标题： 监管下一代可植入脑机接口：伦理开发和实施的建议 显示英文标题

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

摘要： 脑机接口为多种神经生理和神经精神疾病提供了重要的治疗机会，或许在不久的将来能够增强健康大脑的认知和决策能力。 然而，目前为植入式医疗设备设计的监管框架不足以应对下一代联网脑机接口所带来的独特伦理、法律和社会风险。 在本文中，我们提出了九项建议，以支持开发者在设计脑机接口时的参考；同时提出了九项建议，以支持政策制定者在应用脑机接口时的参考，这些建议源于植入式医疗设备（IMDs）的监管历史以及人工智能伦理的原则。 我们首先概述了植入式医疗设备的历史发展以及塑造其监管的重要里程碑。 接下来，我们总结了植入式医疗设备与新兴植入式脑机接口之间的相似之处，并确定了现有针对它们的监管规定。 然后，我们通过两个新兴前沿脑机接口系统——HALO和SCALO计算机系统的案例研究，突出当代芯片架构所带来的下一代脑机接口在设计和应用方面的独特特征，这些特征需要重新评估监管方法。 我们识别了这些脑机接口的关键伦理考量，包括对自主性、身份和心智隐私的独特理解。 基于这些见解，我们提出了脑机接口伦理监管的潜在途径，强调跨学科合作和主动减轻潜在危害的重要性。 目标是支持新型脑机接口负责任的设计和应用，确保其安全和伦理地融入医疗实践。 显示英文摘要

摘要： Brain-computer interfaces 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 are inadequate to address the unique ethical, legal, and social risks associated with next-generation networked brain-computer interfaces. 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 and SCALO computer systems, to highlight distinctive features in the design and application of next-generation 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.