HEARD Act of 2025
- Sponsor
- Rep. Strickland, Marilyn [D-WA-10]
- Committees
- Natural Resources Committee (primary)
- Last action
- Feb 27, 2025
Bottom line
The bill aims to enhance health equity in rare disease research, diagnosis, and treatment for minority populations through comprehensive federal initiatives and targeted funding for workforce development and data collection.
What it actually does
This bill expands and coordinates federal research on rare diseases disproportionately affecting minority populations, establishes grant programs for data collection, health professional training, and minority representation in research, and mandates reviews by the FDA and Medicare to address disparities in rare disease care and clinical trial diversity.
Proponents argue
Proponents argue that this legislation is essential to address critical gaps in medical research and care, promoting health equity by focusing on populations historically underserved in the context of rare diseases. They contend it will lead to a better understanding, earlier diagnosis, and more effective, culturally competent treatments for minority groups, ultimately improving patient outcomes and reducing health disparities.
Opponents contend
No explicit opposition to this bill has been identified. Potential arguments against similar legislation often focus on concerns about the overall cost of new federal programs, the potential for duplication of existing research efforts, or the administrative burden associated with establishing new committees and grant programs. However, these are general concerns and not specific opposition to this bill's stated goals.
The bill is relatively short and clearly structured, allowing for a thorough understanding within a reasonable timeframe, making it accessible for informed readers to evaluate its provisions and implications.
Section 2, amending Part B of title IV of the Public Health Service Act
NIH Research Expansion and Coordination for Rare Diseases Health Equity
This section directs the Director of NIH to expand, intensify, and coordinate research and other activities related to rare diseases health equity. It establishes a Coordinating Committee composed of directors from relevant national research institutes and representatives from other federal agencies (like CDC and FDA) to guide these efforts. The committee is tasked with developing and periodically revising a comprehensive plan for research and education, specifically addressing the disproportionate impact of rare diseases on minority populations.
Supporters argue
Supporters argue this provision is crucial for systematically addressing disparities in rare disease research, ensuring a coordinated federal approach to a complex problem. They believe it will lead to more effective and equitable health interventions by focusing on the unique needs of minority populations.
Critics contend
No specific opposition is typically raised against this provision, as coordinating research efforts and addressing health equity are broadly supported goals. Potential concerns, if any, might relate to the administrative burden of new committees or the allocation of resources away from other research areas, though these are not explicitly stated.
Tradeoffs
The provision navigates the tradeoff between focusing research on specific populations and maintaining a broad research portfolio. It also balances the benefits of increased coordination with the potential administrative overhead of new committees and planning processes.
Section 3, amending Subpart 20 of part C of title IV of the Public Health Service Act
Collaborative Comprehensive Plan for Rare Diseases in Minority Populations
This section requires the Director of NIH and other relevant institute directors, in collaboration and consultation with advisory councils, to develop a comprehensive federal plan within 180 days. This plan will address rare diseases and conditions in minority populations, including a strategy to increase diversity in genetic programs. It also mandates conducting or supporting basic, clinical, and translational research, clinical training programs for health care practitioners, and developing guidance to increase participation of minority health professionals in this research.
Section 4, amending Section 1707(b) of the Public Health Service Act
Grants for Data Collection, Analysis, and Outreach on Rare Diseases in Minority Populations
This section authorizes the Secretary, in coordination with the Director of the Centers for Disease Control and Prevention (CDC), to award grants to public and private nonprofit entities. These grants are for collecting, analyzing, and reporting data on rare diseases and conditions in minority populations, including epidemiological data on incidence. The grants also support outreach and engagement activities to improve health literacy, disseminate information on health and community services, and provide guidance on managing rare diseases within these communities. A biannual report to Congress on these activities is required.
Section 5, amending Subpart II of part C of title VII of the Public Health Service Act
Health Professional Training, Mentoring, Scholarship, and Loan Repayment Programs
This section establishes multiple programs to enhance the healthcare workforce for rare diseases. It authorizes grants to medical, osteopathic, and nursing schools for training health care professionals in rare disease care, including telehealth and research. It also allows for grants to provide education and training on rare diseases in minority populations. Furthermore, it creates a mentoring program for professionals seeking to work in rare diseases and establishes scholarship and loan repayment programs (up to $50,000 annually, adjusted for inflation) for physicians and genetic counselors serving populations with rare diseases.
Section 6, amending Part G of title IV of the Public Health Service Act
Increasing Minority Representation in Rare Disease Research
This section authorizes the Secretary to award grants to eligible entities, such as accredited schools of medicine and nursing, involved in rare disease and minority health research. The purpose of these grants is to establish programs that increase the recruitment and retention of members of minority groups to conduct research related to the cause, diagnosis, prevention, and treatment of rare diseases or conditions. This includes expanding internship and mentoring opportunities for minority researchers.
Section 9
FDA Survey and Report on Clinical Trial Diversity
This section mandates that the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, conduct a survey within two years of enactment. The survey will examine FDA policies and programs aimed at increasing the availability of clinical trial data on minority populations, with a specific emphasis on those with rare diseases. Following the survey, the Secretary must submit a report to Congress detailing the findings, recommending statutory or regulatory changes to increase data availability, and proposing strategies to encourage drug manufacturers to address racial equity and inclusion in the research and development of rare disease treatments disproportionately impacting minority populations.
Section 10, amending Title II of the Indian Health Care Improvement Act
Tribal Epidemiology Center Grant Program
This section establishes a grant program, administered by the Secretary through the Service (Indian Health Service), to award grants to Tribal Epidemiology Centers and Tribal and Urban Indian Health Centers. These grants are intended to support clinically and culturally appropriate research and other activities related to rare diseases and conditions within Native American or Tribal communities. Permissible activities include coordinating data collection on the prevention, diagnosis, treatment, and care of rare diseases by health care professionals serving American Indian and Alaska Native populations.
The plan for NIH activities on rare diseases health equity must reflect input from a broad range of scientists, patients, and advocacy groups.
Section 2(c)(1)(C)
Why it matters:This is standard legislative practice to ensure stakeholder engagement without making it a standalone, highly visible provision. It's a mechanism for accountability and inclusivity.
Case for: Supporters would argue that this ensures the plan is well-informed, responsive to real-world needs, and has buy-in from those most affected by rare diseases, including patients and advocates, leading to more effective and relevant research.
Case against: No specific case against this particular detail. Critics of broad stakeholder input might argue it could slow down decision-making or dilute scientific priorities, but this is a general concern, not specific to this bill.
Estimated impact: Ensures a more inclusive and representative strategic plan for rare disease research, potentially improving the relevance and impact of federal efforts.
Physician training programs are specifically designed to improve the provision of care to individuals with rare diseases or conditions via telehealth.
Section 5(a)(2)
Why it matters:This is a technical detail within a larger program description. Its inclusion reflects a specific policy choice to modernize healthcare delivery, rather than an attempt to obscure it.
Case for: Proponents would argue that explicitly including telehealth training is crucial for expanding access to specialized rare disease care, especially for patients in rural or underserved areas, and aligns with modern healthcare delivery trends.
Case against: No specific case against this detail. Some might argue that telehealth quality for rare diseases needs more research, but the inclusion of training for it is generally seen as a positive step towards access.
Estimated impact: Enhances the capacity of healthcare professionals to deliver specialized rare disease care remotely, potentially increasing access for geographically isolated or mobility-challenged patients.
The loan repayment program for health care professionals serving populations with rare diseases or conditions will pay up to $50,000 (plus an amount determined by the Secretary on an annual basis to reflect inflation) of the principal and interest of educational loans.
Section 5(a)(1) of the new Section 749F (Loan Repayment Program)
Why it matters:This is a technical but important detail for the long-term viability and attractiveness of the loan repayment program, ensuring its value is not eroded by inflation. It's a standard legislative drafting technique for such adjustments.
Case for: Proponents would argue that including an inflation adjustment ensures the loan repayment program remains competitive and attractive to future health care professionals, maintaining its incentive power over time and protecting the value of the benefit.
Case against: No specific case against this detail. Some might argue against any loan repayment program on fiscal grounds, but the inflation adjustment itself is a technical improvement.
Estimated impact: Ensures the financial incentive of the loan repayment program retains its value over time, making it a more effective tool for recruiting and retaining health care professionals in rare disease care.