Buttressing regulation of cognitive enhancement devices with principles of harm reduction

Maslen and colleagues offer an excellent model for regulating cognitive enhancement devices (CEDs), and we largely endorse their approach of extending medical device policy to include CEDs. Maslen et al. argue that since the risks and benefits of CEDs can be identified, consumers are best placed to evaluate the impact of these effects on their own wellbeing: 'experts are to assess what the risks are, the consumer how much they matter'. In principle, we agree: consumers should be allowed to decide what risks are worth taking, but the situation is somewhat more complicated, for the evidence that consumers are in a strong position to evaluate the many risks associated with CED use is lacking. Indeed, a glance at online forums on CEDs suggests that undue risks are already being taken. Importantly, given the ease with which devices can be built using easily obtainable parts, overly tough regulation will not effectively curtail use, but rather push it underground. For these reasons, we suggest that any regulatory framework be buttressed by principles of harm reduction, providing real-world users with expert-backed recommendations for safe use. We argue for the development of tools that facilitate this dialogue, while recognizing the challenges in so doing.