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U.S. Government Information on Organ and Tissue Donation and Transplantation
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Legislation and Policy

The field of organ and tissue donation and transplantation is one of the most regulated areas of health care today.

Both state and federal legislation has been put in place to provide the safest and most equitable system for allocation, distribution, and transplantation of donated organs.

The Health Resources and Services Administration (HRSA) is the Federal agency with responsibility for oversight of the transplant system in the United States.

The following federal agencies also play a part in this lifesaving process: Centers for Medicare and Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), and Food and Drug Administration (FDA). All these agencies are part of the U.S. Department of Health and Human Services.

State laws facilitate organ and tissue donation commitments and make transplants happen.

Explore the Legislation Microsite to examine existing state-level organ donation laws.

 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ADVISORY COMMITTEE ON ORGAN TRANSPLANTATION

The Advisory Committee on Organ Transplantation (ACOT) was established to assist the HHS Secretary in:

  • Enhancing organ donation
  • Ensuring that the system of organ transplantation is grounded in the best available medical science
  • Assuring the public that the system is as effective and equitable as possible
  • Increasing public confidence in the integrity and effectiveness of the transplantation system

For more information:

> Meetings

> Recommendations to the HHS Secretary

> Members

> Legislative Authority

> Charter/Press Releases



ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK POLICIES AND REPORTS

To address the nation's critical organ donation shortage and improve the organ matching and placement process, the U.S. Congress passed the National Organ Transplant Act in 1984. The act established the Organ Procurement and Transplantation Network (OPTN) to maintain a national registry for organ matching.

The act also called for the network to be operated by a private, nonprofit organization under federal contract. The United Network for Organ Sharing (UNOS), based in Richmond, VA, administers the OPTN under contract with the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS).

> Find out more



LEGISLATION AND LEGISLATIVE HISTORY

A list of significant federal laws and regulations enacted since the field of transplant medicine began is contained in the link below.

> Selected Statutory and Regulatory History


TIMELINE OF HISTORICAL EVENTS

A list of the significant milestones that have occurred in organ donation and transplantation is contained in the link below.

> Historical Events Significant Milestones


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