Removing Burdens From Organ Donation Act

Bill Number

H.R. 4470

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-07-16: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Last Updated

2025-09-11T17:22:28Z

AI-Generated Summary

Purpose of the Legislation

The Removing Burdens From Organ Donation Act aims to improve the organ donation process by requiring hospitals that participate in Medicare and Medicaid to automatically notify organ procurement agencies (OPAs) about potential organ donors and provide them with remote access to relevant electronic health records (EHRs). This is intended to speed up identification and coordination for deceased or imminently deceased potential donors, potentially increasing the number of organs available for transplant.

Key Provisions

• Notification Requirements: Hospitals must notify their designated OPA via automated electronic means and grant remote access to the potential donor's EHRs when records indicate the person is deceased or death is imminent (based on existing federal protocols for determining death).
• Implementation Timeline: The new requirements take effect 2 years after the bill's enactment.
• Exemptions:
• Hospitals or critical access hospitals (small, rural facilities) can receive up to a 3-year exemption if compliance causes significant hardship, such as lack of internet in rural areas or other exceptional circumstances.
• Automatic 1-year exemptions for hospitals affected by cybersecurity attacks (defined as malicious activities disrupting hospital information systems or data) or major disasters (natural or man-made events declared under federal law).
• Exemptions can be extended if the hospital demonstrates ongoing need.
• Reporting: The Secretary of Health and Human Services (HHS) must submit annual reports to Congress on exemptions granted, including reasons for each.
• Guidance from HHS:
• Within 1 year of enactment, issue best practices for hospitals, critical access hospitals, OPAs, and EHR vendors on implementing the notifications and access, drawing from successful prior experiences.
• Also provide guidance to state health agencies on explaining these changes to organ donors, potential donors, and their families.
• GAO Study and Report: The Government Accountability Office (GAO) must conduct a study on implementation, covering costs, rural broadband challenges, and exemption data. Within 3 years of enactment, GAO will report to Congress on transplant outcomes, patient data security (involving Medicare/Medicaid and other HHS agencies), and recommendations for improvements.

Significant Changes to Existing Law

This bill amends Section 1138(a) of the Social Security Act, which already requires hospitals to notify OPAs about potential donors and coordinate organ recovery efforts. The key additions are:

• Mandating automated electronic notifications and remote EHR access specifically triggered by updates indicating death or imminent death.
• Introducing exemptions for hardships, cybersecurity, and disasters to make compliance more feasible.
• Adding requirements for HHS guidance and GAO oversight, which were not previously specified.

Potential Impacts

• On Government Agencies: HHS will face new responsibilities for guidance, exemptions, and reporting, potentially increasing administrative workload. GAO will conduct a required study. State health agencies may need to update public education efforts.
• On Citizens: Could lead to more efficient organ transplants, benefiting patients awaiting organs (over 100,000 on U.S. waitlists annually). Potential donors and families may experience faster OPA involvement, but with added focus on explaining privacy protections. Rural or disaster-affected hospitals might delay compliance, possibly slowing local organ recovery.
• On International Relations: No direct impacts, as the bill focuses on domestic U.S. healthcare systems.
• Broader Effects: May reduce delays in organ procurement, potentially increasing donation rates, but implementation costs (e.g., EHR upgrades) could strain smaller hospitals without exemptions.

Main Stakeholders Affected

• Hospitals and Critical Access Hospitals: Primary implementers; must update systems for notifications and access, with possible exemptions.
• Organ Procurement Agencies (OPAs): Gain faster, automated access to donor information, improving efficiency.
• Organ Donors, Potential Donors, and Families: Affected by quicker OPA notifications; guidance ensures they understand data-sharing processes.
• Electronic Health Record (EHR) Companies: Need to support remote access features and comply with best practices.
• Federal and State Agencies: HHS oversees guidance and exemptions; state health departments handle public explanations; GAO evaluates outcomes.
• Transplant Recipients and Waiting List Patients: Indirect beneficiaries through potentially higher organ availability.

Notable Legal, Constitutional, or Political Implications

• Legal/Privacy Implications: Enhances data sharing for deceased or imminently deceased individuals under HIPAA (Health Insurance Portability and Accountability Act, which protects health information), but requires secure access to avoid breaches. The cybersecurity definition and data security review in the GAO study address potential vulnerabilities without creating new privacy laws.
• Constitutional Implications: None significant; aligns with federal authority over Medicare/Medicaid conditions of participation. Exemptions promote equity by accommodating rural and disaster challenges, avoiding undue burdens under equal protection principles.
• Political Implications: Bipartisan sponsorship (from both parties) reflects broad support for boosting organ donation. The bill's focus on exemptions and guidance mitigates concerns about overburdening small hospitals, potentially easing passage. Annual reporting and GAO study provide accountability, which could influence future healthcare policy on technology integration.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Van Duyne, Beth [R-TX-24]

Cosponsors (8)

Rep. DelBene, Suzan K. [D-WA-1], Rep. Miller, Carol D. [R-WV-1], Rep. Costa, Jim [D-CA-21], Rep. Tokuda, Jill N. [D-HI-2], Rep. Gillen, Laura [D-NY-4], Rep. Bost, Mike [R-IL-12], Rep. Wagner, Ann [R-MO-2], Rep. Vindman, Eugene Simon [D-VA-7]

Recent Actions

• 2025-07-16: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• 2025-07-16: Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• 2025-07-16: Introduced in House
• 2025-07-16: Introduced in House

Bill Versions

• Removing Burdens From Organ Donation Act — issued 2025-07-16 — PDF (8 pages)