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Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

Nearly everyone would agree that a device or drug that relieves pain, or alleviates symptoms of depression confers a benefit – plausibly, a substantial benefit – on its user. No matter what your goals are, no matter what you enjoy, you are likely to agree that your life will go better if you are not in pain and not depressed: whether you’re a painter, a footballer, a Sudoku-enthusiast or a musician, you will be better able to pursue your projects and engage in the activities you love. It is unlikely that you will even question whether pain relief or alleviation of depression indeed constitute benefits.

This general consensus with respect to medical benefits makes it relatively straightforward for regulators to conduct risk-benefit assessments of medical products when they decide whether a particular product can be put on the market. A very small risk of a mild rash or gastrointestinal upset, for example, will be considered reasonable in the context of effective pain relief, as long as patients or consumers are informed. Even as the risks get more significant, substantial pain relief will be considered a large enough benefit to out-weigh a range of negative side effects in many cases.

So far, so straightforward.Read More »Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

What are the ethics of using brain stimulation technologies for ‘enhancement’ in children?

New open access publication: announcement:

In a recently published article, Hannah Maslen, Roi Cohen Kadosh, Julian Savulescu and I present an argument about the permissible (and not-so-permissible) uses of non-invasive brain stimulation technology in children. We consider both children who may be suffering from a specific neurological disorder, for whom the stimulation is intended as a ‘treatment’, and those who are otherwise healthy, for whom the stimulation is intended as ‘enhancement’. For the full article and citation, see here:

Maslen, H., Earp, B. D., Cohen Kadosh, R., & Savulescu, J. (2014). Brain stimulation for treatment and enhancement in children: An ethical analysis. Frontiers in Human Neuroscience, Vol. 8, Article 953, 1-5.Read More »What are the ethics of using brain stimulation technologies for ‘enhancement’ in children?

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

“Whoa though, does it ever burn” – Why the consumer market for brain stimulation devices will be a good thing, as long as it is regulated

In many places around the world, there are people connecting electrodes to their heads to electrically stimulate their brains. Their intentions are often to boost various aspect of mental performance for skill development, gaming or just to see what happens. With the emergence of a more accessible market for glossy, well-branded brain stimulation devices it is likely that more and more people will consider trying them out.

Transcranial direct current stimulation (tDCS) is a brain stimulation technique which involves passing a small electrical current between two or more electrodes positioned on the left and right side of the scalp. The current excites the neurons, increasing their spontaneous activity. Although the first whole-unit devices are being marketed primarily for gamers, there is a well-established DIY tDCS community, members of which have been using the principles of tDCS to experiment with home-built devices which they use for purposes ranging from self-treatment of depression to improvement of memory, alertness, motor skills and reaction times.

Until now, non-clinical tDCS has been the preserve of those willing to invest time and nerve into researching which components to buy, how to attach wires to batteries and electrodes to wires, and how best to avoid burnt scalps, headaches, visual disturbances and even passing out. The tDCS Reddit forum currently has 3,763 subscribed readers who swap stories about best techniques, bad experiences and apparent successes. Many seem to be relying on other posters to answer technical questions and to seek reassurance about which side effects are ‘normal’. Worryingly, the answers they receive are often conflicting.Read More »“Whoa though, does it ever burn” – Why the consumer market for brain stimulation devices will be a good thing, as long as it is regulated