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Keywords = medical artificial intelligence

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17 pages, 294 KB  
Article
How Medical Students Use and Perceive Generative Artificial Intelligence for Learning and Assessment: A Cross-Sectional Study at a Regional Australian Medical School
by Eunah Joo, Oliver Ma, Torres Woolley and Nagaraja Haleagrahara
Int. Med. Educ. 2026, 5(3), 89; https://doi.org/10.3390/ime5030089 (registering DOI) - 24 Aug 2026
Abstract
Generative artificial intelligence has been rapidly adopted by university students, yet there is limited evidence describing how and why medical students use it, particularly in regional settings. This cross-sectional study examined the use of generative artificial intelligence for learning and assessment among medical [...] Read more.
Generative artificial intelligence has been rapidly adopted by university students, yet there is limited evidence describing how and why medical students use it, particularly in regional settings. This cross-sectional study examined the use of generative artificial intelligence for learning and assessment among medical students at James Cook University, a regional Australian medical school with three North Queensland campuses. All enrolled students (Years 1–6) were invited to complete a 24-item online survey; closed-ended items were analysed using frequency and bivariate analyses by year level and gender, with correction for multiple comparisons, and open-ended responses were analysed using qualitative content analysis. In total, 438 students responded. Eighty percent reported using artificial intelligence for their studies or assignments, and 95% supported its use in medical education in some capacity. The most common uses were explaining concepts (56%) and answering medical content questions (54%). Pre-clinical students reported greater study-related use, whereas clinical year students reported greater assessment-related use. Male students also reported higher levels of use, willingness to pay, and trust in AI tools. Although uptake was high, trust was moderate, and students expressed concerns about professionalism and critical thinking. Medical schools should provide explicit guidance on acceptable use, incorporate artificial intelligence literacy training and ethical use guidelines, and redesign assessment to protect the skills students perceive to be most at risk. Full article
21 pages, 695 KB  
Article
Value Configurations Associated with Artificial Intelligence Literacy Among Medical Students: Findings from NCA and fsQCA
by Huiying Liu, Jia Xue, Xuesong Shang, Wan Wang, Yuping Wang, Anqi Li and Hanxiao Cheng
Behav. Sci. 2026, 16(9), 1458; https://doi.org/10.3390/bs16091458 - 22 Aug 2026
Abstract
Artificial intelligence (AI) is increasingly integrated into healthcare education, clinical decision-making, and future practice. For medical students, AI literacy entails technical understanding, practical competence, ethical awareness, value-based judgment, and responsible engagement. This study examines how culturally embedded value orientations are associated with Chinese [...] Read more.
Artificial intelligence (AI) is increasingly integrated into healthcare education, clinical decision-making, and future practice. For medical students, AI literacy entails technical understanding, practical competence, ethical awareness, value-based judgment, and responsible engagement. This study examines how culturally embedded value orientations are associated with Chinese medical students’ perceived AI literacy, as assessed using a self-report instrument. In a cross-sectional sample of 1500 medical students enrolled at a comprehensive university in Henan Province, China, AI literacy was assessed using the 12-item Artificial Intelligence Literacy Scale (AILS), a self-report measure whose scores represented perceived AI literacy. Value orientations were measured using the 32-item Chinese Values Questionnaire (CVQ), comprising eight value dimensions. NCA and fsQCA were conducted to examine necessary conditions and configurational associations with membership in the high perceived AI literacy set. No single value dimension met the criterion for set-theoretic necessity with respect to membership in the high self-reported AI literacy set, and no individual condition met the fsQCA necessity consistency threshold of 0.90. Four sufficient configurations associated with high perceived AI literacy were identified, with an overall solution consistency of 0.867 and coverage of 0.383. Moral Self-Discipline and Public Interest repeatedly appeared as core or peripheral conditions. These results suggest that high perceived AI literacy was associated with multiple combinations of value orientations rather than with a single value dimension. High perceived AI literacy was associated with multiple value configurations rather than one dominant value orientation. Empirically, this study applies configurational analysis to understand how value orientations are associated with AI literacy, complementing existing research on knowledge, attitudes, and readiness. These context-bound associations may inform future research on whether medical AI curricula can integrate technical training with ethical reflection and public-oriented professional values. Full article
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30 pages, 1708 KB  
Review
Artificial Intelligence for Diagnostic and Prognostic Support in Breast Cancer: A Literature Overview
by Diana Gina Poalelungi, Anca Iulia Neagu, Ana Fulga, Octavian Stefan Patrascanu and Iuliu Fulga
Cancers 2026, 18(16), 2723; https://doi.org/10.3390/cancers18162723 (registering DOI) - 21 Aug 2026
Viewed by 100
Abstract
Artificial intelligence (AI) is increasingly being integrated into medical practice, offering promising tools to improve diagnostic accuracy and clinical efficiency. In the field of breast pathology, AI applications, particularly those based on deep learning (DL) and machine learning (ML), are emerging as decision-support [...] Read more.
Artificial intelligence (AI) is increasingly being integrated into medical practice, offering promising tools to improve diagnostic accuracy and clinical efficiency. In the field of breast pathology, AI applications, particularly those based on deep learning (DL) and machine learning (ML), are emerging as decision-support tools in both diagnostic and prognostic workflows. This review provides a comprehensive overview of current AI-based approaches, with a focus on their clinical utility in tumor detection, histological classification, biomarker assessment, and prediction of treatment response. In addition to summarizing available AI platforms, the review critically examines their level of clinical validation, regulatory status, and integration into routine practice. Key challenges are also discussed. Overall, AI is expected to play an increasingly important role in supporting pathologists and advancing precision medicine in breast cancer management. Full article
(This article belongs to the Section Methods and Technologies Development)
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15 pages, 1582 KB  
Article
A Multidisciplinary Model for Risk Management and Detection of Ageist Bias in Healthcare Systems in the Era of Artificial Intelligence
by Eyal Cohen, Yehuda Adler and Rachel Nissanholtz-Gannot
Healthcare 2026, 14(16), 2642; https://doi.org/10.3390/healthcare14162642 - 20 Aug 2026
Viewed by 150
Abstract
Background: The rapid integration of Artificial Intelligence (AI), specifically Clinical Decision Support Systems (CDSS), into healthcare offers substantial efficiency but introduces critical ethical and legal challenges, particularly the perpetuation of systemic bias against older adults (“Digital Ageism”). While technological advances may improve care, [...] Read more.
Background: The rapid integration of Artificial Intelligence (AI), specifically Clinical Decision Support Systems (CDSS), into healthcare offers substantial efficiency but introduces critical ethical and legal challenges, particularly the perpetuation of systemic bias against older adults (“Digital Ageism”). While technological advances may improve care, they can violate fundamental bioethical principles when models are trained on unrepresentative data. Aim: This article argues that traditional clinical risk-management models are structurally insufficient to address opaque algorithmic bias and presents a conceptual, multidimensional governance framework designed to prevent the codification of human ageism into AI infrastructure. Methods: Drawing on systemic failures observed during the COVID-19 pandemic, the normative model integrates legal and governance standards aligned with the EU AI Act, Explainable AI (XAI) tools, and a three-phase implementation protocol. Results: To illustrate potential application without overburdening medical staff, the article introduces a theoretical Targeted Escalation Protocol and an Autonomous High-Load Safety Mode. The latter applies deterministic hardcoded constraints to contain age-dominant outputs during acute surges while preserving attending-clinician authority. The framework is explored through an Intensive Care Unit (ICU) thought experiment. Conclusions: The framework provides a structured roadmap for policymakers, ethicists, and healthcare administrators to move from reactive defensive medicine toward proactive ethical safety, safeguarding the dignity of the aging population while aiming to mitigate institutional legal exposure. Full article
(This article belongs to the Section Artificial Intelligence in Healthcare)
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24 pages, 601 KB  
Article
The Constraints of Domain Familiarity: AI Stars, Knowledge Diversity, and Breakthrough Innovation
by Xiao Li, Sheng Lin, Xianglan Chi, Jinmeng Yu and Jinlan Liu
Systems 2026, 14(8), 1024; https://doi.org/10.3390/systems14081024 - 19 Aug 2026
Viewed by 117
Abstract
While artificial intelligence (AI) is expected to drive paradigm-shifting transformations, many initiatives result in merely incremental optimization. Anchored in strategic human capital theory, this study shifts the analytical focus from the scale of elite technical talent, conceptualized as AI stars, to the configuration [...] Read more.
While artificial intelligence (AI) is expected to drive paradigm-shifting transformations, many initiatives result in merely incremental optimization. Anchored in strategic human capital theory, this study shifts the analytical focus from the scale of elite technical talent, conceptualized as AI stars, to the configuration of their knowledge structures to unpack this paradox. Using a dataset of 1270 medical AI patents from corporate R&D teams, we employed high-dimensional fixed-effects models to examine these dynamics. The results reveal that while the knowledge diversity of AI stars acts as a potent engine for breakthrough innovation, this generative capacity is attenuated by excessive domain familiarity. Specifically, direct domain familiarity (derived from internal experience) and indirect domain familiarity (absorbed through external collaborative networks) negatively moderate this relationship, a dynamic theorized to operate through internal cognitive entrenchment and external relational conformity, respectively. Extending the efficiency-driven consensus regarding bilingual expertise, these findings demonstrate that excessive domain embeddedness transforms from an informational bridge into a restrictive constraint during paradigm-shifting innovations, particularly within highly institutionalized environments. Full article
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29 pages, 1106 KB  
Review
Artificial Intelligence in Cardiovascular Ultrasound: Clinical Applications, Foundation Models, and the Path to Precision Cardiology
by Ancuta Elena Tupu, Simona Steliana Tudor, Caterina Nela Dumitru, Claudia Simona Stefan and Ionela Daniela Ferțu
J. Clin. Med. 2026, 15(16), 6398; https://doi.org/10.3390/jcm15166398 - 19 Aug 2026
Viewed by 145
Abstract
Cardiovascular ultrasound is a cornerstone of noninvasive cardiac and vascular assessment, yet conventional interpretation remains operator-dependent, variable, and limited in sensitivity for subclinical disease. Artificial intelligence (AI), particularly machine learning (ML), deep learning (DL), and, most recently, vision–language and foundation models, offers tools [...] Read more.
Cardiovascular ultrasound is a cornerstone of noninvasive cardiac and vascular assessment, yet conventional interpretation remains operator-dependent, variable, and limited in sensitivity for subclinical disease. Artificial intelligence (AI), particularly machine learning (ML), deep learning (DL), and, most recently, vision–language and foundation models, offers tools to automate, standardize, and extend ultrasound analysis. This narrative review examines the role of AI-enhanced cardiovascular ultrasound in the transition from descriptive imaging toward predictive and personalized medicine. We conducted a structured literature search of PubMed/MEDLINE, Scopus, Web of Science, and Google Scholar (January 2016–May 2026), combining Medical Subject Headings and free-text terms related to AI and cardiovascular ultrasound. Original studies, meta-analyses, reviews, consensus documents, and seminal works were considered. AI now spans the entire echocardiographic workflow, acquisition guidance, view classification, segmentation (Dice ≈ 0.92–0.94 on public datasets), and automated quantification of ejection fraction and global longitudinal strain, achieving expert-level accuracy and improved reproducibility. Across clinical domains, AI supports ischemia detection on stress echocardiography, heart-failure phenogrouping, Doppler-independent aortic stenosis detection, and carotid plaque characterization for stroke-risk stratification. Emerging vision–language and multitask foundation models (e.g., EchoCLIP, EchoPrime, and PanEcho) point toward general-purpose interpretation, and a growing number of tools (Caption Guidance, Us2.ai, and Ultromics EchoGo) have obtained FDA clearance and/or CE marking. Increasingly, AI-derived imaging biomarkers feed multimodal models that enable individualized risk prediction and therapy selection. AI-enhanced cardiovascular ultrasound is poised to become a central tool of precision cardiology. Realizing its potential will require prospective multicenter validation, cross-vendor standardization, attention to generalizability, interpretability, and reproducibility, and evolving regulatory and ethical frameworks. Full article
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16 pages, 775 KB  
Article
AI-Enabled Virtual Patients as Part of Clinical Skills Training: A Cross-Sectional Program Evaluation of Student Perspectives on the McMaster Virtual SP Tool
by Bhavya Gandhi, Urmi Sheth, Jeffrey McCarthy and Matthew Sibbald
Int. Med. Educ. 2026, 5(3), 85; https://doi.org/10.3390/ime5030085 - 19 Aug 2026
Viewed by 111
Abstract
Large language model-enabled virtual patients may expand access to clinical skills practice by supporting explicitly defined practice tasks. This program evaluation examined medical students’ awareness, use, and perceptions of the McMaster Virtual SP Tool, a custom generative artificial intelligence tool developed to supplement [...] Read more.
Large language model-enabled virtual patients may expand access to clinical skills practice by supporting explicitly defined practice tasks. This program evaluation examined medical students’ awareness, use, and perceptions of the McMaster Virtual SP Tool, a custom generative artificial intelligence tool developed to supplement clinical skills practice. We conducted an anonymous, single-institution cross-sectional survey of students across three cohorts at McMaster University. Quantitative responses were summarized descriptively, and free-text responses were analyzed using qualitative content analysis informed by task-aligned fidelity, deliberate practice, learner-centred feedback, and simulation instructional design. Thirty-five students responded; 23 (65.7%) were aware of the tool and 16 (45.7%) had used it. Among the 16 users, 15/16 (93.8%) found the tool at least somewhat easy to navigate; 13 (81.3%) would use it again; and 13 (81.3%) would recommend it. Across all respondents, 14/35 (40.0%) reported using AI-enabled virtual patients for OSCE preparation. Users valued its accessibility, independent low-stakes rehearsal, and usefulness for focused history-taking, question wording, and clinical reasoning. Perceived limitations included reduced human connection, nonverbal and emotional realism, physical examination practice, and feedback specificity. AI-enabled virtual patients may therefore be considered as adjuncts for selected cognitive and structural rehearsal tasks. Objective educational outcomes were not assessed. Full article
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26 pages, 19028 KB  
Systematic Review
Applications of Artificial Intelligence in the Health Sector: A PRISMA-Based Systematic Review
by Zakir Hossen Shaikh, Sarita Yadav, Bibhu Prasad Sahoo, Jay Shankar Sharma and Abdelrhman Meero
Healthcare 2026, 14(16), 2604; https://doi.org/10.3390/healthcare14162604 - 19 Aug 2026
Viewed by 104
Abstract
Background: The health sector is getting transformed with the usage of AI, be it diagnosis, treatment planning, disease prediction, and or health system management. Research in this field has picked up in the last few years, which was made possible with the emergence [...] Read more.
Background: The health sector is getting transformed with the usage of AI, be it diagnosis, treatment planning, disease prediction, and or health system management. Research in this field has picked up in the last few years, which was made possible with the emergence of machine learning, natural language processing and the increasing number of e-health records. Objectives: The study aims to investigate the current trends in the implementation of artificial intelligence (AI) applications in medical settings by investigating the global scientific output/landscape on this theme, such as the annual publication trends, country-wise contributions, and publishing patterns. Methods: The current study is based on systematic review by combining bibliometric analysis and cluster analysis using VOSviewer version 1.6.20, R software version 4.5.0, and Biblioshiny (Bibliometrix package in R) along with preferred reporting items for systematic reviews and meta analyses (PRISMA), 2020 which provides transparency and rigorous visualization to examine the articles published in English on the use of AI in healthcare, after the onset of COVID-19 till date i.e., from 2020 to 2026 on the Scopus database. Results: Using the relevant search string, 5940 documents were identified between 2020 and 2026, 1434 were included for analysis after screening and relevant filters. The publications have increased remarkably after 2020 on this theme and more than half of the publications have their roots in the discipline of Medicine. The USA, China, and the United Kingdom have contributed the most to the volume of research. Natural language processing and diagnosis are the emerging themes. The Journal of Medical Internet Research, BMC Medical Informatics and Decision Making, Computers in Biology and Medicine, IEEE Journal of Biomedical and Health Informatics, Frontiers in Public Health, and Digital Health are some of the most influential sources in the field. Li J and Liu X are among the authors with remarkable local impact. Conclusions: The work aims to assist investigators, health care professionals, and policymakers to learn about modern trends and focus on critical areas of future research and collaboration in AI-enhanced health care. The limitation of the study is that it considered only the Scopus database but it has opened up opportunities for researchers for analysis using other databases such as Dimensions, Lens, and PubMed. Also, this review is considering the publication record since the onset of COVID-19 but a comparative analysis of pre and post-pandemic studies can also be conducted to get a holistic view of drastic collaboration of research in this field. Discussions: The findings suggest that the role of artificial intelligence in health care has paramount over recent years, with other supporting technologies but a technologically hesitant population as well as low acceptance of AI due to ethical issues, cannot be ignored for ensuring efficiency in the health sector. Full article
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18 pages, 6309 KB  
Article
SmartMM: A Domain-Specific Large Language Model for Medical Microbiology
by Yongqiang Gong, Ruiqi Ma, Xicheng Wang, Ruixi Li, Han Dong, Yijin Liu, Xi Peng, Quanle Guo and Yin Liu
AI 2026, 7(8), 316; https://doi.org/10.3390/ai7080316 - 18 Aug 2026
Viewed by 169
Abstract
Background: Large language models (LLMs) show considerable promise for medical question answering and reasoning. Their use in medical microbiology, however, remains constrained by limited domain-specific knowledge and the risk of hallucinated outputs. Objective: To develop and evaluate Smart Medical Microbiology (SmartMM), a specialized [...] Read more.
Background: Large language models (LLMs) show considerable promise for medical question answering and reasoning. Their use in medical microbiology, however, remains constrained by limited domain-specific knowledge and the risk of hallucinated outputs. Objective: To develop and evaluate Smart Medical Microbiology (SmartMM), a specialized LLM for accurate, reliable, and context-aware responses in medical microbiology. Methods: SmartMM integrates domain-adaptive continual pretraining, supervised fine-tuning (SFT), reinforcement learning from human feedback (RLHF), knowledge distillation, and retrieval-augmented generation (RAG). We constructed a high-quality microbiology corpus from textbooks, clinical guidelines, the scientific literature, case reports, and other authoritative sources. Model performance was assessed using objective examinations, subjective generation tasks, expert review, and real-world user preference evaluation. Results: SmartMM achieved accuracies of 0.897 and 0.563 on true-or-false and fill-in-the-blank questions, respectively. In subjective generation tasks, it obtained the highest ROUGE-L score (0.265) and BERTScore F1 score (0.771) among all compared models. Expert assessment showed excellent inter-rater reliability, with all ICC(C,3) values exceeding 0.970. In a user evaluation involving 20 participants and 100 real-world questions, SmartMM received the largest number of first-place rankings (33), placing it among the top-performing systems overall. Conclusions: SmartMM showed strong domain adaptability in medical microbiology knowledge organization, semantic generation, and retrieval-augmented reasoning. These findings support its potential use in educational support, infectious disease knowledge assistance, and retrieval-enhanced medical question answering. Full article
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15 pages, 6130 KB  
Article
Artificial Intelligence-Assisted Structural Analysis of Bones with Paget’s Disease of Bone and Osteoporosis: Lessons from Mouse Models
by Jie Liu, Shun-Yu Kan, Xiwen Xin, Tianle Chen, Henry Tseng, Yung-Chieh Hsu, Tai-Hsien Wu, Do-Gyoon Kim and Ching-Chang Ko
Diagnostics 2026, 16(16), 2618; https://doi.org/10.3390/diagnostics16162618 - 18 Aug 2026
Viewed by 170
Abstract
Background/Objectives: Paget’s disease of bone (PDB) and osteoporosis are chronic metabolic bone disorders characterized by disrupted bone remodeling and increased skeletal fragility; however, the underlying mechanism of PDB remains poorly understood. Artificial intelligence (AI) has emerged as a transformative tool in medical imaging, [...] Read more.
Background/Objectives: Paget’s disease of bone (PDB) and osteoporosis are chronic metabolic bone disorders characterized by disrupted bone remodeling and increased skeletal fragility; however, the underlying mechanism of PDB remains poorly understood. Artificial intelligence (AI) has emerged as a transformative tool in medical imaging, enabling automated feature extraction and improved diagnostic classification of skeletal disorders. This study aimed to investigate whether AI could distinguish subtle variations in bone morphology between PDB and osteoporotic bone. Methods: C57BL/6 mice femurs were scanned by µCT: 16 optineurin-knockout mice with a PDB phenotype (20–26 months), 25 genetically matched wild-type Aging mice (20–26 months), and 15 ovariectomized (OVX) mice with osteoporotic bone phenotype (4.5 months). Two AI algorithms were investigated: a machine learning (ML) model using 22 µCT-derived features trained with a Random Forest (RF) classifier, and a deep learning (DL) model using a 3D convolutional neural network (3D-CNN) trained on raw µCT images. Leave-one-out cross-validation was applied to evaluate model robustness. Results: Significant differences in volumetric, density, and morphological parameters of cortical and trabecular bone were observed between PDB and osteoporosis (p < 0.05). The RF algorithm achieved 90% accuracy in distinguishing PDB from both aging- and OVX-induced osteoporosis and provided feature importance rankings that improved model interpretability. The 3D-CNN achieved classification accuracies of 70% for PDB vs. OVX and 68% for PDB vs. aging, demonstrating the feasibility of an image-based DL approach. Conclusions: AI-based RF and 3D-CNN models demonstrated promising performance in differentiating PDB from osteoporosis using µCT-derived bone features. These findings suggest potential for using AI to assist with analyzing skeletal images in the diagnosis of metabolic bone disorders. Full article
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35 pages, 717 KB  
Article
Generational Differences in the Acceptance of Care Robots Among Portuguese Adults: Evidence from the Almere Model, ADL and IADL Frameworks
by Paula Tavares de Carvalho, Ricardo Jorge Raimundo and Nuno Piçarra
Healthcare 2026, 14(16), 2592; https://doi.org/10.3390/healthcare14162592 - 18 Aug 2026
Viewed by 183
Abstract
Background: Population ageing, increasing care demands, and rapid advances in artificial intelligence and robotics have intensified interest in care robots as potential tools to support independent living and complement human caregiving. However, the successful implementation of robotic technologies depends largely on public acceptance, [...] Read more.
Background: Population ageing, increasing care demands, and rapid advances in artificial intelligence and robotics have intensified interest in care robots as potential tools to support independent living and complement human caregiving. However, the successful implementation of robotic technologies depends largely on public acceptance, which is influenced by functional, psychological, ethical, cultural, and generational factors. Objective: This study examined generational differences in the acceptance of care robots among Portuguese adults by integrating the Almere Model of technology acceptance with the Katz Index of Activities of Daily Living (ADL) and the Lawton–Brody Instrumental Activities of Daily Living (IADL) Scale. The research sought to determine whether acceptance varies according to generation and the type of caregiving activity performed by the robot. Methods: A cross-sectional quantitative study was conducted using an online questionnaire administered to a purposive sample of 235 adults residing primarily in the Lisbon Metropolitan Area, Portugal. The questionnaire combined constructs from the Almere Model with perceptions of robotic assistance for ADLs and IADLs. Principal Component Analysis, reliability analysis, descriptive statistics, and inferential analyses were performed to examine differences across generational groups. Results: Acceptance of care robots was strongly task-dependent. Participants expressed significantly greater acceptance of robots assisting with instrumental activities, including housekeeping, shopping, transportation, meal preparation, and medication management, than with intimate personal care activities such as bathing, dressing, toileting, feeding, and continence care. Contrary to common assumptions regarding digital natives, Generation Z reported higher levels of fear, discomfort, and perceived intimidation than Generation X and Baby Boomers. Older generations generally demonstrated more pragmatic acceptance of robotic assistance, particularly regarding future support needs associated with ageing. Across generations, respondents preferred robots with more human-like appearances; however, emotional trust remained substantially lower than perceived functional usefulness. Conclusions: The findings suggest that acceptance of care robots is conditional rather than universal and is shaped by the nature of the caregiving task, generational differences, and broader emotional and cultural perceptions of care. Integrating the Almere Model with established ADL and IADL frameworks provides a novel perspective by linking technology acceptance to specific functional domains of caregiving. The results support the view that care robots are more likely to be accepted as complementary tools that enhance human-centred care rather than as substitutes for professional or family caregivers. Given the purposive and geographically limited sample, the findings should be interpreted cautiously and not generalised to the wider Portuguese population. They nevertheless provide valuable implications for the design of socially assistive robots, healthcare practice, and public policy in ageing societies. Full article
(This article belongs to the Special Issue AI-Driven Healthcare: Transforming Patient Care and Outcomes)
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19 pages, 521 KB  
Article
QAI/ML-SaMD: A Hybrid Health–Technology Quantifiable Quality Metric for Artificial Intelligence/Machine Learning-Based Software as a Medical Device
by Shouki A. Ebad
Healthcare 2026, 14(16), 2587; https://doi.org/10.3390/healthcare14162587 - 17 Aug 2026
Viewed by 209
Abstract
Background: The increasing integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices necessitates robust quality evaluation methods. However, existing approaches remain qualitative, sector-specific, or focused on isolated attributes, leaving a gap in quantifiable assessment for AI/ML-driven Software as a Medical [...] Read more.
Background: The increasing integration of Artificial Intelligence (AI) and Machine Learning (ML) into medical devices necessitates robust quality evaluation methods. However, existing approaches remain qualitative, sector-specific, or focused on isolated attributes, leaving a gap in quantifiable assessment for AI/ML-driven Software as a Medical Device (SaMD). Objective: This study introduces QAI/ML-SaMD, a novel hybrid metric that provides a comprehensive, quantifiable measure of AI/ML-SaMD quality by synthesizing health and information technology (IT) dimensions into a single composite, benchmark-ready score. Methods: The metric integrates key attributes from a systematic literature review, classified into Health and IT domains. Sub-metrics (QHealth and QIT) use weighted sums, while the overall score employs a Weighted Geometric Mean with configurable parameters to penalize domain imbalances. Validation included (a) theoretical validation against four mathematical properties, (b) an illustrative example with sensitivity analysis, (c) expert-based validation with six specialists, and (d) an evidence-based case study on FDA-authorized IDx-DR using public regulatory and clinical documentation. Results: The illustrative example yielded a score of 29.7 (“Unsuitable”). Sensitivity analysis confirmed robustness across weight, score, and combined uncertainty perturbations, with classification unchanged. Expert validation showed 83.3% agreement. The IDx-DR case study produced a score of 82.3 (“Admissible”), correctly aligning with the device’s regulatory status and supporting external validity. Conclusions: The QAI/ML-SaMD metric provides a foundational, quantifiable framework for AI/ML-SaMD quality assessment, bridging qualitative regulatory principles and measurable outcomes. It offers a practical tool for developers, regulators, and clinicians to benchmark and track quality across the SaMD lifecycle. Full article
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14 pages, 1971 KB  
Article
XGBoost Classification of Epileptic EEG Using Nonlinear Dynamical Features and SHAP
by Xiaojie Lu, Hui Lou, Xiaoyang Jin and Bianmei Zhang
Entropy 2026, 28(8), 920; https://doi.org/10.3390/e28080920 - 17 Aug 2026
Viewed by 168
Abstract
To evaluate whether nonlinear descriptors of electroencephalogram (EEG) signals support interpretable XGBoost classification and to determine how analysis window duration affects performance. A secondary analysis of the public Bonn EEG dataset was performed. Nine nonlinear features were extracted from non-overlapping 1, 5, 10, [...] Read more.
To evaluate whether nonlinear descriptors of electroencephalogram (EEG) signals support interpretable XGBoost classification and to determine how analysis window duration affects performance. A secondary analysis of the public Bonn EEG dataset was performed. Nine nonlinear features were extracted from non-overlapping 1, 5, 10, and 20 s windows after an original-recording-level train/validation/test split, and a multiclass XGBoost model was interpreted with class-specific SHAP values. The model achieved 93.3% overall accuracy; the class-specific AUC values were 0.978 for Z/O, 0.978 for N/F, and 0.984 for S. Across the four fixed-split duration conditions, the 1 s condition had the lowest descriptive performance, whereas the 5, 10, and 20 s conditions were broadly comparable; no uniquely optimal duration was established. The nonlinear-feature/XGBoost framework provides interpretable benchmark segment classification evidence. Because EEG is modeled as a stochastic process and the dataset is small and heterogeneous, the SHAP attributions do not establish physiological causality or clinical diagnostic validity. Full article
(This article belongs to the Special Issue Computational Intelligence and Biomedical Signal Processing)
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20 pages, 1464 KB  
Review
Artificial Intelligence and Digital Pathology: Technological Transformation and Strategic Impact in Clinical Research and Medical Affairs
by Carmela Baviello, Daniela Maria Capuano and Roberto Verna
Life 2026, 16(8), 1346; https://doi.org/10.3390/life16081346 - 16 Aug 2026
Viewed by 313
Abstract
The progressive integration of Whole Slide Imaging (WSI) technology and Artificial Intelligence (AI) architectures is driving a structural transformation in pathology and precision oncology. This structured critical review analyzes and systematizes the impact of this technological transition along two fundamental operational dimensions of [...] Read more.
The progressive integration of Whole Slide Imaging (WSI) technology and Artificial Intelligence (AI) architectures is driving a structural transformation in pathology and precision oncology. This structured critical review analyzes and systematizes the impact of this technological transition along two fundamental operational dimensions of the modern biopharmaceutical industry: pre-registration Clinical Research and post-launch strategies governed by Medical Affairs. The first section explores how computational pathology is improving efficiency and reducing risk in drug development. Replacing analog visual assessment—intrinsically subject to inter-observer and intra-observer variability—with quantitative algorithms for cellular classification and segmentation enables optimization of patient recruitment in clinical trials, reducing screening failure rates. This review also examines the emerging role of Spatial Biology in extracting complex topological metrics from the Tumor Microenvironment (TME) and the use of AI for the objective and auditable quantification of critical surrogate endpoints, such as Pathological Complete Response (pCR), while acknowledging that algorithmic precision remains sensitive to pre-analytical variables and dataset biases. In the second section, the study investigates the strategic evolution of Medical Affairs, acting as a vital scientific communication and translational bridge between the complexity of Data Science and clinical hospital practice. Challenges related to AI adoption by clinicians are examined, emphasizing the importance of educational programs based on Explainable AI (XAI) to overcome the cognitive limitations of the black-box paradigm and the complex regulatory validation pathway for Software as a Medical Device (SaMD) under the stringent European IVDR framework—supported by an analysis of historical regulatory benchmarks such as the Paige Prostate case. The paper also explores the potential of AI in the large-scale generation of Real-World Evidence (RWE), applied to the creation of synthetic control arms in pharmacoeconomic settings. In conclusion, the study highlights that the diagnostic algorithm has ceased to be merely a laboratory support tool and has become a strategic asset and an integral adjunct to therapeutic decision-making. Overcoming current challenges related to data privacy through Federated Learning architectures, together with the imminent transition toward Foundation Models, foreshadows a fully data-driven healthcare ecosystem, making continuous skills development (digital upskilling) an essential requirement for professionals in the biopharmaceutical sector. Full article
(This article belongs to the Section Artificial Intelligence in the Life Sciences)
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40 pages, 1067 KB  
Review
Trustworthy AI-Powered Intrusion Detection for the Internet of Medical Things (IoMT): A Review
by Jahidul Islam, Dristi Datta and Fowzia Akhter
Sensors 2026, 26(16), 5182; https://doi.org/10.3390/s26165182 - 16 Aug 2026
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Abstract
The Internet of Medical Things (IoMT) is transforming healthcare through continuous patient monitoring, telemedicine, cloud–edge services, and Healthcare 5.0. However, the rapid growth of interconnected medical devices has expanded the healthcare cyberattack surface, making intelligent intrusion detection essential for protecting sensitive medical data [...] Read more.
The Internet of Medical Things (IoMT) is transforming healthcare through continuous patient monitoring, telemedicine, cloud–edge services, and Healthcare 5.0. However, the rapid growth of interconnected medical devices has expanded the healthcare cyberattack surface, making intelligent intrusion detection essential for protecting sensitive medical data and ensuring resilient clinical operations. Existing reviews examine specific aspects of AI-powered intrusion detection but rarely provide a deployment-oriented synthesis linking technical performance with operational and clinical requirements. This review critically examines Artificial Intelligence (AI)-powered Intrusion Detection Systems (IDSs) for IoMT across six analytical dimensions: detection performance, explainability, privacy preservation, computational efficiency, benchmarking practices, and cross-dataset generalization. This structured narrative review adopted the PRISMA 2020 framework to ensure transparent record identification, screening, and reporting, with evidence synthesized qualitatively rather than through quantitative meta-analysis. A total of 5127 records published between 2021 and 2026 were screened, resulting in 24 primary studies supported by 115 complementary studies. The findings show that machine learning, deep learning, hybrid AI, Explainable Artificial Intelligence (XAI), Federated Learning (FL), blockchain-assisted security, and edge intelligence have significantly advanced IoMT intrusion detection. However, despite benchmark accuracies often exceeding 95%, deployment remains constrained by dataset dependency, weak cross-dataset generalization, computational overhead, limited explainability, fragmented benchmarking, and insufficient operational validation. This review identifies deployment readiness, rather than predictive accuracy alone, as the principal challenge for next-generation healthcare cybersecurity and provides a practical framework for developing trustworthy, interoperable, privacy-preserving, and deployment-ready IoMT cybersecurity architectures supported by standardized evaluation protocols. Full article
(This article belongs to the Section Internet of Things)
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