Who, If not the FDA Should Regulate Implantable Brain-Computer Interface Devices
This viewpoint explores the use of implantable brain-computer interfaces (BCIs) and the distinction between therapeutic and enhancement uses of such devices and emphasizes that ethical considerations for both definition and regulation are needed.
"It is well within the FDA’s purview to assess devices, including spectrum-use BCIs, strictly along the lines of what is safe and effective. However, implicit in considerations of safety and efficacy is also an assessment of risk and benefit. This assessment involves a value judgment not only about a device’s absolute level of risk and benefit but also about what is the right balance between the two. The FDA is not qualified to make these kinds of value judgments about spectrum-use BCIs, however."
Charles E. Binkley, MD, bioethics fellow, Michael S. Politz, MA, Dominican School of Philosophy and Theology, and Brian P. Green, PhD, director of technology ethics, published in the American Medical Association Journal of Ethics.