Regulating Next-Generation Implantable Brain-Computer interfaces: Recommendations for Ethical Development and Implementation

Brain-computer interfaces (BCIs) offer significant therapeutic opportunities for a variety of neurophysiological and neuropsychiatric disorders and may perhaps one day lead to augmenting the cognition and decision-making of the healthy brain. However, existing regulatory frameworks designed for implantable medical devices (IMDs) are inadequate to address the unique ethical, legal, and social risks associated with next-generation networked brain-computer interfaces (BCIs). In this article, we make nine recommendations to support developers in the design of BCIs and nine recommendations to support policymakers in the application of BCIs, drawing insights from the regulatory history of IMDs and principles from AI ethics. We begin by outlining the historical development of IMDs and the regulatory milestones that have shaped their oversight. Next, we summarize similarities between IMDs and emerging implantable BCIs, identifying existing provisions for their regulation. We then use two case studies of emerging cutting-edge BCIs-the HALO (Hardware Architecture for LOw-power BCIs) and SCALO (SCalable Architecture for LOw-power BCIs) computer systems-to highlight distinctive features in the design and application of nextgeneration BCIs arising from contemporary chip architectures, which necessitate reevaluating regulatory approaches. We identify critical ethical considerations for these BCIs, including unique conceptions of autonomy, identity, and mental privacy. Based on these insights, we suggest potential avenues for the ethical regulation of BCIs, emphasizing the importance of interdisciplinary collaboration and proactive mitigation of potential harms. The goal is to support the responsible design and application of new BCIs, ensuring their safe and ethical integration into medical practice.