H.R. 1750 — HEARD Act of 2025

This section establishes a rare diseases health equity initiative (new section 409K) in part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.). It requires the NIH Director to expand, intensify, and coordinate NIH research and activities on rare diseases health equity—defined using the rare disease or condition standard in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) (i.e., affecting fewer than 200,000 persons in the United States or with no reasonable expectation that development and commercialization costs will be recovered from U.S. sales)—with a focus on minority populations (as defined in section 464z–3 of such Act), and to allocate appropriated amounts among relevant national research institutes. The section further requires the Secretary to maintain a Coordinating Committee—composed of directors (or designees) of NIH institutes involved in rare diseases and minority health or health equity research, plus representatives from other relevant federal entities (e.g., CDC and FDA)—chaired by an official responsible to the NIH Director who advises the Secretary and other specified officials. Not later than one year after enactment, the committee must develop (and periodically update) a plan for NIH research and education activities on rare diseases health equity, including priorities, input from scientists and advocates, and elements such as studies on incidence and etiology, epidemiological research by sex and racial/ethnic group, improved screening, clinical research on treatments, and information programs; the NIH Director must ensure NIH implementation of the plan.

This section directs the NIH Director, the Director of the National Institute on Minority Health and Health Disparities, the Director of the National Center for Advancing Translational Sciences, the Director of the National Heart, Lung, and Blood Institute, and other NIH agency directors—not later than 180 days after enactment, in collaboration and in consultation with the relevant advisory council—to (1) develop a comprehensive federal plan to address rare diseases and conditions in minority populations (as defined in section 409K of the Public Health Service Act), including a strategy to increase diversity in genetic programs at NIH's Therapeutics for Rare and Neglected Diseases program; (2) conduct or support basic, clinical, and translational research on such diseases and conditions in those populations, including research on early detection, diagnosis, treatment, and improving quality of life for affected individuals and families; (3) conduct or support clinical training programs for physicians and other health care practitioners on detecting, diagnosing, and treating such diseases and conditions in those populations; and (4) develop guidance for increasing participation of health professionals who are members of minority groups (as defined in section 464z–3 of the PHS Act) in NIH research on such diseases and conditions.

This section directs the Secretary, in coordination with the CDC Director, to award grants to public and private nonprofit entities to (1) collect, analyze, and report data on rare diseases and conditions in minority populations, including epidemiological data on incidence; and (2) conduct outreach and engagement activities with affected minority populations by improving health literacy with respect to such diseases and conditions, disseminating information on related health and community services, and providing information regarding their maintenance. The section further requires the Secretary to submit to Congress a report describing these grant activities on a biannual basis, beginning not later than two years after the date of enactment of the HEARD Act of 2025.

This section establishes four new programs in subpart II of part C of title VII of the Public Health Service Act (42 U.S.C. 293 et seq.) to support health professional training, education, mentoring, and service related to rare diseases or conditions (as defined in section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), i.e., any disease or condition affecting fewer than 200,000 persons in the United States or affecting more than 200,000 persons for which there is no reasonable expectation that the cost of developing and making the drug available in the United States will be recovered from sales in the United States). (1) Section 749C authorizes grants to accredited schools of allopathic medicine, osteopathic medicine, nursing, and other health professional training programs to train professionals in improving care for individuals with rare diseases (including via telehealth) and conducting related research; requires grantees to submit periodic reports on activities and patient outcomes and the Secretary to submit a report to Congress within two years of enactment and disseminate best practices. (2) Section 749D authorizes grants, cooperative agreements, and contracts to accredited schools of medicine, nursing, and other health professional training programs to develop and implement curricula on the causes and effects of rare diseases in minority populations (as defined in section 464z–3 of the Public Health Service Act). (3) Section 749E authorizes the Health Resources and Services Administration to award grants, contracts, or cooperative agreements to public and nonprofit private entities (including Tribal entities) to establish a mentoring program for health care professionals seeking to treat patients with rare diseases. (4) Section 749F establishes a loan repayment program under which the Secretary enters contracts with eligible medical students, agreeing to repay up to $50,000 (plus annual inflation adjustment) per year of service as a health care professional serving rare disease populations, and a scholarship program requiring at least five years of such service; both programs apply certain provisions of the National Health Service Corps Loan Repayment and Scholarship Programs (subpart III of part D of title III of the Public Health Service Act), with modifications.

This section establishes a grant program authorizing the Secretary of Health and Human Services, in carrying out the Ruth L. Kirschstein National Research Service Awards program (i.e., provides stipends and training for pre- and postdoctoral researchers in biomedical and behavioral research), to award grants to eligible entities involved in rare diseases and minority health research. The grants support programs to increase recruitment and retention of minority group members conducting research on the cause, diagnosis, prevention, and treatment of rare diseases or conditions (e.g., by expanding internships and mentoring opportunities). Eligible entities include accredited schools of allopathic medicine, osteopathic medicine, nursing, and other health professional training programs.

This section directs the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH) and in consultation with the Director of the Centers for Disease Control and Prevention (CDC), to submit to Congress, not later than two years after enactment, a report that includes (1) federal research and public health activities on rare diseases or conditions in minority populations (as defined in section 409K of the Public Health Service Act); (2) a comprehensive list of known rare diseases and conditions that heavily or disproportionately impact minority populations; and (3) an analysis of data gaps regarding such diseases and conditions and their effects on minority populations.

This section establishes new section 317W of the Public Health Service Act, directing the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, to conduct or support research and public health awareness campaigns on rare diseases and conditions in minority populations (as defined in section 409K). The Secretary must also establish, directly or through grants or contracts, a public education program in cooperation with existing national public awareness campaigns to increase awareness through culturally and linguistically appropriate information on prevention and management of such diseases and conditions.

This section directs the Secretary of Health and Human Services, acting through the Commissioner of Food and Drug Administration (FDA), to conduct a survey of FDA policies and programs supporting increased availability of clinical trial data on minority populations—with emphasis on those with rare diseases and conditions—and to submit a report to Congress not later than two years after enactment. The report must include (1) the survey findings, (2) recommendations for statutory or regulatory changes to increase such data availability, (3) strategies to encourage drug manufacturers to address racial equity and inclusion in research and development of treatments for rare diseases or conditions disproportionately impacting minority populations, and (4) strategies to address research and development of such treatments.

This section establishes a grant program under Title II of the Indian Health Care Improvement Act for Tribal Epidemiology Centers and Tribal and Urban Indian Health Centers to support clinically and culturally appropriate research and activities on rare diseases and conditions in Native American or Tribal communities. Permissible activities include coordination of data collection on the prevention, diagnosis, treatment, and care of such diseases by health care professionals serving American Indian and Alaska Native populations.

This section directs the Secretary of Health and Human Services, not later than 180 days after enactment, to review and report to Congress on (1) Medicare regulatory barriers inhibiting access to rare disease treatments for Medicare beneficiaries of color (i.e., racial and ethnic minorities), including barriers to health care providers improving such care; and (2) Medicare requirements for telehealth services related to rare disease treatment. The report must include any recommendations the Secretary determines appropriate.