Much-needed neurotech guidelines help consumers and developers alike

The term ‘neurotech’ refers to neurotechnology that aims to measure and regulate the state of the human brain. Although there are currently many neurotech products available for purchase, the neurotech industry risks losing public trust due to a lack of regulations regarding product efficacy and safety, meaning that many products don’t quite live up to their hype. To address this problem, a research group in Japan has recently released a guidebook that informs consumers how to choose good-quality products, and guides businesses to develop effective and safe neurotech.

Worldwide, neurotech represents a growing industry, with high-profile companies such as Elon Musk’s Neuralink and Blackrock Neurotech attracting much attention. Neuralink aims to create brain–computer interfaces to help people with neurological injuries and diseases, while Blackrock Neurotech develops brain–computer interface technology for a range of different applications. Current neurotech products that are directly available to consumers include electroencephalogram products that record brain activity and provide related metrics, and transcranial stimulation devices that stimulate the brain to improve brain activity.

However, neurotech is not currently regulated as an industry in the way that medical and research products are, meaning that any kind of neurotech product can be marketed and sold without evidence of effectiveness, or even safety standards having been met. This is a problem not only for the general public as consumers, but also for entrepreneurs and business owners who wish to commercialize reliable neurotech products.

Considering this lack of regulation, researchers from universities and private companies in Japan recognized a couple of big gaps in the neurotech industry that needed to be addressed. In 2021, financial backing for a research project was obtained through the Moonshot Research & Development Program, a funding program set up by the Japanese government to promote the creation of disruptive innovation. The project, led by Ryota Kanai from Araya Inc. and the Advanced Telecommunications Research Institute International (ATR), falls into Goal 1 of the Moonshot program: Overcoming limitations of body, brain, space, and time. The project aims to create an “Internet of Brains”, with an overall goal of making neurotech a commonly used technology in society.

Of great importance to the Internet of Brains project is ensuring that any developed neurotech is considered trustworthy by the general public, which requires honest science behind the products. As part of this aim, the researchers had originally planned to write a users’ manual for neurotech. However, after researching the range of products on the market, they realized that there was a basic lack of safety and efficacy data for most commercially available neurotech. For example, a 2019 study of wearable neurotechnology available for direct purchase by consumers found that less than 20% of all devices linked to a relevant peer-reviewed article; approximately 20% linked to no scientific research at all, and the remaining devices linked to less robust evidence—such as from general science research or customer testimonials.

“When we noticed this lack of robust data behind the products, we decided to first write a guide for businesses that were looking to develop and commercialize neurotech products, to promote the production of technologies supported by solid evidence,” says Mitsuaki Takemi from Keio University, one of the guidebook’s authors. “We also wanted to include information for the general public as potential consumers, so that they can make informed decisions about the benefits and risks of neurotech products.”

They first published the guidebook in Japanese in 2022, and have recently released the English version online. The authors felt it was particularly important to publish the guidebook in English because, although there is a relatively large neurotech market across English-speaking countries, there is a global lack of guidelines for the reliability of neurotech products.

The guidebook is freely available and can be used by anyone, from potential consumers of neurotech to government agencies looking to regulate such technology. It is loosely based around general questions about neurotech and the neurotech industry, and was written with the cooperation of industry, relevant government departments, academia, and the private sector. Valuable input from the general public was also received.

The guidebook is unique in that it contains information aimed at the general public as well as for neurotech businesses, including startups. It consists of several different sections that provide clear information about all aspects of neurotech products that are aimed directly at consumers. In the first sections, everyday language is used to describe exactly what is meant by the terms neurotech (and the related brain–machine interface/brain–computer interface concepts), neurofeedback, and neuromodulation. The guide then provides a brief summary of what to look out for when buying a neurotech product, which is primarily aimed at potential consumers of this technology. It then moves on to business-related information, with a deep dive into what businesses should consider when developing and commercializing neurotech products, including a section on the related laws and regulations in Japan (which could be updated in future editions to include regulations from other interested countries). Next, the guidebook details the possible ethical issues and risks that are associated with neurotech use; for example, the ethical issues around what is essentially brain “doping,” or the risks of producing unexpected or unwanted brain changes. The last section explains how to get up-to-date, accurate information about neurotech and provides a comprehensive list of websites that provide reliable information.

As part of the project, Takemi is also leading the development of an evidence book that collates specific evidence relating to the efficacy and safety of non-medical neurotechs. So far, two systematic reviews have been completed, one in a peer-reviewed journal and one in preprint. The evidence book will be released as soon as it is completed. However, unlike the guidebook, which is aimed at the general public, the evidence book will focus more toward researchers, businesses, and active neurotech users.

One somewhat unintended benefit of creating both the guidebook and the evidence book has already been noted: because the researchers are actively involved in the evaluation of evidence for neurotech, they have identified many new research opportunities. In addition, by guiding businesses to appropriately develop and commercialize neurotech products, the researchers expect to obtain feedback on basic research as well as further research development, which will then feed into the cycle of research and commercialization. Fortuitously, this fits directly into one of the overall goals of the Internet of Brains project: the development of a "new science" that cycles between basic research and commercialization.

To disseminate the English-language guidebook, the authors intend to present the Internet of Brains project’s activities—including the guidebook development—at international conferences such as those of the Society for Neuroscience and the Federation of European Neuroscience Societies.

“We’re also seeking international collaborations, for example with organizations such as the Organization for Economic Co-operation and Development and the Institute of Electrical and Electronics Engineers,” says Kanai. “We hope that such international organizations and academic groups will concur that having a set of neurotech guidelines is vital, and will be supportive of our pioneering work in Japan to improve public trust in neurotech products.”

The growing number of neurotech startups, the increasing range of commercially available neurotech products worldwide, and the ever-expanding body of research demonstrating potential neurotech products, suggests the importance of the release of these neurotech guidelines—and the work of the Internet of Brains project as a whole. Public confidence in neurotech will be key to the widespread adoption of such products, and to the subsequent development of more and better neurotech. The authors of the guidebook also hope that their efforts will bring international attention to the need for specific regulations for the efficacy and safety of neurotech, to improve the quality of products under development. Eventually, the authors hope that commercial neurotech products will indeed live up to their hype—that people with brain injuries will be able to connect their brain activity to computers to improve their everyday lives, or that people who want to improve their memory or have healthier brains will be able to wear a headset for a few hours a day to see huge improvements. Whether or not this comes to fruition, this new neurotech guidebook is a big step in the right direction.