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.
William F. Parker, MD, MS and Marshall H. Chin, MD, MPH
Given organ scarcity, transplantation programs state that patient promises of compliance cannot be taken at face value, excluding candidates who are deemed untrustworthy.
AMA J Ethics. 2020;22(5):E408-415. doi:
10.1001/amajethics.2020.408.
Drs Katrina Bramstedt and Ana Iltis discuss the development of QoL assessment tools to help patient-subjects considering reconstructive transplantation.
Proliferation of innovative procedures and treatments in surgery has led to novel and distinct ethical challenges. Medicine can learn from plastic surgeons’ approaches to informed consent and potentially harmful treatments.
AMA J Ethics. 2018;20(4):349-356. doi:
10.1001/journalofethics.2018.20.4.nlit1-1804.