that certain remuneration related to participation in clinical trials does not constitute remuneration under the federal civil money penalties law (1) In general Section 1128A(i)(6)(F) of the Social Security Act (42 U.S.C. 1320a–7a(i)(6)(F)) is amended by inserting (including remuneration offered or transferred to an individual to promote the participation in an approved clinical trial, as defined in subsection (d) of the first section 2709 of the Public Health Service Act (42 U.S.C. 300gg–8) (relating to coverage for individuals participating in approved clinical trials), as so designated by section 1563(c)(10)(C) of the Patient Protection and Affordable Care Act, that is registered with the database of clinical trials maintained by the National Library of Medicine (or any successor database), so long as such remuneration facilitates equitable inclusion of patients from all relevant demographic and socioeconomic populations and is related to patient participation in the approved clinical trial) after promotes access to care. (2) Effective date The amendment made by paragraph (1) shall apply to remuneration provided on or after the date of the enactment of this Act. (c) National academy of medicine study (1) In general The Secretary shall seek to enter into an arrangement with the National Academy of Medicine under which the National Academy agrees to study and propose a design for a national interoperable data platform to improve access to health data, and other relevant data needs, during public health emergencies. (2) Report The arrangement under paragraph (1) shall provide that the National Academy of Medicine, not later than 180 days after the date of enactment of this Act, shall submit a report to the Secretary and Congress on the results of the study under paragraph (1) and the design proposed based on such study.