Neurotechë bøøk
Where is Neurotech today?
2023/06/23 v1.3

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Table of Contents

GQ1

Preface1

GQ1

What is Neurotech/BMI?

3

GQ2

What is neurofeedback?

4

GQ3

What is neuromodulation?

6

GQ4

What should I be aware of with regards to commercial products?

8

GQ5

What should I keep in mind when developing a product?

13

AppendixDefinition of medical devices and treatment of consumer Neurotech products
117

Appendix
2

19

Risks and ethical issues associated with the use of Neurotech

Appendix
How to get the latest information on Neurotech
323This guidebook was produced as part of the "Liberation from Biological Limitations via Physical,
Cognitive and Perceptual Augmentation (Project Manager Ryota Kanai)" project for Goal 1 of the Cabinet
Office Moonshot Research and Development Program, "Overcoming limitations of body, brain, space andtime” by 2050.

Preface
This guidebook is written for those interested in thecurrent situation and challenges around Neurotech
products. In recent years, “Neurotechnology” or so-called“Neurotech”, which is the technology that aims to estimate
and regulate the state of the human brain, is spreading
rapidly. When you search the Internet or social media, youwill find many Neurotech products for general consumers.
Brochures for such products make enticing claims such as“improved concentration,” “improved sleep,” or “improved
athletic performance”. However, is there any scientificbasis for these claims? Are there any dangers in ordinary
consumers using such products on their own?
Neurotech is a developing technology whose efficacy

for med ical purposes such as diagnosing and treating
diseases are not the subject of this guidebook, and therefore not addressed. For product intended as medical
devices (medical/research-grade Neurotech products),
please refer to the information published by related academic societies and industry associations.
This guidebook was developed by a Guidebook Development Committee consisting of experts from universities, research institutions, and private companies. Basicquestions such as “What is Neurotech?”and “What should I
be aware with regards to commercial products?” were set
as General Questions (GQ), and answers were compiled
based on the scientific knowledge and opinions gatheredand safety have not yet been fully clarified. Because it
works on the brain itself, a specialized organ that controls thought and personality, it is necessary to consider
not only safety but also ethical, social, and legal issues.
However, no official standards exist yet to address theseissues. Consumers must be cautious when purchasing
and using products, recognizing that there are still
unknown and unresolved issues. Neurotech businesses
must also develop trusted products and services while
confronting these realities.

by the committee members.
This guidebook was originally published in Japanese as apart of the Moonshot R&D program “Liberation from
Biological Limitations via Physical, Cognitive and Perceptual Augmentation.1” The English version of the guidebook
is intended to inform the international community about
the current situation and challenges around Neurotech.
We hope that this guidebook will deepen your understanding of Neurotech and that it will develop as a safe
and secure technology.

Towards a trusted Neurotech

1.

2.

3.

Organizing

Accumulation

Establishment

current

of scientificof standards

situation andevidence

challenges

Can I trust this ?

BrainTechë bøøk
ブレイン・テックのいまを知ろう！

Güïd

and
regulations

Towards safe usage

BrainTechøkñçë bø

Consumer Neurotech products are a developing technology. In this first

ブレイン・テック エビデンスブック

edition of the series, we have organized current situations and challenges.
This guide will be revised in the future with accumulation of scientificevidence, and developments in the standards for safe and secure use.

Given this situation, Neurotech is not something that
we can recommend to the general public yet. Therefore, we published this guidebook to accurately sharethe current situation and challenges around Neurotech
with you. We hope that this guidebook will be helpful toconsumers and businesses by providing basic information about Neurotech, the risks and challenges associated with its use, and considerations when selecting
and developing products and services. This document was compiled based mainly on research conducted on healthy adults. Minors and Neurotechs

ëvïdë【Guidebook】
・For those who are interested in Neurotech products
・Created by a committee of researchers, physicians, andindustry persons who are knowledgeable in neuroscience
・Provides correct knowledge and perspectives that are
currently available, as well as information on how toapproach Neurotech【Evidence Book】
・For Neurotech users and providers of products andservices・Created by an evidence evaluation committee consisting of researchers specializing in neuroscience
・Summarizes the effectiveness and safety of Neurotech
based on the results of systematic reviews

Apart from this, we are developing an “Evidence Book” thatsummarizes evidence related to Neurotech, under an
Evidence Evaluation Committee composed of several
researchers specializing in neuroscience. The Evidence Evaluation Committee is answering the question of how muchscientific evidence there are for the claims made by Neurotech products through the scientific method of systematic
review. Some results of this analysis will be available in July2023.
By Neurotech Guidebook Development Committee

1Preface

People involved in this guidebook development (alphabetical order)
Guidebook Development Committee
Takuya Ibaraki, Neuro Innovation Unit, NTT Data Institute of Management Consulting, Inc.
Ryota Kanai, ARAYA Inc., Chairman of Guidebook Development Committee
Mitsuaki Takemi, Graduate School of Science and Technology, Keio University
Junichi Ushiba, Faculty of Science and Technology, Keio University
Takufumi Yanagisawa, Institute for Advanced Co-creative Studies, Osaka University
Secretariat
Yumiko Kakubari, Araya Inc.
Ayumi Kusano, Araya Inc.
Tomoya Nakanishi, Neuro Innovation Unit, NTT Data Institute of Management Consulting, Inc.
Shiho Tenmoto, Knowledge Mobility based System Institute
Guidebook External Review Board
Akifumi Shimanouchi, School of Pharmacy and Pharmaceutical Sciences, Hoshi University
Ryuma Shineha, Research Center on Ethical, Legal and Social Issues, Osaka University
Yoshiyuki Takimoto, Graduate School of Medicine, The University of Tokyo
Editing
Ririko Sano (Illustration & Design)
Yui Yoshioka (English editing)
Karin Yamakawa (English editing)Disclaimer: Please read carefully
The authors of this guidebook have carefully checked that the matters and analysis described are accurate,
and furthermore, its contents have been verified by an external review board composed by experts in thefields of medicine and medical ethics, and revised after receiving feedback from relevant academic societies
and legal experts. However, the accuracy of the content cannot be completely guaranteed due to anumber of uncertain factors, including future technological developments, the uniqueness of targeting thebrain, changes in views due to the accumulation of research and social circumstances, differences in views
depending on one’s positions, differences in physical characteristics and usage conditions of theconsumers, characteristics of the products, and revisions to the legal system. Therefore, we assume no
responsibility for any health hazards or legal issues that may arise in reference to this guidebook. In
addition, please do not refer to this guidebook with regards to Neurotech intended for minors or medicalcare, such as the diagnosis or treatment of illnesses, as they are outside the scope of this guidebook.

2

GQ1

What is Neurotech/BMI?

Summarynects the brain and machinery (machines and computers). By measuring brain activity and estimating humanintentions and conditions, it is possible to control machines or, conversely, to send stimulation to the brain
from machines. These are also applied in technologies that aim to modulate brain functions, such asneurofeedback and neuromodulation.

Neurotech is a term that combines the words “neuro-”(relating to nerves or the nervous system) and “technology”, and refers to products, systems, and services
developed by integrating knowledge and techniques inneuroscience and engineering. It is also called
Brain-Machine Interface (BMI) or Brain-Computer
Interface (BCI ) in the sense of technology that con-

Explanation
Neurotech is a term that combines the words “neuro-”(relating to nerves or the nervous system) and “technology” and is also called “Neurotechnology”. It is sometimes called BMI or BCI, with the focus on the interface
technology that connects the brain and machines.
There is no clear distinction between BMI and BCI.
In the Neurotech market, it is often referred to as BMI
when the purpose is operating a machine. When we
take action, we first think, decide what to do, and sendcommands to move our bodies with our brains. BMI
measures the brain signals (brain activity) in thatthinking state, estimates the intention, and transmits it to the machine. As a result, successfully readingand processing brain signals allows for the machine to
be moved without physically moving. For example,
people who are physically immobile because of illness
or injury can now operate machines with BMI to supplement their physical functions, such as inputting text toconvey their intentions, or moving robots. Additionally,
BMI products have also been developed for entertainment purposes, such as controlling toys and drones, aswell as avatars in games (Table1). Other applications ofthese technologies include neurofeedback (GQ2), which
adjusts brain states, and neuromodulation (GQ3), which
stimulates the brain to regulate brain function.

Neurotech Examples
BMI

Neurofeedback

Neuromodulation

Connects your brain with machines

Informs brain state

Modifies neural functionHëlløWhat is Neurotech?
Neurotech includes products such as BMI, which connects the brain to machinery (machines and computers), neurofeedback, whichuses this technology to inform about the brain’s condition, and neuromodulation, which stimulates the brain. The time may come when
Neurotech products will be accessible in a form similar to “health devices” . But what kind of effects will we actually feel? Will there be any
negative effects on the brain or body? Will others be able to read our thoughts and misuse them? These are the current state of various
expectations and anxieties.

3

GQ2

What is neurofeedback?

Summary
Neurofeedback is a technology that measures brain
activity and communicates it to the user throughimages, sounds, or even touch, taste, and smell of thefive senses. It is expected to enable users to easily
understand their own brain activity and to train
themselves to adjust the magnitude of their brain
activity. Among Neurotech products for general con-sumers, those that claim to improve concentration andto promote relaxation fall into this category, and a variety of benefits have been claimed. However, it isimportant to note that more than a few of theseproducts have not been adequately tested for efficacy and safety.

Explanation

capability enhancement usages (Table1). For example,
it is said that by measuring the brain waves of users andoutputting images and sounds based on those brain
waves, users can train themselves to change their own
brain waves using the images and sounds as cues. The
products are sold and marketed with the expectationthat this will improve concentration and relaxation.
However, the reality is that these claims are only madeby sellers on their websites or in their product catalogs, and their effectiveness has not been sufficiently
verified.

What types of neurofeedback products
for general consumers are available?
According to a survey2 by NTT DATA Management Consulting, the main applications advocated by BMI andneurofeedback products for general consumers werecategorized into healthcare, capability enhancement,
fundamental technology for IOT, marketing, entertainment, and education (as of 2022). Of these, neurofeedback is about to be used for healthcare andDomainHealthcare

Enhancement of Ability

ExamplesStress and anxiety relief / Improving
sleep quality / Support for mindfulness and meditation / Assessmentof cognitive function / Assessmentof concussion / Relief of eye strain/ Pain relief /Assist in psychotherapy / Fatigue
detection
Improving concentration / Improving learning skill / Improving
memory function / Improving
sports performance

DomainExamplesFundamental
Technologies for IoT

Application to online platforms / Application
to API systems / BMI to operate devices
and communicate intentions

MarketingEmotional estimation / Design evaluation

Entertainment

Avatar control / Telepathic games / Communication tools / Music playback

Education

Support for monitoring and improving concentration

Table 1. Areas of BMI and neurofeedback products marketed to the public and the effects they advocate.
Caution: The above product examples are only one-sided claims made by the sellers on their websites or in their product catalogs. Whether theefficacy and safety of the products have been scientifically proven was not verified by this Guidebook. In addition, most of the products are soldoverseas and have gone through a translation process into Japanese, but if such efficacy claims are made, they may contain products that,
according to the law and regulations, should be manufactured and sold as medical devices in Japan. Please thoroughly check the relevant laws
and regulations when selling products.

An Example of Neurofeedback
For example, in the figure on the right, brain signals are measured by an electroencephalograph and processed on a computer to estimate the “sadness” that
person is feeling. Depending on the estimated degree of “sadness,” music in asad mood is played (feedback). As a result, when you listen to the music played,
you become aware of your own emotional state . By further adjusting one's own
brain activity and by trying to hear more “pleasant” music (training), one acquires
the skill of self-regulating one's own brain activity. As in the above example,“through sounds and other means, perceiving (feedback of)” one's “own brain
activity (neuro)” is called neurofeedback.

4

Estimates emotions from brain waves
and plays music that matches them.

GQ2

What is neurofeedback?

Are consumer-grade neurofeedback products safe?
The safety of consumer neurofeedback products has notbeen fully tested, and it is unclear what risks are associated with the use of consumer neurofeedback productsin everyday life. A report published in 2020 on the side
effects of using medical/research-grade products reported the occurrence of side effects in 5 out of 21 experiments that used neurofeedback3. The most commonlyoccurring side effects were headset discomfort anddrowsiness, followed by irritation and headache 3.
Another report in 2015 also identified side effects suchas decline in performance and sleep disturbances 4.
However, these reports include people with medical
conditions and may not be directly applicable tohealthy adults (Table 2). We also do not know if casesof particular products can be applicable to neurofeedback technology in general. There are otherprecautions to keep in mind with brain interventions
Authors

Hassan et al.

5

Elbogen et al.6

Vuckovic et al.7

Hershaw et al.8

themselves, as discussed in Appendix 2, “Risks andEthical Issues Associated with the Use of Neuro Technology''.
Thus, there are still unknown risks and unresolved
issues with neurofeedback. When using consumer
neurofeedback products, be aware of these uncertainties and use them with caution. If symptoms of concern appear, stop using the product immediately andconsult a healthcare provider. Depending on the symptoms, we also recommend reporting to the National
Consumer Center (see Note 1). However, even if side
effects do occur, if the product is not an approved medical device, the Relief Systems for Adverse Drug Reactions (see Note 2) does not apply. In other words,
please keep in mind that the use of consumer-gradeneurofeedback products is based on the premise of
self-responsibility.

Year

Participants

Interventions

Reported side effects

2015

Seven spinal cord injury
patients with paralysis andpain in the lower limbs.

Using a 16-channel electroencephalograph,audiovisual neurofeedback to promoterelaxation and reduce lower extremity pain
was administered 3-5 times per week, for a
total of 40 sessions.

Three participants developed
cramps in the lower extremities.
Symptoms abated later that
day.

2021

Forty-one veterans sufferingfrom traumatic brain injury
and PTSD.

Using a commercially available EEG headset and neurofeedback application,
auditory neurofeedback to promote relaxation was administered four times per
week for three months.

Discomfort due to headset(n=14), Drowsiness after training (n=13), Irritability (n=6),
Headache (n=3), Dizziness (n=1),
Tinnitus (n=1), Muscle cramps(n=14). All of the patients' symptoms disappeared when they
stopped training.

2019

Seven spinal cord injury
patients with paralysis and painin the limbs.

Using a commercially available EEG headset and feedback application, visual neurofeedback to promote relaxation for fiveminutes per session was given 5-6 times
per day for two months.

Some participants felt headaches, plantar tingling, andhypersensitivity symptoms.
Symptoms disappeared whentraining time was reduced.

2020

Thirty-eight veterans sufferingfrom traumatic brain injury and
PTSD.

Using a 19-channel electroencephalograph, a custom neurofeedback wasadministered 10-30 minutes per session,
and was repeated for a minimum of 15
sessions within 6 weeks.

Two participants felt nausea andheadache.

Table 2. Examples of side effects associated with neurofeedback intervention
Note 1) National Consumer Affair Center of Japan (NCAC) is an administrative agency that provides information and conducts research on
consumer affairs from a comprehensive perspective, to create a stable and improved life for consumers, as well as contributing to theirsafety and wellbeing9. NCAC also undertakes Alternative Dispute Resolution (ADR) procedures to resolve important consumer disputes.
Note 2) In Japan, Relief Systems for Adverse Drug Reactions is a system that compensates for health hazards caused by adverse drug
reactions that can occur even if the drug was properly used10. The purposes of the compensation include medical fees, disabilities, death,
supporting the dependents of the affected person, and funeral expenses that were incurred due to the adverse drug reaction.

5

GQ3

What is neuromodulation?

Summary

Explanation

Neuromodulation is the modification of neurological
function, including both neuronal and glial cell activity,
through delivery of a stimulus, such as electricalstimulation, magnetic stimulation, or chemical agents,
to specific neurological targets 11 . Research anddevelopment in medical and research institutions is
ongoing, and some technologies, such as deep brain
stimulation and transcranial magnetic stimulation, arecovered by public health insurance in Japan. On theother hand, neuromodulation products distributed forthe general public are completely different from these
medical/research-grade Neurotech products, and their
methodologies, safety, and effectiveness have not been
sufficiently established. A technology often found in
consumer-grade products is the transcranial direct
current stimulation (tDCS) device, which delivers weak
direct currents via electrodes placed on the scalp. There
are a lot of unknowns surrounding the potential risks oftDCS. Therefore, we recommend that the generalpublic, without specialized knowledge, should not use
consumer-grade neuromodulation products.

What types of neuromodulation products
for general consumers are available?
Neuromodulation products for general consumers mainly
make claims for the following fields and uses2 (Table 3).
However, these claims are only made by the sellers on
their websites or in their product catalogs, and theireffectiveness has not been sufficiently verified.
Health Care
Relaxation / Sleep Improvement : Magnetic field stimulation promotes relaxation and sleep onset.
Appetite suppression : electrical stimulation of the mastoid
process suppresses appetite through stimulation of the hypothalamus via the vestibular nerve.
Improved mood : electrical stimulation of the prefrontal cortex
improves depressed mood.
Neuroprotective and restorative effects : transcranial andnasal irradiation of light at 10 Hz (near alpha-frequency band),protects nerves.
Capacity Improvement
Improved motor performance : stimulates the motor
cortex and increases the effectiveness of motor training forskill, speed, endurance, etc.
Improvement of cognitive function : Stimulation of thefrontal lobe by generating micro-electrical signals with aheadset temporarily improves cognitive function.

Caution: The above product examples are only one-sided claims
made by the sellers on their websites or in their product catalogs.
Whether the efficacy and safety of the products have beenscientifically proven was not verified as a part of this guidebook.
In addition, most of the products are sold overseas and havegone through a translation process into Japanese, but containexpressions that under the law and regulations, should bemanufactured and sold as medical devices in Japan. Pleasethoroughly check the relevant laws and regulations when selling
products.

An Example of Neuromodulation

Various physical stimuli are applied from outside the body to thecentral nervous system such as the brain, to adjust the function of
the nervous system. Typical stimulation is through the use of electricity or magnetism. Recently, ultrasound and light stimulation
methods have also been studied. Although the brain is the main
stimulation site, there are also stimulation methods that aim to act
indirectly on the brain by stimulating peripheral nerves such as thevestibular nerve. On the other hand, it is difficult for the generalpublic to correctly set or adjust parameters such as the stimulation
method, location, intensity, and frequency, which can be counterproductive or pose unforeseen risks.

6

GQ3

What is neuromodulation?

Are neuromodulation products for general
consumers safe?
The Guidebook Development Committee recommends that the general public, without specialized
knowledge, do not use consumer-grade neuromodulation products. These products are different fromthose used for medical purposes; to add to the fact that
their safety has not been adequately confirmed,
because they work directly on the brain and nerves,both physically and chemically, they are considered tohave higher potential risks compared to other Neurotechs. The efficacy of consumer-grade neuromodulation products also remains unclear. As an international
expert opinion published in 2022 noted, companies
manufacturing consumer-grade products are increasing sales of their products despite the effects of theirproducts not being clear, because there are no strict
screening processes for selling their products12.
In Japan, as of 2022, neuromodulation products for general consumers have not been determined either applicable or non-applicable as medical devices, and there
are no regulations or management systems in place forsuch products. Therefore, the user is responsible in thecase that side effects or health hazards result from theuse of neuromodulation. Considering that neuromodulation directly stimulates the brain and nervous system,and therefore poses the highest risk of health hazards
among Neurotech products, we do not recommend its
use until its efficacy and safety are confirmed. The Japanese Society of Clinical Neurophysiology has also cautioned, “The usage effectiveness of these devices has
not been sufficiently verified scientifically13. As shown in
the fact that there have been reports of cognitive
decline with the use of commercially available tDCS
devices, the safety of the devices themselves has notbeen sufficiently verified. No recommendations are
made regarding the use of self-treatment devices andtheir protocols unless both efficacy and safety havebeen demonstrated by the International Federation ofClinical Neurophysiology.” 14 Internationally, there are
few reliable data on neuromodulation products for consumer use, and it is stated that further validation isneeded12. Therefore, current neuromodulation technology should be viewed as a medical or researchdevice to be used for specific purposes and withsafety management practices, by medical and academic institutions. Casual use should be avoided.

7

GQ4

What should I be aware of withregards to commercial products?

Summary
selecting a commercially available product, it is yourresponsibility to carefully evaluate whether the performance, effectiveness, and safety of the producthave been thoroughly verified and explained, andwhether a post-purchase support system is in place.
Personal use of more dangerous neuromodulation products that stimulate the brain is not recommended.

Consumer Neurotech products can be purchased
directly by the general public. However, it should be
noted that unlike medical/research products, there isno system of approval or certification, and the frameworks for regulation or compensation of the products
are not yet established, so use is at your own risk. Thereis a possibility that dangerous or dubious productswith unknown efficacy may be on the market. When

Explanation
As of 2022, consumer Neurotech products sold for
health promotion and entertainment purposes are
sold through corporate e-commerce sites, major
online shopping websites, and import agent shopping websites, and direct transactions by consumers
are not regulated. However, unlike medical devices,

their quality, efficacy, and safety are not verified bythird parties such as the public sectors or specialized
agencies. Since scientific support and certainty are
not guaranteed, consumers themselves need to be
more careful. Specifically, consumers should beaware of the following.

Confirm product safety and usage purposes

information such as brain waves to control air conditioners, alarm clocks, and music players” would pose
little danger because it is not trying to affect the body orbrain in any way. However, we cannot rule out the possibility that even these products may cause side effects
such as headaches or brain fatigue beyond what was
initially anticipated, due to trying to use the brain as
hard as possible. If any unusual symptoms occur, stopusing the product immediately and seek medical attention. Afterwards, please report to the National Consumer Center that you have experienced a change in yourhealth condition.
On the other hand, if a consumer Neurotech productappears to be making claims on affecting the size,
shape, or function of the brain, such as “preventing
brain atrophy” or “improving cognitive function,” usewith caution. This is because such products must
undergo a rigorous review process as a medical device
before it can be sold (Appendix 1). If the product has
not been approved or certified as a medical device, thescientific evidence for its effectiveness in changing brain
structure and function is insufficient. In the first place,since there is no mechanism or institution to test for
efficacy and safety, it is up to the company to decide
whether or not to conduct sufficient verification, and it is
up to the users themselves to determine them.

Since Neurotech is a product applied to the human
body, safety is the most important aspect. Safety
refers to both the safety of the product itself (e.g., “Is
the device sharp enough not to injure the head?” , “Is
the output too strong and cause burns?” , “Will it
break easily? ” ) and the safety of the effects on thehuman body when using the device (e.g., “Will it cause
pain?”, “Will it make me sick?”, “Will it have an counterproductive effect?”). For product safety, it is desirable
to confirm that products are designed, manufactured, and inspected for shipment in accordance with
JIS (Japanese Industrial Standards), ISO (International
Organization for Standardization), and IEC (International Electrotechnical Commission) standards for safe
design of industrial products. However, since this is avoluntary standard, not following the standard does not
immediately mean that the product is unsafe. Since theeffects on the human body vary depending on the technology, please refer to GQ2 “What is Neurofeedback?”and GQ3: “What is neuromodulation?” for more information. Next, carefully read the product's functions andintended use to see if it affects the structure and function of the brain and nerves. For example, a Neurotech
product such as “a program that detects physiological

8

GQ4

What should I be aware of with regards to commercial products?

Correctly understand the meaning of the written “effect”
It is also important not to have an exaggerated interpretation of product effects and not to have an overly
high expectation. For example, if a product claims that
it is “expected to improve concentration,” this onlymeans that “it was created with the expectation ofsuch an effect, but it has not yet been proven that itreally does so”. If a published paper or in-houseresearch has verified the effectiveness of the product,
it would be beneficial to correctly understand underwhat conditions, with whom, and in what way was the
product used, for an improvement in which functions,

it is not for certain that the same effect will be seen inother situations, such as in studying or sports. Also, if
individual characteristics such as gender, age, and their
original cognitive or motor abilities are different, it isuncertain that the same effect can be expected foreveryone. It is necessary to read the product description carefully and correctly understand what is known
about the product.
Based on these considerations, we believe that thefollowing conditions are essential for a reliable Neurotech product (Box 1). We recommend that you thor-

and to what degree. Even if an improvement in concentration has been observed in one limited situation,oughly check these points when selecting a Neurotech product.

Three checkpoints to select a reliable Neurotech product① Product reliability→ Has the efficacy, safety, and performance been verified using the product? If a product is
not properly tested for effectiveness, it may not be effective even when used correctly.

② Reliability of the technology→ Is information about risks and how to address risks provided? Please check if the user
manual describes anything regarding usage that should be followed, such as the recommended time of use per day. Besides, information on the scientific basis and limitations
should be disclosed in an appropriate and detailed manner.

③ Reliability of the seller→ Is a support system in place? Post-purchase follow-up, such as a contact person, would be agreat help for general consumers if something goes wrong. In other words, the seller
should have a post-purchase follow-up system in place, including having a contact point forinquiries and conducting recalls if necessary.

9

GQ4

What should I be aware of with regards to commercial products?
Reliability of the product itself First, let's check the performance, effectiveness, and safety of the device itself
・Is the accuracy of the measurement equipment and signal processing acceptable?
obtained, the signal processing, such as noise reduction andthe creation of brain decoding models, must be accurate. As
described, the correct brain state may not be estimateddue to various factors such as the device itself, signal processing, consumer usage, and the environment in which
the device was used. A product that displays the actual
measured EEG and allows the user to check and makeadjustments on whether it is being measured and processed correctly would be more reliable.
Although the reliability of such measuring instruments andinformation processing is often not known from theoutside because they are not required to be labeled, it ismeaningful to evaluate reliability from the perspectives
described above. This is an area where manufacturers
should make efforts to disclose information with moretransparency.

Here, we will discuss the reliability of signal quality, that is,whether the equipment is able to accurately record brain
activity (biological signals), and the reliability of signal processing, that is, whether the signals obtained inside themachine are correctly processed. EEG, the most commonlyused method of recording brain activity, is a weak biologicalsignal that is easily mixed with noise, making it difficult torecord accurately. Therefore, there are many considerations
that must be made in order to correctly record EEG signals.
First, the EEG electrodes are checked for proper placementon the head. In addition, the electrodes must be designed forthe purpose of EEG measurement and must have a mechanism to hold the electrodes securely in place. Consumers are
required to maintain the correct posture during the measurement and to be aware of noise sources in theirsurrounding environments (e.g., conduction/ radiationnoise and physical vibrations). Even when correct signals are

・Has the product itself been used to verify its effectiveness through scientifically sound procedures?
When selecting a Neurotech product, whether or not the
product itself has been used to verify its effectiveness isanother important piece of information to determine its
credibility. For example, for a product to claim to improvemuscle strength, it must be shown through scientific validation that “muscle strength actually improved significantly
when the product has been used” . In addition, it is preferable for the process and results to be reviewed (peer-reviewed) by a third party, approved, and published as an
academic paper. As mentioned above, a good rule of thumbis whether the verification of the product's effectivenesshas been published as a peer-reviewed academic paper.
However, since the quality of papers varies, the existence of apaper does not necessarily provide sufficient evidence. Therefore, in the future, it would be beneficial to have a third-party
committee that can further verify the validity of the product.
A 2019 international study examined 41 different consumer
Neurotech products and found that only 8 had scientificallyverified the product's claimed benefits and published themin a paper15. Additionally, 29 of the products made it appear

as if they had evidence by having links to websites or articles
that provided scientific evidence15. However, the articles
were about the results of using similar products, and no verification was conducted using the product itself. Of course, it
is possible that those products are also effective, butthere is insufficient certainty. Confirming whether theeffectiveness of a product has been verified using the
product itself is very important in order to determine thereliability of the product.
In fact, making excessive claims can violate Article 5of the Act against Unjustifiable Premiums and Misleading Representations (see Note 3), which prohibits misrepresentation, misrepresentation of quality, and misrepresentation of advantage, as is the case with health foods
and health appliances, and can be the subject of disciplinary action. However, there are also some labeling thatcleverly manipulates impressions, and consumers themselves need to be more careful in judging the effectiveness and safety of such labeling.
A signal measured by an EEG system

EEG is prone to noise
EEG is a difficult biological signal to measure because it is easily mixed withnoise (i.e., components other than EEG). For example, when a person walks

EEG

or moves, noise from muscle activity and physical vibration are contaminated into the EEG signal. If these are not removed from the “EEG” data, it may

Muscle activity

lead to incorrect results. A product that carefully explains how to correctly
measure brain waves and allows the user to check the actual signals will be
more likely to produce the correct effect.

Body movement

10

GQ4

What should I be aware of with regards to commercial products?

Reliability of the technology itself - Is it even possible with current neuroscience?

The sales websites of Neurotech products claim a wide
variety of functions. However, are they really feasible
with the current understanding of neuroscience? The
validity of these functions must be carefully verified. It is
a common understanding among researchers that
although an increasing amount of things can beaccomplished using neuroscience, there are still manythings that we do not know about or can only partiallyachieve. We don't know if the features claimed by Neurotech products are scientifically valid. In other words,

personalities, and complex emotions from brain waves.
Specifically what and how much can be done will becovered in the Evidence Book to be published soon. We
recommend that you evaluate how reliable the neuroscientific evidence and techniques used in the products
currently are, referring to the Evidence Book. Online
information can also be helpful if they are reliable sources of information (Appendix 3). Note that products that
do not even describe what kind of neuroscience technology they use (so-called black box products) are less

it is necessary to evaluate how reliable the neuroscientific evidence and technology used by these products,
currently are. For example, with current technology, it
is not easy to accurately read sophisticated thoughts,

reliable because it is difficult to evaluate and judge
them from the outside. For all Neurotech, scientifictransparency is an essential element.

What can we read from the EEG?
This picture shows a person measuring their brain activity (EEG).
EEG is recorded as a continuous wave “signal” as shown in the
figure. It does not measure the activity of individual neurons (thebrain’ s nerve cells), but only the synchronous activity of 10 to 100
million cells, and the activity of many cells is averaged out. Therefore, it only reads out fragmentary information; the EEG recording
systems with a small number of channels, such as those that arecommercially available, can only decipher general brain statessuch as “are the eyes open or closed”, and “is the user sleepy orawake”, and general movement intents such as “whether theuser wants to go right or left”, or “whether the user is trying tomove a device, appliance, or game”. Current technology has not
yet reached the point of analyzing the full range of brain activity,

She wants togo right

She is sleepy

Her eyes
are openand scientists believe that this is likely impossible with today's
technology.

Note 3) Act against Unjustifiable Premiums and Misleading Representations (Act No. 134 of 1962), as defined under Japanese law, wascreated in order to protect the interests of general consumers by preventing their inducement by means of unjustifiable premiums andmisleading representations with regards to the transaction of goods and services, this Act places limitations on and prohibits acts that arelikely to interfere with general consumers' voluntary and rational choice-making.

11

GQ4

What should I be aware of with regards to commercial products?

Reliability of the sellerDoes the seller provide a comprehensive explanation of the product and support system?

When selecting a distributor of Neurotech products, an
important aspect to consider is whether the company ishonest in its disclosure of information to you, the consumer. Specifically, does the website or instruction
manual provide a thorough explanation of how the
product is used, how its functions are verified, and therisks involved? For example, the company must have a
support system in place with clear and sufficient information disclosure, such as product description, scientificbasis, usage, risks of use, related knowledge, contents of
ethics committee review, glossary, customer feedback,frequently asked questions, and customer support contact.
Suppose the product itself is defective (i.e., lacks thesafety that a product should normally have) and causes
damage to life or health. In that case, the Product Liability Law (PL Law) may be used to seek compensation fromthe manufacturer, or for imported products, from theimporter. However, the consumer must prove a causal
relationship between the defect and the health hazard,
and even if the claim is approved, there is a possibility
that overseas manufacturers or small start-ups may not
be able to immediately provide adequate compensation.

Furthermore, side effects may occur even if the productis not defective and is used according to the instruction
manual. While there are public compensation programs such as the Japanese Postmarketing Relief Systems for Adverse Drug Reactions (see Note 2), for side
effects that occur despite the correct use of a productapproved as a drug, public compensation for healthhazards is not applicable to consumer Neurotech products because they are not approved as a medical
device.
Compensation and support systems are common
issues to all non-medical devices in general, but compared to health devices such as those used for resistance training and relaxation devices, Neurotech products require even greater caution because the risks are
not yet well understood (Appendix 2). For this reason,
consumers must use them at their own risk, referring toalerts issued by academic societies, notifications fromthe National Consumer Center, or online sources about
related issues. When selecting a product, it is importantto carefully read the descriptions about the post-purchase support system and choose reliable distributors
and products.

12

GQ5

What should I keep in mind
when developing a product?

SummaryThis section is intended not for the general public, but forcompanies that are considering operating a businessusing Neurotech products or services. As we have shownin this document, several issues have been raised internationally regarding Neurotech products for general consumers, such as assuring their quality, safety and efficacy,
management and protection of privacy, and establishing
follow-up systems15. The ethical and moral responsibility

to assure these is required of businesses and industry
associations. Even without waiting for legislation, it would
be desirable for industry associations to voluntarily establish standards and build a system to enforce compliance.
More responsible information disclosure and communication with consumers will be essential for Neurotech to
become a technology trusted by society.

Explanation
Challenges identified internationally for Neurotech businesses
Issue 1. Insufficient verification and information disclosure on efficacy and safety,
which may lead to misunderstanding by general consumers.
designs in order to demonstrate the effects of a product. For
example, to show that a product reduces pain, it is necessary
to prepare sham products that are indistinguishable from thereal product to the user, test both real and sham products
under the same conditions, and show that the real productreduces pain better than the sham product. This is to show
the product is more effective than the placebo effect of experiencing pain suppression simply by using a sham product.
So, what points should we be aware of in validations in orderto say that we can trust the claimed effects of a product orservice? Scientists generally verify reliability by checking thefollowing points (Box 2).

General consumers are not able to verify the validity of theeffects claimed by Neurotech products on their own. It is
desirable for businesses as providers to verify the effectiveness, performance, and safety of their products, disclose
the results in detail, and establish a sales system thatenables consumers to correctly judge the effectivenessand safety of their products16. Even if validation tests havebeen conducted, it may be uncertain whether results
obtained in a controlled experimental environment are
directly applicable to consumer-grade products used ineveryday life. In addition, it is essential to have appropriate
control groups, experimental settings, and experimental● The design of the experiment: What kind of design was used? Are biases and confounds controlled?

● Who is being tested: Effects may be different for different ethnic groups, ages, genders, and personality traits.

● Subject recruitment methods: Are recruitment methods appropriate? Free from conflicts of interest (COI) or any otherpotential biases?
● Individual differences: There may be individual differences due to genetic diversity or differences in brain characteristics.

● State of participant: Effects can vary due to the participants’ mental state, physical conditions, diurnal variation, hormonal
status, etc.
● State of verification performed: Under what circumstances, how much, and how often?

● Pre-registration: Has the research hypothesis and data collection/analysis plan been submitted to a third party before
collecting data?
● Monitoring: Is a third-party oversight system in place for the verification process?
● Data publication: Is the actual verification data itself available to the public?
● COI disclosures: Are COI disclosures being made appropriately?

● Comparison with other methods: Between traditionally available methods and the new Neurotech product being tested,which one would be recommended, based on a comprehensive comparison of factors such as whether other traditional methods would achieve the same effect, and the hurdles in the implementation of new technology?

● Generalizability of the results: Can the results that were directly verified be expected to have the same effect under otherconditions?

13

GQ5

What should I keep in mind when developing a product?

Issue 2: Ambiguous definitions of effectiveness or
making claims beyond the limits of neuroscience.

Issue 4: Issues related to privacy and identity in using
brain information.

Abstract terms such as concentration and stress arereceived in different ways by consumers. For example,
when someone says “improved concentration,” some may
think of improved focus while working, while others may
think of improved performance in sports, improvement from
distraction due to disability, and many other effects. It
is thought that instead of only mentioning the improvement in concentration, also providing an explanation of
specifically what it is effective for, and in what circumstances, would prevent excessive expectations and misunderstandings. It is also important to explain how effective

Brain signals obtained by measuring brain activity canbe considered personal information if they are managed in combination with information that can identify
the subject. On the other hand, it is difficult to identify
the subject based on the brain signals alone, and at
this stage, they are not considered personal information and are not regulated. However, sales, resales, or
third party usages of these data without the consent of
the subject is undesirable. Furthermore, there arerecent reports that individuals can be identified with acertain degree of accuracy from EEG characteristics17,18,

they are, including the effect size. If it only stated, “it was
effective,” consumers may expect a near 100%, immediate
improvement. Since there is a considerably wide range ofeffects, it is necessary to mention what specific effects wereconfirmed, such as whether the effects are noticeable, whether they produce behavioral changes, what percentage of
people benefited, how strong the effects are compared toother standard methods, and whether the effectiveness ofthe method changes when used in combination with othermethods.

and depending on future technological developments,
it may become necessary to strictly treat brain signals as
personally identifiable information, even on its own. In
addition to the issue of privacy, it is necessary to takemeasures to prevent prejudice and discrimination if it
becomes possible to determine a person's personal
preferences and abilities from neural data.

Issue 3: Lack of communication about possible risks
and countermeasures.
Even within “Neurotech,” different risks can beassociated with different technologies and products, and there are many things we do not yet
know. For example, in the case of electrical stimulators,
there may be physical harm such as burns, and in thecase of products that use EEG, there may be psychological harm where inaccurate measurements provide
untrue results and consumers are driven by unnecessary anxiety (such as becoming anxious when they arelabeled as stressed when they are not really stressed). It
has been pointed out that half of the products on themarket overseas do not adequately describe theinvolved risks and what to do if the condition worsens14.
Please see Appendix 2 for more information. Businesses are expected to be willing to communicate
with consumers by fully explaining possible risks
and providing a post-purchase support system.

14

GQ5

What should I keep in mind when developing a product?
Measures to consider when running a Neurotech businessIn order to address the issues noted above, the Guidebook
Development Committee suggests, as an example, thatsellers consider the following items. Please note, however,that these items are not a complete list of necessary requirements.
1. Check the relevant laws and regulations and confirm
whether or not the device is considered as a medical
deviceAs described in Appendix 1, in Japan, Neurotech products(both hardware and software) may be categorized as medical devices depending on their mechanism or purpose.
Although defined in writing, Regulations under the Pharmaceutical and Medical Device Act do not draw a clear line inoperation, and applicability tends to be judged comprehensively based on the mechanism and function of individual
products, the intended use, and reports of health hazards.
Especially in the developing Neurotech market, it is undeniable that a product may become subject to regulations after
its launch, depending on the accumulation of future findings
and damage reports. When developing and marketing a
product, it is recommended to thoroughly check the relevantlaws and regulations, and if necessary, consult with the Pharmaceuticals and Medical Devices Agency (PMDA, see Note 4),
the Pharmaceuticals Division of each prefecture, or officials in
the pharmaceuticals division of other local governments.
2. Ensure safety as a manufactured product and biological safety
Since Neurotech products are industrial products that are
applied to the human body, it is necessary to ensure theproduct is defect-free (safety as a manufactured product) andthat no adverse effects on the human body when the product is used (biological safety). For safety as a product, it is desirable to comply with industrial standards such as JIS (JapaneseIndustrial Standards), ISO (International Organization for Standardization), and IEC (International Electrotechnical Commission). If there is no appropriate standard, it is desirable to startby establishing a new standard.
With regards to biological safety, carefully investigate anddisclose whether any side effects or adverse events have everoccurred in similar products or technologies. In addition,
under the review and advice of the Ethics Committee, verify
the efficacy and safety of the product by conducting
Proof-of-Concept studies using the product in question in an
ethically sound manner. In particular, if there is concern about
the effects of the product on the human body, it is desirable
to establish a research system that includes physicians.

15

GQ5

What should I keep in mind when developing a product?

-Methods of data processing: specific statistical method,etc.
-Evaluation items and indicators employed to verify claims:
whether they are subjective indicators, behavioral indicators, or other biomarkers.
-Exact effects of using the product: difference from control
condition, effect size.

8. Publish compliance guidelines for privacy and rights
protection
It is recommended that you establish and post privacy andrights protection policies, and this applies not only for Neurotech, but for all modern technologies including AI-based
products. The following are particularly important for Neurotech.
-Handling and protection of information regarding an individual’ s brain and information obtained through use of Neurotech.
-Security assurance to protect against unauthorized use without consent.
-Facilitating opportunities for individuals to choose how
their data is used and will be retained, including options
for access, correction and deletion of personal data.

5. Define the expected effects in detail and describe
them correctly to avoid misunderstandings or excessive expectations
As mentioned above, general and abstract claims can leadto misunderstandings and excessive expectations since
the interpretation of such claims is left to the consumer.
Therefore, it is recommended to use easy-to-understandexpressions and describe in detail what is confirmed bywhat kind of validation, what can be changed, how, and towhat extent. It is also desirable to carefully describe what
has not been verified, what could not be done, or what
could not be understood (e.g., it has not been tried on
young people or in different environments, there are large
individual differences because half of the people did not
find it effective).

9. When conducting research and development, cooperate with medical and research institutions and otherresearch organizations, and comply with ethical standards
When conducting research and development, it is desirable to proceed in the form of joint research withresearch institutions, and to verify efficacy and safety inan ethical manner under the review and advice of an
ethics committee. In particular, if there is concern about
effects on the human body, it is desirable to establish a
research system that includes physicians. The ethicaland moral obligation to reduce the uncertainties andresolve the challenges associated with Neurotech, as
discussed in this document, lies with the developer, notthe consumer. While cost and effort may be a concern,
please consider careful development of Neurotech sothat it becomes a trusted industry.

6. Include warnings in the instructions to avoid unintended use or misuse
Since Neurotech is a new technology that has not yet permeated our daily lives, it is necessary to carefully explain how to
use it correctly, and furthermore, to take measures to prevent
unintended use or misuse of the technology. It is recommended to provide tutorials with videos, documents or otherreferences to ensure correct use. Preset monitoring
programs that can mechanically check if the device is actually
being used correctly, are also recommended.
7. Describe possible risks and ways to handle them, andprovide a contact address for inquiries
There are risks associated with the use of Neurotech, as
described in Appendix 2. Since risks themselves exist with any
technology, it is important to explain to consumers inadvance the possibility of such risks and ways to deal withthem, and to establish a system that allows consumers todecide whether or not to use the product after fully understanding and agreeing to the risks. It is also recommended
that a contact or inquiry form be established to provide asystem for answering any problems or concerns that may
arise after purchase.

Note 4) Pharmaceuticals and Medical Devices Agency (PMDA) is aJapanese regulatory agency with the aim of protecting publichealth through assuring the safety, efficacy, and quality ofpharmaceutical and medical devices10. Its main functions areproviding relief compensations for health hazards, approving
pharmaceuticals and medical devices for marketing authorization
through conducting scientific reviews, and monitoring theirpost-market safety.

16

Appendix Definition of medical devices and1 treatment of consumer Neurotech products
Remark: This Appendix contains topics related to pharmaceutical laws and regulations in Japan. The following
contents may only apply in Japan.

Are consumer-grade products not considered as medical devices?
human function can be considered as a medical device. From
this definition, a product that merely operates a game using
brain waves would not be considered as a medical device.
However, since the purpose of the Pharmaceutical and Medical Device Act is to protect the public from health hazards, thelaw, cabinet orders, and their interpretations are flexibly
revised as needed. There are no clear standards or lines
regarding the applicability of medical devices, so deci-

Article 2, paragraph 4 of the Pharmaceutical and Medical
Device Act (see Note 5) refers to medical devices as, “appliances or instruments, etc. which are intended for use in the diagnosis, treatment or prevention of disease in humans or
animals, or intended to affect the structure or functioning of
the bodies of humans or animals (excluding regenerative
medicine products), and which are specified by Cabinet
Order19.” In other words, Neurotech products that are
intended to diagnose, treat, or prevent diseases or toaffect the structure or function of the body, that are also
specified by a Cabinet Order (Article 1 of the Order for
Enforcement of the Pharmaceutical and Medical Device
Act; Cabinet Order No. 11 of 1961), are classified as medical
devices. Medical devices must be approved and certified by
the law with respect to the quality of the product itself, theeffectiveness of the device’ s impact on humans in diagnosis,
treatment, and prevention of medical conditions, and thesafety and usage method of the device when used onhumans. Only medical device manufacturers and distributors
are allowed to manufacture, import, and sell medical devices
in the domestic market, and only devices that have beenverified for quality, efficacy, and safety and approved, certified,and notified by the Minister of Health, Labour and Welfare ora third-party certification body are allowed to be sold. If the
product is considered as a medical device, it will be marked
as such. It will be labeled with either its approval number,license number, certification number, or notification
number.
Does that mean a Neurotech product that uses brain waves
to control a game does not need to be approved as a medical
device? If one only superficially reads the text of the Pharmaceutical and Medical Device Act, which states, “appliances or
instruments, etc. intended to affect the structure or functionof the human or animal body,” any device intended to affectsions are made based on a comprehensive review offactors, including product characteristics, reports of damage,the accumulation of new knowledge, and technologicaladvances. Neurotech products for general consumers thatare currently not considered as medical devices by thenational or prefectural governments will be subject to thePharmaceutical and Medical Device Act if any effects on
brain function or side effects are revealed in the future.

Applicability as a medical device is not clear-cut,
and is determined comprehensively
Is it claiming
the same effects
as medical devices?

What kind of program
does the system use?

Have
any health hazards
occurred?

Have any new ﬁndings
or expert opinions
been reported?

Consumer Neurotech product17

Appendix

1

Definition of medical devices and treatment of consumer Neurotech products
What should I be aware of when a product is not a medical device or its applicability is unknown ?
For Neurotech products that are not labeled as medical devices or are unclear, it is advisable for the general public to first
confirm whether they are indeed not applicable as medical
devices. This is because some Neurotech products that claim
not to be medical devices may affect the structure and functions of the human body, and if used incorrectly, it may
cause health hazards. Products that are marketed andclaim indications and effects similar to those of medical
devices without approval are considered as unapproved
medical devices and may be subject to apprehension.
Here we introduce what to do if you see a suspicious product suspected of being an unapproved medical device
or if you experience a health hazard. To be approved asa medical device, a product must undergo a review byronmental Health Bureau and the Pharmaceuticals Divisions of prefectural governments (click here for a list20) arein charge of regulating pharmaceutical affairs for products that are already on the market. The “Ayashii Yakubutsu Contact Net” 21 provides consumers with information
and a contact point for reporting incidents. If you find a
Neurotech product for general consumers that is anunapproved medical device intended to diagnose, treat,or prevent a disease or affect the structure or functionof the body, such as “brain stimulation,” please report itto these helplines. Let us make society a place where
safe and secure Neurotech is nurtured through smoothcooperation between industry, government, academia,
and the private sector.

the Pharmaceuticals and Medical Devices Agency (PMDA)10, an independent administrative agency that is
responsible for performing the three functions ofhealth hazard remedy, approval review, and creating
safety measures, with regards to pharmaceuticals
and other products. On the other hand, the Compliance and Narcotics Division of the Ministry of Health,Labour and Welfare's Pharmaceuticals Safety and Envi-

If you experience any health hazards, please seek medical
attention immediately. At the same time, please keep adetailed record of which product was used, as well as
when, what kind, and to what extent symptoms occurred,along with other information such as photographs. Report
the information to the above helplines or the National
Consumer Center.

【Contact points for reporting suspected medical device products】①If the address of the business is known from its website, or other such sources
If you know the prefecture, the city or special ward where the business has its address, please contact the respective
local government. Contact e-mail addresses and other information can be found in the Ministry of Health, Labour andWelfare's “Request for Information on Internet Sites Suspected of Violating the Pharmaceuticals and Medical Devices
Act” .
②Cases where the address of the business is unknown or is an overseas business
Please contact one of the following.
a. Contact the “Ayashii Yakubutsu Contact Net” by phone or report form.
Contact: +81-3-5542-1865 or https://www.yakubutsu.mhlw.go.jp/#form
b. Contact the Compliance and Narcotics Division of the Ministry of Health, Labour and Welfare's Pharmaceuticals Safety
and Environmental Health Bureau by email.
yakuji-net@mhlw.go.jp【Information on unapproved and unlicensed drugs and health hazards can be found at:】
①Ministry of Health, Labour and Welfare website, “Information on Unapproved and Unlicensed Drugs.” (https://www.mhlw.go.jp/stf/kinkyu/diet/musyounin.html)②National Consumer Center Website.
(https://www.kokusen.go.jp/ )Note 5) Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960), also
called the Pharmaceutical and Medical Device Act, was added to the Japanese law with the purpose of improving public health andhygiene. This law allows for conducting the necessary regulations to ensure the quality, efficacy and safety of pharmaceuticals,quasi-pharmaceutical products, cosmetics, medical devices, and regenerative medicine products, and for preventing the occurrence or
spread of health-related hazards due to usage of these products. It also includes taking measures against designated substances, andtaking necessary measures for the promotion of research and development of pharmaceuticals, medical devices and regenerative
medicine products that fulfill high medical needs.

18Appendix

2

Risks and ethical issues associatedwith the use of Neurotech

Summary

Explanation

Risks are different depending on the type of Neurotech
product. BMI and neurofeedback products, which measure brain waves and other signals and output them toa machine, are considered to have a low risk of serious
side effects if used properly. On the other hand, neuromodulation-type products that apply stimulation to thebrain are considered to have relatively high risks to thebody, and it is recommended that laypeople refrain fromusing them. Furthermore, since Neurotech targets thebrain, a special organ that controls the human mind (personality and identity), there are unique risks and ethical,
social, and legal issues that are not present in other technologies. Because it is a developing technology, new risks
may emerge as the technology progresses. It is necessary to use Neurotech with caution while gathering
information and recognizing that there are still
unknown and unresolved issues.
When using these products, keep and follow the established methods and ranges. Even if the change seems
meaningless at first glance, the effects on livingorganisms may change drastically in unexpected
ways, so great care must be taken.

In the Ethical Guide to BMI Research22 published by Japanese researchers, it is thought to be essential to consider
the following risks when using Neurotech:
1) Risks associated with technology and devices intervening in brain function.
2) Time, physical, and mental strain that occurs while
becoming familiar with novel technology and devices.
3) Psychological burden and anxiety may arise due to theuser's inability to use the technology and devices properly.
4) Daily life can be transformed with the use of technology
and devices.
5) Current science cannot always predict the effects oflong-term use of novel technology and devices.
6) Measures are not fully in place to ensure the safety ofthe technology and devices and to reduce the above burdens.
In addition to these issues, because the brain is a specialorgan that controls the personality and mind, unique
ethical, social, and legal issues that do not exist withother technologies can arise. While international discussions are underway to resolve these issues, many have yet
to be resolved as of 2022. As technology develops, theindustry, government, academia, and the private sector
must engage in discussions to establish rules andshared understanding. In the following, we will discuss
the particularly important issues of risks associated withintervening in brain functions and ethical issues. For
more information on other topics, please see the Ethics
Guide for BMI Research22.

19

Appendix

2

Risks and ethical issues associate with the use of Neurotech

What are the risks of intervening in brain function?
When considering the risks associated with Neurotech, it isnecessary to distinguish between risks to the body, suchas pain and itching, and risks to brain function. The risks tothe body vary depending on the type of technology andcan be referred under GQ2 “What is Neurofeedback?”and GQ3 “What is Neuromodulation?” Typical risks to brain
function include the following.

3. The risks associated with daily and long-term use
are yet unknown
The risks identified to date have occurred in studies thathave been carefully conducted under the supervision of
medical or research institutions, with the approval of ethics
committees. When we use the products in our daily lives,
previously unreported risks may occur. In particular, thepotential risks associated with long-term use of the product have not been studied on a larger scale, and reviews
regarding safety need to be more comprehensive. As technology progresses, new products may be developed, andnew risks may arise. When using a product, careful use isrecommended by closely monitoring daily changes and consulting an inquiry desk or healthcare providers if any
abnormalities occur.

1. Unexpected changes may be irreversible
Neuroplasticity refers to the brain’ s ability to change andmaintain the change. In other words, if the brain is changed
through training or other means, it is not known whether
the original (pre-training) state can be restored, even if
undesirable side effects occur. In addition, once the brain isaltered, it may not return to its original state (irreversibility).
There is no known way to immediately reverse the changes
when the results are unexpected. This point needs carefulconsideration. Of course, if good changes occur and aremaintained, it may be possible to resolve issues that previous
methods could not resolve. However, it is important to notethat irreversibility can work for the better or for the worse.

Desired changes
might not occur.

It might produce
unexpected changes.

2. It may not produce the expected effects or may
even produce opposite effects
Even for the technology and devices that have been scientifically proven to be effective, unforeseen factors (e.g.,weather, the person's physical characteristics, and physicalcondition) may prevent the reproduction of the same
results. This is called the reproducibility problem. For
example, even if the same methods were used as
described in the paper, the same results may not be
obtained due to some factors. This has also been a problem in studies using medical devices on human subjects. In
worse cases, the opposite effect of the intended outcome(e.g., loss of concentration, an increase in stress) may be
produced. However, it is unknown why these phenomena
occur and under what conditions they can be prevented. It
is important to know that the brain responds moreunpredictably than any other organ, and experienced
effects differ between individuals.

20

It might produce
the opposite effect.

We still donʼt know
the risks ofeveryday usage.

Appendix

2

Risks and ethical issues associate with the use of Neurotech

What ethical issues are involved?
・Concerns about enhancement (artificially improving
abilities)
When Neurotech products are used in daily life for the purpose of enhancing human abilities themselves, there areconcerns, for example, about whether it is morally permissible to enhance abilities that were originally impossible forhumans, whether it would be a form of doping in sports,
and whether it would be an impermissible intervention to
the human body. Concerns also lie in the possibility of
inequality between those who do and do not engage inenhancement, as well as the widening gap between therich and the poor due to their differences in abilities toaccess technology.
On the other hand, the effects and scope of what canbe achieved with currently available commercial Neurotech products are not large. For more information,please refer to the forthcoming Evidence Book and thereview12 on neuroenhancement by brain stimulation
experts. The actual effects on the body are estimatedto be comparable to those of other enhancement
techniques (e.g., strength training, electrical stimulation of skin and muscles, coffee, and taking dietary
supplements) and are not as powerful and immediate as doping with drugs. Neurotech is often associated with doping, but as of 2022, no Neurotech products are listed on the World Anti-Doping Code. However, the situation may change with advances in technology, so it is advisable to check for the latest information.

Ethical challenges can be brought with any technologicaldevelopment. Many ethical issues raised in neuroscience
research are in common with those in other fields ofscience and are not unique23. However, Neurotech deals
with the brain, a specialized organ that controls the
personality and mind. Therefore, there are unique challenges, such as the protection of privacy, including
thoughts and feelings, threats to personal will, and violations of self-determination. These issues are the subjectof much international discussion (see Note 6) but have
yet to be resolved. These challenges must be recognized
not only by Neurotech developers but also by the consumers who want to use them. In order to solve these issues, it
is important to aim for consensus building throughdiscussions and collaboration between the industry,
government, academia, and the private sector, in parallel with technological development. This section introduces ethical issues that should be considered when using
consumer Neurotech products.

Note 6) For example, in parallel with the development of advanced neuroscience technologies, the BRAIN Initiative (Brain Researchthrough Advancing Innovative Neurotechnologies Initiative) promoted in the U.S., is developing guidelines to address ethical issues thatwere brought up by the U.S. Presidential Commission for the Study of Bioethical Issues.

21Appendix

2

Risks and ethical issues associate with the use of Neurotech

・Privacy concerns
Brain signals obtained by measuring brain activity may
contain sensitive information because they are informationfrom the brain which controls thoughts and personality. Thus,
there may be concerns about privacy, such as “Thoughts andfeelings may be read” and “Thoughts may be misused.” Infact, it is possible, though not 100% accurate, to determine general brain states such as “Are eyes open or
closed?” or “Sleepy or awake?” and general motor intentions such as “Do you want to go right or left?,” or“Which device, appliance, or game are you trying to
move?” On the other hand, it is not yet possible to estimate advanced thoughts, personalities, and complex
emotions, such as, “What are they thinking right now?”or “What are their personalities, interests, and hobbies?”
It is impossible to read everything from brain signals and weare only able to estimate vague physical or mental states bymathematically processing extremely weak signals. Therefore, there is no need to be overly concerned about
privacy when using Neurotech products for general
consumers at this time. However, as Neurotech
becomes more widely used, more functions will likely
be achieved, and discussions should be held in parallel with development.
There is also progress in the development of technologythat aims at identifying individuals using their brain signals.

Some have suggested that brain signals alone, without any other identifying information, should be treated as
personal information. Although personal identification isconsidered difficult to achieve with the current technology
due to its low accuracy, it may be achieved in the future.
Although ethical issues related to Neurotech, such as
the ones mentioned above, are being debated aroundthe world, no unified guidelines or viewpoint has beenreached. Since the responsibility for proactively resolving
ethical issues lies not with consumers but with the industry, it
is imperative that they take the initiative to recognize theseissues, take action to address them, and apply measures
to protect consumer rights and privacy. Particularly, when
conducting research and development, it is recommended to proceed in collaboration with medical or research
institutions and to proceed with ethical standards under
the review and advice of an ethics committee. On theother hand, having consent based on the proactive understanding on the consumer side is also essential. It is necessary to aim for the sound development of the industry
through repeated discussions and consensus building
among industry, government, academia, and the private
sector, and establishing rules in a manner similar tosetting voluntary self-imposed standards (see Note 7)
without waiting for legislation.

Note 7) An example from another field is the “Voluntary Standards to be Observed by Businesses Handling Personal Genetic
Information” . The Association of Genetic Information (https://aogi.jp/), which developed the standards, was established to enableconsumers to select technically, ethically, legally, and socially respectable and appropriate genetic testing services, to promote theprovision of easy-to-understand and appropriate genetic testing services by businesses to consumers, and to ensure that genetic testing
services are properly understood and permeated soundly through society. As described in the above example, it is expected thatcompanies and other entities that sell products will voluntarily establish rules to promote the sound development of the industry.

22

Appendix

3

How to get the latest information
on Neurotech

Summary

Explanation

There are three primary sources of information about
Neurotech. The first is the latest news from companies and media outlets. Mass media, marketing companies, and more recently, individual researchers andexperts are broadcasting news about neuroscience.
The second is the latest academic papers publishedin peer-reviewed neuroscience journals. The third isstatements and other documents issued by publicorganizations such as the Organization for Economic
Co-operation and Development (OECD). Some publishers and organizations send out up-to-datee-newsletters or provide the latest information
through their social media accounts. By registeringor following these and checking their posts regularly,
you can stay up-to-date with the latest information. It
is also a good idea to check websites for official
announcements and news on safety issues issued by
the National Consumer Center, the National Consumer Affairs Center, and related academic societies.

Latest news and topics
from companies and media
For example, the following websites, some of whichcharge a fee, provide up-to-date information about
product development and company initiatives in aneasy-to-understand manner. In many cases, the information is linked to the publication of academic
papers, and if you want to stay informed, it is recommended that you sign up for email newsletters, memberships, or follow social networking accounts. However, please be sure to thoroughly check the sourceof the information, as it may contain information ofquestionable authenticity.
[English]-IEEE brain (https://brain.ieee.org/)-Neuroscience News.com (https://neurosciencenews.com/)-Science (https://www.science.org/)[Japanese]-Brain Tech Consortium (https://brain-tech.jp/)-Consortium for Applied Neuroscience (https://www.can-neuro.org/index.html)-Forbes Japan (https://forbesjapan.com/)-Medical AI Times (https://aitimes.media/)-MIT Tech review (https://www.technologyreview.jp/)-Mynavi News Business information media “TECH+” .
-Neuroscience News Summary Page (https://news.mynavi.jp/tag/brain/)-NeurotechJP (https://www.neurotechjp.com/jp/)

In addition, it is also effective to utilize search engine
alert functions, for example, Google's alert function to
set automatic delivery of news searched by keywords
such as BMI, BCI, neurofeedback, and Neurotech.
However, please note that gathering informationfrom search engines may result in notification of malicious or potentially dangerous sites. Also, please notethat while this method allows you to quickly search
for information from a wide range of sources, there isa possibility that inaccurate or unreliable information
may be detected. Please exercise caution.

23

Appendix

3

How to get the latest information on Neurotech

Academic Information

Public Agency Information
・OECD (https://www.oecd.org/naec/brain-capital/)
OECD stands for Organization for Economic Co-operation and Development. It was established in 1961 topromote the improvement of economic and social
welfare around the world. As such, it disseminates awide range of information, but has a page devoted
exclusively to neuroscience topics, providing a reliable and up-to-date overview of the latest topics andtrends.

If you want to know more specialized information, it isrecommended to read academic papers. Conversely,
it is also very important to check whether information
spread on websites and social media is based on academic papers or not. Recently, several news sites andsocial media accounts explain the latest academic
papers, so it is a good idea to first come in contact
with academic papers through such media. There area vast number of papers on neuroscience, and you
may feel lost. However, indicators such as whether
the paper is peer-reviewed (has it been reviewed by a・IEEE（https://brain.ieee.org/）IEEE stands for Institute of Electrical and Electronics
Engineers, an academic research organization andtechnical standards organization in the field of engineering. It contains reliable information on engineering, computing, and technology information fromaround the world. “IEEE brain" is a page that provides
information especially on advanced brain and neuroscience technologies.

third party?) and how many citations it has (howmany people have referenced the paper in otherresearch) will help you select a high-quality research
paper. Although this is only a guide, for your reference, we have listed some major neuroscience journals that meet these criteria. By regularly checking
the websites of these journals, as well as their social
media accounts, you can keep up with the latest
scholarly achievements in the world.
(Examples of major journals related to the field of
neuroscience)
Acta Neuropathologica / Annals of Neurology /Annual Review of Neuroscience / Brain / Brain Stimulation / Clinical Neurophysiology / Current Biology /EMBO Journal / JAMA Neurology / Journal of Neuroscience / Nature Neuroscience / Nature Review Neurology / Nature Reviews Neuroscience / NeuroImage/ Neurology / Neuron / Neuroscience & Biobehavioral
Reviews / Progress in Neurobiology / The Lancet
Neurology / Trends in Neuroscience24

Supplementary information
tion of the answers to each GQ within the Guidebook Development Committee. Next, we carefully
examined the content of the report by exchanging
opinions with academic societies and government
agencies in specialized fields, and by conducting a questionnaire survey of the general public, while incorporating the opinions of industry, government, academia,
and the private sector. For example, GQ3, “What is neuromodulation?” was written with the guidance andadvice of the members of the Subcommittee on Brain
Stimulation Methods of the Japanese Society of Clinical
Neurophysiology25, which is the most knowledgeable

Guidebook Creation Process
The “Liberation from Biological Limitations via Physical,
Cognitive and Perceptual Augmentation” (Project Manager: Ryota Kanai, Representative Organization:
Advanced Telecommunications Research Institute International, hereinafter referred to as “Moonshot Kanai
Project” ), an R&D project under Moonshot Goal 1 of theMoonshot Research & Development Program, established the “BMI Usage Guideline Development Committee” (Issue Promoter: Ryota Kanai, Araya Co., Ltd.) in July
2021 and started its activities with the aim of developing“BMI Usage Guideline” 1. To make the Usage Guideline
more neutral, in the interest of the public, and based on
scientific evidence, the committee has been working on
creating its organizational structure with reference tothe Minds Manual for Guideline Development 2020 ver.
3.0 24.
Meanwhile, a survey was conducted on the sales statusof Neurotech products for general consumers in Japanand abroad and whether they are accompanied byscientific evidence. The survey revealed that although
the number of products is increasing, most of them
have not been sufficiently verified for efficacy and safety.
It also became clear that although there are scientificpapers that have validated these products, there are
not enough high quality papers that meet the criteria of
the Minds Manual for Guideline Development 2020 ver.
3.024. In other words, the necessary sources for thedevelopment of the guideline do not exist. Thus, wethought that the formulation of the BMI Usage Guideline is not appropriate at this time, and it is necessary togroup in Japan in this field and is engaged in academic
activities and alerting the public to the issue. The Ministry of Health, Labour, and Welfare (MHLW), Surveillance
Guidance and Narcotics Control Division, helped us
improve the text in addition to holding opinion
exchange sessions on Appendix 1, “Definition of Medical Devices and Treatment of Consumer Neurotech
Products''. After the tentative text was completed, we
asked the general public to read this document andsurveyed them to see how their awareness of Neurotech had changed before and after reading the guidebook draft, and whether they had an appropriate
understanding (i.e., whether the intent of the guidebook was conveyed).
Following these processes, an external evaluation was
conducted by the Guidebook External Review Board,and the text was revised based on the points raised by
the board members. The revised text as a whole wasreviewed from a critical perspective by the members of
the Subcommittee on Brain Stimulation Methods of
the Japanese Society of Clinical Neurophysiology andfirst conduct high-quality research to verify efficacy andsafety. However, it is also necessary to inform the general public immediately about the current situation to prevent inappropriate market proliferation and health hazards. Products are increasingly being marketed without
clear evidence of efficacy and safety, as well as thesystems and organizations that guarantee them. Therefore, we changed the name to a guidebook and beganwriting it to inform the general public about the current
status of Neurotech products for general consumers.
The writing process began with the establishment ofGeneral Questions (hereinafter referred to as “GQ” )based on contents that the general public might havequestions about based on the market research2 andliterature review, and the discussion and formula-from a legal perspective by jurists and attorneys, andrevisions were made to make the text more appropriate. After these reworkings, a second external evaluation was conducted by the Guidebook External Review
Board, who verified the reliability and appropriatenessof the text from an objective and neutral perspective. In
addition, public comments were solicited before theguidebook was released to the public, and some of thepoints raised were reflected in the text26. All in all, theNeurotech Guidebook has been completed today withthe cooperation of many experts from industry, government, academia, and the private sector, and the generalpublic. The contents of the guidebook will be updated
as necessary after its release, based on the development of future research and discussions.

25Supplementary information

Acknowledgements
search use, opinions from a critical standpoint, and ethical considerations.
Dr. Keigo Komamura, Dr. Yoshinori Oshima, Dr. Takeyuki
Matsuo, and Dr. Masahiko Sudo: for their efforts in refining the text from a legal perspective.
The members of the Evidence Evaluation Committee:
We received various suggestions for revisions to thefirst draft of the guidebook.

We would like to thank the following individuals for theiradvice and guidance in the development of this guidebook.
Dr. Satoko Koganemaru and member of the Subcommittee on Brain Stimulation Methods of the JapaneseSociety of Clinical Neurophysiology25: for their usefuladvice on the risks and the importance of verifying theeffectiveness of Neurotech products for medical/re-

Management of COI and how to respond when it occurs
Conflict of interest (COI) is widespread in academic
and scientific publications. COI has the potential toskew several aspects of research, including how a
study is designed, how data is collected, processed,
and published, and who is involved in the work.
COI is briefly divided into economic COI, which isrelated to financial relationships and acquisition ofresearch funds with specific companies/organizations, and COI such as academic COI (research activities and expertise) that are non-economic in nature(hereinafter referred to as “academic COI” ). In addition to personal COI, financial and academic COI witheducational institutions such as universities and otheracademic organizations such as academic societies,
to which the committee members belong may also
affect guidebook development. Therefore, theGuidebook Development Committee formulated amethod of managing COI prior to the formulationof the guidebook in accordance with the Minds
Manual for Guideline Development 2020 ver. 3.0 24
and published a guideline regarding COI1. Specifically, the members of the Guidebook Development

Committee and Secretariat, as well as members of
the Guidebook External Evaluation Committee, areobliged to clarify any COI, and are required to reporttheir financial and academic COI for the three-year
period prior to their appointment. In addition, we ask
them to report the existence or non-existence of COI
during the previous year, if there is any COI thatexceeds the standards we have set. If it is found that
there is an error in previously self-reported information, they are obliged to notify the secretariat andpromptly file a revised report.
Based on the COI declarations submitted by members,
we checked for conflicts of interest and, if any, evaluated whether a management plan was necessary.
The declaration criteria for economic and academic
COI are published on the website¹. In addition, thecontents of the declarations themselves will be madepublic at the same time as the guidebook is published27 . Through these efforts, we are striving toensure that the content of the guidebook is neutral
and appropriate, and to earn the trust of society inthe use of Neurotech.

26

Supplementary information

Selection of External Review Board Members
Dr. Yoshiyuki Takimoto (Associate Professor / Physician,Graduate School of Medicine, University of Tokyo)
Dr. Takimoto is an expert in the field of medical ethics
and ELSI, and has been serving as the Director of theCenter for Patient Relations and Clinical Ethics Center at
the University of Tokyo Hospital since 2013. In addition,in the “Strategic Research Program for Brain Sciences,” aproject by the Japan Agency for Medical Research andDevelopment, he has been working on “research on
resolving ethical, legal, and social issues in neuroscience
research” , and as a result, he managed the “Intellectual
Network for Human, Society, and Brain Sciences28” andThe Minds Manual for Guideline Development 2020 ver.
3.024 recommends that an external evaluation organization including diverse experts and citizens be nominated and constituted by the committee that controls theoverall guideline development. Therefore, in the development of this guidebook, we considered it essential tonominate experts who have no conflict of interest or
master-disciple relationship with the Guidebook Development Committe as External Review Board members,
and to receive neutral and objective evaluation from athird party. In particular, considering that this guidebook
deals with consumer Neurotech, a technology that canbe used by anyone and, in some cases, has the potential to affect the brain, the Committee decided that it
would be appropriate to request an external evaluation
by a physician or an expert who is familiar with the fieldof Neuroethics. The names of the External Review Board
members and their areas of expertise are as follows.

wrote the “Ethical Guide for BMI Research22” . With sucha wealth of experience in solving issues in the field of
neuroethics, he was nominated by the Guidebook
Development Committee as a member of the External
Review Board because it was believed that he will beable to give an evaluation from a consumer-oriented
point of view, which outlines Neurotech.
Dr. Akifumi Shimanouchi (Associate Professor, Faculty of
Pharmaceutical Sciences, Hoshi University of Pharmacy
and Life Sciences)
Dr. Shimanouchi specializes in ethics and has an extensive record of research on ethical, legal, and social
issues that should be considered when drugs exert
their effects on humans, particularly from the perspective of “drug humanism” . He is also a co-author of the“Ethics Guide for BMI Research22” with Dr. Takimoto, andis well versed in ELSI. He was nominated by the Guidebook Development Committee as a member of theExternal Review Board because the knowledge and perspectives accumulated in the field of pharmacology
could be applied if society experienced a situation
where Neurotech is marketed without regulation andhas an effect on humans, and additionally that it is necessary to receive evaluation on the role and content of
this guideline from a neutral standpoint from a fieldother than neuroscience.

Dr. Ryuma Shineha (Associate Professor, ResearchCenter on Ethical, Legal and Social Issues, Osaka University)
Dr. Shineha specializes in the sociology of science, social
theory of science and technology, and science and technology policy, and has worked to clarify and resolve
issues that arise when novel technologies permeate
society, not only in Ethical, Legal and Social Issues (ELSI),
but also in many fields such as regenerative medicine,
molecular robotics, and genome editing. In particular,
he has focused on addressing issues from the perspective of science and technology governance, which
involves designing a system for society to make decisions or designing specific systems. Based on theseachievements, he was nominated as a member of theExternal Review Board by the Guidebook Development
Committee. It was believed that he can give an objective
evaluation on how to communicate what kind of content, when it came to educating society about the newtechnology of Neurotech.

27

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Contact for the Neurotech Guidebook
Neurotech Guidebook Development Committee Secretariat
E-mail：info_guideline@brains.link

28