This bill adds a new section to the Public Health Service Act to regulate the consensual donation of human bodies and body parts for education, research, or mortuary science, explicitly excluding use in transplantation. It creates a federal registration regime for entities that acquire or sell whole bodies or parts in interstate commerce, with detailed application requirements, renewal duties, and oversight by the Secretary.
The act also sets labeling, packaging, and recordkeeping standards, establishes use and disclosure limitations, and outlines disposition obligations and penalties for violations. It applies to most entities outside the Organ Procurement and Transplantation Network (OPTN) and its members, including funeral professionals, medical and dental schools, and non-profit or for-profit research and training organizations that do not sell bodies for profit.
At a Glance
What It Does
It establishes a registration regime for entities that acquire or transfer whole bodies or parts for education, research, or mortuary science (not for transplantation), plus associated inspections, recordkeeping, labeling, and disposition requirements.
Who It Affects
Registrants in interstate commerce—hospitals, medical/dental schools, tissue banks, funeral services, research and training organizations—along with their donors’ families.
Why It Matters
It standardizes consent, traceability, labeling, and disposal, increasing accountability and donor protections while imposing new compliance obligations across education and research activities.
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What This Bill Actually Does
The bill creates a federal framework to govern the consensual donation of human bodies and body parts that are not to be used for transplantation. It adds a new section to the Public Health Service Act establishing a registration process for anyone who acquires or sells whole bodies or parts across state lines, including what information must be in an application and how renewals work.
Some groups are exempt, notably members of the Organ Procurement and Transplantation Network and certain funeral service professionals and education or research entities that do not sell for profit. The Secretary will set and collect registration fees based on the cost of implementing and enforcing these rules, and registrants must allow inspections and keep detailed records.
The recordkeeping provisions require documentation of donor consent, disposition obligations, donation timelines, and chains of custody for each body or body part. Labeling and packaging rules mandate specific information on outer packaging, including the donor’s name, the contents, the transferrer, tissue types, and a clear statement that the item is not for transplantation, among other safety and privacy details.
The law also limits how donor information can be used or disclosed and ties proper disposition to either returning the remains or transferring the obligation to a successor. Violations carry penalties under federal law and can result in the suspension or revocation of registration.
The rules come with an effective date two years after enactment, giving affected entities time to prepare for compliance. This act thus creates a formal, auditable process to ensure donors’ autonomy and the responsible handling of education- and research-related human remains.
The Five Things You Need to Know
The bill adds Section 373A to regulate non-transplant human body donations.
Registration is required for entities acquiring whole bodies or body parts for education or research, with defined application content and renewal.
The Secretary will set annual registration fees based on implementing and enforcing costs.
Labeling, packaging, and recordkeeping rules establish chain-of-custody and donor-consent documentation, plus a 'not for transplantation' designation.
Violations trigger penalties and possible suspension or revocation of registration; the rules apply two years after enactment.
Section-by-Section Breakdown
Every bill we cover gets an analysis of its key sections.
Registration regime
This provision creates a registration framework for entities that acquire or sell whole human bodies or body parts in interstate commerce for education, research, or mortuary science (not for transplantation). It requires a detailed application to be submitted to the Secretary, including identity, locations, premises, equipment, services, a designated representative, consent to inspections and recordkeeping, labeling, use restrictions, and privacy protections. It also authorizes the Secretary to set and collect registration fees, renew registrations periodically, and require changes in information to be reported within a set timeframe.
Fees and renewal
Fees must be established by the Secretary based on projected costs of implementing and enforcing the section, and fee collections are limited to amounts provided in advance by appropriations acts. Registrations must be renewed at intervals determined by the Secretary, ensuring ongoing compliance and oversight of entities handling non-transplant donation activities.
Inspections
The Secretary is authorized to conduct regular inspections of registrants’ premises (as specified in the registration) to verify compliance with the section’s requirements, including records and facilities used for handling human bodies and body parts.
Recordkeeping
Registrants must maintain case records for every acquisition or transfer, including donor consent, disposal obligations, dates, transfer details, donor identity, medical history, and chain-of-custody documentation. Records must be maintained in a form and location specified by regulation and be sufficient to trace all movements of bodies and parts.
Labeling and packaging
All bodies and parts must be labeled and packaged to prevent contamination, protect safety, and preserve integrity. Labels must include donor identifiers, contents, transferring entity information, tissue types, cause of death (if known), any relevant tests or implants, and a clear non-transplantation statement, among other required details.
Use and disclosure restrictions
Individually identifiable donor information may be used or disclosed only for purposes explicitly authorized by regulation, including the return of remains to families or other disposition-related needs, ensuring privacy protections.
Disposition obligations
Registrants must ensure proper disposition of bodies or parts, either by returning them to a relative or personal representative or by transferring the obligation to another party that will carry out the disposition in accordance with the donor’s instructions and applicable law.
Violations and penalties
Violations can be punished under title 18, U.S. Code, with the possibility of suspending or revoking a registration for noncompliance. Altering or falsifying labels is expressly prohibited and subject to penalties.
Definitions
Key terms are defined, including donor, education, human body, human body part, and research. Definitions clarify what counts as education and what is excluded from research (e.g., autopsy in a criminal investigation).
Effective date and applicability
The amendments apply to the acquisition or transfer of human bodies or parts two years after enactment, giving regulated entities time to come into compliance with the new regime.
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Explore Healthcare in Codify Search →Who Benefits and Who Bears the Cost
Every bill creates winners and losers. Here's who stands to gain and who bears the cost.
Who Benefits
- Medical and dental schools and mortuary science programs gain clear standards for handling donated bodies and parts, improving training environments and compliance.
- Funeral service professionals and related teams receive defined procedures for preparation, transportation, and disposition, reducing ambiguity in practice.
- Tissue banks, universities, and research institutions engaged in education or non-profit research obtain a regulated framework that supports responsible use of donated material and clearer accountability.
- Donors and their families benefit from explicit consent documentation, disposal obligations, and privacy protections in the handling of remains.
Who Bears the Cost
- Registrants—hospitals, educational institutions, research labs, funeral services, and other entities—face registration fees, recordkeeping duties, labeling/packaging costs, and inspection obligations.
- Regulators incur ongoing costs to administer registrations, perform inspections, and enforce compliance with labeling, recordkeeping, and disposition requirements.
- Businesses that handle bodies in interstate commerce may incur capital and operational costs to maintain premises, records, and compliant packaging systems.
- Potentially higher costs for disposal and logistics due to standardized labeling, packaging, and chain-of-custody requirements.
Key Issues
The Core Tension
The central dilemma is balancing rigorous donor consent, privacy, and traceability with the administrative and cost burden on a wide range of entities that rely on non-transplant donations for education and research.
The bill creates a robust, auditable regime for consent-based donation of non-transplant human bodies and parts, but it also imposes a significant compliance burden on a broad set of entities, from hospitals and medical schools to funeral services and research organizations. The interplay with existing federal and state privacy and disposition laws will require careful alignment to avoid duplicative or conflicting requirements.
Practical challenges include ensuring accurate donor consent documentation, maintaining ultra-clear chain-of-custody records, and safeguarding donor information while enabling lawful use for education and research. The two-year lead time before applicability is helpful, but smaller operators may still struggle to implement the full suite of labeling, packaging, and reporting obligations.
The act also raises questions about how to coordinate enforcement with state regulators and how to handle cross-border shipments or transfers that involve multiple jurisdictions.
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