November 2025 was a big moment for the governance of two very similar things: neurotechnology and neural organoids. On November 5, the United Nations Educational, Scientific and Cultural Organization (UNESCO) formalized an international instrument providing a Recommendation on the Ethics of Neurotechnology, after member states voted to support it.[1] While legally nonbinding, the UNESCO instrument adds to a growing list of national and international efforts to set new law about “neurotechnologies,” such as a similar instrument codified by the Organisation for Economic Co-operation and Development (OECD) in 2019.[2]

The next day, on November 6, an opinion paper was published in Science detailing the consensus of experts across the natural and social sciences, law, and bioethics, that “neural organoids” require governance interventions involving, at minimum, a global monitoring system for the burgeoning field and its applications.[3] The following week, a group of experts and stakeholders met at the Asilomar Conference Grounds in California to discuss such issues around these neural organoids.[4]

Notably, though, the term “neurotechnology” does not appear anywhere in the article about neural organoids, nor in news coverage of the Asilomar event. Nor does the term “organoid” appear in either the UNESCO or OECD instruments.

In fact, it is difficult to tell whether these two objects are one and the same, or different, and on what grounds. Neither the nascent law of neurotechnologies nor the scientific discourse on neural organoids provide sufficient clarify on this question. This blog explores the sources of this uncertainty and identifies how issues in legal predictability or policy mismatches may flow from the absence of clarity.

Neural Organoids

A budding scientific field has been working with new “organoid” techniques to help model and better study neural tissue in vitro—meaning in the lab, outside of the body. Organoids are “organ-like,” but are very small and much less sophisticated than the actual organs they are based on, such as the brain. Scientists can use these small clumps of brain cells to understand how parts of the brain work or develop, or even to study how infections or other diseases may affect the brain and what treatments they may respond to.[5] The field has notable promise for scientific and clinical applications, but multiple technical challenges remain before that promise can be fully realized.[6]

However, describing what these nascent technologies are and what they are for is difficult. The field is still struggling to communicate internally and to the public about neural organoids. A notable perspective paper was published in Nature in 2022 by a group of organoid researchers trying to issue terminological norms for their field.[7] The paper also strongly objects to several ways these innovations have been described in journalistic media, such as “mini-brain” or “brain-in-a-dish,” but provides no compelling alternative or easier metaphor to use. This intervention illustrates that progress is being made in institutionalizing and standardizing the field of neural organoids—but also just how recently that work has commenced and how much difficulty there is in communicating to actors outside of the scientific field about what these innovations are.

What Are Neurotechnologies? Do Neural Organoids Count?

The term neurotechnology has begun to acquire a legal definition in national and international lawmaking efforts. In the UNESCO Recommendation, for instance, “[n]eurotechnology refers currently to devices, systems and procedures–encompassing both hardware and software–that directly measure, access, monitor, analyse, predict or modulate the nervous system to understand, influence, restore or anticipate its structure, activity and function.”[1] This provides a sweeping scope for the object of regulation, but does not specifically mention organoids.

The OECD’s legal instrument has a very similar definition to UNESCO, raising similar questions about whether neural organoids fit.[2] In the US, at the federal level, legislation was recently introduced in the Senate that would call on the Federal Trade Commission (FTC) to investigate whether and how “neurotechnology” raises data protection issues. The proposed MIND Act would contain a definition of neurotechnology that also very closely mirrors the UNESCO and OECD instruments, providing no greater clarity.[8]

While the term “neurotechnology” appears to have a very broad definition in emerging legal instruments, lawmakers generally use the term to mean something much narrower. The focus of lawmaking bodies and the experts consulting with them is predominantly on physical devices with software components—primarily, and sometimes exclusively, on “brain-computer interfaces” (BCIs) or brain stimulation devices.[9]

But neural organoids could still potentially fit into these instruments. The UNESCO definition, by including the clarifying clause “encompassing both hardware and software,” does appear to suggest that the definition applies to physical and digital devices. But its interpretation would depend on whether the clause is read to be the full extent of what “devices, systems, and procedures” can mean, or merely two examples of what those larger terms can be. Of note, the UNESCO instrument goes on to provide examples of neurotechnology that do focus on devices, but is proceeded by the caveat that “[n]eurotechnology includes, but is not limited to:”.[1] These elements of the instrument illustrate the lack of complete clarity in its scope.

Within the UNESCO instrument, at least, it is not wholly unreasonable that neural organoids could be interpreted to be “systems and procedures . . . that directly . . . analyse, predict, or modulate the nervous system,” especially to “understand [or] anticipate its structure, activity and function.”[1] Whether the UNESCO instrument applies exclusively to physical and digital devices or could apply to biological objects appears unclear at present.

The Potential for Legal Unpredictability or Mismatches

Where does this leave the governance of neural organoids? It is currently not clear, legally or scientifically, whether neural organoids are a part of neurotechnology. National and global rules are being set for neurotechnology, but not specifically for organoids.

This prompts the question: Do rules for neurotechnology apply to neural organoids?

When looking at current legal definitions, it looks likely—but not certain—that those rules do not apply to organoids. Yet, lawmaking bodies, regulators, or courts appear to have at least some interpretive room that could be used to position neural organoids as neurotechnology, and therefore subject to at least some of these new rules or norm-setting processes on neurotechnology. At the same time, the scientific field of neural organoids is still in the process of organizing itself and has had trouble communicating to external actors about what they do and why.[7] This lack of clarity within the scientific field itself, while understandable given its youth, may invite or enable decision-makers to more readily engulf neural organoids within neurotechnology rules.

This lack of legal and scientific clarity could create predictability issues, since organoid scientists and product developers may not know whether any of the emerging rules on neurotechnology will apply to their activities. It could also raise concerns for funders and investors, or even insurers for organoid-based therapeutics, who may or may not want to see compliance with those rules as a condition of supporting neural organoid work.

The definitional uncertainty also raises questions about whether neurotechnology rules are fit and appropriate for neural organoids, or if applying those rules could result in policy mismatches. Most of the rules about neurotechnology that have been set have mostly or only medical and consumer devices in mind—not biological innovations like organoids.[9] Applying those rules to neural organoids without thoughtfully considering whether and how they should be adapted to biologics could result in poor match between the goals of those rules and the issues that organoids may pose.

Clarifying Definitions, For Now

Since most existing and emerging legal instruments on neurotechnologies appear to only have medical and consumer devices in mind, this blog tentatively recommends that lawmaking and regulatory bodies should consider clarifying that these rules do not apply to neural organoids—at least, for now. At minimum, clarifying that neurotechnology rules do not currently apply to neural organoids would provide short-to-medium-term predictability to scientists and other stakeholders and avoid applying rules that may not be fit-for-purpose.

Since definitions are vague, it is unlikely that this path would require full amendments of these legal instruments. Clarification could instead come in the form of formal guidance issued by governing bodies, or less formally, in the form of public statements from officials about whether the implementation of those rules would cover neural organoids.

It may, however, be prudent to not close the door entirely to these legal instruments applying to neural organoids at some point in the future. While the neural organoid field would benefit from predictability, an international and interdisciplinary group of experts has agreed it is likely that governance for these emerging technologies will be required at some point.[3] Custom rules for neural organoids may be preferable, but having governance instruments for neurotechnologies available in reserve may be valuable if no such tailored rules arise.

References

[1] UNESCO, Recommendation on the Ethics of Neurotechnology (2025).

[2] OECD, Recommendation of the Council on Responsible Innovation in Neurotechnology, OECD/LEGAL/0457 (2019).

[3] Sergiu P. Pașca, et al., The Need for a Global Effort to Attend to Human Neural Organoid and Assembloid Research, 390 Science 574 (2025).

[4] Mitch Leslie, Lab-Grown Models of Human Brains are Advancing Rapidly. Can Ethics Keep Pace?, Science (Nov. 18, 2025), https://www.science.org/content/article/lab-grown-models-human-brains-are-advancing-rapidly-can-ethics-keep-pace.

[5] H. Isaac Chen, Hongjun Song & Guo‐li Ming, Applications of Human Brain Organoids to Clinical Problems, 248 Developmental Dynamics 53 (2019).

[6] Madeline G. Andrews & Arnold R. Kriegstein, Challenges of Organoid Research, 45 Annual Review of Neuroscience 23 (2022).

[7] Sergiu P. Pașca, et al., A Nomenclature Consensus for Nervous System Organoids and Assembloids, 609 Nature 907 (2022).

[8] MIND Act of 2025, S.2925, 119th Cong. §3(5) (2025).

[9] Walter G. Johnson, It’s (Not) Just Semantics: “Neurotechnology” as a Novel Space of Transnational Law, 50 Law & Social Inquiry 865 (2025).