New Japanese guidelines to help neurotech developers worldwide

Imagine a technology that interacts directly with the brain, performing measurements and making alterations to surpass your body’s natural capabilities. Known as neurotech, this rapidly growing field is transforming the healthcare, gaming, and memory aid industries. Wearable detectors can alert caregivers when a person with epilepsy has a seizure. Gamers, no longer chained to their controllers, can carry out key moves by merely thinking about them. Memory aids can gently guide the brain into an optimized state for memorization.

If you didn’t know about the neurotech revolution until now, don’t feel discouraged: regulatory agencies haven’t been exactly well prepared either. Many non-medical neurotech devices, aimed at a mainstream audience, are subject to similar regulation as, say, a toaster. This is concerning because the safety and privacy risks inherent in controlling your TV with your brain are of a far different nature than the risks inherent in toasting a slice of bread.

Enter Ryota Kanai, of Araya Research and the Advanced Telecommunications Research Institute International (ATR), and his multi-institutional team of researchers from across Japan. The team has worked to address these regulatory gaps as part of the Internet of Brains (IoB) project (JST, Moonshot R&D Program [JPMJMS2012]), which aims to develop and disseminate technologies that enhance physical and cognitive abilities. Their efforts have culminated in the release of Neurotech Guidebook Volume 2: For Responsible Development by Enterprise, a comprehensive resource designed to guide the neurotech industry.

While their first guidebook, Neurotech Guidebook Volume 1: Where is Neurotech Today?, introduced the fundamental concepts of neurotech to the general public, the newly released second volume is aimed squarely at developers of neurotech. It provides a series of guidelines covering the entirety of the development and commercialization process. Furthermore, by addressing legal compliance, safety assurance, scientific validity, and consumer support, the guidebook offers a clear roadmap to help both startups and established providers to create safer and more effective neurotech products.

“One of the key features in our new guidebook is a visual summary of the risks associated with consumer-marketed neurotech products,” says Mitsuaki Takemi from Keio University, who is the secretary-general of the guidebook development committee and one of its authors. “We have mapped out these risks along two axes: physical to non-physical risks, and whether the risk’s source is the product manufacturer or the consumer.” The guidebook also clarifies whether each risk is covered under existing laws, covered only by guidelines, or is merely a subject of discussion without any current regulations. This clear and intuitive format will help developers to better understand and manage these risks.

In addition to risk mapping, the guidebook provides a detailed framework for the responsible development, marketing, and post-sale support of neurotech products. Although much of the information is based on Japanese regulations, the framework translates well to other countries and regions, and offers guidance for developers navigating safety, privacy, and compliance challenges in diverse markets.

“We categorized the information in the book into four sections: legal compliance, safety assurance, scientific validity, and consumer support,” explains Dr. Kanai. “This structure ensures the guidebook covers critical considerations across all stages of neurotech development, making it an invaluable resource.”

The legal compliance section addresses a range of important points that developers might overlook, such as whether a consumer-marketed product could inadvertently be classified as a medical device, or whether it complies with personal information and data-collection laws. The safety assurance section recommends how a product’s physical and biological safety profile should be assessed, and also briefly covers software and data safety. The scientific validity section guides developers in creating evidence-based neurotech, including trial design, research ethics, and managing conflicts of interest. Finally, the consumer support section provides guidance on how to inform consumers about appropriate use, product properties, and other important information.

“To make our guidebook more accessible, we also included five hypothetical case studies,” explains Dr. Takemi. “Each case describes a fictional product and marketing claims while highlighting common oversights in development and marketing. These examples aim to help readers to understand and address key issues when developing and commercializing neurotech products.”

Alongside the guidebook, the team also updated the Neurotech Evidence Book. The first edition examined four of twelve questions relating to the efficacy, safety, and reliability of neurotech. The new edition answers five more of these questions: specifically, whether neurofeedback training improves memory aptitude, if non-invasive brain stimulation enhances motor performance, memory, or attention, and whether emotions can be decoded from scalp electroencephalography. This evidence-based reference helps both users and developers to understand the current capabilities and safety of neurotech.

Together, the guidebook and evidence book serve as a significant stepping stone toward making neurotech a widely accepted and safe technology. By addressing key challenges such as regulation and scientific validity, these resources provide a foundation for integrating neurotech into everyday life, from healthcare to education. Neurotech is here to stay; these contributions will help spur development in this fledgling industry and, ultimately, offer great benefit to countless people worldwide.