Newborn Screening Saves Lives Reauthorization Act of 2025
The Newborn Screening Saves Lives Reauthorization Act of 2025 would reauthorize and expand federal programs under the Public Health Service Act related to genetic diseases and newborn screening. The bill aims to improve how newborn screening is conducted, followed up, and communicated to families and patient groups. Key elements include enhanced educational efforts for families, pilot testing of new screening approaches, stronger data collection and surveillance, tighter ethics guidance for research using newborn specimens, and increased federal funding for screening programs and related activities. It also updates the operations and transparency of the Advisory Committee on Heritable Disorders in Newborns and Children, and requires that the Hunter Kelly Research Program emphasize piloting reliable technologies and coordinating with state health departments. Overall, the bill seeks to modernize, expand, and fund newborn screening activities—emphasizing follow-up care, data sharing, and ethical oversight—so that more newborns with heritable conditions can be identified, monitored, and linked to appropriate services throughout childhood.
Key Points
- 1Improved newborn screening and follow-up: The act broadens language to facilitate, enhance, and improve education and services for parents and families, including follow-up and long-term care, with emphasis on appropriate literacy levels and strategies to re-engage patients who missed recommended follow-up.
- 2Advisory Committee and transparency enhancements: The bill requires new consumer-friendly materials about the screening nomination process (including data standards and international data use), details on obtaining technical assistance, and guidance on conflicts of interest; it also expands topics the advisory committee can address, including appropriate use of genetic testing in newborns and children.
- 3Clearinghouse and data sharing: Reforms ensure the clearinghouse information complements other federal newborn screening information-sharing efforts, improving how information is shared across programs.
- 4Laboratory quality, surveillance, and data systems: Adds a new focus on developing screening test performance tools, data analysis, harmonization, and dissemination of best practices; strengthens surveillance coordination through real-time data tracking from screening to long-term care, and promotes data linkages between newborn screening and state birth defects/developmental disabilities surveillance programs.
- 5Hunter Kelly Research Program updates: Requires that funded entities work with state health departments where appropriate and pilots demonstrate reliable newborn screening technologies ready for use.
- 6Higher funding authorization: The bill increases and extends funding for newborn screening programs and activities, updating authorized years to 2026 and 2030 with higher dollar amounts to support the expanded activities.
- 7Ethics guidance on research with newborn samples: Updates to treat research using nonidentified newborn dried blood spots as secondary research, aligning with federal research definitions and ethics considerations.