Emerging neurotechnologies such as brain–computer interfaces bring together components of biotechnology and digital technology, creating a number of different policy issues. These challenges can range from the safety of medical products to privacy issues with collecting and processing data from the human brain. Such different issues may call for different policy responses. For example, in April 2024, the UK government sent mixed messages about using a new type of policy instrument, regulatory sandboxes, to manage the risks of neurotechnologies¹. Regulators using sandboxes can allow small, short-term trials of new products and may modify typical rules to do so. British policymakers appeared to reject the idea of sandbox policies for medical devices involving neurotechnology, but left room for using privacy sandboxes for data collected by similar devices, including consumer-oriented neurotechnologies.

Regulatory sandboxes are a relatively new class of policy tool that aims to accelerate innovation by allowing technology developers to test their products or services in a small setting where regulators relax existing rules or provide special guidance². In return, participating entities often must propose and adhere to their own internal system of risk management, which can involve testing new rules, best practices or management systems. Regulators must decide who can enter a sandbox and under what conditions, supervise all entities while they participate, and protect patients or consumers during these trials and as they wind down.

脑机接口等新兴神经技术将生物技术和数字技术的组成部分结合在一起，产生了许多不同的政策问题。这些挑战的范围从医疗产品的安全性到收集和处理人脑数据的隐私问题。这些不同的问题可能需要不同的政策反应。例如，2024 年 4 月，英国政府发出了关于使用新型政策工具（监管沙箱）来管理神经技术风险的混合信息¹。使用沙箱的监管机构可以允许对新产品进行小规模、短期的试验，并可能为此修改典型规则。英国政策制定者似乎拒绝为涉及神经技术的医疗设备制定沙盒政策的想法，但为使用隐私沙盒来处理类似设备（包括面向消费者的神经技术）收集的数据留下了空间。

监管沙盒是一类相对较新的政策工具，旨在通过允许技术开发人员在监管机构放宽现有规则或提供特殊指导的小型环境中测试其产品或服务来加速创新²。作为回报，参与实体通常必须提出并遵守自己的内部风险管理系统，这可能涉及测试新规则、最佳实践或管理系统。监管机构必须决定谁可以在什么条件下进入沙箱，在所有实体参与时对其进行监督，并在试验期间和结束时保护患者或消费者。