Charles E. Binkley, MD, Michael S. Politz, MA, and Brian P. Green, PhD
If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.
AMA J Ethics. 2021;23(9):E745-749. doi:
10.1001/amajethics.2021.745.
Priorities far beyond generating morbidity or mortality data are needed to improve patients’ experiences, innovate metrics, and advance surgical palliation as a field.
AMA J Ethics. 2021;23(10):E806-810. doi:
10.1001/amajethics.2021.806.
Jeffrey Bedard joins Ethics Talk to discuss his article: "What Should Patients Be Told About Device Representatives’ Roles at the Point of Surgical Care?"
Dr Charles Binkley joins Ethics Talk to discuss his article, coauthored with Michael Politz and Dr Brian Green: "Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices?"