The Brain, Cognitive Enhancement Devices, and European Regulation

Abstract

Few things excite the imagination like human enhancement. With regards to cognitive enhancement, neuroscience is making steady progress. Devices capable of increasing human cognitive capabilities for brief periods are now sold worldwide. This concerns Maslen et al.—authors of the article, The Regulation of Cognitive Enhancement Devices: Extending the Medical Model—not because of the implications of artificially enhanced humans, but because there are unaddressed possible harms from such equipment. Specifically, cognitive enhancement devices (CED) are 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. The authors’ assessment, however, while demonstrating legitimate concerns, presents a flawed analysis of CEDs and is ultimately unnecessary.

Keywords: European Regulation, Cognitive Enhancement Devices, Health Law, Neurolaw, Neuroscience, Transcranial Direct Current Stimulation, Neurofeedback

JEL Classification: K10, K19, K20, K23, K29,