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.
Editorial fellow Dr Ariel Wampler describes what few know about material and device regulation, and Dr Adriane Fugh-Berman explains why we should ask more questions about device representatives’ intraoperative roles during implantations.
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?"
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.
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.
More frequent use of robotic-assisted surgeries means we need to ask more questions about care quality and equity, informed consent, and conflicts of interest.
AMA J Ethics. 2023;25(8):E605-608. doi:
10.1001/amajethics.2023.605.