CSR-EHCS(CPS),TM: Architecture for the Safe Composition of Complex Medical Systems

每年有数千例患者受伤和未遂事件是由不适当或不安全的医疗器械相互作用造成的，因为有时对器械-器械和器械-人相互作用的后果了解不多，导致危险情况。 为了提供一个框架，以应对这些挑战，一个财团的医疗，工业，学术和政府机构一直在合作，通过？医学博士Pennsylvania？（医疗器械即插即用）计划，以确定在高敏度环境中集成医疗器械的广泛要求。这些要求的一个子集形成了安全集成临床环境（ICE）功能要求的拟议ASTM委员会F29标准的框架。该标准委员会由Co-PI Julian Goldman博士担任主席。 然而，在扩展现行标准以实现医疗器械的安全和动态组成方面存在许多开放的研究问题。本项目的目的是为安全的医疗设备即插即用开发正式的和医疗过程上下文敏感的系统组合架构。 该项目将不仅仅是确保互操作性;它将提供决策支持，并确保具有不同安全级别的医疗设备和信息系统的组成将产生可验证的安全MD PIPE技术。 我们预计新技术将嵌入到未来的标准中，从而大大改善医疗设备系统。

Each year thousands of patient injuries and near-misses are caused by improper or unsafe medical device interactions, because the consequences of device-device and device-human interactions are sometimes poorly understood, leading to hazardous situations. To provide a framework for addressing these challenges, a consortium of medical, industrial, academic, and government bodies have been collaborating through the ?MD PnP? (Medical Device Plug-and-Play) program to identify the broad requirements for the integration of medical devices in high-acuity settings. A subset of these requirements formed the framework for a proposed ASTM Committee F29 standard for the functional requirements of a safe Integrated Clinical Environment (ICE). The committee for this proposed standard is chaired by Co-PI Dr. Julian Goldman. However, there are many open research questions in extending the current standard to achieve the safe and dynamic composition of medical devices. The purpose of this project is to develop formal and medical procedure context sensitive system composition architecture for safe medical device plug-and-play. This project will do more than just ensure interoperability; it will provide decision support and make sure that the composition of medical devices and information systems with different safety levels will result in a verifiably safe MD PnP technologies. We expected the new technologies will be embedded into future standards, leading to a greatly improved medical device system.