The bill, HB 1292-FN, expands the existing Right to Try Act to include patients diagnosed with "qualifying severe illness," thereby broadening access to unapproved treatments. It introduces new definitions such as "human cells, tissues, or cellular or tissue-based products," and "individualized investigational treatment," while deleting the previous definition of "investigational drug, biologic, or device." The legislation establishes regulations for regenerative stem cell therapies, including requirements for consent, accreditation, advertising, and disclosure, while explicitly prohibiting the use of stem cells derived from a fetus or embryo following an abortion.

Additionally, the bill allows patients with terminal or qualifying severe illnesses to seek injunctive relief and attorney's fees against regulatory authorities for violations of the chapter. It introduces provisions for "remote signing" of informed consent and "telehealth prescreening" to assess eligibility for clinical trials. The bill clarifies that manufacturers are not required to provide coverage for investigational treatments and protects healthcare providers from liability when recommending these treatments under certain conditions. It also permits physicians to perform unapproved stem cell therapies, provided they follow strict guidelines, and establishes penalties for violations. The act is set to take effect on January 1, 2027.

Statutes affected:
Introduced: 126-Z:1, 126-Z:6, 126-Z:8
HB1292 text: 126-Z:1, 126-Z:6, 126-Z:8