Outstanding questions concerning the regulation of cognitive enhancement devices

The authors (Maslen et al., 2014) propose to regulate cognitive enhancement devices (CEDs) as medical devices. Extending medical device regulations to CEDs raises some important questions that need to be adequately addressed before it makes sense to pursue this path. A first problem concerns the definition of 'cognitive enhancement' and 'CEDs'. Where does treatment end and enhancement begin? Secondly, since most CEDs such as neurofeedback and transcranial direct current stimulation are currently performed by non-medical health care providers, how will this regulation impact the current practice, and which requirements need to be put in place to regulate their use? Thirdly, distributive justice issues present an obvious ethical limitation. Fourthly, if CEDs are indeed prescribed off-label similar to the off-label prescription of psychopharmacological enhancers by MDs, this will pose problems regarding a lack of sufficient knowledge and expertise due to the highly specialized nature of CEDs. And finally, are we faced with unnecessary worries and unrealistic hopes when it comes to CEDs? In sum, we propose to regulate them regarding product safety and restrict them to competent adult use including professional oversight where indicated.