Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and Play Interoperability

医疗行业约占美国国内生产总值的20%。控制医疗设备的软件使用迅速增加，使得医疗设备软件和系统的开发和生产成为一个至关重要的问题，无论是对美国经济还是确保医疗保健服务的安全进步。人们对推进研究和开发以改进医疗设备软件和系统的设计、认证和操作（医疗保健从业人员和消费者）有浓厚的兴趣，从而实现更好、更具成本效益的医疗保健。HCMDSS/MD PnP研讨会的目的是将来自临床环境、工业、研究实验室、学术界和政府的医疗器械专家（包括研究人员、工程师和临床医生）聚集在一起，以推进科学、技术和实践为目标，解决医疗器械在设计、制造、认证、使用和互操作性方面的关键软件和系统问题和挑战。本次关于HCMDSS（高可信度医疗设备、软件和系统）和医疗设备即插即用（MD PnP）互操作性的联合研讨会为展示研究和开发活动提供了一个工作论坛，涵盖了高完整性医疗设备、软件和系统的所有方面，这对于支持创新的网络医疗设备系统以提高医疗保健的安全性和效率至关重要。在医疗设备互操作性和高可信度嵌入式系统领域召集这群思想领袖，为将推进该领域的知识交流提供了独特的机会。以前的研讨会产生了广泛的网络和协作活动，促进了技术、方法和标准开发方面的并行工作。这一议程的更广泛影响包括协作开发技术和方法，以实现(1)采用创新方法提高患者安全和工作流程效率，(2)由此降低医疗保健成本，(3)支持在偏远环境中获得医疗保健，以及(4)改进需求方法，为技术开发提供临床基础。

The medical sector represents about 20% of the United States gross domestic product. The rapidly increasing use of software to control medical devices makes the development and production of medical device software and systems a crucial issue, both for the U.S. economy and to assure safe advances in healthcare delivery. There is strong interest in advancing research and development to improve the design, certification, and operation (by both healthcare practitioners and consumers) of medical device software and systems to result in better and more cost-effective medical care.The purpose of the HCMDSS/MD PnP workshop is to bring together medical device specialists (including researchers, engineers, and clinicians) from clinical environments, industry, research laboratories, academia, and government with the goal of advancing science, technology, and practice to address crucial software and systems issues and challenges in the design, manufacture, certification, use, and interoperability of medical devices.This joint workshop on HCMDSS (High Confidence Medical Devices, Software, andSystems) and Medical Device Plug-and-Play (MD PnP) Interoperability provides a working forum for the presentation of research and development activities covering all aspects of high integrity medical devices, software, and systems, which is essential to support innovative, networked medical device systems to improve safety and efficiency in health care. The convening of this group of thought leaders in the areas of medical device interoperability and high confidence embedded systems offers a unique opportunity for the kind of intellectual exchange that will advance the field. Previous workshops have resulted in extensive networking and collaborative activities that have facilitated parallel efforts in technology, methodology, and standards development. The broader impacts of this agenda include the collaborative development of technology and methodology to enable (1) the adoption of innovative approaches to improve patient safety and workflow efficiency, (2) the resulting reduction of healthcare costs, (3) the support of access to health care in remote environments, and (4) the improvement of requirements methodologies to provide a clinical basis for technology development.