Tuesday, May 27, 2014

Here’s how we should regulate brain enhancement devices

Hannah Maslen, lead author of "Mind Machines," wearing a tDCS device (The Oxford Martin School / University of Oxford)
Hannah Maslen, lead author of “Mind Machines,” wearing a tDCS device. (The Oxford Martin School / University of Oxford)
In the future, using cognitive enhancement devices to boost your brainpower could become just about as common as getting a bit of plastic surgery is today. It’s already possible to order online a number of cognitive enhancement devices, including some –like the foc.us – that are popular with online gamers. But how exactly are we going to regulate and control these cognitive enhancement devices so that people don’t start (literally) losing their minds once they start using these devices for boosting memory, focus and concentration on an everyday basis?
To answer that question, the Oxford Martin School at the University of Oxford assembled a team of interdisciplinary researchers led by Hannah Maslen, a research fellow in ethics at the Oxford Martin School, who focuses on the ethical, legal and social implications of brain intervention technologies. The goal was to come up with a regulatory framework for cognitive enhancement devices (CEDs). The “Mind Machines” policy paper from Oxford starts off with a broad classification of the four types of “mind machines” already available today – Transcranial Direct Current Stimulation (tDCS), Transcranial Magnetic Stimulation (TMS), Cranial Electrotherapy Stimulation and Neurofeedback – before delving into a broader strategy of how society should regulate them.

What’s important to keep in mind is that a wide variety of these devices already exist in the marketplace today, even if they are not explicitly described as cognitive enhancement devices. And people are already posting their experiences using them in popular online communities like Reddit. That means that these devices are already starting to crossover into the mainstream, and that’s creating greater urgency to regulate them. “Until recently, it had been the preserve of the DIY tDCS community: people would construct their own devices from batteries, wires and electrodes,” Maslen says. “Now, an online market has emerged for whole-unit devices specifically manufactured for non-therapeutic tDCS.” Demand appears to be highest from gamers, who are looking for a hidden edge, whether it’s greater focus or faster reaction times.
Until laboratory experiments prove conclusively that these devices can improve certain cognitive functions in healthy individuals, say the Oxford researchers, the primary regulatory principle should be that all cognitive enhancement devices — even ones not marketed for medical and therapeutic purposes — should be regulated as medical devices. Consumers, when they’re buying these, need to be aware of the risks and trade-offs, as well as how exactly it’s best to run an electromagnetic wave through your brain without frying a few neurons. (The  “Whoa though, does it ever burn!” problem.) In some cases, consumers are taking devices intended for transmitting magnetic stimulation to one part of body and using them instead to connect to the brain for completely different uses – like giving themselves the ability of super-memory or super-cognition. Or a few extra IQ points.
As we’ve already seen with the reaction to pop culture offerings like the new Johnny Depp sci-fi film “Transcendence” the ethical and philosophical lines start to blur very quickly once we start toying with the cognitive properties of the brain. “The most important ethical question will arise if or when it becomes clear that they in fact confer significant cognitive benefits,” says Maslen. “That’s because non-universal access to these devices would create or exacerbate inequality: Those who are informed and wealthy enough to obtain and use cognitive enhancement devices would, if effective, be in a position to privilege themselves further.” In other words, wealthy parents might buy these things for their kids if it will help them get into a prestigious university.
Despite these risks, in the “Mind Machines” paper the Oxford researchers argue for a liberal approach to the regulation of CEDs: “Within limits, consumers should be allowed to choose for themselves what level of risk they are willing to take in the pursuit of the expected benefits.” Maslen notes that this differs from the standard approach taken to medical devices “where benefits must clearly outweigh the risks in order for a device to be approved.” Given how unproven these brain enhancement devices are, regulators have a difficult task ahead of them. Place the bar too low, and you fail to optimize consumer freedom or any potential benefits. Place the bar too high, and you may not prevent consumers from using devices that are too dangerous to approve for sale.
In other words, technologists are facing another Collingridge Dilemma when it comes to regulating these cognitive enhancement devices. Attempt to regulate them now before they’ve entered the consumer mainstream, and you’re dealing with a lot of unknowns. Wait too long, though, and it could become impossible to ever regulate these devices properly. As David Collingridge noted back in 1980, “When change is easy, the need for it cannot be foreseen; when the need for change is apparent, change has become expensive, difficult and time consuming.”
So, for now, the basic regulatory framework is to create as much freedom of choice for consumers in a way that keeps them away from the particularly dangerous stuff. Safety comes first, but you still need to leave room for innovation. While most people would think twice about wrapping a metal coil around their head or zapping their brains with magnets, what about some types of fairly innocuous-looking devices that gamers already buy that might have negative side-effects? Transcranial magnetic stimulation (TMS) devices, for example, pose the greatest safety concerns due to the heightened risk of seizures, says Maslen.

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