Ethical risks and regulatory considerations in neurofeedback technology_Journal of Biomedical Engineering

Authors：

XUE Yuhang ^1,2 , LI Zhihao ^1,2 , WANG Fan ^1,2 , ZHAO Lei ^2,3 , LI Tianwen ^2,3 , GONG Anmin ⁴ , NAN Wenya ⁵ ,  FU Yunfa ^1,2

1. Faculty of Information Engineering and Automation, Kunming University of Science and Technology, Kunming 650500, P. R. China;
2. Brain Cognition and Brain-Computer Intelligence Integration Innovation Team, Kunming University of Science and Technology, Kunming 650500, P. R. China;
3. Faculty of Science, Kunming University of Science and Technology, Kunming 650500, P. R. China;
4. School of Information Engineering, Engineering University of PAP, Xi’an 710000, P. R. China;
5. School of Psychology, Shanghai Normal University, Shanghai 200234, P. R. China;

Corresponding?author：

Keywords：

Neurofeedback; Ethical risks; Ethical norms; Autonomy and privacy; Informed consent

DOI：

10.7507/1001-5515.202507052

Video：

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Neurofeedback transforms real-time brain activity features into multimodal feedback to guide self-regulation of brain function, showing potential applications in neuropsychiatric treatment and cognitive enhancement. However, its use entails ethical risks including cognitive autonomy, personal identity integrity, safety and efficacy, privacy protection, and the safeguarding of vulnerable populations, with informed consent challenges being particularly pronounced in implicit neurofeedback. Based on these risks, this paper proposes establishing an ethical evaluation framework for neurofeedback, promoting ethics-embedded design, and strengthening international cooperation and public education, emphasizing responsible innovation to align technological development with ethical safeguards.

Citation： XUE Yuhang, LI Zhihao, WANG Fan, ZHAO Lei, LI Tianwen, GONG Anmin, NAN Wenya, FU Yunfa. Ethical risks and regulatory considerations in neurofeedback technology. Journal of Biomedical Engineering, 2026, 43(2): 414-420. doi: 10.7507/1001-5515.202507052 Copy

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6.	Collura T F. Technical foundations of neurofeedback. New York: Routledge, 2014.
7.	伏云發, 龔安民, 南文雅, 等. 神經反饋原理與實踐. 北京: 電子工業出版社, 2021.
8.	Weiskopf N, Birbaumer N, Veit R, et al. Functional magnetic resonance imaging neurofeedback: principles and practice. 伏云發, 龔安民, 俞彥成, 等, 譯. 北京: 電子工業出版社, 2025.
9.	Gruzelier J H. EEG-neurofeedback for optimising performance. III: a review of methodological and theoretical considerations. Neurosci Biobehav Rev, 2014, 44: 159-182.
10.	Sulzer J, Haller S, Scharnowski F, et al. Real-time fMRI neurofeedback: progress and challenges. Neuroimage, 2013, 76: 386-399.
11.	袁密桁, 丁鵬, 南文雅, 等. 神經反饋訓練促進精神障礙康復的方法及其應用現狀. 中華神經醫學雜志, 2022, 21(9): 956-963.
12.	Shibata K, Lisi G, Cortese A, et al. Toward a comprehensive understanding of the neural mechanisms of decoded neurofeedback. Neuroimage, 2019, 188: 539-556.
13.	Taschereau-Dumouchel V, Cortese A, Chiba T, et al. Towards an unconscious neural reinforcement intervention for common fears. Proc Natl Acad Sci USA, 2018, 115(13): 3470-3475.
14.	Hammond D C. What is neurofeedback: an update. J Neurother, 2011, 15(4): 305-336.
15.	Enriquez-Geppert S, Huster R J, Herrmann C S. EEG-neurofeedback as a tool to modulate cognition and behavior: a review tutorial. Front Hum Neurosci, 2017, 11: 51.
16.	Arns M, De Ridder S, Strehl U, et al. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci, 2009, 40(3): 180-189.
17.	Young K D, Siegle G J, Zotev V, et al. Randomized clinical trial of real-time fMRI amygdala neurofeedback for major depressive disorder: effects on symptoms and autobiographical memory recall. Am J Psychiatry, 2017, 174(8): 748-755.
18.	Snowball A, Tachtsidis I, Popescu T, et al. Long-term enhancement of brain function and cognition using cognitive training and brain stimulation. Curr Biol, 2013, 23(11): 987-992.
19.	Keynan J N, Cohen A, Jackont G, et al. Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Nat Hum Behav, 2019, 3(1): 63-73.
20.	Shibata K, Watanabe T, Kawato M, et al. Differential activation patterns in the same brain region led to opposite emotional states. PLoS Biol, 2016, 14(9): e1002546.
21.	Ienca M, Andorno R. Towards new human rights in the age of neuroscience and neurotechnology. Life Sci Soc Policy, 2017, 13(1): 5.
22.	Schermer M. The mind and the machine: on the conceptual and moral implications of brain-machine interaction. Nanoethics, 2009, 3(3): 217-230.
23.	Cortese A, Amano K, Koizumi A, et al. Multivoxel neurofeedback selectively modulates confidence without changing perceptual performance. Nat Commun, 2016, 7: 13669.
24.	Erler A. Does memory modification threaten our authenticity? Neuroethics, 2011, 4(3): 235-249.
25.	Micoulaud-Franchi J A, Geoffroy P A, Fond G, et al. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci, 2014, 8: 906.
26.	Illes J, Bird S J. Neuroethics: a modern context for ethics in neuroscience. Trends Neurosci, 2006, 29(9): 511-517.
27.	Rainey S. An anticipatory approach to ethico-legal implications of future neurotechnology. Sci Eng Ethics, 2024, 30(3): 18.
28.	Ramot M, Kimmich S, Gonzalez-Castillo J, et al. Direct modulation of aberrant brain network connectivity through real-time neurofeedback. eLife, 2017, 6: e28974.
29.	Kragel P A, LaBar K S. Multivariate pattern classification reveals autonomic and experiential representations of discrete emotions. Emotion, 2013, 13(4): 681-690.
30.	Martin A, Becker K, Darragh M, et al. A four-part working bibliography of neuroethics: part 3: “second tradition neuroethics”: ethical issues in neuroscience. Philos Ethics Humanit Med, 2016, 11(1): 7.
31.	Adomaitis L, Grinbaum A. Neurotechnologies, ethics, and the limits of free will. Integr Psychol Behav Sci, 2024, 58(3): 894-907.
32.	Koizumi A, Amano K, Cortese A, et al. Fear reduction without fear through reinforcement of neural activity that bypasses conscious exposure. Nat Hum Behav, 2016, 1: 0006.
33.	Davidson B, Lipsman N. Neuroethics// Ethical challenges for the future of neurosurgery. Cham: Springer, 2024: 187-206.
34.	Farahany N A. The battle for your brain: defending the right to think freely in the age of neurotechnology. New York: St. Martin’s Press, 2023.
35.	Ligthart S, Ienca M, Meynen G, et al. Minding rights: mapping ethical and legal foundations of neurorights. Camb Q Healthc Ethics, 2023, 32(4): 461-481.
36.	國家科技倫理委員會人工智能倫理分委員會. 腦機接口研究倫理指引. 北京: 科學出版社, 2024.
37.	Schalk G, Brunner P, Allison B Z, et al. Translation of neurotechnologies. Nat Rev Bioeng, 2024, 2(8): 637-652.
38.	Eke D. Ethics and governance of neurotechnology in Africa: lessons from AI. JMIR Neurotechnology, 2024, 3(1): e56665.
39.	Taddeo M, Blanchard A, Thomas C. From AI ethics principles to practices: a teleological methodology to apply AI ethics principles in the defence domain. Philos Technol, 2024, 37(1): 42.
40.	Ferrell M L, Beatty A, Dubljevic V. The ethics of neuromarketing: a rapid review. Neuroethics, 2025, 18(1): 1-22.
41.	World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
42.	Winickoff D E, Garden H. The OECD approach to responsible innovation// Eyre H A, Berk M, Lavretsky H, et al. Convergence mental health: a transdisciplinary approach to innovation. Oxford: Oxford University Press, 2021: 79-95.
43.	Ienca M, Haselager P. Hacking the brain: brain–computer interfacing technology and the ethics of neurosecurity. Ethics Inf Technol, 2016, 18(2): 117-129.
44.	Racine E. Neuroscience, neuroethics, and the media// Handbook of neuroethics. Dordrecht: Springer, 2015: 1465-1471.
45.	Curot J, Valton L, Barbeau E J. Is iEEG-based cognitive neuroscience research clinically relevant? Examination of three “neuromemes”// Axmacher N. Intracranial EEG: a guide for cognitive neuroscientists. Cham: Springer, 2023: 155-175.
46.	Ros T, Enriquez-Geppert S, Zotev V, et al. Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). J Clin Neurophysiol, 2020, 37(6): 491-498.
47.	Yuste R, Goering S, Arcas B A Y, et al. Four ethical priorities for neurotechnologies and AI. Nature, 2017, 551(7679): 159-163.
48.	Salles A, Farisco M. Neuroethics and AI ethics: a proposal for collaboration. BMC Neurosci, 2024, 25(1): 41.
49.	Fins J J. Deep brain stimulation, deontology and duty: the moral obligation of non-abandonment at the neural interface. J Neural Eng, 2009, 6(5): 050201.
50.	Ferrarello S. Human emotions and the origins of bioethics. New York: Routledge, 2020.
51.	Stahl B C, Timmermans J, Flick C. Ethics of emerging information and communication technologies: on the implementation of responsible research and innovation. Sci Public Policy, 2017, 44(3): 369-381.
52.	Campos-Mu?iz D, Mendoza-Franco G A, Gardu?o-García C, et al. On the social complexity of neurotechnology: designing a futures workshop for the exploration of more just alternative futures. J Futures Stud, 2023, 28(2): 1-18.
53.	Hampson M. fMRI neurofeedback. London: Academic Press, 2021.
54.	Freberg L A. An introduction to applied behavioral neuroscience: biological psychology in everyday life. New York: Routledge, 2022.

1. Sitaram R, Ros T, Stoeckel L, et al. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci, 2017, 18(2): 86-100.
2. Thibault R T, Lifshitz M, Raz A. The self-regulating brain and neurofeedback: experimental science and clinical promise. Cortex, 2016, 74: 247-261.
3. Chaudhary U. Neurofeedback basics and applications: techniques, benefits, and ethical considerations// Expanding senses using neurotechnology: volume 1: foundation of brain-computer interface technology. Cham: Springer, 2025: 363-400.
4. Sandua D. Neurotechnology: brain-computer interface and the future of humanity. New York: David Sandua, 2024.
5. Wolpaw J R. Brain–computer interfaces// Handbook of clinical neurology. Amsterdam: Elsevier, 2013, 110: 67-74.
6. Collura T F. Technical foundations of neurofeedback. New York: Routledge, 2014.
7. 伏云發, 龔安民, 南文雅, 等. 神經反饋原理與實踐. 北京: 電子工業出版社, 2021.
8. Weiskopf N, Birbaumer N, Veit R, et al. Functional magnetic resonance imaging neurofeedback: principles and practice. 伏云發, 龔安民, 俞彥成, 等, 譯. 北京: 電子工業出版社, 2025.
9. Gruzelier J H. EEG-neurofeedback for optimising performance. III: a review of methodological and theoretical considerations. Neurosci Biobehav Rev, 2014, 44: 159-182.
10. Sulzer J, Haller S, Scharnowski F, et al. Real-time fMRI neurofeedback: progress and challenges. Neuroimage, 2013, 76: 386-399.
11. 袁密桁, 丁鵬, 南文雅, 等. 神經反饋訓練促進精神障礙康復的方法及其應用現狀. 中華神經醫學雜志, 2022, 21(9): 956-963.
12. Shibata K, Lisi G, Cortese A, et al. Toward a comprehensive understanding of the neural mechanisms of decoded neurofeedback. Neuroimage, 2019, 188: 539-556.
13. Taschereau-Dumouchel V, Cortese A, Chiba T, et al. Towards an unconscious neural reinforcement intervention for common fears. Proc Natl Acad Sci USA, 2018, 115(13): 3470-3475.
14. Hammond D C. What is neurofeedback: an update. J Neurother, 2011, 15(4): 305-336.
15. Enriquez-Geppert S, Huster R J, Herrmann C S. EEG-neurofeedback as a tool to modulate cognition and behavior: a review tutorial. Front Hum Neurosci, 2017, 11: 51.
16. Arns M, De Ridder S, Strehl U, et al. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci, 2009, 40(3): 180-189.
17. Young K D, Siegle G J, Zotev V, et al. Randomized clinical trial of real-time fMRI amygdala neurofeedback for major depressive disorder: effects on symptoms and autobiographical memory recall. Am J Psychiatry, 2017, 174(8): 748-755.
18. Snowball A, Tachtsidis I, Popescu T, et al. Long-term enhancement of brain function and cognition using cognitive training and brain stimulation. Curr Biol, 2013, 23(11): 987-992.
19. Keynan J N, Cohen A, Jackont G, et al. Electrical fingerprint of the amygdala guides neurofeedback training for stress resilience. Nat Hum Behav, 2019, 3(1): 63-73.
20. Shibata K, Watanabe T, Kawato M, et al. Differential activation patterns in the same brain region led to opposite emotional states. PLoS Biol, 2016, 14(9): e1002546.
21. Ienca M, Andorno R. Towards new human rights in the age of neuroscience and neurotechnology. Life Sci Soc Policy, 2017, 13(1): 5.
22. Schermer M. The mind and the machine: on the conceptual and moral implications of brain-machine interaction. Nanoethics, 2009, 3(3): 217-230.
23. Cortese A, Amano K, Koizumi A, et al. Multivoxel neurofeedback selectively modulates confidence without changing perceptual performance. Nat Commun, 2016, 7: 13669.
24. Erler A. Does memory modification threaten our authenticity? Neuroethics, 2011, 4(3): 235-249.
25. Micoulaud-Franchi J A, Geoffroy P A, Fond G, et al. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci, 2014, 8: 906.
26. Illes J, Bird S J. Neuroethics: a modern context for ethics in neuroscience. Trends Neurosci, 2006, 29(9): 511-517.
27. Rainey S. An anticipatory approach to ethico-legal implications of future neurotechnology. Sci Eng Ethics, 2024, 30(3): 18.
28. Ramot M, Kimmich S, Gonzalez-Castillo J, et al. Direct modulation of aberrant brain network connectivity through real-time neurofeedback. eLife, 2017, 6: e28974.
29. Kragel P A, LaBar K S. Multivariate pattern classification reveals autonomic and experiential representations of discrete emotions. Emotion, 2013, 13(4): 681-690.
30. Martin A, Becker K, Darragh M, et al. A four-part working bibliography of neuroethics: part 3: “second tradition neuroethics”: ethical issues in neuroscience. Philos Ethics Humanit Med, 2016, 11(1): 7.
31. Adomaitis L, Grinbaum A. Neurotechnologies, ethics, and the limits of free will. Integr Psychol Behav Sci, 2024, 58(3): 894-907.
32. Koizumi A, Amano K, Cortese A, et al. Fear reduction without fear through reinforcement of neural activity that bypasses conscious exposure. Nat Hum Behav, 2016, 1: 0006.
33. Davidson B, Lipsman N. Neuroethics// Ethical challenges for the future of neurosurgery. Cham: Springer, 2024: 187-206.
34. Farahany N A. The battle for your brain: defending the right to think freely in the age of neurotechnology. New York: St. Martin’s Press, 2023.
35. Ligthart S, Ienca M, Meynen G, et al. Minding rights: mapping ethical and legal foundations of neurorights. Camb Q Healthc Ethics, 2023, 32(4): 461-481.
36. 國家科技倫理委員會人工智能倫理分委員會. 腦機接口研究倫理指引. 北京: 科學出版社, 2024.
37. Schalk G, Brunner P, Allison B Z, et al. Translation of neurotechnologies. Nat Rev Bioeng, 2024, 2(8): 637-652.
38. Eke D. Ethics and governance of neurotechnology in Africa: lessons from AI. JMIR Neurotechnology, 2024, 3(1): e56665.
39. Taddeo M, Blanchard A, Thomas C. From AI ethics principles to practices: a teleological methodology to apply AI ethics principles in the defence domain. Philos Technol, 2024, 37(1): 42.
40. Ferrell M L, Beatty A, Dubljevic V. The ethics of neuromarketing: a rapid review. Neuroethics, 2025, 18(1): 1-22.
41. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
42. Winickoff D E, Garden H. The OECD approach to responsible innovation// Eyre H A, Berk M, Lavretsky H, et al. Convergence mental health: a transdisciplinary approach to innovation. Oxford: Oxford University Press, 2021: 79-95.
43. Ienca M, Haselager P. Hacking the brain: brain–computer interfacing technology and the ethics of neurosecurity. Ethics Inf Technol, 2016, 18(2): 117-129.
44. Racine E. Neuroscience, neuroethics, and the media// Handbook of neuroethics. Dordrecht: Springer, 2015: 1465-1471.
45. Curot J, Valton L, Barbeau E J. Is iEEG-based cognitive neuroscience research clinically relevant? Examination of three “neuromemes”// Axmacher N. Intracranial EEG: a guide for cognitive neuroscientists. Cham: Springer, 2023: 155-175.
46. Ros T, Enriquez-Geppert S, Zotev V, et al. Consensus on the reporting and experimental design of clinical and cognitive-behavioural neurofeedback studies (CRED-nf checklist). J Clin Neurophysiol, 2020, 37(6): 491-498.
47. Yuste R, Goering S, Arcas B A Y, et al. Four ethical priorities for neurotechnologies and AI. Nature, 2017, 551(7679): 159-163.
48. Salles A, Farisco M. Neuroethics and AI ethics: a proposal for collaboration. BMC Neurosci, 2024, 25(1): 41.
49. Fins J J. Deep brain stimulation, deontology and duty: the moral obligation of non-abandonment at the neural interface. J Neural Eng, 2009, 6(5): 050201.
50. Ferrarello S. Human emotions and the origins of bioethics. New York: Routledge, 2020.
51. Stahl B C, Timmermans J, Flick C. Ethics of emerging information and communication technologies: on the implementation of responsible research and innovation. Sci Public Policy, 2017, 44(3): 369-381.
52. Campos-Mu?iz D, Mendoza-Franco G A, Gardu?o-García C, et al. On the social complexity of neurotechnology: designing a futures workshop for the exploration of more just alternative futures. J Futures Stud, 2023, 28(2): 1-18.
53. Hampson M. fMRI neurofeedback. London: Academic Press, 2021.
54. Freberg L A. An introduction to applied behavioral neuroscience: biological psychology in everyday life. New York: Routledge, 2022.

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