Wearables sold to individuals with the promise that they can monitor brain functions and mood have more in common with dietary supplements than medical technology.
Smart watches and fitness trackers have exploded in popularity over the last five years, monitoring sleep cycles, steps taken, and pulse rate. More recently, the market has seen the release of neurotechnologies: direct-to-consumer devices that claim to understand emotions, cognitive functions, and mental performance. The industry is growing rapidly, and is predicted to be worth more than $3 billion by 2020.
Trouble is, many neurotechnology products are not regulated with the same scrutiny as medical devices.
There are two main types of sensors. At-home EEG devices are supposed to monitor brain activity, and at-home transcranial direct current stimulations (tDCS) devices send mild electrical impulses to the brain with the aim of improving cognitive performance or mental health. In addition, games and apps that claim to sharpen your thinking, improve your “brain-age”, or better a person’s mood also fall under the neurotechnology umbrella.
In the view of UBC professor Peter Reiner and University of Pennsylvania academic Anna Wexler, the promises made by these technologies are cause for concern.
“Many companies have conducted little to no original research on the effectiveness of the underlying neurotechnology,” says Reiner. “Without much research, there is potential risk of both physical and psychological harm. For example, some users of tDCS have reported skin burns from the electrical current on their scalp. An EEG device could erroneously show than an individual is in a stressed state, which may cause him or her to become stressed, resulting in unwarranted psychological harm. A smartphone app user may be told they have symptoms of depression, but the diagnosis is provided without the support of a psychologist or mental health counsellor.”
The key issue, he suggests, is that creators of neurotechnology can avoid being classified as drugs if they refrain from making explicit claims about it treating or diagnosing disease. Like the dietary supplement industry, which also has limited evidence about its efficacy, wearable technology can get away with making vague claims about health benefits.
Reiner believes that the scientific community needs to offer more oversight over neurotech devices.
“We propose an independent working group that would survey the current neurotechnologies on the market, and provide short appraisals of the potential harms and usefulness of these products,” he says. “Rather than evaluating each and every product, the working group’s appraisals would outline the existing evidence behind the device and the potential risks of using it, as well as identify any gaps in the current knowledge. The working group would also be responsible for disseminating those appraisals to the public and partnering with organizations to communicate the potential risks and benefits of products to consumers.
“Given that many government agencies and corporations are actively funding research into monitoring and manipulating brain function, we think that the current neurotechnology devices on the market may only be the tip of the iceberg," he continues. “The need for an independent working group has never been more urgent.”
Kate Wilson is the Technology Editor at the Georgia Straight. Follow her on Twitter @KateWilsonSays