Health Informatics, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
J Med Internet Res. 2023 Apr 5;25:e43386. doi: 10.2196/43386.
Given the impact artificial intelligence (AI)-based medical technologies (hardware devices, software programs, and mobile apps) can have on society, debates regarding the principles behind their development and deployment are emerging. Using the biopsychosocial model applied in psychiatry and other fields of medicine as our foundation, we propose a novel 3-step framework to guide industry developers of AI-based medical tools as well as health care regulatory agencies on how to decide if a product should be launched-a "Go or No-Go" approach. More specifically, our novel framework places stakeholders' (patients, health care professionals, industry, and government institutions) safety at its core by asking developers to demonstrate the biological-psychological (impact on physical and mental health), economic, and social value of their AI tool before it is launched. We also introduce a novel cost-effective, time-sensitive, and safety-oriented mixed quantitative and qualitative clinical phased trial approach to help industry and government health care regulatory agencies test and deliberate on whether to launch these AI-based medical technologies. To our knowledge, our biological-psychological, economic, and social (BPES) framework and mixed method phased trial approach are the first to place the Hippocratic Oath of "Do No Harm" at the center of developers', implementers', regulators', and users' mindsets when determining whether an AI-based medical technology is safe to launch. Moreover, as the welfare of AI users and developers becomes a greater concern, our framework's novel safety feature will allow it to complement existing and future AI reporting guidelines.
鉴于人工智能（AI）为基础的医疗技术（硬件设备、软件程序和移动应用程序）对社会的影响，围绕其开发和部署原则的争论正在出现。我们以精神病学和医学其他领域应用的生物心理社会模式为基础，提出了一个新的三步框架，为人工智能医疗工具的行业开发者和医疗保健监管机构提供指导，以确定是否推出产品——一种“去或不去”的方法。更具体地说，我们的新框架将利益相关者（患者、医疗保健专业人员、行业和政府机构）的安全置于核心位置，要求开发者在推出之前展示其人工智能工具的生物心理（对身心健康的影响）、经济和社会价值。我们还引入了一种新颖的具有成本效益、时间敏感且注重安全的混合定量和定性临床分阶段试验方法，以帮助行业和政府医疗保健监管机构测试和审议是否推出这些人工智能医疗技术。据我们所知，我们的生物心理、经济和社会（BPES）框架和混合方法分阶段试验方法是第一个将“不伤害”的希波克拉底誓言置于开发者、实施者、监管者和用户的思维中心，以确定基于人工智能的医疗技术是否安全推出。此外，随着对人工智能用户和开发者福利的关注越来越大，我们框架的新颖安全功能将使其能够补充现有的和未来的人工智能报告指南。
