14,198 research outputs found

    Towards Assurance for Plug & Play Medical Systems

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    Traditional safety-critical systems are designed and integrated by a systems integrator. The system integrator can asses the safety of the completed system before it is deployed. In medicine, there is a desire to transition from the traditional approach to a new model wherein a user can combine various devices post-hoc to create a new composite system that addresses a specific clinical scenario. Ensuring the safety of these systems is challenging: Safety is a property of systems that arises from the interaction of system components and it’s not possible to asses overall system safety by assessing a single component in isolation. It is unlikely that end-users will have the engineering expertise or resources to perform safety assessments each time they create a new composite system. In this paper we describe a platform-oriented approach to providing assurance for plug & play medical systems as well as an associated assurance argument pattern

    Open source health systems

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    The space physics environment data analysis system (SPEDAS)

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    With the advent of the Heliophysics/Geospace System Observatory (H/GSO), a complement of multi-spacecraft missions and ground-based observatories to study the space environment, data retrieval, analysis, and visualization of space physics data can be daunting. The Space Physics Environment Data Analysis System (SPEDAS), a grass-roots software development platform (www.spedas.org), is now officially supported by NASA Heliophysics as part of its data environment infrastructure. It serves more than a dozen space missions and ground observatories and can integrate the full complement of past and upcoming space physics missions with minimal resources, following clear, simple, and well-proven guidelines. Free, modular and configurable to the needs of individual missions, it works in both command-line (ideal for experienced users) and Graphical User Interface (GUI) mode (reducing the learning curve for first-time users). Both options have “crib-sheets,” user-command sequences in ASCII format that can facilitate record-and-repeat actions, especially for complex operations and plotting. Crib-sheets enhance scientific interactions, as users can move rapidly and accurately from exchanges of technical information on data processing to efficient discussions regarding data interpretation and science. SPEDAS can readily query and ingest all International Solar Terrestrial Physics (ISTP)-compatible products from the Space Physics Data Facility (SPDF), enabling access to a vast collection of historic and current mission data. The planned incorporation of Heliophysics Application Programmer’s Interface (HAPI) standards will facilitate data ingestion from distributed datasets that adhere to these standards. Although SPEDAS is currently Interactive Data Language (IDL)-based (and interfaces to Java-based tools such as Autoplot), efforts are under-way to expand it further to work with python (first as an interface tool and potentially even receiving an under-the-hood replacement). We review the SPEDAS development history, goals, and current implementation. We explain its “modes of use” with examples geared for users and outline its technical implementation and requirements with software developers in mind. We also describe SPEDAS personnel and software management, interfaces with other organizations, resources and support structure available to the community, and future development plans.Published versio

    Foundations for Safety-Critical on-Demand Medical Systems

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    In current medical practice, therapy is delivered in critical care environments (e.g., the ICU) by clinicians who manually coordinate sets of medical devices: The clinicians will monitor patient vital signs and then reconfigure devices (e.g., infusion pumps) as is needed. Unfortunately, the current state of practice is both burdensome on clinicians and error prone. Recently, clinicians have been speculating whether medical devices supporting ``plug & play interoperability\u27\u27 would make it easier to automate current medical workflows and thereby reduce medical errors, reduce costs, and reduce the burden on overworked clinicians. This type of plug & play interoperability would allow clinicians to attach devices to a local network and then run software applications to create a new medical system ``on-demand\u27\u27 which automates clinical workflows by automatically coordinating those devices via the network. Plug & play devices would let the clinicians build new medical systems compositionally. Unfortunately, safety is not considered a compositional property in general. For example, two independently ``safe\u27\u27 devices may interact in unsafe ways. Indeed, even the definition of ``safe\u27\u27 may differ between two device types. In this dissertation we propose a framework and define some conditions that permit reasoning about the safety of plug & play medical systems. The framework includes a logical formalism that permits formal reasoning about the safety of many device combinations at once, as well as a platform that actively prevents unintended timing interactions between devices or applications via a shared resource such as a network or CPU. We describe the various pieces of the framework, report some experimental results, and show how the pieces work together to enable the safety assessment of plug & play medical systems via a two case-studies

    Investigating subsumption in DL-based terminologies: A case study in SNOMED CT

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    Formalisms such as description logics (DL) are sometimes expected to help terminologies ensure compliance with sound ontological principles. The objective of this paper is to study the degree to which one DL-based biomedical terminology (SNOMED CT) complies with such principles. We defined seven ontological principles (for example: each class must have at least one parent, each class must differ from its parent) and examined the properties of SNOMED CT classes with respect to these principles. Our major results are: 31% of the classes have a single child; 27% have multiple parents; 51% do not exhibit any differentiae between the description of the parent and that of the child. The applications of this study to quality assurance for ontologies are discussed and suggestions are made for dealing with multiple inheritance

    Challenges in the Regulatory Approval of Medical Cyber-Physical Systems

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    We are considering the challenges that regulators face in approving modern medical devices, which are software intensive and increasingly network enabled. We then consider assurance cases, which o er the means of organizing the evidence into a coherent argument demonstrating the level of assurance provided by a system, and discuss research directions that promise to make construction and evaluation of assurance cases easier and more precise. Finally, we discuss some recent trends that will further complicate the regulatory approval of medical cyber-physical systems

    Point-of-care C reactive protein for the diagnosis of lower respiratory tract infection in NHS primary care: a qualitative study of barriers and facilitators to adoption

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    OBJECTIVES: Point-of-care (POC) C reactive protein (CRP) is incorporated in National Institute of Health and Care Excellence (NICE) guidelines for the diagnosis of pneumonia, reduces antibiotic prescribing and is cost effective. AIM: To determine the barriers and facilitators to adoption of POC CRP testing in National Health Service (NHS) primary care for the diagnosis of lower respiratory tract infection. DESIGN: The study followed a qualitative methodology based on grounded theory. The study was undertaken in 2 stages. Stage 1 consisted of semistructured interviews with 8 clinicians from Europe and the UK who use the test in routine practice, and focused on their subjective experience in the challenges of implementing POC CRP testing. Stage 2 was a multidisciplinary-facilitated workshop with NHS stakeholders to discuss barriers to adoption, impact of adoption and potential adoption scenarios. Emergent theme analysis was undertaken. PARTICIPANTS: Participants included general practitioners (including those with commissioning experience), biochemists, pharmacists, clinical laboratory scientists and industry representatives from the UK and abroad. RESULTS: Barriers to the implementation of POC CRP exist, but successful adoption has been demonstrated abroad. Analysis highlighted 7 themes: reimbursement and incentivisation, quality control and training, laboratory services, practitioner attitudes and experiences, effects on clinic flow and workload, use in pharmacy and gaps in evidence. CONCLUSIONS: Successful adoption models from the UK and abroad demonstrate a distinctive pattern and involve collaboration with central laboratory services. Incorporating antimicrobial stewardship into quality improvement frameworks may incentivise adoption. Further research is needed to develop scaling-up strategies to address the resourcing, clinical governance and economic impact of widespread NHS implementation
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