EAGER: Implantable Medical Device and Body Area Networks: A System Resilience by Construction

低功耗和高度集成技术的进步为植入式医疗设备（imd）和身体区域网络（ban）的部署提供了巨大的机会。ban和imd要么为医疗决策提供关键的临床信息，要么直接提供医疗服务，以维持个人健康。S健康状态。但是，这些设备的故障，无论是由于设备故障还是恶意攻击，都可能对用户造成不良影响。甚至造成生命损失。随着设备复杂性的显著增加，对设备的可靠性、安全性和安全性提出了重大挑战。首先，来自不同领域的研究人员，特别是工程和医学，对患者的安全、保障和可靠性有各自的观点、关注和定义。事实上，（患者）安全的概念经常因语言的不一致而受到损害。根据美国食品和药物管理局（FDA）的记录，对医疗保健和工程学科方面的观点缺乏一致的理解可能是近年来医疗器械召回和不良事件数量上升的原因。此外，由于上市时间有限以及缺乏容错和可靠系统设计领域的知识，这些设备设计中的安全性和安全性考虑往往在设计阶段被忽略或忽视。这项工作建议考虑一种新的系统弹性设计方法，该方法集成了多学科的观点，并考虑了复杂性和设计约束的许多维度，以设计一个持续预防、检测、减轻或改善危害和事件的系统。该项目的智力优势在于开发了一种基于模型的通用容错技术，该技术将“按结构恢复”原则应用于下一代imd和ban的设计。主要目标是开发一种设计方法，可以在任何功能设计中自动包含安全监视器，而无需设计者在设计过程中明确指定监视器。具体而言，该设计方法/框架包括：(i)严格的安全要求开发环境，使工程师、医疗专业人员和监管机构之间能够密切有效地协作，以确定所有潜在的安全隐患，并制定指导产品设计的安全要求；（ii）针对更具弹性的ban和imd的标准化架构，使设计人员能够专注于功能器件的开发，而不必担心安全性和容错特性。一旦功能架构完成，设计人员将能够根据设备的特定安全要求添加标准化的硬件和软件安全机制。本文将研究基于模型和基于知识的故障检测和诊断方法以及两者的结合，以设计有效的标准化安全机制。

The advances of low-power and highly integrated technology provide enormous opportunities for the deployment of implantable medical devices (IMDs) and body area networks (BANs). BANs and IMDs either provide critical clinical information for medical decision-making or directly deliver medical treatment to maintain an individual?s health status. However, failures of these devices, either caused by device faults or malicious attacks, can have negative impact on the user?s health or even cause the loss of life. The significant increase in device complexity has created major challenges in ensuring reliability, safety, and security of these devices. First, researchers from the different domains, specifically engineering and medicine, have developed their respective perspectives, concerns and definitions regarding patient safety, security, and dependability. In fact, the concept of (patient) safety is often compromised by inconsistent use of language. The lack of a consistent understanding of the perspectives with respect to the healthcare and engineering disciplines could be the cause of the rising number of recalls and adverse events of medical devices in recent years, as recorded by the US Food and Drug Administration (FDA). In addition, the consideration of safety and security in the design of these devices is often ignored or overlooked in the design phase due to the limited time-to-market and lack of knowledge of the area of fault tolerant and dependable system design. This work proposes to consider a new system-resilience design methodology which integrates the multidiscipline perspectives and considers the many dimensions of complexity and design constraints to design a system that continuously prevents, detects, mitigates, or ameliorates hazards and incidents. The intellectual merit of this project is in development of a generalized fault-tolerant model-based technique that applies the principle of "resilience-by-construction" to design of the next generation IMDs and BANs. The main goal is to develop a design methodology that provides the automatic inclusion of safety monitors in any functional design without the designer having to explicitly designate monitors during the design process. To be specific, this design methodology/framework includes: (i) a rigorous safety requirement development environment that enables the close and effective collaboration between engineers, medical professionals, and regulators to identify all the potential safety hazards and develop safety requirements that guide product design; and (ii) a standardized architecture for more resilient BANs and IMDs that enables the designers to concentrate on the development of a functional device and not be concerned about the safety and fault tolerance features. Once the functional architecture is complete, the designer will be able to add standardized hardware and software safety mechanisms based on the specific safety requirements of the device. Both model-based and knowledge-based fault detection and diagnosis methods and the combination of the two will be investigated for design of effective standardized safety mechanisms.