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?"
Douglas E. Paull, MD, MS and Paul N. Uhlig, MD, MPA
Risk managers can help patient-subjects and clinician-researchers make informed novel device implantation decisions in the absence of preclinical trial data.
AMA J Ethics. 2020;22(11):E911-918. doi:
10.1001/amajethics.2020.911.
In the 1910s, the American Medical Association fought quackery promoted in pamphlets for drugs and treatments for everything from teething to epilepsy.
AMA J Ethics. 2018;20(11):E1082-1093. doi:
10.1001/amajethics.2018.1082.
Rachel Koch, MD, John G. Meara, MD, DMD, MBA, and Anji E. Wall, MD, PhD
Single-procedure interventions with minimal follow-up and clear quality-of-life gain are well suited for surgical mission trips. But not all risks and benefits are easily assessed.
AMA J Ethics. 2019;21(9):E729-734. doi:
10.1001/amajethics.2019.729.