Expert workshop on cognitive enhancement device regulation: Are there ‘two worlds’ of devices?

Last week, we held an expert workshop with key stakeholders to discuss our recent Oxford Martin School policy paper. Our policy paper put forward proposals for how we thought cognitive enhancement devices such as brain stimulators should be regulated. At present, if these sorts of devices do not make medical treatment claims (but instead claim to make you smarter, more creative or a better gamer, say) then they are only subject to basic product safety requirements. In our paper we suggested that cognitive enhancement devices should be regulated in the same way as medical devices and discussed how this could be implemented. Indeed, the devices that are being sold for enhancement of cognitive functions use the very same principles as devices approved by medical device regulators for research into the treatment of cognitive impairment or dysfunction associated with stroke, Parkinson’s disease and depression (amongst other conditions). Being the same sorts of devices, acting via similar mechanisms and posing the same sorts of risks, there seemed to be a strong argument for regulation of some form and an equally strong argument for adopting the same regulatory approach for both medical and enhancement devices.

Having published our paper, we were very keen to hear what people more closely involved in making policy and drafting legislation thought of our proposals. Individuals from the Medical and Healthcare Products Regulatory Agency, the EU New and Emerging Technologies Working Group, a medical devices company, the Nuffield Council on Bioethics, and experts on responsible innovation and on brain stimulation joined us. Overall, the response to our recommendations was positive: all participants agreed that some regulatory action should be taken. There was a general consensus that this regulation should protect consumers but not curtail their freedom to use devices, that manufacturers should not be over-burdened by unnecessary regulatory requirements, and that innovation should not be stifled.

However, there was debate and disagreement over a number of issues. These included whether the argument that cognitive enhancement devices should be regulated within medical devices legislation was conclusive, whether cognitive enhancement devices should be regulated as strictly as medical devices and how regulators should proceed in the face of relative uncertainly about the risks and benefits that cognitive enhancement devices do (and could) confer on users.

Are there two worlds of devices – medical and consumer?

In our paper we argued that the similarity between devices used for cognitive enhancement and medical treatment (in terms of mechanisms employed and the risks posed) provided an argument for regulating them under the Medical Devices Directive. A similar position was taken by the Nuffield Council in their report on Novel Neurotechnologies: Intervening in the Brain: ‘it seems both inconsistent and disproportionate that a neurostimulation device marketed for a non-medical purpose, but which nevertheless has the same capacity to intervene in the brain and impact upon its functions, should not be subject to the same level and kind of regulatory oversight as it would if marketed for a medical purpose’.

During the workshop, this argument was challenged using an interesting counterexample, presented in support of the suggestion that there might be ‘two worlds’ of devices, calling for two separate regulatory approaches. Consider fitness trainers that measure the user’s heart rate. In a medical setting where doctors might be overseeing a patient’s return to physical activity, for example, it will be imperative that the heart rate monitor is accurate. Doctors will be drawing conclusions about the patient’s health and progress based on the readings the machine provides. Strict regulation must be in place to ensure that no fitness machines used in medial settings will be giving inaccurate readings. In a gym, however, such strictness of regulatory oversight does not seem necessary. Although the fitness machines used in gyms would give accurate readings in an ideal world, it does not seem that the degree of need for accuracy here would justify incurring the same regulatory burden and resources as it would in the medical setting. This example was intended to show that similarity of a device to a medical device is not enough to make a conclusive case for regulating in the same way as medical devices.

This example indeed raises a prima facie challenge to our argument. I here wish to point to two related ways in which cognitive enhancement devices might be importantly different from fitness machines in an attempt to reinstate the appeal of using the same regulatory approach for cognitive enhancement devices and comparable medical brain stimulation devices.

Relative level of risk

In the case of fitness trainers, a suboptimal heart-rate monitor poses less risk to the gym-goer than it does to someone undergoing rehabilitative exercise in a medical setting. Presumably, the person using the fitness machine heart-rate monitor for rehabilitation will be in ill health or recovering from ill heath. Medical practitioners overseeing an exercise session will use the heart monitor either to avoid overexertion or to measure a patient’s progress. Having accurate information will be very important for maintaining an appropriate course of exercise to improve the patient’s health and to identify when certain targets have been reached which indicate successful treatment.

The level of risk that inaccuracy poses to the gym-goer is arguably much less. People attending a gym and using cardio machines will be of a higher level of fitness than a patient who is using a fitness machine as part of a treatment. If some gym-goers are at risk of overexertion, it is unlikely that an inaccurate heart monitor will be instrumental in overexertion materializing: people will be much less likely than medical practitioners to use the machine’s heart monitor to determine whether they should continue to exercise at a given intensity or not. Most gym-goers will therefore not have their health put at risk by a sub-optimal heart-rate monitor. Whilst the monitor is a nice feature of a gym machine, it is not central to the purpose of using the machine, as it can be in a medical setting.

There is not the same difference when it comes to archetypal cognitive enhancement devices. Whereas it does not matter (or matters little) if the heart-rate monitor of a gym machine is sub-optimal, it can matter a lot whether the stimulation provided by a cognitive enhancement device is sub-optimal regardless of whether it is used in a clinical or non-clinical setting. Incorrect stimulation (and, in some cases, correct stimulation) poses the same risks to patients and home users alike: stimulation that is too strong, or persists for too long or is of the wrong polarity will cause harm or adverse effects to any brain, not just the brains of patients or research participants. In fact, it could be argued that, unlike the heart monitor of the fitness trainer, non-medical use will present greater risks if a device is faulty, as home users are not supervised by a qualified researcher or medical practitioner.

Thus, cognitive enhancement devices, unlike fitness devices, are not separated into two worlds on the grounds of the level of risk posed to different categories of users.

The risk is to the brain

Even if it were the case that there be a greater (relative) need for regulation when it comes to medical devices than comparable ‘lifestyle’ devices, it could be argued that the special status of the brain makes the medical approach of regulation appropriate.  This is really a point about how high the level of risk is and what is being risked. The Nuffield Council argues that: ‘The brain has a special status in human life that distinguishes it from other organs. Its healthy functioning plays a central role in the operation of our bodies, our capacities for autonomous agency, our conceptions of ourselves and our relationships with others – and thus in our abilities to lead fulfilling lives.’ This means, they conclude, that brain intervention technologies raise various concerns that are not raised to the same extent by other biomedical technologies. Correspondingly, given that the risks that cognitive enhancement devises pose are directly to brains, the argument for having regulatory oversight that has a medical focus and framework seems stronger than for other technologies that do not effect parts of our physiology so central to our functioning and personhood. The appropriateness of medical device regulation for non-medical products might be a matter of degree rather than categorical distinction, but the argument seems pretty strong for devices that directly modulate brain activity.

Medical device legislation might be appropriate after all

There might be two worlds of devices in terms of treatment versus enhancement uses. The patient using brain stimulation to ameliorate impairments in speech caused by a stroke will appear worlds away from the gamer using brain stimulation in an attempt to focus better than his competitors on his moves. However, these devices converge when it comes to the risks they can present any user, and the importance of the organ that is risked. So, whilst general product safety legislation might be appropriate for devices in gym equipment, brain stimulation might require a medical regulatory framework, regardless of whether it is being used in the world of medicine, gaming, or some other enhancement pursuit.

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