House Bill 395, introduced in the Tennessee State Legislature on April 4, 2025, aims to regulate the handling of genetic information and organ transplant coverage within health benefit plans. The bill establishes strict penalties for violations related to organ transplants and the storage of genetic sequencing data, reflecting growing concerns over genetic privacy and ethical medical practices.

Key provisions of HB395 include significant fines for health benefit plans that knowingly cover organ transplants prohibited under the bill, with penalties set at $100,000 per violation. Additionally, entities that store genetic sequencing data outside the United States face fines of $10,000 for each infraction. The bill also allows individuals whose genetic information is misused to seek statutory damages of at least $5,000 for each unique instance of misuse.

The legislation empowers the health facilities commission to investigate violations and allows any individual to report potential infractions. However, the commission's ability to act may be limited if it requires authorization from the Centers for Medicare and Medicaid Services (CMS) and is denied entry to investigate.

Debate surrounding HB395 has focused on the balance between protecting individual genetic privacy and the implications for medical research and healthcare providers. Supporters argue that the bill is essential for safeguarding personal genetic data and ensuring ethical practices in organ transplantation. Critics, however, express concerns about the potential chilling effect on research and the administrative burden on healthcare entities.

The bill's implications extend beyond legal compliance; it raises important questions about the future of genetic research and patient rights in Tennessee. As the state grapples with these issues, HB395 is set to take effect on January 1, 2026, pending further legislative discussions and potential amendments.

In conclusion, House Bill 395 represents a significant step in regulating genetic information and organ transplant practices in Tennessee, with potential long-term effects on healthcare policy and patient rights. The ongoing discussions surrounding the bill will likely shape its final form and implementation.