Division of Primary Care Medicine, Geneva University Hospitals, Geneva, Switzerland.
Direction of Communication, Geneva University Hospitals, Geneva, Switzerland.
Swiss Med Wkly. 2024 Oct 25;154:3954. doi: 10.57187/s.3954.
Chatbots are computer programs designed to engage in natural language conversations in an easy and understandable way. Their use has been accelerated recently with the advent of large language models. However, their application in medicine and healthcare has been limited due to concerns over data privacy, the risk of providing medical diagnoses, and ensuring regulatory and legal compliance. Medicine and healthcare could benefit from chatbots if their scope is carefully defined and if they are used appropriately and monitored long-term. The confIAnce chatbot, developed at the Geneva University Hospitals and the University of Geneva, is an informational tool aimed at providing simplified information to the general public about primary care and chronic diseases. In this paper, we describe the certification and regulatory aspects applicable to chatbots in healthcare, particularly in primary care medicine. We use the confIAnce chatbot as a case study to explore the definition and classification of a medical device and its application to chatbots, considering the applicable Swiss regulations and the European Union AI Act. Chatbots can be classified anywhere from non-medical devices (informational tools that do not handle patient data or provide recommendations for treatment or diagnosis) to Class III medical devices (high-risk tools capable of predicting potentially fatal events and enabling a pre-emptive medical intervention). Key considerations in the definition and certification process include defining the chatbot's scope, ensuring compliance with regulations, maintaining security and safety, and continuously evaluating performance, risks, and utility. A lexicon of relevant terms related to artificial intelligence in healthcare, medical devices, and regulatory frameworks is also presented in this paper. Chatbots hold potential for both patients and healthcare professionals, provided that their scope of practice is clearly defined, and that they comply with regulatory requirements. This review aims to provide transparency by outlining the steps required for certification and regulatory compliance, making it valuable for healthcare professionals, scientists, developers, and patients.
聊天机器人是一种旨在以简单易懂的方式进行自然语言对话的计算机程序。随着大型语言模型的出现，它们的应用最近得到了加速。然而，由于对数据隐私、提供医疗诊断的风险以及确保监管和法律合规性的担忧，它们在医学和医疗保健领域的应用受到了限制。如果聊天机器人的应用范围得到仔细定义，并且能够被恰当地使用和长期监控，那么它们可以使医学和医疗保健受益。由日内瓦大学附属医院和日内瓦大学开发的 confIAnce 聊天机器人是一种信息工具，旨在向公众提供关于初级保健和慢性病的简化信息。在本文中，我们描述了适用于医疗保健领域的聊天机器人的认证和监管方面，特别是在初级保健医学中。我们使用 confIAnce 聊天机器人作为案例研究，探讨了医疗设备的定义和分类及其在聊天机器人中的应用，同时考虑了适用的瑞士法规和欧盟人工智能法案。聊天机器人可以被归类为从非医疗设备（不处理患者数据或提供治疗或诊断建议的信息工具）到 III 类医疗设备（能够预测潜在致命事件并实现预防性医疗干预的高风险工具）的任何类别。在定义和认证过程中的关键考虑因素包括定义聊天机器人的应用范围、确保符合法规、维护安全性和可靠性，以及不断评估性能、风险和实用性。本文还介绍了与医疗保健、医疗设备和监管框架相关的人工智能相关术语的词汇表。聊天机器人为患者和医疗保健专业人员提供了潜力，前提是它们的实践范围得到明确界定，并且符合监管要求。本综述旨在通过概述认证和监管合规所需的步骤来提供透明度，这对医疗保健专业人员、科学家、开发人员和患者都具有重要价值。
