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About the Authors

Karen S. Rommelfanger is an internationally recognized neurotech ethicist and strategist. She founded the Institute of Neuroethics, the first international think and do tank dedicated wholly to neuroethics; offers strategic consulting for nonprofits, transnational policy entities, and companies, and maintains a faculty position in Emory University’s Departments of Neurology and Psychiatry & Behavioral Sciences.

Amanda Pustilnik is a Professor of Law at the University of Maryland School of Law, a program director at the Center for Law, Brain & Behavior at Massachusetts General Hospital, and a member of the Institute of Neuroethics. She serves as an advisor to Paradromics, a U.S.-based developer of medical brain-computer interfaces.

Arleen Salles is a Senior Researcher at the Center for Research Ethics and Bioethics at Uppsala University, Sweden. At present, she serves as Deputy Leader of Responsible Research an Innovation in the Human Brain Project. She is a founding board member of the Institute of Neuroethics.

Article

Mind the Gap: Lessons Learned from Neurorights

Why Neurorights Now?

Transnational organizations, think tanks, and scholars are currently debating the implications of new and powerful neurotechnologies, including whether there is need for regulations and new “neurorights” to protect individual cognitive liberty. The Organisation for Economic Co-operation and Development (OECD), an international policy organization with 38 member countries, generated the Recommendation on Responsible Innovation in Neurotechnology, and, together with the Council of Europe, recently organized a roundtable, “Neurotechnologies and Human Rights Framework: Do We Need New Rights?” Neurorights is also on the Organization of American States (OAS) Inter-American Juridical Committee (CJI)’s agenda, and the UN considered neurotechnology development in its 2021 report to the Secretary-General. Numerous civil society organizations are currently evaluating legal and ethical frameworks for neurotechnologies, notably the Neurorights Foundation, whose mission to develop “new human rights for the age of neurotechnology.” At the national level, Chile has enshrined a right to neuroprotection at the highest possible legal level—its constitution—and is developing legislation for neuroprotection as well.

Policy makers, scientists, ethics councils, and ethics and legal scholars are evaluating whether neurotechnologies present issues that must be addressed, and, if so, which legal and policy vehicles would best advance rights or interests.

Key questions for policymakers to consider include: which neurotechnologies are generating international and national interest across governmental and nongovernmental sectors? Which individual and societal interests could be impacted by these technologies and their uses? To advance or protect these interests, are neurorights necessary? If so, who should define neurorights, and which legal structures are best suited to embody and advance them? Experts in the neurotechnology and neurorights space disagree on fundamental aspects of these issues in proposals for neurorights, even on key definitions. We offer an overview of definitions and debates, and then outline some issues raised by the Chilean right to neuroprotection.

Neurotechnologies, Neurodata, and Ethical Issues

For our purposes, neurotechnologies are devices that interface with the brain that can sense or “read” information about or produced by the brain’s function, and/or offer input or “write” information into the brain to modulate function. Neurotechnologies include a diverse array of technologies that can be invasive or noninvasive and therapeutic or nontherapeutic. Neurotechnologies that detect the most detailed information about brain processes, and that have greater capability to affect brain processes, are often invasive, require surgical implantation, and are designed for clinical applications. Invasive neurotechnologies can have richer “read-write” capabilities; they typically sense and record information by measuring electrical activity from the brain, and then may modulate brain function (such as via stimulation).1 Implanted neurotechnologies have shown great promise for patients with movement disorders such as Parkinson’s disease and even can provide increased functionality to people with tetraplegia and other severe, previously untreatable disorders of mobility and communication.2 In these clinical contexts, neurotechnologies are empowering to patients, restoring and enabling a range of their functions. However, there have also been ethical concerns, given reports of unexpected changes to personality, identity, and decision-making, as well as positive and negative impacts on a personal sense of agency; non-invasive technologies may present similar and additional concerns.

Noninvasive neurotechnologies are more widely available than implantable devices and are currently consumer-ready. Hundreds of such devices are already on the market, primarily for gaming and consumer wellness, with many more under development. So far, most of these devices are based on the electroencephalogram, or EEG, which measures electrical activity via the scalp. Although EEG is a longstanding technology, historically its output was too imprecise or “noisy” to detect specific neurological activity. Now advances in combining EEG with AI-based data analysis, often through pattern classification algorithms, allow for increasingly sophisticated inferences from brain data about a person’s current state and possible future behavior. Such data can be derived from numerous other non-invasive neurotechnologies as well, such as functional magnetic resonance (fMRI) and functional near infrared spectroscopy (fNIRS).

Wider accessibility to neurotechnologies could allow individuals to gain better insights into their own behavior and make proactive lifestyle changes. Some might even view these as “enhancing” technologies. However, consumers may also face risks of exploitation wherein data from neurodevices is sold for marketing purposes, and could lead to discrimination from healthcare providers, insurance carriers, or employers. Uses (or misuses) by law enforcement are being explored. Brain-derived data detected and/or collected from neurotechnologies are arguably more sensitive and intimate than other biometric data, not only because of what can be interpreted regarding current mental states, but also what could be inferred from such data regarding the future, such as predictions of future cognitive capacity and neurological illness.3 For these reasons, “neurodata” have been singled out for their potential significance in the evolving landscape of the global data economy. Their implications and practical risks, particularly related to violations of privacy, have sparked conversations about the need for new ethical and regulatory frameworks.

Legal Protection for Neurodata

Some argue that existing laws, regulations, and soft law approaches, such as ethical guidelines, encompass neurodata (even while not using the term “neurodata”), offering sufficient protections from the unwanted application of neurotechnologies. Yet, most existing laws relating to health information and data privacy do not cover most uses of neurodata, leaving sensitive neurodata even less protected than other forms of personal data. In the U.S., for example, a patchwork of laws covers only limited scenarios relating to neurodata and neurotechnology. Healthcare privacy laws do include guidance for certain uses of brain-based data. But HIPAA, the Health Insurance Portability and Accountability Act of 1996, principally covers specific entities that hold data, such as hospitals, limiting what those entities can do with the data, and fails to limit other entities, like device makers. Nor does it protect the data itself. It also does not cover any consumer (non-medical) neurodata. Disability law could provide partial protections: under the Americans with Disabilities Act (ADA), for example, an employer cannot use neurodata (or any other) data to discriminate in hiring or promoting a worker on the basis of an actual or perceived disability.4 Still, this does not stop an employer from using neurodata for hiring or promotion decisions in any other way. The most protective law in the U.S. concerning personal biological information is the Genetic Information Nondiscrimination Act (GINA). This law, which prohibits discrimination in health insurance coverage or employment based on genetic information, could serve as one model for legislation to protect neurodata; as it stands, however, its protections are limited exclusively to genetics.

Data protection regulations in other countries are more comprehensive. One of the most notable and influential international comprehensive policies for protecting data is the European Union (EU)’s General Data Protection Regulation (GDPR). The GDPR places a number of requirements on data controllers and processors while providing rights (of access, erasure, rectification, and portability, as well as the right to opt out for a legitimate interest) to individuals over their personal data. The GDPR further acknowledges the sensitivity of biometric data as a “special category of data,” prohibiting the processing of biometric data subject to certain exemptions. Neurodata—if sufficient to identify an individual—would likely be covered under the law as biometric data.

However, even in existing regulatory frameworks that could be used to govern neurodata, there are significant gaps. For instance, laws and regulations that likely would classify neurodata as a type of biometric data, such as GDPR, generally focus on whether an individual can be identified based on these data, rather than inferences about an individual’s interests, preferences, health status, and psychology based on neurodata. Using such inferences to make decisions impacting the user or patient—such as which content to provide online, whether to sell this sensitive information to third parties for advertising or other purposes, or whether and how to tailor content or experiences that could be more addictive for certain individuals, based on psychology—could allow these entities to influence users’ commercial, social, and political behavior. Further, current regulations do not protect against discrimination based on neurological inferences, nor do they limit the use of neurodata-based technologies by law enforcement for surveillance or other purposes related to investigation or prosecution.

A Proposal for New Regulation and Rights

Not only are neurotechnological applications outpacing international legal protections, but they also reveal shortcomings in existing international human rights law.5 A growing call for special brain rights has been met with the formation of a U.S.-based Neurorights Initiative in 2019; the Digital Rights Charter in Spain, which includes specific neurotechnology provisions; and a proposed amendment to Brazil’s General Personal Data Protection Law (2018) to protect neurodata.6 Advocates for neurorights generally agree that (1) neurodata is a special category of information inextricably connected to people’s identity and agency, which serve as the basis for all other freedoms, and (2) individuals have a right to the integrity and privacy of their neurological processes, including related data.7

While some have argued that neurorights are indispensable tools to guide neurotechnology development, others call for caution. There is consensus that human interests must be protected; however, the articulation of new neurorights is not necessarily the appropriate legal tool. Proposals for neurorights could lead to “rights inflation,” that is, to a proliferation of new rights that dilute existing rights and the concept of “rights” itself. This is a particular risk should there be a rapid increase of unclearly scoped and potentially un-implementable neurorights. Neurorights may also be redundant, considering the UN Universal Declaration of Human Rights.8

Establishing Neurorights and Neuroprotection Governance in Chile

With neurotechnology nascent in Chile, the country has attempted to create a first-of-its kind neurorights governance framework. In December 2020, the Chilean Congress, after joint deliberation with leading international scholars and policy makers, and the strong support of the Columbia University Neurorights Initiative became a pioneer of neurorights governance. Highlighting the need to protect human dignity, Congress approved a reform of Article 19 of the Constitution to include the right to neuroprotection.9 The constitutional amendment was signed into law by the president in October 2021.10 The Chilean legislature is now developing a neuroprotection bill to implement Article 19 and related rights, including mental privacy, personal integrity, self-determination, and equal access to enhancing neurotechnologies.11 In December 2021, the Senate approved a new version of the neuroprotection bill based on input from the Senate Commission on Challenges of the Future, Science, Technology and Innovation, and it is currently being considered by the House of Representatives.

The Chilean proposals initially triggered diverse reactions. DerechosDigitales (“DigitalRights”), a Latin American advocacy group for individual digital rights, emphatically critiqued the Chilean efforts as misunderstanding and undermining the human rights and individual liberties of those subject to the new protections.12 Some Chilean scholars have questioned the need for constitutional reform and/or a neuroprotection bill on both practical and philosophical grounds.13 Others question the need for constitutional reform, but are nonetheless largely supportive of regulation to address the challenges stemming from neurotechnologies.14 Some consider both the constitutional reform and the bill necessary.15 Importantly, however, there seems to be consensus that the neuroprotection bill would benefit from further legal and conceptual clarification prior to implementation.

The latest version of the bill frames rights and requirements as pertaining only to healthcare and omits commercial or other uses. It requires that neurotechnologies be registered with the Chilean Institute of Public Health. Additionally, the bill provides authority to Chilean health regulators to prohibit the use of neurotechnologies under specific circumstances, such as when a neurotechnology may influence a person’s conduct without their consent or exploit vulnerabilities of at-risk populations. While health authorities are likely best suited to assess the efficacy and risks of devices related to healthcare, failing to provide authority to other regulatory bodies related to commerce is potentially dangerous, as health authorities might lack the expertise to assess and effectively curtail harm in the commercial arena.

Even if much neurotechnology R&D and use currently occurs in healthcare, history shows that technologies developed for research and clinical applications often migrate outward to other domains; consider smartphones or something now as ubiquitous as the Internet, which were developed for research and national defense purposes and yet now have transformed commercial activity, and social and political life. Lack of attention to some of the most significant commercial risks involving neurotechnology, such as inferences derived from collected neurodata negatively impacting or limiting the user experience, leaves these potential harms unaddressed and unregulated. Moving forward, given the significant role of the private sector in developing neurotechnology, private sector voices could participate in co-creating a neurorights framework that leaves room for ethical technology innovation in the non-medical space.

Challenges for Implementation

Conceptual and Philosophical Challenges

Several non-trivial conceptual obscurities require attention before “neurorights” governance can be practically implemented anywhere.16 To illustrate, the need for further conceptual reflection is evident in the evolving Chilean bill: while provisions referring to contested notions such as “psychic continuity,” “identity,” and “harm to psychological and psychic continuity” have been removed from the latest bill, there remain broad, vague concepts such as “mental integrity” that may challenge any court tasked with applying and interpreting them. Other parts of the Chilean example demonstrate ontological and definitional concerns about the relationship between brain and mental states, and what counts as “neurodata.” In the bill, the term “neurodata” refers to patterns of neuronal activation and appears to exclude other important types of data, such as morphological data, which could allow for discrimination based on actual or perceived neurotype. Similarly, the bill’s definition of neurotechnologies focuses on devices that read, record, or modify brain activity from the central nervous system, leaving neurotechnologies that connect with the peripheral nervous system outside of the bill’s scope. This provision is also sufficiently broadly drafted that it could inadvertently “protect” individuals from a vast range of positive, even essential activities, and interfere with established medical treatments. Indeed, some Chilean scholars worry about this possibility, noting that past Chilean legislation intended to protect the vulnerable has had a negative impact on medical care and research.17 If interpreted literally, they argue, the neuroprotection bill could have a similar negative impact on effective treatments for neurological and psychiatric disorders and halt the development of some of the most promising neurotechnology-based treatments.18

The above strongly suggests that, without conceptual clarity and terminological precision, neurorights governance may stand in tension with its own purposes, protecting both too much and not enough.19 Any effort to protect neurorights would benefit from deeper conceptual clarity, which would give it a more robust ability to be implemented.

Missing Voices

At present, scientists, lawmakers, and scholars in the humanities and the social sciences are largely shaping the debate over neurorights. However, such debate tends to lack representation from a key stakeholder: citizens and community members who will be subject to these new rights. To illustrate, in the Chilean case, while policy makers and academics were and continue to be actively involved, it is not clear that stakeholders such as patients and other consumers of neurotechnologies played a significant role in the process.20 The implementation of a novel, relevant neuroprotection bill should be a priority for public engagement, meaning a multidirectional dialogue between policymakers, scholars, and the public.

One model of public engagement in shaping new rights, which could inform the work on neurorights, comes from the domain of constitutional drafting. In most modern constitutional processes, notably in Ireland, Iceland, Kenya, and Tanzania, the public has played a key part in drafting and revising the constitution. Their participation gives substantive constitutional rights to the governed, ensures that the final documents meet their interests and needs and is perceived to enhance the legitimacy and stability of the resulting constitution.21 Participation by the public can help define of key notions in the neurorights conversation, such as integrity and harm in the context of neurotechnology and neurodata. Similarly, the participation of diverse publics can influence the criteria used to assess the potential risks and benefits of having additional “neurorights.” Successful neuroprotection legislation would ideally be informed by a diverse set of voices on a number of issues, such as whether neurorights guarantee individual freedoms, and even whether individuals should be free to choose or reject these new rights.22

Conclusion

The debate on neurorights is evolving in response to the need to regulate technologies that can have unprecedented impacts at individual and societal levels. Clarifying neurorights governance proposals is not only difficult but urgent: as neurotechnologies expand in both capability and market presence, proposals to define and protect neurorights will continue to proliferate across the globe. The neurorights of Chile today may very well be the neurorights of the EU, the United States, and beyond in the future. In its recently released Common Agenda, the UN expressed interest in considering “frontier issues,” such as human rights governance related to digital and technology spaces, including neurotechnology.23 Now is the time to achieve conceptual clarity on what neurorights are or should be, and what they are intended to protect, and to begin a participatory dialogue among all relevant stakeholders.

 

Disclaimer

KSR offers consultation to nonprofits and neurotechnology companies and holds a grant from the Kavli Foundation to develop neuroethics engagement activities with the International Brain Initiative. She is also co-chair of the International Brain Initiative Global Neuroethics Working Group and a member of the NIH BRAIN Neuroethics Working Group. ACP serves on the advisory board of Paradromics, a medical devices company that develops brain-computer interfaces to restore function to people with total paralysis.

 

Acknowledgements

We sincerely thank Abel Wajnerman Paz for his insights into the Chilean Legislative Process.

 

Endnotes

  1. Liam Drew, “The Ethics of Brain-Computer Interfaces,” Nature 571 (July 24, 2019): S19–S21.
  2. Dennis J. McFarland et al., “Therapeutic Applications of BCI Technologies,” Brain-Computer Interfaces 4 (2017): 37–52; Jonathan R. Wolpaw et al., “Independent Home Use of a Brain-Computer Interface by People with Amyotrophic Lateral Sclerosis,” Neurology 91 (July 17, 2018): e258–e267; Francis R. Willett et al., “High-Performance Brain-to-Text Communication via Handwriting,” Nature 593 (May 12, 2021): 249–254.
  3. Ryan H. Purcell and Karen S. Rommelfanger, “Internet-Based Brain Training Games, Citizen Scientists, and Big Data: Ethical Issues in Unprecedented Virtual Territories,” Neuron 86 (April 22, 2015): 356–359. https://doi.org/10.1016/j.neuron.2015.03.044; Nathan S. Ahlgrim et al., “Prodromes and Preclinical Detection of Brain Diseases: Surveying the Ethical Landscape of Predicting Brain Health,” eNeuro 6 (June 20, 2019): 1–11; Amanda C. Pustilnik, “The Perils of Opening the Mind,” Boston Globe (February 23, 2020), www.bostonglobe.com/2020/02/23/opinion/perils-opening-mind.
  4. U.S. Department of Labor, Americans with Disabilities Act, www.dol.gov/general/topic/disability/ada.
  5. Marcelli Ienca and Roberto Andorno, “Towards New Human Rights in the Age of Neuroscience and Neurotechnology,” Life Sciences Society and Policy 13 (2017): 1–27, https://doi.org/10.1186/s40504-017-0050-1.
  6. Jan Christoph Bublitz and Reinhard Merkel, “Crimes Against Minds: On Mental Manipulations, Harms and a Human Right to Mental Self-Determination,” Criminal Law and Philosophy 8 (2014): 51–77; Ienca and Andorno, “Towards New Human Rights”; Rafael Yuste et al., “Four Ethical Priorities for Neurotechnologies and AI,” Nature 551 (November 9, 2017): 159–163, https://doi.org/10.1038/551159a; Andrea Lavazza, “Freedom of Thought and Mental Integrity: The Moral Requirements for Any Neural Prosthesis,” Frontiers in Neuroscience 12 (2018): 1–10, https://doi.org/10.3389/fnins.2018.00082; Paolo Sommaggio and Marco Mazzocca, “Cognitive Liberty and Human Rights,” in Neuroscience and Law: Complicated Crossings and New Perspectives, ed. Antonio D’Aloia and Maria Chiara Errigo (Cham: Springer International Publishing, 2020), 95–111; Gobierno de Espana, Carta Derechos Digitales, 2021, www.lamoncloa.gob.es/presidente/actividades/Documents/2021/140721-Carta_Derechos_Digitales_RedEs.pdf.
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  9. Senado, Republica de Chile, Boletin 13.827-19 (2020), Modifica el Artículo 19, número 1°, de la Carta Fundamental, para Proteger la Integridad y la Indemnidad Mental con Relación al Avance de las Neurotecnologías.
  10. Ley 21.383, “Modifica la Carta Fundamental, Para Establecer el Desarrollo Científico y Tecnológico al Servico de las Personas,” www.bcn.cl/leychile/navegar?idNorma=1166983.
  11. Senado, Republica de Chile, Boletin 13.828-19 (2020), Sobre Protección de los Neuroderechos y la Integridad Mental, y el Desarrollo de la Investigación y las Neurotecnologías.
  12. Vladimir Garay et al., “Neuroderechos para Qué, Maldita Sea,” DerechosDigitales (April 29, 2021), www.derechosdigitales.org/15760/neuroderechos-para-que-maldita-sea.
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  14. Pablo López-Silva, “Ley de Neuroderechos, el Concepto de la Mente y el Escenario de la Investigación en Neurociencias,” El Mostrador (June 8, 2021), www.elmostrador.cl/noticias/opinion/columnas/2021/06/08/ley-de-neuroderechos-el-de-concepto-de-la-mente-y-el-escenario-de-la-investigacion-en-neurociencias; Pablo López-Silva and Raúl Madrid, “Sobre la Conveniencia de Incluir los Neuroderechos en la Constitución o en la Ley,” Revista Chilena de Derecho y Tecnología 10 (June 30, 2021): 53–76, https://doi.org/10.5354/0719-2584.2021.56317.
  15. Abel Wajnerman Paz, “We Need to Regulate Mind-Reading Tech before it Exists,” Rest of World (July 7, 2021), https://restofworld.org/2021/chile-neuro-rights.
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  19. Akmazoglu and Chandler, “Mapping the Emerging Legal Landscape.”
  20. Senado de Chile, Boletin 13827-19.
  21. David M. Farrell, Clodagh Harris, and Jane Suiter, “Bringing People into the Heart of Constitutional Design: The Irish Constitutional Convention of 2012–14,” in Participatory Constitutional Change: The People as Amenders of the Constitution, eds. Xenophon Contiades and Alkmene Fotiadou (London: Routledge, 2018), 125–136.
  22. Silvia Inglese and Andrea Lavazza, “What Should We Do With People Who Cannot or Do Not Want to Be Protected From Neurotechnological Threats?” Frontiers in Human Neuroscience 15 (2021): 1–6. https://doi.org/10.3389/fnhum.2021.703092.
  23. United Nations, Our Common Agenda: Report of the Secretary-General (September 10, 2021), www.unep.org/resources/report/our-common-agenda-report-secretary-general.