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.
Elina E. Pliakos and Dr Ankur Pandya join Ethics Talk to discuss how economic decision modeling and value analyses can help reduce waste in health care spending and improve patient care.
Dr Paul T. Menzel joins Ethics Talk to discuss his article: "How Should Willingness-to-Pay Values of Quality-Adjusted Life-Years Be Updated and According to Whom?"
Beatrice L. Brown joins Ethics Talk to discuss her article, coauthored with Dr Aaron S Kesselheim: "How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?"
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?"