Toward an Ethical Framework for Regulating the Market for Cognitive Enhancement Devices
In the past few years, a visible market has emerged for devices that promise to improve the user’s cognitive capacities in some way.1-2 Marketed to healthy individuals, manufacturers make a variety of claims about improved focus, improved memory, and improved creativity, among other things. Using principles of transcranial electrical or magnetic stimulation, these devices have many similarities to devices sold to the research community for clinical research. For example, transcranial direct current stimulation (tDCS) is a technique that is currently being investigated as a potential treatment for impairments following stroke, for depression, and for symptoms of Parkinson’s disease. Researchers are also investigating the potential for using brain stimulation in healthy participants to improve cognitive function. Early results show some promise: tDCS has been shown to improve some cognitive abilities of healthy adults, including working memory, attention, language, mathematics, and decision-making.3 Transcranial magnetic stimulation (TMS) has, among other things, been shown to improve working memory, enhance performance on various complex motor learning tasks, induce faster object naming, and improve visuospatial processing.4 There is also some evidence to suggest that TMS can unmask so-called savant-like abilities.5
However, despite the similarities in mechanism, the devices sold for research are closely regulated by medical devices legislation, whereas devices sold for enhancement are held only to basic standards of product safety. The reason for this is that, in many jurisdictions, whether a device attracts regulatory oversight is largely dependent on the claims that the manufacturer makes about the purpose of the product. The European Union (EU)’s Medical Devices Directive, for example, only deems a device to be a medical device if its intended purpose is for the treatment, diagnosis, or prevention of disease.6 The same is true of the Federal Food, Drug, and Cosmetic Act in the United States.7 Thus, if a device were to be marketed, say, as a treatment for stroke patients suffering with aphasia, then it would be identified by the directive as a medical device and held to particular standards of production and surveillance deemed appropriate for devices with medical risks and benefits. If, however, a manufacturer were to market the same device as a product that could improve, for example, the focus of gamers, then it would be subject to only minimal regulation because no treatment claims would have been made in the marketing of the device.
There have been a number of calls from academics and others to address this regulatory gap.8-9 Given the risks that the devices pose and the media (and, sometimes, academic) hype that surrounds these technologies,10 there is a strong case for putting controls on cognitive enhancement devices (CEDs) similar to those that are put on medical devices. However, although some of the claims in the popular media exaggerate the benefits of CEDs (and fail to mention their risks), the scientific evidence is accumulating to suggest that stimulation within certain parameters, coupled with the right cognitive training, can produce effects in healthy individuals. The idea of using CEDs for enhancement is not a scam dreamed up by those selling the devices, although whether the devices currently on the market produce the effects their manufacturers claim is unknown.
Fitz and Reiner emphasize that any regulatory action should not stifle innovation: if brain stimulation is an effective route to cognitive enhancement, then it should, they claim, be welcomed.9 The difficult task remaining, however, will be to regulate CEDs in a way that provides some degree of protection from unnecessary harm while not imposing unreasonable barriers on manufacturers or users. The concept of “managed technological optimism” captures this fine balance, offering “a perspective that acknowledges the potential for substantial benefit from the technology coupled with active oversight.”9: 1
However, even if it is broadly agreed that CEDs must be regulated in a way that does not stifle innovation or use, the details of how to achieve this are not obvious. In what follows, I consider two of the challenges that must be resolved in order to craft a principled policy for regulating CEDs. The first challenge is to determine what the general approach to regulation should be. Comparable devices used in a clinical context are currently regulated by medical devices legislation. Accordingly, it might be claimed that the similarity of the devices means that we ought to take a similar approach to legislating them. Second, regulators must decide how they will assess whether a CED presents too much risk to the user to be approved for sale. The key question here is whether the benefits of a CED must clearly outweigh its risks if it is to be made available to the public, as is the case for medical devices. Through addressing these challenges using the EU regulatory context as the primary case study, I hope to make steps toward an ethical framework for regulating the market for CEDs. The conclusions I reach will be applicable to the regulatory systems of other jurisdictions.