A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021; 23(9):E712-720. doi:
10.1001/amajethics.2021.712.
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.
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?"
COVID-19 underscores historical precedent for fear-driven responses that disregard autonomy among persons with low income who are also persons of color.
AMA J Ethics. 2021; 23(11):E840-846. doi:
10.1001/amajethics.2021.840.
Deborah M. Eng, MS, MA and Scott J. Schweikart, JD, MBE
A just culture perspective suggests that punitive responses to those who err should be reserved for those who have willfully and irremediably caused harm.
AMA J Ethics. 2020; 22(9):E779-783. doi:
10.1001/amajethics.2020.779.