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?"
Katherine Gentry, MD, MA and Aaron Wightman, MD, MA
A patient’s refusal of tracheostomy during an anticipated difficult intubation prompts critical questions about how to best express respect for a pediatric patient’s autonomy and whether and when deviation from standard of care is clinically and ethically appropriate.
AMA J Ethics. 2018;20(8):E683-689. doi:
10.1001/amajethics.2018.683.
When deciding whether to offer deep brain stimulation earlier than usual for Parkinson disease, it is important to consider not only the patient’s autonomy but also the validity of the evidence and concepts of harm that are being used to form practice policies.