Safety Analysis of Body Sensor Networks

该项目是NSF-FDA驻校学者（SIR）计划下的合作项目。无线身体传感器网络（BSNs）是一种新兴的网络物理系统（CPS），它能够提供远程、连续的健康监测，正在改变医疗保健模式。BSN技术正迅速从研究原型领域转向商业医疗保健应用，并带来相关的安全影响。然而，由于缺乏公认的bsn安全定义以及指定和验证其安全特性的相关技术，制造商没有关于如何设计bsn以满足安全规范的指导方针，FDA（这些系统的主要监管机构）在评估bsn以确定其是否适合医疗保健市场的能力方面受到阻碍。BSNs的本质使监管问题更加复杂：无线传感、计算和通信设备以协调的方式运行，以提供有关人的身体状态的重要信息。该项目探讨：(1)根据BSNs的移动、网络物理性质，制定其安全属性的定义；(2)开发BSN参考模型（称为“通用BSN”），从中可以指定和实例化特定的BSN设计，并有助于提取和正式验证实例化设计的分析技术，以确定安全属性。这些发展将为制造商提供设计符合安全规范的bsn的能力，并将使FDA能够以客观、可重复和系统的方式更好地评估这些系统。

This project is a collaboration under the NSF-FDA Scholar-In-Residence (SIR) program. Wireless body sensor networks (BSNs) are an emerging class of cyber-physical system (CPS) that are changing the healthcare paradigm with their ability to provide remote, continuous health and wellness monitoring. BSN technology is rapidly moving from the domain of research prototypes to commercial healthcare applications, with associated safety implications. However, because of a lack of an accepted definition of safety for BSNs and associated techniques for specifying and verifying their safety properties, manufacturers do not have guidelines for how to design BSNs to meet safety specifications, and the FDA (the primary regulatory body for these systems) is handicapped in their ability to evaluate BSNs to determine their suitability for the healthcare market. The regulatory problem is compounded by the nature of BSNs: wireless sensing, computing, and communicating devices operating in a coordinated manner to provide vital information about the physical state of a person. This project explores: (1) the development of a definition of safety properties for BSNs in light of their mobile, cyber-physical nature; (2) the development of a reference model for BSNs (termed the "generic BSN") from which specific BSN designs can be specified and instantiated and which lends itself to analysis techniques for extracting and formally verifying the instantiated design against identified safety properties. These developments will provide manufacturers with the ability to design BSNs to meet safety specifications and will enable the FDA to better evaluate such systems in an objective, repeatable, and systematic manner.