建模和整合医疗信息物理系统设计中的人类交互假设

Zhicheng Fu, Chunhui Guo, Shangping Ren, Yizong Ou, L. Sha
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引用次数: 5

摘要

对于网络物理系统来说,其执行行为经常受到人类交互行为的影响。然而,关于网络物理系统预期人类交互行为的假设通常是非正式记录的,甚至在系统设计中留下隐式和未指定的。不幸的是,由安全关键网络物理系统(如医疗网络物理系统(M-CPS))做出的这种隐含的人类交互假设可能导致灾难。最近几次美国食品和药物管理局(FDA)医疗器械召回是由于隐含的人类互动假设。在本文中,我们对医学领域中人类交互假设中的约束类别进行了分类,并开发了一个数学假设模型,该模型允许M-CPS工程师明确和精确地指定关于人类交互的假设。开发了将数学假设模型与系统模型相结合的算法,使系统的安全性不仅可以由医学和工程专业人员验证,而且可以通过现有的形式化验证工具进行正式验证。我们使用FDA召回的医疗呼吸机场景作为案例研究,以展示数学假设模型及其在M-CPS设计中的集成如何总体上提高呼吸机和M-CPS的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Modeling and Integrating Human Interaction Assumptions in Medical Cyber-Physical System Design
For a cyber-physical system, its execution behaviors are often impacted by human interactive behaviors. However, the assumptions about a cyber-physical systems expected human interactive behaviors are often informally documented, or even left implicit and unspecified in system design. Unfortunately, such implicit human interaction assumptions made by safety critical cyber-physical systems, such as medical cyber-physical systems (M-CPS), can lead to catastrophes. Several recent U.S. Food and Drug Administration (FDA) medical device recalls are due to implicit human interaction assumptions. In this paper, we classify the categories of constraints in human interaction assumptions in the medical domain and develop a mathematical assumption model that allow M-CPS engineers to explicitly and precisely specify assumptions about human interactions. Algorithms are developed to integrate mathematical assumption models with system model so that the safety of the system can be not only validated by both medical and engineering professionals but also formally verified by existing formal verification tools. We use an FDA recalled medical ventilator scenario as a case study to show how the mathematical assumption model and its integration in M-CPS design may improve the safety of the ventilator and M-CPS in general.
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