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

医疗部门约占美国国内生产总值的20%。控制医疗设备的软件的使用迅速增加，这使得医疗设备软件和系统的开发和生产成为一个关键问题，这对美国经济和确保医疗保健服务的安全进步都是如此。人们对推进研究和开发以改进医疗器械软件和系统的设计、认证和操作(由医疗从业者和消费者)以产生更好和更具成本效益的医疗保健具有强烈的兴趣。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，目标是促进科学、技术和实践，以解决医疗器械设计、制造、认证、使用和互操作性中的关键软件和系统问题和挑战。这次关于HCMDSS(高信度医疗器械、软件、医疗器械即插即用(MD PnP)和医疗器械即插即用(MD PnP)互操作性为展示涵盖高完整性医疗器械、软件和系统的方方面面的研发活动提供了一个工作论坛，这对于支持创新的联网医疗器械系统以提高医疗保健的安全性和效率至关重要。医疗设备互操作性和高信心嵌入式系统领域的这一思想领袖的召开，为推动该领域发展的那种智力交流提供了一个独特的机会。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努力。这一议程的更广泛影响包括合作开发技术和方法，以实现(1)采用创新方法来提高患者的安全性和工作流程效率，(2)由此产生的医疗成本的降低，(3)支持远程环境中获得医疗保健的机会，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.