Thank you for your comments on the Draft NeuroTech Guidebook. Please find below the comments received and the committee’s reply.
Comments on the Draft NeuroTech Guidebook and the Committee’s Reply
|No.||Comments received||Committee’s reply|
I think it is good to describe the findings that there is still no proper data and little evidence because of the increasing number of scandalous NeuroTechs.
|Thank you very much for your opinion. The Committee prepared this document not to promote NeuroTech, but to provide the facts as our priority. We have repeatedly explained that “there is no proper data and little evidence (certainty)” is also an issue in this field.|
|2||The Guidebook clearly describes the limitations and risks of the current NeuroTech, and I think it is so excellent that I would like to distribute it not only to “interested parties,” which is the target of the Guidebook but also to researchers and investigators. We are convinced that product development, marketing, sales, and other activities that do not follow the contents of this Guidebook will not be accepted by society in the long term, even if they temporarily attract attention, and we endorse this initiative, believing that it is important for social development.||Thank you very much for your endorsement. As you have pointed out, this is a field that is easily highlighted by the media, etc., but we believe that information based on scientific evidence has not been widely disseminated. In particular, we believe that unless a system is established to guarantee efficacy and safety, we will not be able to gain the trust of society. In the future, we intend to engage in activities to formulate voluntary standards (e.g., how to accumulate and disclose evidence to ensure the reliability of products) that can be used as a reference during product development, marketing, sales, and other activities.|
|3||At the beginning of the “Preface” it is stated that the purpose of this Guidebook is “to make people aware of the current situation and issues,” but why not go further and say “to promote the sound development of NeuroTech by making people aware of the current situation and issues? ” The limitations and risks of NeuroTech described in this Guidebook could be misunderstood as setting a restriction for the development of NeuroTech. To avoid such an interpretation, we think it would be desirable to set the objective of “development” rather than just “making people aware of it.”||Thank you very much for your comments. We have carefully considered whether to include the phrase “to promote sound development” in the Guidebook. As a result, we did not include it in the Guidebook at the time of its publication. The reason for this is the fact that there is no system or methodology in place to ensure “soundness,” not only in the field of NeuroTech but also in the field of healthcare in general. The creation of criteria for “soundness” itself is required in all non-healthcare fields, and we have decided not to include it in this document because we believe that the definition of “soundness” cannot be sufficiently defined at this time.|
In the explanation of “GQ1 What is NeuroTech/BMI?” there is a statement that “it is possible to actually move a machine by simply imagining it moving in your mind without moving your body.” I believe that there are quite a few people who take this expression to mean “visually imagining the machine in motion (and the machine operating as it does),” but this is not the case, as Appendix 2 of this Guidebook states, “High-level thinking such as ‘what are you thinking now… …’ is not realized.” I think we are pushing the technical limits of what is possible. It is unfortunate because other parts of the report are extremely accurate and carefully described. For example, how about rephrasing it as “It will be possible to actually move machines by successfully reading and processing brain signals without moving the body”?
|Thank you very much for pointing this out. As mentioned, the phrase “just by imagining” was considered to be an expression that could lead to misinterpretation or misunderstanding. We have changed the phrase to “…successfully reading and processing brain signals allows for the machine to be moved without physically moving,” as you suggested.|
While it is great that learning resources for readers to learn on their own and contact points at the Ministry of Health, Labor and Welfare and the National Consumer Affairs Center to report cases of serious violations are indicated, we feel that both actions pose a high hurdle. A contact point (by the Guidebook Development Committee, Moonshot Kanai Project, or its members) where more casual questions can be discussed would contribute to the dissemination of the contents of this Guidebook. Of course, even if such a contact point exists, it would not be and should not be appropriate to directly answer questions about the efficacy and risks of individual products, but it would be useful, for example, if the respondent says, “I read the paper myself, but I can’t judge whether the experimental design is good or bad,” a meaningful response might be provided by introducing an appropriate reference. Or, even if it is difficult to establish a clear “contact point” for inquiries, I think it would be useful to post the e-mail address of the Guidebook Development Committee.
|Thank you very much for your suggestion. As you pointed out, it is necessary to have a contact point where people can easily consult with us. We have included the contact information of the Committee as contact.|
Thank you very much for the Guidebook. I think it is a very good Guidebook. One minor point is that the neurofeedback in GQ2 seems to refer only to visual and auditory feedback. Recently, tactile feedback is also being developed, so how about changing the part “through visual and sound representations” to something like “through the five senses”? Thank you for your consideration.
|Thank you very much for your comments. Regarding the sense of touch, we have changed the description to “…through images, sounds, or even touch, taste, and smell of the five senses” because it is an important method of feedback.|
|7||We believe that your proposed Guidebook is a timely proposal that is necessary for the present society, even looking into the near future. We salute you for creating such a useful proposal. At this point, I have not read the entire document in detail, but there is one thing that initially caught my attention. That is the lack of any mention of the age of the target population. The description of NeuroTech and the precautions for its application in this proposal all seem to be geared toward adults. However, for example, a NeuroTech product that aims to improve motor skills and cognitive functions could be used by middle and high school students, students preparing for entrance exams, and in some cases, kindergarten and elementary school students. The results of modern research on NeuroTech are probably mostly for adults. The impact of NeuroTech applications on the developing brain may be more serious, but there is probably little data available. Therefore, I think it should be clearly stated at the outset that this Guidebook is intended for adults and does not apply to minors. Otherwise, this Guidebook is long and extensive, and it took me quite some time to read through it. I think it would be better to simplify the descriptions a little more. As mentioned above, I greatly appreciate the suggestions you have made. I hope that you will consider the public comments and complete an even better Guidebook.||Thank you very much for your comments. As you have pointed out, there is very little data available on studies conducted on minors. Therefore, this Guidebook does not apply to minors. We have not explained this point well enough. In the “Preface” section, we have added the phrase “This document is composed mainly based on research conducted on healthy adults. Minors and NeuroTechs for medical purposes such as diagnosing and treating diseases are not the subjects of this document.” In addition, we have revised the simplified descriptions so that readers can understand only the important information by reading only the colored sections without reading the entire Guidebook.|
|8||(1) The target and purpose of the Guidebook are unclear.
(2) If the Guidebook is intended for the general public, no one will look at it unless it is easily accessible.
(3) If you are interested in the Guidebook before purchasing, you would rather use other search engines, so you will not be inclined to bother to look at the Guidebook. Whether search engines are fair or not is one question, but they seem to be fair at first glance. It seems that many members of the public have the impression that Guidebooks published by academic societies and corporations are somewhat less impartial.
(4) The public is not so concerned about the line between medical devices and consumer-oriented NeuroTech.
(5) They may think that commercial products are being sold because almost all the risks and ethical issues have been cleared.
(6) Even if they notice a difference between their expectations and reality when they purchase the device, they may think it is a common occurrence.
|Thank you very much for your opinion.
Regarding comment (1), we state at the beginning of the document, “This Guidebook was developed to inform those who are interested in NeuroTech products about the current status and issues.” at the beginning of the Guidebook.
As for comment (2), the file of the Guidebook will be posted on the web page so that anyone can access the Guidebook.
As for comment (3), this Guidebook does not prevent you from using search engines or other sources of information. On the other hand, such information may contain insufficiently reliable or optimistic information (i.e., they do not explain the risks). This Guidebook is based on information, and we believe that this Guidebook plays a significant role as a medium for such enlightenment.
As for comment (4), regulation of NeuroTech products is currently underway, and we have included this information to prevent health hazards caused by the use of dangerous products (products that should be approved as medical devices but are not, for example). The purpose of this article is to prevent the use of dangerous products (i.e., products that should be approved as medical devices but are not) that may cause health problems.
As for comment (5), it has been pointed out as an international issue that products are sold without clearing these issues, and it is significant to make this fact known to the public.
As for comment (6), it has been regarded that the NeuroTech field is prone to excessive expectations (or anxiety), and we would not be able to judge whether they have been factored in or not. It is the purpose of this document to eliminate any differences.
|9||Before publishing Guidebook, a close examination of the technology for each technique and discussion among experts is necessary. It is thought that doing this seems like building a tower on the sand and it is very dangerous.||Thank you very much for your comments. We believe that you are right about the need for close examination of each technology and discussion among experts, but this Guidebook was developed to inform general consumers of the fact that “we have not yet even had that discussion.” Therefore, we have taken great care to avoid any expressions of “endorsement” of NeuroTech in this document. We have also clearly stated the points that have not been made clear and the issues that need to be addressed in the future. Therefore, the Committee believes that there is no suggestion that we are building a very dangerous tower on the sand.|
|10||The followings are the comments from a group of foreign experts: especially in Japan, experts themselves are no longer able to disseminate correct knowledge, and there is an absence of academia, scientists, and experts. We need to review the fundamental aspects.||Thank you very much for your comments. We will refrain from answering whether “experts themselves are no longer able to disseminate correct knowledge in Japan,” as this is outside the scope of this Committee’s work. We are also unable to judge whether there is an “absence of academia, scientists, or experts.”|