Tennessee § 68-11-1901 - Part definitions.

§ 68-11-1901. Part definitions.

As used in this part, unless the context otherwise requires: “Countermeasure” means a vaccine or the component parts used in the design, development, clinical testing or investigation or manufacture of a vaccine, including seed stocks, cell lines and plasmids, used to diagnose, mitigate, prevent, treat, cure or otherwise limit the harm of an infectious disease that is: Approved or cleared under Chapter V of the Federal Food, Drug, and Cosmetic Act, compiled in 21 U.S.C. § 351 et seq., or licensed under § 351 of the federal Public Health Service Act, codified in 42 U.S.C. § 262; The object of research for possible use as described in subdivision (1)(A) and is the subject of an exemption under § 505(i) of the Federal Food, Drug and Cosmetic Act, codified in 21 U.S.C. § 355(i); or Authorized for emergency use in accordance with § 564 of the Federal Food, Drug, and Cosmetic Act, codified in 21 U.S.C. § 360bbb-3; “Healthcare research institution” means any non-governmental, nonprofit research institution with its principal place of business in this state, that is, or that is affiliated with, a hospital or clinic for the treatment of pediatric patients, that does not seek payment for treatment provided to patients in the absence of insurance coverage for the treatment. “Healthcare research institution” includes any or all of the parents, subsidiaries, affiliates, successors and assigns of the institution, and any or all individual trustees, officers, directors, employees, and agents of the institution; and “Willful misconduct” means an act or omission that is taken: Intentionally to achieve a wrongful purpose; Knowingly without legal or factual justification; and In disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. Acts 2007, ch. 43, § 1. Compiler's Notes. Acts 2007, ch. 43, § 2 provided that nothing in the act shall be construed to amend, abrogate or otherwise limit liability protections currently available to health care institutions referenced in the act, and the institutions' employees, as otherwise provided by law. For the Preamble regarding liability of non-profit healthcare research institutions and their employees, agents, directors, and officers for research activities conducted in connection with efforts to diagnose, treat, or prevent infectious diseases, please refer to Acts 2007, ch. 43.