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的医疗设备协调框架和一个基于模型的面向组件的设备协调编程方法，并由一个用于设备行为和临床工作流程推理的正式框架支持。该项目的智力价值在于框架的正式基础，该框架将能够快速开发、验证和认证医疗系统及其设备组件，以及它们实施的临床场景。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，用于对系统故障进行取证分析。支持该框架的工具的开源分发将加强其采用和技术转让。一个严格的整合和协调多种医疗设备的框架将加强复杂临床场景的实施，并减少涉及这些场景的医疗差错。此外，它将加快和简化协调医疗设备的监管批准过程，而正式推理框架将提高设计过程和批准决策的信心。总体而言，该框架将有助于降低成本，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 forthe 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 willspeed 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.