Regulatory sandbox and brain-computer interfaces: an interdisciplinary perspective for governing emerging technologies
A study by the Sant'Anna School of Advanced Studies in Pisa published in Nature Communications explores the interaction between neuroscience, bioengineering and law to propose an innovative approach capable of addressing the regulatory challenges associated with the development of Brain-Computer Interfaces, technologies that enable direct communication between the brain and machines
How can we regulate technologies that connect the human brain and machines directly? A study by the Sant'Anna School of Advanced Studies in Pisa, published as a “comment” in the journal Nature Communications, proposes the use of a regulatory sandbox, controlled environments in which technological innovations can be tested under flexible regulatory conditions, as a tool to promote the balanced and responsible development of Brain-Computer Interfaces.
The study is the result of interdisciplinary work involving Edoardo Chiti, professor of administrative and public law at the Interdisciplinary Research Centre on Sustainability and Climate, Erica Palmerini, professor of private law at the Dirpolis Institute, and Silvestro Micera, professor of bioengineering at the BioRobotics Institute. Neuroscience, bioengineering and law are used to address the regulatory challenges of one of the most advanced frontiers of scientific and technological research and to chart a new course in the international scientific landscape, overturning the traditional mistrust of the application of regulatory experimentalism to the field of neuroscience.
'This Comment points the way forward for regulation if it is to support and guide the development of Brain-Computer Interfaces. We need to overcome mistrust of the most innovative regulatory tools and commit to building a regulatory sandbox. In other words, we need to develop a regulatory space in which to find a positive balance between the various interests at stake, starting with those of patients, and guide the innovation process."
The interdisciplinary approach
Another original feature of the study is its interdisciplinary method: the research integrates the perspectives of bioengineering and law, constructing a framework for analysis that takes into account the interactions between science, technology and regulation. This approach makes it possible to outline a proposal for a regulatory sandbox tailored to the specific challenges posed by brain-computer interfaces, from technical reliability to the protection of the fundamental rights of the people involved.
The prospects
According to the authors, this approach could form the basis for a more detailed future regulatory proposal, useful not only for the sustainable development of brain-computer interfaces, but also for defining general principles for the regulation of highly innovative technologies with far-reaching ethical and social implications.
'Our Comment answers the question of what the essential elements of a possible regulatory sandbox are. More generally, the approach we have chosen, which integrates the bioengineering perspective with the legal perspective, shows how fruitful the integration of experimental science and social science expertise can be. The advancement of science regulation depends on this integration'.
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