H.R.1082 - Shandra Eisenga Human Cell and Tissue Product Safety Act (119th Congress)
Summary
H.R.1082, the Shandra Eisenga Human Cell and Tissue Product Safety Act, aims to enhance the safety and awareness surrounding human cell and tissue product transplants. The bill mandates the Secretary of Health and Human Services to conduct a national education campaign for both the public and healthcare providers. This campaign will focus on the potential risks and benefits associated with these transplants.
The Act also introduces civil penalties for violations of existing regulations concerning human cell and tissue products. Furthermore, it seeks to streamline the regulatory oversight of these products by improving information dissemination and regulatory updates.
Finally, the bill directs the Secretary to establish a public docket for comments and to report to Congress on modernizing the regulation of human cell and tissue products.
Expected Effects
This bill is likely to increase public and healthcare provider awareness regarding human cell and tissue products. It will also strengthen the regulatory framework surrounding these products.
The introduction of civil penalties should encourage greater compliance with existing safety standards. The streamlining of regulatory oversight could lead to more efficient and predictable processes for tissue establishments.
Ultimately, the Act aims to improve patient safety and promote the responsible use of human cell and tissue products.
Potential Benefits
- Enhanced public awareness of the risks and benefits of human cell and tissue product transplants.
- Improved safety standards and regulatory compliance within the industry.
- Streamlined regulatory processes for tissue establishments.
- Increased transparency through public information and reporting requirements.
- Potential for scientific advancement in the field due to workshops and stakeholder engagement.
Potential Disadvantages
- Potential for increased regulatory burden on tissue establishments, leading to higher costs.
- Civil penalties could disproportionately affect smaller establishments.
- The education campaign may not reach all segments of the population equally.
- The streamlining of regulations could inadvertently weaken some safety measures if not carefully implemented.
- The act does not address the ethical concerns surrounding the procurement and use of human tissue.
Most Disadvantaged Areas:
Constitutional Alignment
The bill appears to align with the general welfare clause of the US Constitution, as it aims to improve public health and safety related to human cell and tissue products. Specifically, the preamble of the Constitution states the goal to "promote the general Welfare".
Congress's authority to regulate interstate commerce, as outlined in Article I, Section 8, Clause 3 (the Commerce Clause), provides a basis for regulating human cell and tissue products that are often transported across state lines. The bill does not appear to infringe upon any specific individual rights or liberties protected by the Constitution or its amendments.
However, the specific implementation and enforcement of the regulations and penalties outlined in the bill would need to adhere to due process requirements to ensure fairness and avoid arbitrary application.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).