CPS: Large: Assuring the Safety, Security and Reliability of Medical Device Cyber Physical Systems

本研究的目的是建立一种新的开发范式，使医疗器械网络物理系统的有效设计，实施和认证成为可能。 该方法是追求以下研究方向：1）支持医疗设备的互联性和互操作性与网络使能控制; 2）应用医疗设备之间的协调，以支持新兴的临床场景; 3）？结束这一切该项目的智力价值是：1）严格开发的基础，包括临床场景的形式化、操作程序和医疗设备系统的架构，以及患者和护理人员的建模; 2）医疗器械系统的高置信度软件开发，包括将临床场景和器械安全有效地组合到动态组装系统中; 3）医疗器械网络物理系统的确认和认证;以及4）教育下一代医疗设备系统开发人员，他们必须在设备的计算和物理方面都有知识。该项目的更广泛影响将通过三种方式实现。新的设计方法和认证技术将显著提高患者安全性。 在临床实践中引入闭环方案将减轻护理人员目前面临的负担，并有可能降低医疗保健的总体成本。 最后，教育工作和外联活动将提高对医疗器械系统领域职业的认识，并有助于吸引妇女和代表性不足的少数民族进入该领域。

The objective of this research is to establish a new development paradigm that enables the effective design, implementation, and certification of medical device cyber-physical systems. The approach is to pursue the following research directions: 1) to support medical device interconnectivity and interoperability with network-enabled control; 2) to apply coordination between medical devices to support emerging clinical scenarios; 3) to ?close the loop? and enable feedback about the condition of the patient to the devices delivering therapy; and 4) to assure safety and effectiveness of interoperating medical devices.The intellectual merits of the project are 1) foundations for rigorous development, which include formalization of clinical scenarios, operational procedures, and architectures of medical device systems, as well as patient and caregiver modeling; 2) high-confidence software development for medical device systems that includes the safe and effective composition of clinical scenarios and devices into a dynamically assembled system; 3) validation and certification of medical device cyber-physical systems; and 4) education of the next-generation of medical device system developers who must be literate in both computational and physical aspects of devices.The broader impacts of the project will be achieved in three ways. Novel design methods and certification techniques will significantly improve patient safety. The introduction of closed-loop scenarios into clinical practice will reduce the burden that caregivers are currently facing and will have the potential of reducing the overall costs of health care. Finally, the educational efforts and outreach activities will increase awareness of careers in the area of medical device systems and help attract women and under-represented minorities to the field.