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

EAGER：植入式医疗设备和身体区域网络：通过构建实现系统弹性

• 批准号: 1748737
• 负责人: Homa Alemzadeh
• 金额: $ 19.93万
• 依托单位: University of Virginia Main Campus
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1748737&HistoricalAwards=false
• 关键词: EAGER; Implantable; Medical; Device; Body

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.

低功耗和高度集成技术的进步为植入式医疗设备（IMD）和体域网（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，要么直接提供医疗以维持个体？的健康状况。然而，这些设备的故障，无论是由设备故障或恶意攻击造成的，可能会对用户产生负面影响？的健康，甚至造成生命的损失。设备复杂性的显著增加在确保这些设备的可靠性、安全性和安全性方面带来了重大挑战。首先，来自不同领域的研究人员，特别是工程和医学，已经发展了他们各自的观点，关注和定义有关患者的安全性，安全性和可靠性。 事实上，（患者）安全的概念经常因语言使用不一致而受到损害。 根据美国食品药品监督管理局（FDA）的记录，对医疗保健和工程学科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增加的原因。 此外，由于有限的上市时间和缺乏容错和可靠系统设计领域的知识，在设计阶段往往忽略或忽视了这些设备的设计中的安全性和安全性的考虑。 这项工作建议考虑一个新的系统弹性设计方法，它集成了多学科的观点，并考虑了许多方面的复杂性和设计约束，设计一个系统，不断防止，检测，减轻，或改善危害和事件。该项目的智力价值在于开发了一种基于模型的广义容错技术，该技术将“结构服从性”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，该方法可在任何功能设计中自动包含安全监视器，而无需设计师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）严格的安全要求制定环境，使工程师、医疗专业人员和监管机构能够密切有效地合作，以识别所有潜在的安全危害，并制定指导产品设计的安全要求;以及（ii）一个标准化的架构，用于更有弹性的BAN和IMD，使设计人员能够专注于功能设备的开发，而不必担心安全和容错功能。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。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将被研究，以设计有效的标准化安全机制。

项目成果

Design and Validation of an Open-Source Closed-Loop Testbed for Artificial Pancreas Systems

人工胰腺系统开源闭环测试台的设计和验证

• 发表时间: 2022
• 期刊: Systems and Engineering Technologies (CHASE
• 作者: Zhou, X.;Kouzel, M.;Ren, H.
• 通讯作者: Ren, H.

Real-Time Context-Aware Detection of Unsafe Events in Robot-Assisted Surgery

• DOI: 10.1109/dsn48063.2020.00054
• 发表时间: 2020-05
• 期刊: 2020 50th Annual IEEE/IFIP International Conference on Dependable Systems and Networks (DSN)
• 作者: M. S. Yasar;H. Alemzadeh

Data-driven Design of Context-aware Monitors for Hazard Prediction in Artificial Pancreas Systems

用于人工胰腺系统危险预测的上下文感知监视器的数据驱动设计

• DOI: 10.1109/dsn48987.2021.00058
• 发表时间: 2021
• 期刊: 2021 51st Annual IEEE/IFIP International Conference on Dependable Systems and Networks (DSN
• 作者: Zhou, Xugui;Ahmed, Bulbul;Aylor, James H.;Asare, Philip;Alemzadeh, Homa
• 通讯作者: Alemzadeh, Homa

Poster Abstract: Analysis of Cyber-Security Vulnerabilities of Interconnected Medical Devices

海报摘要：互联医疗设备的网络安全漏洞分析

• DOI: 10.1109/chase48038.2019.00017
• 发表时间: 2019
• 期刊: Systems and Engineering Technologies (CHASE
• 作者: Xu, Yanchen;Tran, Daniel;Tian, Yuan;Alemzadeh, Homa
• 通讯作者: Alemzadeh, Homa