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The concept of "system of systems" architecture is increasingly prevalent in many critical domains. Such systems allow information to be pulled from a variety of sources, analyzed to discover correlations and trends, stored to enable real-time and post-hoc assessment, mined to better inform decision-making, and leveraged to automate control of system units.(More)
Medical devices historically have been monolithic units – developed , validated, and approved by regulatory authorities as stand-alone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single(More)
Both researchers and industry vendors are exploring the concept of systems of interoperable medical devices and health information systems that support safety and enhance clinical functionality. The Integrated Clinical Environment (ICE) has been proposed as an architecture for such systems, and several research and commercial implementations are being(More)
The Integrated Clinical Environment (ICE) has been proposed as an open platform for integrating heterogeneous medical devices and coordinating their activities to automate clinical workflows. A key element of the ICE vision is that pieces of an ICE system are verified and receive regulatory clearance in a component-wise fashion (instead of a pair-wise(More)
Medical devices historically have been monolithic units --- developed, validated, and approved by regulatory authorities as standalone entities. Modern medical devices increasingly incorporate connectivity mechanisms that offer the potential to stream device data into electronic health records, integrate information from multiple devices into single(More)
Body sensor networks (BSNs) are an emerging class of medical cyber-physical systems which have the potential to change the healthcare paradigm. However, they present many new challenges, chief of which (like any medical device) is assuring patient safety. This requires not only a precise definition of safety, but also techniques for assessing the safety of(More)
This paper describes why "device state" and "patient context" information are necessary components of device models for safe interoperability. This paper includes a discussion of the importance of describing the roles of devices with respect to interactions (including human user workflows involving devices, and device to device communication) within a(More)
Introduction: Medical devices have had some level of data logging capabilities for decades. The data logs are not standardized as to content or format and may include device performance metrics for technical troubleshooting and maintenance, and clinical data for patient care. These logs are downloaded as needed to perform an adverse event analysis, but even(More)