Clinicians must avoid violating professional ethical principles and patients’ legal rights and they may not ever discriminate. So, what does that mean in practice?
AMA J Ethics. 2016;18(3):229-236. doi:
10.1001/journalofethics.2016.18.3.ecas4-1603.
A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.
AMA J Ethics. 2021;23(9):E712-720. doi:
10.1001/amajethics.2021.712.
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.
Beatrice L. Brown joins Ethics Talk to discuss her article, coauthored with Dr Aaron S Kesselheim: "How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?"
Dr Donna-Bea Tillman joins Ethics Talk to discuss her article: "What Should the Public Know About Implantable Material and Device Innovation in the US?"