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

每年数以千计的患者受伤和险些错过是由不适当或不安全的医疗设备相互作用造成的，因为设备-设备和设备-人类相互作用的后果有时被人们所知，导致危险的情况。为了提供一个应对这些挑战的框架，一个由医疗、工业、学术和政府机构组成的联盟一直在通过MD PNP？(医疗设备即插即用)计划，以确定高清晰度环境中医疗设备集成的广泛要求。这些要求的子集形成了拟议的ASTM委员会F29标准的框架，用于安全综合临床环境(ICE)的功能要求。这一拟议标准的委员会由联合国际朱利安·戈德曼博士担任主席。然而，在扩展现有标准以实现医疗器械的安全和动态组合方面，仍有许多有待研究的问题。本项目的目的是为安全的医疗器械即插即用开发形式化和医疗过程上下文敏感的系统组合体系结构。该项目将不仅仅是确保互操作性；它将提供决策支持，并确保不同安全级别的医疗设备和信息系统的组合将导致可验证的安全MD PNP技术。我们预计新技术将被嵌入到未来的标准中，导致医疗器械系统得到极大改进。

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.