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Towards GraphQL-Based Interoperability Between Business Meta-Models and FHIR Resources. 实现业务元模型与FHIR资源之间基于graphql的互操作性。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251526
Elis Saarelaid, Rainer Randmaa, Gunnar Piho, Peeter Ross

This paper presents a GraphQL-based solution for achieving interoperability between business meta-models and FHIR resources while reducing query complexity. A GraphQL API is implemented for data retrieval from the meta-model and tested using ChilliCream's Nitro tool. It is integrated with GraphQL Mesh, which maps FHIR R5 resource types to corresponding business meta-models. The Mesh API processes queries or mutations, translates them into GraphQL API calls, and converts the results back into FHIR objects. Testing is conducted using Hive Gateway. Future work includes validating this approach through artificial medical data exchanges.

本文提出了一种基于graphql的解决方案,用于实现业务元模型和FHIR资源之间的互操作性,同时降低查询复杂性。GraphQL API用于从元模型中检索数据,并使用ChilliCream的Nitro工具进行测试。它与GraphQL Mesh集成,后者将FHIR R5资源类型映射到相应的业务元模型。Mesh API处理查询或变化,将其转换为GraphQL API调用,并将结果转换回FHIR对象。使用Hive Gateway进行测试。未来的工作包括通过人工医疗数据交换验证这种方法。
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引用次数: 0
Risk Management in "Other Clinical Investigations" According to Art. 82 MDR - Lessons Learnt from the EDITh Project. 根据MDR第82条“其他临床研究”的风险管理-从EDITh计划中吸取的教训。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251484
Ariadna Pérez Garriga, Stefan Wolking, Josua Kegele, Christian M Bosselmann, Beatrice Coldewey, Raphael W Majeed, Rainer Röhrig, Yvonne Weber, Myriam Lipprandt

With the implementation of the EU Medical Device Regulation (MDR), clinical trials of clinical decision support systems (CDSS) now often fall under Article 82 of the MDR. This mandates systematic risk management even for academic feasibility studies. This article presents a risk management strategy based on the EDiTh project, which evaluated a CDSS for epilepsy treatment recommendations in accordance with the 2023 S2k guideline First epileptic seizure and epilepsy in adulthood. A Preliminary Hazard Analysis and System Failure Mode and Effects Analysis identified key error types such as incorrect diagnoses or dosing recommendations. Due to the potential for catastrophic harm, a dual-visit study design was implemented, including a second, blinded expert consultation via videoconference to independently confirm diagnosis and treatment decisions. This design supports both risk mitigation and assessment of guideline adherence as the primary endpoint. The risk matrix and study setup illustrate how safety and regulatory requirements can be met in academic environments, while offering insights for future MDR-compliant investigations of digital health technologies.

随着欧盟医疗器械法规(MDR)的实施,临床决策支持系统(CDSS)的临床试验现在通常属于MDR第82条。这就要求对学术可行性研究进行系统的风险管理。本文提出了一种基于EDiTh项目的风险管理策略,该项目根据2023 S2k指南对癫痫治疗建议的CDSS进行了评估。初步危害分析和系统故障模式及影响分析确定了关键错误类型,如不正确的诊断或剂量建议。由于潜在的灾难性伤害,实施了双访研究设计,包括通过视频会议进行第二次盲法专家咨询,以独立确认诊断和治疗决策。该设计支持风险缓解和指南依从性评估作为主要终点。风险矩阵和研究设置说明了如何在学术环境中满足安全和监管要求,同时为未来数字卫生技术的耐多药合规调查提供了见解。
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引用次数: 0
Assessing Electromedical Device Obsolescence: A Comparison Between Linear and Fuzzy Logic Approaches. 评估电子医疗设备过时:线性和模糊逻辑方法的比较。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251538
Andrea Adele Grassi, Simone Falco, Laura Oddera, Ezio Nicolàs Bruno Urbina, Mauro Giacomini

The focus of this study is the evaluation of electromedical devices through different methods of analysis, thanks to which it is possible to determine the obsolescence and therefore the need for decommissioning or revaluation of the same. The study has been conducted in parallel with the wave of renewal that is involving the IRCCS Giannina Gaslini Institute, particularly with the construction of the new Pavilion Zero, organized by intensity of care. This transformation requires a reorganization and awareness of all the existing medical equipment, along with the need for appropriate management, redistribution, and, in some cases, disposal. To support this process, the present study focuses on the evaluation of medical devices within the Institute, through the use of two different assessment methodologies: MVO (Obsolescence Evaluation Method) and a custom-developed index based on fuzzy logic. The analysis involved more than 8,000 devices. The first index (MVO) was developed by the company, which is responsible for maintaining medical devices within the Institute, namely Hospital Consulting S.p.A., which has used some objective parameters from the internal database. The second one was designed by the authors using the same parameters employed in the MVO, but was later refined through further analysis, which led to the exclusion or inclusion of parameters deemed crucial for the evaluation. This index was also developed with the support of some fuzzy logic based parameters. In the end, the two methodologies were compared in order to determine the consistency of the two methods used and the differences obtained.

本研究的重点是通过不同的分析方法对电子医疗设备进行评估,因此有可能确定其过时程度,从而确定是否需要退役或重新评估。这项研究是与IRCCS Giannina Gaslini研究所的更新浪潮同时进行的,特别是根据护理强度组织的新零号馆的建设。这一转变需要对现有的所有医疗设备进行重组和认识,同时需要进行适当的管理、重新分配和在某些情况下进行处置。为了支持这一进程,本研究侧重于通过使用两种不同的评估方法对研究所内的医疗器械进行评价:MVO(过时评价法)和基于模糊逻辑的定制指数。这项分析涉及8000多台设备。第一个索引(MVO)是由负责维护研究所内医疗设备的公司,即医院咨询公司开发的,该公司使用了内部数据库中的一些客观参数。第二个是由作者使用MVO中使用的相同参数设计的,但后来通过进一步分析进行了改进,这导致了对评估至关重要的参数的排除或包含。在模糊逻辑参数的支持下,建立了该指标。最后,对两种方法进行比较,以确定所使用的两种方法的一致性和所获得的差异。
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引用次数: 0
"Digital Unless?" Evaluating Digital Transformation in a Dutch Hospital. “数字除非?”评估荷兰医院的数字化转型。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251510
Felix Cillessen, Sanne van Logten, Jacob Hofdijk

Facing rising care demands, workforce shortages, and cost pressures, healthcare systems increasingly view digital transformation as essential rather than optional. This paper presents a qualitative evaluation of such efforts within a Dutch hospital that formally embraced the "digital unless" principle, providing care digitally by default unless not feasible. Despite strategic commitment, actual implementation often lags behind due to organizational, cultural, and practical barriers. In April 2025, a structured internal session was held involving a diverse group of stakeholders, including the executive board, board of medical staff, nursing staff board, tactical management representatives, the innovation committee, CMIO, CIO, and the patient advisory council. The session included (1) a strategic proposition review, (2) a "fishbowl" dialogue focused on staff experience, and (3) a debate on patient needs and autonomy. Central questions included "Are we doing digitally what can be done digitally?" and "What is needed to make that a reality?" Thematic analysis of the session revealed five key lessons: (1) hybrid care is the realistic default; (2) mindset and working technology are interdependent; (3) tailored support for staff is critical; (4) adopting proven innovations from others is efficient and effective; and (5) patient autonomy must remain central. These findings are contextualized using current literature and implementation frameworks like the Technology-Organization-Environment (TOE) model. External sources provide empirical support for the operational, clinical, and human value of digital health. The study concludes that digital success depends less on vision and more on cultural readiness, staff alignment, and meaningful patient inclusion. This paper offers practical, evidence-informed recommendations to help hospitals translate digital ambitions into measurable impact.

面对不断增长的护理需求、劳动力短缺和成本压力,医疗保健系统越来越多地将数字化转型视为必不可少的,而不是可有可无的。本文对荷兰一家医院的此类努力进行了定性评估,该医院正式接受了“数字除非”原则,除非不可行,否则默认提供数字护理。尽管做出了战略承诺,但由于组织、文化和实践方面的障碍,实际实施往往滞后。2025年4月,举行了一次有组织的内部会议,有不同利益攸关方参加,包括执行委员会、医务人员委员会、护理人员委员会、战术管理代表、创新委员会、CMIO、首席信息官和患者咨询委员会。会议包括(1)战略主张回顾,(2)以员工经验为重点的“鱼缸”对话,以及(3)关于患者需求和自主权的辩论。核心问题包括“我们正在做数字化可以做的事情吗?”以及“需要什么才能使之成为现实?”会议的主题分析揭示了五个关键教训:(1)混合护理是现实的默认值;(2)心态与工作技术相互依存;(3)为员工提供量身定制的支持至关重要;(4)采用他人已被证明有效的创新是高效的;(5)病人的自主权必须保持核心地位。这些发现使用当前文献和实现框架(如技术-组织-环境(TOE)模型)进行了背景化。外部资源为数字健康的操作、临床和人类价值提供了经验支持。该研究的结论是,数字化的成功更少地取决于愿景,而更多地取决于文化准备程度、员工一致性和有意义的患者包容。本文提供了实用的、基于证据的建议,以帮助医院将数字化目标转化为可衡量的影响。
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引用次数: 0
Development of a Machine Learning Model for Screening Sleep Apnea in Heart Failure Patients Using Sleep Sensor Data. 利用睡眠传感器数据筛选心力衰竭患者睡眠呼吸暂停的机器学习模型的开发。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251496
Mathushan Gunasegaram, Birthe Dinesen, Nikolaj Müller Larsen, Ghazal Ghamari Gilavai, Kristine Røge, Mathias Kirk Østergaard, Mads Rovsing Jochumsen

Sleep apnea (SA) is a prevalent disorder among individuals with heart failure (HF), often leading to complications. Early identification is essential for timely interventions and better outcomes. This study explores the feasibility of developing a screening tool for SA in patients with HF using data from the Future Patient Telerehabilitation program. A random forest classifier was used to develop a predictive model, achieving a promising receiver operating characteristic area under the curve (ROC-AUC) of 0.85, suggesting that the random forest classifier has the potential as a SA screening tool for HF patients. However, the study lacked key variables, such as oxygen saturation, that are strong predictors for SA assessment according to current literature; this limits the model's generalizability. Despite this, the findings indicate that the ML model shows promise for screening SA in HF patients, highlighting the need for high-quality, standardized data from future clinical trials to enhance its accuracy and clinical utility.

睡眠呼吸暂停(SA)是心力衰竭(HF)患者中常见的疾病,常导致并发症。早期识别对于及时干预和取得更好的结果至关重要。本研究利用未来患者远程康复项目的数据,探讨开发一种心衰患者SA筛查工具的可行性。使用随机森林分类器建立预测模型,受试者工作特征曲线下面积(ROC-AUC)为0.85,表明随机森林分类器具有作为心衰患者SA筛查工具的潜力。然而,该研究缺乏关键变量,如血氧饱和度,根据现有文献,这些变量是SA评估的有力预测因子;这限制了模型的可泛化性。尽管如此,研究结果表明,ML模型有望筛查心衰患者的SA,强调需要从未来的临床试验中获得高质量、标准化的数据,以提高其准确性和临床实用性。
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引用次数: 0
Feasibility of Fuzzy Control Aggregation in Clinical Decision Support Using HL7 Arden Syntax. 基于HL7 Arden语法的模糊控制聚合在临床决策支持中的可行性。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251491
Moritz Grob, Julia Liepold, Leonhard Hauptfeld, Vladik Kreinovich, Robert A Jenders, Klaus-Peter Adlassnig

Fuzzy control systems provide a robust framework for clinical decision support in settings characterized by uncertainty and overlapping variable states. Since Version 2.9, HL7 Arden Syntax has natively supported fuzzy logic constructs, enabling more accurate and expressive medical logic. This feasibility study explores fuzzy aggregation in Arden Syntax for clinical decision support. We implement a rule from FuzzyKBWean, a fuzzy control system supporting ventilator therapy decisions, recommending adjustment of FiO2 based on PaO2 and PaCO2 levels. It is executed using Medexter Healthcare's Arden Syntax compiler, demonstrating the practical utility of native fuzzy logic in Arden Syntax for real-time, interpretable clinical decision support. Observations during implementation led to a suggestion for further refinement of the standard regarding stricter data type enforcement in fuzzy operations, enhancing the robustness of Arden-Syntax-based systems.

模糊控制系统为不确定和重叠变量状态的临床决策支持提供了一个强大的框架。从2.9版开始,HL7 Arden Syntax原生支持模糊逻辑结构,从而实现更准确、更有表现力的医疗逻辑。本可行性研究探讨模糊聚合的Arden语法临床决策支持。我们实现了模糊控制系统fuzzykb断奶的规则,这是一个支持呼吸机治疗决策的模糊控制系统,建议根据PaO2和PaCO2水平调整FiO2。它使用Medexter Healthcare的Arden Syntax编译器执行,展示了Arden Syntax中本地模糊逻辑在实时、可解释的临床决策支持中的实际效用。在实施过程中的观察导致了进一步改进标准的建议,关于模糊操作中更严格的数据类型强制,增强基于arden语法的系统的鲁棒性。
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引用次数: 0
Virtual Resilience, Real Consensus: Methodological Framework for a VR-Based Resilience Intervention Using a Modified Delphi Approach. 虚拟弹性,真实共识:使用改进的德尔菲方法进行基于虚拟现实的弹性干预的方法框架。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251539
Martin Ernst, Yvonne Prinzellner, Nina Dalkner, Sebastian Egger-Lampl, Eva Turk

This concept paper outlines the methodological design and rationale behind a modified Delphi study conducted within the Horizon 2020 project XR2esilience, which aims to develop a virtual reality (VR)-based resilience training for nurses. The paper focuses on the consensus-oriented Delphi approach to support the early-phase co-development of digital health interventions. Experts from nursing, psychology, education, and VR development participated in a multi-round process to prioritize content areas, implementation strategies, and contextual considerations. The Delphi method was adapted to the needs of interdisciplinary collaboration and stakeholder integration in digital intervention design. As a concept paper, it outlines methodological foundations and consensus processes, offering guidance for similar initiatives seeking to combine technological innovation with participatory, consensus-driven development in healthcare.

这篇概念论文概述了地平线2020项目XR2esilience中进行的一项修改后的德尔菲研究的方法设计和基本原理,该研究旨在为护士开发基于虚拟现实(VR)的弹性培训。本文重点讨论了以共识为导向的德尔菲方法,以支持数字健康干预措施的早期共同开发。来自护理、心理学、教育和VR开发的专家参与了多轮过程,以确定内容领域、实施策略和背景考虑的优先级。德尔菲法适应了数字化干预设计中跨学科协作和利益相关者整合的需要。作为一份概念文件,它概述了方法基础和协商一致进程,为寻求将技术创新与卫生保健领域参与性、协商一致驱动的发展相结合的类似举措提供指导。
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引用次数: 0
Future Domain Experts - Integrating AI Education into Existing Master Programs for Health Professions. 未来领域专家——将人工智能教育整合到现有的卫生专业硕士课程中。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251549
Madeleine Blusi, Ingeborg Nilsson, Caroline Fischl, Helena Lindgren

Medical and health disciplines are facing a change of their clinical practices with the integration of new transformative technologies including artificial intelligence (AI). There is an interest to elevate knowledge and skills in designing and developing adaptive technology for clients, patients and practices. In this study the possibility to integrate education on human-centered AI in the education on advanced level of nurses, physiotherapists and occupational therapists was explored. A blueprint of a 3-course AI education on human-centered AI for health and wellbeing was developed and evaluated at two universities. The course contents range from theory to practical exercises with application to clinical practice on AI, responsible AI design and AI technology, with a structured progression between each level. The evaluation showed that the proposed courses could be integrated into the existing master programs to different extent, from full integration in 120-credit programs to limited integration in 60-credit programs. It was concluded that the proposed education is feasible and desirable to integrate, and future work will continue the development.

随着包括人工智能(AI)在内的新变革技术的融合,医学和卫生学科正面临着临床实践的变化。在为客户、患者和实践设计和开发适应性技术方面,有兴趣提高知识和技能。本研究探讨了以人为本的人工智能教育在高级护士、物理治疗师和职业治疗师教育中整合的可能性。两所大学制定并评估了以人为本的人工智能健康福祉3门课程的人工智能教育蓝图。课程内容涵盖人工智能、负责任的人工智能设计和人工智能技术的理论到实践,并应用于临床实践,每个级别之间有结构的递进。评估结果表明,拟开设的课程可以不同程度地与现有硕士课程进行整合,从完全整合120学分的专业到有限整合60学分的专业。结论提出的教育是可行的,值得整合,今后的工作将继续发展。
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引用次数: 0
Towards an Analytical System for Supervising Fairness, Robustness, and Dataset Shifts in Health AI. 健康人工智能中监督公平性、鲁棒性和数据集转换的分析系统。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251537
Ángel Sánchez-García, David Fernández-Narro, Pablo Ferri, Juan M García-Gómez, Carlos Sáez

Ensuring trustworthy use of Artificial Intelligence (AI)-based Clinical Decision Support Systems (CDSSs) requires continuous evaluation of their performance and fairness, given the potential impact on patient safety and individual rights as high-risk AI systems. However, the practical implementation of health AI performance and fairness monitoring dashboards presents several challenges. Confusion-matrix-derived performance and fairness metrics are non-additive and cannot be reliably aggregated or disaggregated across time or population subgroups. Furthermore, acquiring ground-truth labels or sensitive variable information, and controlling dataset shifts-changes in data statistical distributions-may require additional interoperability with the electronic health records. We present the design of ShinAI-Agent, a modular system that enables continuous, interpretable, and privacy-aware monitoring of health AI and CDSS performance and fairness. An exploratory dashboard combines time series navigation for multiple performance and fairness metrics, model calibration and decision cutoff exploration, and dataset shift monitoring. The system adopts a two-layer database. First, a proxy database, mapping AI outcomes and essential case-level data such as the ground-truth and sensitive variables. And second, an OLAP architecture with aggregable primitives, including case-based confusion matrices and binned probability distributions for flexible computation of performance and fairness metrics across time or sensitive subgroups. The ShinAI-Agent approach supports compliance with the ethical and robustness requirements of the EU AI Act, enables advisory for model retraining and promotes the operationalisation of Trustworthy AI.

考虑到作为高风险人工智能系统对患者安全和个人权利的潜在影响,确保基于人工智能(AI)的临床决策支持系统(cdss)的可靠使用需要对其性能和公平性进行持续评估。然而,卫生人工智能性能和公平性监测仪表板的实际实施存在一些挑战。混乱矩阵衍生的性能和公平性指标是非可加性的,不能可靠地跨时间或人口子组进行聚合或分解。此外,获取真实标签或敏感变量信息以及控制数据集移位(数据统计分布的变化)可能需要与电子健康记录额外的互操作性。我们介绍了ShinAI-Agent的设计,这是一个模块化系统,可以对健康AI和CDSS的性能和公平性进行连续、可解释和隐私感知的监测。探索性仪表板结合了多个性能和公平性指标的时间序列导航、模型校准和决策截止探索以及数据集移位监控。系统采用两层数据库。首先,一个代理数据库,映射人工智能结果和基本案例级数据,如基础真相和敏感变量。第二,具有可聚合原语的OLAP体系结构,包括基于案例的混淆矩阵和分箱概率分布,用于跨时间或敏感子组灵活计算性能和公平性指标。ShinAI-Agent方法支持遵守欧盟人工智能法案的道德和鲁棒性要求,为模型再培训提供咨询,并促进可信赖人工智能的运作。
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引用次数: 0
Input System for a GPT Model Simulating Doctor-Patient Interactions During Medical Consultation. 模拟医疗咨询过程中医患互动的GPT模型输入系统。
Pub Date : 2025-10-02 DOI: 10.3233/SHTI251562
Jonathan Kambire, Seydou Golo Barro, Pascal Staccini

The introduction of the Licence-Master-Doctorate (LMD) system in African higher education has significantly reshaped university organization, particularly in health-related fields, by exacerbating structural challenges such as the shortage of faculty and inadequate infrastructure. In this context, the present work aims to construct a structured dialogical corpus designed for the training of a customized GPT-2 model, with the goal of simulating medical consultations and supporting the training of medical students. The methodology combines the use of reliable medical sources, the controlled generation of dialogues using existing artificial intelligence systems, and role-playing exercises involving medical students, with detailed annotation of clinical, emotional, and behavioral metadata. The final corpus comprises over 36 million tokens for pre-training and more than 8,326 simulated dialogues for fine-tuning, covering the most prevalent pathologies in Burkina Faso. This multilingual and culturally contextualized approach represents a significant departure from dominant Western corpora, laying the groundwork for a medical conversational model adapted to African realities. While the model is still in training, the complete results will be presented at a later stage. Nevertheless, the collected data already constitute a valuable resource for the development of realistic, diverse, and reusable educational simulators across various medical training contexts.

在非洲高等教育中采用执照-硕士-博士(LMD)制度,加剧了师资短缺和基础设施不足等结构性挑战,从而大大改变了大学组织,特别是在卫生领域。在此背景下,本研究旨在构建一个结构化对话语料库,用于定制GPT-2模型的培训,目的是模拟医疗咨询并支持医学生的培训。该方法结合了可靠医学资源的使用,使用现有人工智能系统控制对话的生成,以及涉及医学生的角色扮演练习,以及临床、情感和行为元数据的详细注释。最终的语料库包括超过3600万个用于预训练的代币和超过8326个用于微调的模拟对话,涵盖了布基纳法索最普遍的病症。这种多语言和文化语境化的方法代表了对占主导地位的西方语料库的重大背离,为适应非洲现实的医学对话模式奠定了基础。虽然该模型仍在训练中,但完整的结果将在稍后阶段呈现。尽管如此,收集到的数据已经构成了在各种医学培训背景下开发现实的、多样化的和可重复使用的教育模拟器的宝贵资源。
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引用次数: 0
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Studies in health technology and informatics
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