The Medicines and Healthcare products Regulatory Agency (MHRA) has launched its regulatory sandbox, AI Airlock, to address the challenges in regulating medical devices that use AI. A regulatory sandbox is a tool which allows businesses to explore and experiment with new and innovative products, services or businesses under the supervision of a regulator.The MHRA initiative aims to  respond to the unique challenges that AI as a medical device (AlaMD) products present.In a press release, published on 9 May 2024, the MHRA says that AI Airlock is “designed to assist in safe development and deployment of AIaMDs” so that manufacturers “can deliver what is required to ensure the real-world viability of these devices”.The launch of the regulatory sandbox is part of the MHRA’s strategic approach to AI, published in April 2024, which aims to help the government agency “identify and address the challenges for regulating standalone AI medical devices, initially seeking out and supporting four to six virtual or real-world projects through simulation”.It adds that this will allow the MHRA to “test a range of regulatory issues for the devices when they’re used in the NHS for direct clinical purposes”.Dr Paul Campbell, head of software and AI at MHRA, said: “We are currently seeing a marked increase in innovative AlaMD products entering the UK market that have the potential to revolutionise the healthcare landscape and provide improved ways to address patient and public needs”.“The launch of the AI Airlock will enhance our collective understanding and accelerate solutions to novel regulatory challenges, ultimately improving the experience of patients,” he added.Commenting on AI Airlock, Haris Shuaib, CEO of Newton’s Tree and consultant clinical scientist at Guys and St Thomas’ NHS Foun.

药品和保健品管理局（MHRA）推出了其监管沙箱AI Airlock，以应对监管使用AI的医疗设备的挑战。监管沙箱是一种工具，允许企业在监管机构的监督下探索和试验新的创新产品、服务或业务。MHRA倡议旨在应对AI作为医疗器械（ALMD）产品所面临的独特挑战。在2024年5月9日发布的新闻稿中，MHRA表示，AI Airlock“旨在帮助AIAMD的安全开发和部署”，以便制造商“能够提供确保这些设备在现实世界中生存所需的”。监管沙箱的推出是MHRA于2024年4月发布的人工智能战略方法的一部分，旨在帮助政府机构“识别和应对监管独立人工智能医疗设备的挑战，最初通过模拟寻找并支持四到六个虚拟或现实世界的项目”。它补充说，这将允许MHRA“在NHS中用于直接临床目的时测试设备的一系列监管问题”。MHRA软件和人工智能负责人保罗·坎贝尔博士表示：“我们目前看到进入英国市场的创新型ALMD产品显着增加，这些产品有可能彻底改变医疗保健格局，并提供改进的方法来满足患者和公众的需求”。他补充道：“AI气闸的推出将增强我们的集体理解，加速解决新的监管挑战，最终改善患者的体验。”。Haris Shuaib是Newton's Tree的首席执行官，也是Guys和St Thomas'NHS Foun的顾问临床科学家，他对AI Airlock发表了评论。