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.
Lee C. Zhao, MD, Gaines Blasdel, Augustus Parker, and Rachel Bluebond-Langner, MD
Tension between realistic goals and unrealistic views about how to achieve them is compounded when patients are eager to revise a prior surgeon’s gender-affirming procedure.
AMA J Ethics. 2023;25(6):E391-397. doi:
10.1001/amajethics.2023.391.
William J. Rifkin, Rami S. Kantar, MD, Safi Ali-Khan, Natalie M. Plana, J. Rodrigo Diaz-Siso, MD, Manos Tsakiris, PhD, MSc, and Eduardo D. Rodriguez, MD, DDS
Facial transplantation provides a viable option for those patients with severe facial defects who are more likely to adapt to their new facial appearance.
AMA J Ethics. 2018;20(4):309-323. doi:
10.1001/journalofethics.2018.20.4.peer1-1804.