CPS:Medium:Collaborative Research: Infrastructure and Technology Innovations for Medical Device Coordination

本研究的目的是开发一个框架，用于开发和部署由集成和协作医疗设备组成的下一代医疗系统。 该方法是设计和实现一个开源医疗设备协调框架和一个基于模型的面向组件的编程方法，用于设备协调，由一个用于推理设备行为和临床工作流程的正式框架支持。该项目的智力价值在于框架的正式基础，这将使医疗系统及其设备组件的快速开发，验证和认证成为可能，以及他们实施的临床场景。 基于模型的方法将为监管审批过程提供证据，而嵌入系统的运行时监控组件将启用“黑匣子”记录功能，用于系统故障的法医分析。 支持该框架的开源工具的分发将促进其采用和技术转让。一个用于集成和协调多个医疗设备的严格框架将促进复杂临床场景的实施，并减少涉及此类场景的病例中的医疗错误。 此外，它将加快和简化协调医疗设备的监管审批流程，而正式的推理框架将提高设计流程和审批决策的信心。总的来说，该框架将有助于降低成本和提高医疗质量。

The objective of this research is to develop a framework for the developmentand deployment of next-generation medical systems consisting of integrated andcooperating medical devices. The approach is to design and implement anopen-source medical device coordination framework and a model-based componentoriented programming methodology for the device coordination, supported by aformal framework for reasoning about device behaviors and clinical workflows.The intellectual merit of the project lies in the formal foundations of theframework that will enable rapid development, verification, and certificationof medical systems and their device components, as well as the clinicalscenarios they implement. The model-based approach will supply evidence for the regulatory approval process, while run-time monitoring components embeddedinto the system will enable "black box" recording capabilities for the forensicanalysis of system failures. The open-source distribution of tools supportingthe framework will enhance its adoption and technology transfer.A rigorous framework for integrating and coordinating multiple medical deviceswill enhance the implementation of complicated clinical scenarios and reducemedical errors in the cases that involve such scenarios. Furthermore, it will speed up and simplify the process of regulatory approval for coordination-enabled medical devices, while the formal reasoning framework will improve the confidence in the design process and in the approval decisions.Overall, the framework will help reduce costs and improve the quality of thehealth care.