The brain, cognitive enhancement devices, and European regulation.

Abstract

Exciting advances in neuroscience have given rise to devices—now being sold worldwide—which hold the promise of enhancing human cognition. This concerns Maslen et al.—authors of the article, The Regulation of Cognitive Enhancement Devices: Extending the Medical Model—because there are unaddressed possible harms from such equipment. Cognitive enhancement devices (CEDs) are currently entering the European market without special regulations. Their unique ability to influence the brain in potentially deleterious ways is not being accounted for by the law, exposing consumers to risk. In arguing for such regulation, Maslen et al. present risk analyses of certain devices that interact with the brain. They then propose CED-specific additions to existing European medical device regulation. First, they recommend a positive list of CEDs to be regulated. Second, they offer a three-tiered framework for categorizing CEDs, determining market approval, and what level of government scrutiny they receive based on risks and benefits. The authors’ assessment, while demonstrating legitimate concerns, presents a flawed analysis of CEDs and is ultimately unnecessary. We disagree with their definition of CEDs and classifications for certain devices. Moreover, we believe that the regulatory gap Maslen et al. seek to address is not as profound as they portray. Steps are underway to fill this gap in the immediate future, obviating the need for their proposal. Finally, we argue that the authors incorrectly balance risk and benefit when determining CED market approval.