Regulatory sandboxes could be fruitfully used to boost Invasive Brain-Computer Interfaces, but they should be carefully designed. We highlight five elements are essential: they concern the entry criteria, the participated, adaptive and supervised design of decision-making process, and long-term risk management.

Should I stay or should I go? iBCIs and sandboxes

So far, the use of regulatory sandboxes – that is, a controlled environment in which innovative products and services can be developed and tested under tailored, often simplified, regimes – has been more opposed than welcomed for novel neurotechnologies such as invasive Brain-Computer Interfaces (iBCIs). Johnson’s 2024 correspondence in “Nature Biotechnology” exemplifies such critical stance1. By referring to the contrasting decisions taken by the UK policy-makers, Johnson argued that emerging neurotechnologies should not go into the sandbox. This for one main reason: sandboxes are necessarily short-term. They fail to establish long-term obligations toward vulnerable populations, who might be left without clear remedy in case a firm providing an implant goes out of business. In Johnson’s view, this is a major weakness, especially when it comes to devices that pose long-term risks and could cause patients to suffer irreversible harm.

In this Comment, we take a different position. Our claim is that sandboxes could be fruitfully used to boost iBCIs. In making this claim, we take a realistic and pragmatic approach. We are not inclined to share the somehow messianic promise accompanying sandboxes, often presented as a one-size-fits-all solution to various issues, from the removal of barriers to technology innovation to the anticipation of unintended consequences and disruptive effects. Our point is more nuanced and less simplistic: as regards neurotechnologies, sandboxes are a potentially useful regulatory tool in specific situations where novel technologies meet important public health needs but face complex medical, ethical and socio-economic challenges. This is the case of iBCIs.

Regulation as part of the problem

As a cutting-edge frontier in neurotechnology, iBCIs offer extraordinary promise while grappling with formidable real-world hurdles. Since their inception in the late 1990s, iBCIs have unlocked life-changing potential for individuals with conditions like spinal cord injury and amyotrophic lateral sclerosis, restoring critical motor and communication functions. The incidence of neurogenerative disorders is expected to rise in the coming years, fostering the potential demand for iBCS. Despite their transformative capabilities, iBCIs remain entangled in technical, economic, social, ethical and regulatory complexities.

From a clinical point of view, factors that delay the deployment and increase the costs of development of iBCIs include the length of clinical trials, the requirement for constant monitoring of the device throughout its entire lifespan, and the need for long-term maintenance, training and fine-tuning2,3,4. iBCIs are medical devices designed to restore sensory, motor and speech abilities, thus representing a vital part of healthcare delivery and the potential for social inclusion for people with disabilities. However, compared with the case of medical devices and drugs widely used for common diseases and impairments, market demand for such therapeutic appliances is, at least for the moment, much smaller, therefore inadequate to incentivize research efforts and sustain the trajectory towards full development, especially in the private sector. In addition to this, social and ethical factors also have a significant impact: iBCIs connected to the nervous system must align with a broad array of fundamental values such as dignity, identity, privacy, and autonomy, both during training and real-word use5,6,7,8. Add to this a tangle of regulatory constraints and you get a perfect storm of innovation bottlenecks. iBCIs’ path to widespread clinical deployment and market release is obstructed by regulatory frameworks that were not originally designed for such innovative technologies, are not laid down in a single legal source but often result from several concurring pieces of legislation, and are essentially oriented to verify the compliance of the proposed technology with a set of existing standards, instead of engaging in its development and testing. This is clearly exemplified by the European Union (EU) legislation, where iBCIs have to comply with overlapping requirements stemming from safety schemes designed for a variety of different technologies, including the EU Medical Devices Regulation and, prospectively, the Artificial Intelligence (AI) Act. In this overall context, it is unsurprising that no iBCI technology has yet received regulatory approval for clinical use, in spite of the efforts to develop these systems since 19989,10.

The potential of regulatory sandboxes for iBCIs

While regulation is certainly part of the problem, it may also be part of the solution. Sandboxes are a relevant tool in relation to iBCIs. They are, of course, only one option among several potentially available to decision-makers, ranging from more traditional instruments (e.g. authorization procedures and other command-and-control approaches) to experimental regulations (e.g. testbeds, pilot regulation and innovation deals). Yet, they represent a promising option in relation to iBCIs because of their specific functional rationale.

In general terms, sandboxes are described by policy-makers and regulatory studies as ad hoc and temporary schemes providing a controlled but flexible regulatory environment to test innovative technologies, products and services in view of possible further deployment and market release[11](https://www.nature.com/articles/s41467-025-65584-4#ref-CR11 “European Commission, ‘Better regulation’ toolbox 2023, at https://commission.europa.eu/document/download/9c8d2189-8abd-4f29-84e9-abc843cc68e0_en?filename=BR%20toolbox%20-%20Jul%202023%20-%20FINAL.pdf

(2023).“),12. Although much of the academic conversation emphasizes their potential for delivering on innovation goals and the customized guidance on compliance provided by supervisory authorities, sandboxes should not be simply seen as a deregulatory or relaxed policy instrument aimed at accelerating innovation. Sandboxes are potentially sophisticated regulatory tools, whose fundamental distinguishing feature is neither the flexibility of the decision-making process nor the acceleration of innovation as such, but rather their functional orientation to both sustain and shape novel and challenging technologies. In the specific field of healthcare, in particular, they could be used to achieve the goal of developing and testing highly innovative technologies that address important and so far unmet public health needs but face uneasy medical, ethical and socio-economic concerns. More precisely, sandboxes can provide a participatory, adaptive and supervised regulatory environment in which an emerging technology like iBCIs can be tested, incrementally developed, and iteratively improved with a view to contributing to the making of a safe, cost-effective and people-centred healthcare.

This functional rationale – promoting and shaping the development of promising but problematic novel technologies - is what differentiates sandboxes from other regulatory tools and justifies their use in relation to iBCIs. Traditional regulatory options, based on command and control, respond to the need to verify that the relevant technology complies with a number of predefined standards, instead of enabling the innovation process, which is what is needed in the case of iBCIs. As for other types of experimental regulation, they share with sandboxes the effort to reconcile the needs of innovators and regulators, but they do so through arrangements pointing to certain specific concerns, such as providing advisory services on regulatory aspects, as in the case of testbeds, and allowing citizen engagement, as for living labs: while such aspects are certainly relevant to iBCIs, they would only partially address the variety and complexity of issues involved in the iBCIs innovation process. In this overall regulatory horizon, an iBCIs sandbox may be seen as a promising regulatory option as it aims at developing an innovative technology - one which has not received so far regulatory approval for clinical use, as already stressed - while simultaneously addressing the medical, ethical and socio-economic challenges raised by the development path.

Five key aspects

In order to keep its promise and exploit its potential, however, a regulatory sandbox for iBCIs should be carefully designed. While there are no established good practices in this field to use as source of inspiration, five aspects are essential in order to properly elaborate an iBCIs sandbox. We derive such aspects - visually indicated in Fig. 1 - from the functional rationale of sandboxes in the field of healthcare. As a whole, they refer to a framework which is different from others proposed by regulatory studies as ideal types of sandboxes, based on partially different rationales13, as well as alternative to horizontal, non-sector specific sandboxes, such as those envisaged by the AI Act in the EU.

Fig. 1

The 5 essential elements of an iBCIs sandbox.

Firstly, as the sandbox deserves to be set up only for really innovative technologies facing development issues and raising uneasy concerns, policy-makers should pay the greatest attention to its entry criteria and operational scope. The entry criteria should be carefully articulated in order to avoid unduly favouring certain projects that do not fulfil relevant societal needs and provide only minimal benefits. Likewise, for reasons of fairness, equivalent initiatives should not be subject to substantially different regulatory requirements, as this would damage competitors and, in the end, leave the prospective market for these devices underserved14. At the same time, a certain degree of flexibility is needed given the experimental nature of these endeavours and their unpredictable outcome.

Secondly, the sandbox should be constructed as a highly participatory process. It should systematically involve innovators, industry representatives, consumer and patients associations, medical providers, researchers, legal scholars, and social science experts, with a view to bringing all relevant perspectives and needs in the iBCI development process, including those of end-users and patients. Indeed, the purpose is not only that of improving the clinical translation of research through scientific assessment and risk management, by minimizing the possible impact of specific threats and positively affecting the usability of implanted devices, as in the case of more traditional arrangements such as risk regulation and regulatory science. More ambitiously, the procedural objective of the sandbox is to take into consideration all relevant public and private interests and needs in the iBCI development, thereby upholding a non-unilateral, systemic and multidimensional perspective in the innovation process. Such interests and needs include the quality, efficacy, and safety of innovative devices, the sustainability of development costs, a high level of protection of fundamental rights, and the social embeddedness of iBCIs and technological innovation in the field of public health. The recognition of their relevance and dynamic inter-dependence is an essential feature of the sandbox.

Thirdly, the iBCIs sandbox should be designed as an iterative and adaptive regulatory environment, going beyond the structure and features of traditional regulatory patterns. While the latter are based on linear proceedings, from application’s submission to administrative decision, the iBCIs sandbox should be conceived as a set of circular procedures, allowing for continuous feedback loops where the various actors collaborate to identify the relevant problems and gradually determine the specific arrangements of iBCIs. Moreover, differently from traditional regulatory arrangements, which aim at verifying that innovation complies with the relevant legislative requirements, the iBCIs sandbox should enable innovators to derogate from specific legal obligations for the purpose of testing scientific outcomes while preserving overarching regulatory objectives: outside the health sector, such flexibility is already experimented in a variety of policy-fields, as illustrated by the sandboxes for developing and testing innovative net-zero technologies in the EU. Again, the iBCIs sandbox should be procedurally devised in such a way to promote regulatory learning, by enhancing the regulators’ awareness, sustaining cross-sectoral coordination and linking with future legislation. The case of sandboxes to facilitate the development of innovative medicinal products in the EU provides an interesting example, as the legislative text currently under discussion provides that the learning stemming from a regulatory sandbox «should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation»[15](https://www.nature.com/articles/s41467-025-65584-4#ref-CR15 “Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, COM (2023) 193 final. https://eur-lex.europa.eu/resource.html?uri=cellar:e3f40e76-e437-11ed-a05c-01aa75ed71a1.0001.02/DOC_1&format=PDF

.“).

Fourthly, the iBCIs sandbox should provide a controlled regulatory environment. Given its iterative, circular dynamic and the diversity of the interests at stake, the whole process should be supervised by one or more specialized regulatory authorities, carrying out its ultimate responsibility. Under the current EU regime, the decentralised nature of approval decisions and the confidentiality of information submitted to notified bodies are considered to hinder the transparency of research results and approved devices, thus preventing a better understanding of their opportunities and risks16. On the contrary, a specialized agency such as the European Medicines Agency, the Medical Devices Coordination Group or a new EU regulatory and supervisory authority with a specific expertise in the neurotechnology field would be called upon to oversee the development path. It would do so by adapting the regulatory framework based on the concrete evolution of the process, providing tailored responses to any unanticipated problems that arise during clinical experimentation, and ensuring regulatory coherence and predictability. Reduced regulatory burdens would be counteracted by enhanced communications with the regulators, leading to proactive advice and more expedited decisions.

Finally, the sandbox should also address the issue of long-term risk management of devices that will be used for an extended period after surgery, as well as the liability costs arising from their real-world use. As previously said, Johnson expressed reservations against the lack of long-term obligations that producers owe to patients involved in a trial. However, the problem does not arise from the use of sandboxes. Rather it is a problem common to all implantable devices, for which there are no effective remedies in the event of damage, as illustrated by European case-law with regard to both breast implants and hip prostheses17,18. What is more, sandboxes might actually provide a reasonable solution to such issue: combining ex ante safety norms specifically tailored to govern the risks associated with implanted devices with ex post liability rules could prevent the chilling effect on downstream innovation, while enabling easy access to compensation if damage occurs. Given the societal value that this technology fosters, it could be justified to introduce a special regime that distributes liability costs through compensation programmes or compulsory insurance mechanisms for the professional operators involved in the manufacturing and operational processes. Allocating the responsibilities emanating from the provision of these pioneering technologies between the public and private domains is substantiated by the existence of a positive obligation on the part of States signatory to the Convention on the Rights of Persons with Disabilities to encourage the research, development, availability and use of novel technologies. On the other hand, participation in the sandbox by private parties can be considered a regulatory privilege, which carries wider accountability and follow-on responsibilities.

The way forward

Admittedly, the five aspects illustrated above represent only the general structure of a possible iBCIs sandbox. In order to elaborate a fully accomplished proposal, they should be further developed and translated into a detailed regulatory framework – a task which goes beyond the purpose of this Comment. Yet, they reflect a specific understanding of regulatory sandboxes, one pointing to sandboxes as a distinct mode of policy delivery that should be used, in the field of healthcare, to sustain and shape really innovative and important technologies facing development issues and raising uneasy concerns.

This understanding is in line with the approach taken by the OECD in its 2019 Recommendation on Responsible Innovation in Neurotechnology, which identifies a number of principles to guide governments and innovators in managing social and ethical challenges while promoting innovation19. It is also in line with the developments occurring in the EU, where the setting up of sandboxes is increasingly envisaged in sensitive fields such as energy, net-zero technologies, aviation security, financial services and artificial intelligence. The same applies to other Western countries, including Canada, Australia and some US states, such as Arizona and Utah, while a Breakthrough Devices Program has been launched at the federal level. A further example is the AI Airlock, the regulatory sandbox which was introduced in the UK for AI-based medical devices.

Governments have not yet proven ready to elaborate sandbox policies for iBCIs. However, as potentially transformative technologies that respond to unmet public health needs but raise at the same time very serious concerns, iBCIs deserve to go into sandboxes. The careful design and implementation of an iBCIs sandbox is a worthwhile exercise in which governments should engage.

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Sant’Anna School of Advanced Studies, Pisa, Italy

Edoardo Chiti, Silvestro Micera & Erica Palmerini

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1. Edoardo Chiti
2. Silvestro Micera
3. Erica Palmerini

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E.C. and E.P. were responsible for the first draft, with inputs from S.M. All authors critiqued various draughts of the manuscript and approved the final draft for submission.

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Correspondence to Edoardo Chiti.

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Chiti, E., Micera, S. & Palmerini, E. Making the case for sandboxes in implantable neurotechnologies. Nat Commun 16, 9783 (2025). https://doi.org/10.1038/s41467-025-65584-4

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Received: 05 June 2025

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DOI: https://doi.org/10.1038/s41467-025-65584-4