Suya Li, Hui-Jun Chen, Jie Zhou, Yi-Bei Zhouchen, Rong Wang, Jinyi Guo, Sharon R Redding, Yan-Qiong Ouyang
[This corrects the article DOI: .].
[更正文章DOI: .]。
{"title":"Correction: Effectiveness of a Web-Based Medication Education Course on Pregnant Women's Medication Information Literacy and Decision Self-Efficacy: Randomized Controlled Trial.","authors":"Suya Li, Hui-Jun Chen, Jie Zhou, Yi-Bei Zhouchen, Rong Wang, Jinyi Guo, Sharon R Redding, Yan-Qiong Ouyang","doi":"10.2196/91835","DOIUrl":"10.2196/91835","url":null,"abstract":"<p><p>[This corrects the article DOI: .].</p>","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e91835"},"PeriodicalIF":6.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052590","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pascal Raszke, Godwin Denk Giebel, Jürgen Wasem, Michael Adamzik, Hartmuth Nowak, Lars Palmowski, Philipp Heinz, Nina Timmesfeld, Marianne Tokic, Frank Martin Brunkhorst, Nikola Blase
<p><strong>Background: </strong>Global digitalization continues to advance, extending its influence into medicine and health care systems worldwide. In recent years, substantial advancements have been made in the research and development of artificial intelligence (AI), raising questions about its potential in medicine. The integration and application of AI in intensive care medicine, particularly in sepsis treatment, presents significant potential for advancing patient outcomes and enhancing patient-relevant benefits. However, a comprehensive and systematic overview of the full spectrum of patient-relevant benefits associated with AI-based clinical decision support systems (CDSS) remains lacking.</p><p><strong>Objective: </strong>This scoping review aimed to identify and categorize evidence on patient-relevant benefits of AI-based CDSS in sepsis care.</p><p><strong>Methods: </strong>Systematic research was conducted in 4 electronic databases: MEDLINE via PubMed, Embase, the ACM Digital Library, and IEEE Xplore. In addition, a comprehensive search on the websites of relevant international organizations, along with a citation search of the included articles, was conducted. Articles were included if they (1) focused on sepsis and (2) described patient-relevant benefits of AI-based CDSS. Articles published between January 1, 2008, and March 2, 2023, were considered for inclusion. Study selection was performed independently by 2 reviewers. The manuscript was drafted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included articles was conducted using the program MAXQDA (VERBI Software GmbH), with systemization finalized in a consensus workshop.</p><p><strong>Results: </strong>A total of 3368 records were identified across the 4 databases, of which 24 met the inclusion criteria and were included in the scoping review. The additional search on international websites and in reference lists identified 6 more relevant articles, resulting in 30 included studies. Of these, 20 were quantitative, comprising 7 prospective and 13 retrospective designs. In addition, 1 qualitative study, 1 mixed methods study, 6 review articles, and 2 articles from institutional websites were included. Patient-relevant benefits were systematized in six main categories: (1) prediction, (2) earlier treatment and prioritization of high-risk patients, (3) individualized therapy, (4) improved patient outcomes (including improved Sequential Organ Failure Assessment score, reduced length of stay, and reduced mortality), (5) general improvements in care, and (6) reduced readmission rate.</p><p><strong>Conclusions: </strong>This scoping review underscores the potential of AI-based CDSS to positively impact patient-relevant benefits, particularly in sepsis care, where they demonstrate considerable promise for improving intensive care. However, the majority of the identified s
{"title":"Patient Benefits in the Context of Sepsis-Related AI-Based Clinical Decision Support Systems: Scoping Review.","authors":"Pascal Raszke, Godwin Denk Giebel, Jürgen Wasem, Michael Adamzik, Hartmuth Nowak, Lars Palmowski, Philipp Heinz, Nina Timmesfeld, Marianne Tokic, Frank Martin Brunkhorst, Nikola Blase","doi":"10.2196/76772","DOIUrl":"10.2196/76772","url":null,"abstract":"<p><strong>Background: </strong>Global digitalization continues to advance, extending its influence into medicine and health care systems worldwide. In recent years, substantial advancements have been made in the research and development of artificial intelligence (AI), raising questions about its potential in medicine. The integration and application of AI in intensive care medicine, particularly in sepsis treatment, presents significant potential for advancing patient outcomes and enhancing patient-relevant benefits. However, a comprehensive and systematic overview of the full spectrum of patient-relevant benefits associated with AI-based clinical decision support systems (CDSS) remains lacking.</p><p><strong>Objective: </strong>This scoping review aimed to identify and categorize evidence on patient-relevant benefits of AI-based CDSS in sepsis care.</p><p><strong>Methods: </strong>Systematic research was conducted in 4 electronic databases: MEDLINE via PubMed, Embase, the ACM Digital Library, and IEEE Xplore. In addition, a comprehensive search on the websites of relevant international organizations, along with a citation search of the included articles, was conducted. Articles were included if they (1) focused on sepsis and (2) described patient-relevant benefits of AI-based CDSS. Articles published between January 1, 2008, and March 2, 2023, were considered for inclusion. Study selection was performed independently by 2 reviewers. The manuscript was drafted in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The analysis of the included articles was conducted using the program MAXQDA (VERBI Software GmbH), with systemization finalized in a consensus workshop.</p><p><strong>Results: </strong>A total of 3368 records were identified across the 4 databases, of which 24 met the inclusion criteria and were included in the scoping review. The additional search on international websites and in reference lists identified 6 more relevant articles, resulting in 30 included studies. Of these, 20 were quantitative, comprising 7 prospective and 13 retrospective designs. In addition, 1 qualitative study, 1 mixed methods study, 6 review articles, and 2 articles from institutional websites were included. Patient-relevant benefits were systematized in six main categories: (1) prediction, (2) earlier treatment and prioritization of high-risk patients, (3) individualized therapy, (4) improved patient outcomes (including improved Sequential Organ Failure Assessment score, reduced length of stay, and reduced mortality), (5) general improvements in care, and (6) reduced readmission rate.</p><p><strong>Conclusions: </strong>This scoping review underscores the potential of AI-based CDSS to positively impact patient-relevant benefits, particularly in sepsis care, where they demonstrate considerable promise for improving intensive care. However, the majority of the identified s","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e76772"},"PeriodicalIF":6.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12834200/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ian René Solano-Kamaiko, Michael Dicpinigaitis, Melissa Tan, Irene Yang, Kexin Cheng, Ronica Peramsetty, Michelle Shum, Yanira Escamilla, Jennifer Bayly, Meghan Reading Turchioe, Ariel Avgar, Aditya Vashistha, Nicola Dell, Madeline R Sterling
<p><strong>Background: </strong>Home health aides and attendants (HHAs) provide in-home care to the growing population of older adults who want to age in place. Despite their vital role in patient care, HHAs are an underserved and vulnerable population of health care professionals who often experience poor health themselves. Activity tracking devices offer a promising way to improve HHAs' health-related awareness and promote health behavior change, particularly regarding physical activity and sleep quality, 2 areas in which the workforce struggles.</p><p><strong>Objective: </strong>This study aimed to understand how feasible it is for HHAs to use activity tracking devices and assess their perceptions of such devices for improving their health. Specifically, we conducted (1) a field study to assess the use, feasibility, and acceptability of these devices among HHAs and (2) a qualitative study to understand HHAs' perspectives on and reactions to activity trackers on and off the job.</p><p><strong>Methods: </strong>We partnered with the 1199 Service Employees International Union Training and Employment Fund to conduct a field study with home care agency-employed HHAs working in New York City, New York. Participants wore activity tracking devices for 4 weeks that collected data on physical activity and sleep. The HHAs were subsequently interviewed on their experiences with and attitudes toward the devices and asked to reflect on personalized visualizations of their data to prompt them to think aloud. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed using grounded theory.</p><p><strong>Results: </strong>A total of 17 HHAs participated; their mean age was 48.7 (SD 12.2) years, 15 (88%) were women, 11 (65%) identified as Black, 5 (29%) identified as Hispanic or Latinx, and they had worked as HHAs for a mean of 11.7 (SD 7.5) years. In total, 94% (n=16) of the HHAs wore their activity trackers for the full 28-day study period. Participants took a mean of 10,230 (SD 3586) daily steps during the study period and slept for a mean of 6.27 (SD 0.58) hours per night. Overall, 4 key themes emerged: (1) activity tracking devices enhanced participants' health awareness by providing empirical data for self-reflection; (2) this increased awareness led to positive behavior changes, including setting and achieving health-related goals; (3) HHAs believed that these devices could improve not only their own health but also that of their patients through positive behavior changes; and (4) despite this optimism, participants emphasized that their ability to modify sleep and activity patterns was constrained by social and occupational determinants, with sleep improvements being particularly challenging.</p><p><strong>Conclusions: </strong>Our findings suggest that appropriately designed personal tracking interventions could offer a promising approach to supporting positive health-related changes in this historically overlooked wor
{"title":"Feasibility, Acceptability, and Perspectives Regarding the Use of Activity Tracking Wearable Devices Among Home Health Aides: Mixed Methods Study.","authors":"Ian René Solano-Kamaiko, Michael Dicpinigaitis, Melissa Tan, Irene Yang, Kexin Cheng, Ronica Peramsetty, Michelle Shum, Yanira Escamilla, Jennifer Bayly, Meghan Reading Turchioe, Ariel Avgar, Aditya Vashistha, Nicola Dell, Madeline R Sterling","doi":"10.2196/77510","DOIUrl":"https://doi.org/10.2196/77510","url":null,"abstract":"<p><strong>Background: </strong>Home health aides and attendants (HHAs) provide in-home care to the growing population of older adults who want to age in place. Despite their vital role in patient care, HHAs are an underserved and vulnerable population of health care professionals who often experience poor health themselves. Activity tracking devices offer a promising way to improve HHAs' health-related awareness and promote health behavior change, particularly regarding physical activity and sleep quality, 2 areas in which the workforce struggles.</p><p><strong>Objective: </strong>This study aimed to understand how feasible it is for HHAs to use activity tracking devices and assess their perceptions of such devices for improving their health. Specifically, we conducted (1) a field study to assess the use, feasibility, and acceptability of these devices among HHAs and (2) a qualitative study to understand HHAs' perspectives on and reactions to activity trackers on and off the job.</p><p><strong>Methods: </strong>We partnered with the 1199 Service Employees International Union Training and Employment Fund to conduct a field study with home care agency-employed HHAs working in New York City, New York. Participants wore activity tracking devices for 4 weeks that collected data on physical activity and sleep. The HHAs were subsequently interviewed on their experiences with and attitudes toward the devices and asked to reflect on personalized visualizations of their data to prompt them to think aloud. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed using grounded theory.</p><p><strong>Results: </strong>A total of 17 HHAs participated; their mean age was 48.7 (SD 12.2) years, 15 (88%) were women, 11 (65%) identified as Black, 5 (29%) identified as Hispanic or Latinx, and they had worked as HHAs for a mean of 11.7 (SD 7.5) years. In total, 94% (n=16) of the HHAs wore their activity trackers for the full 28-day study period. Participants took a mean of 10,230 (SD 3586) daily steps during the study period and slept for a mean of 6.27 (SD 0.58) hours per night. Overall, 4 key themes emerged: (1) activity tracking devices enhanced participants' health awareness by providing empirical data for self-reflection; (2) this increased awareness led to positive behavior changes, including setting and achieving health-related goals; (3) HHAs believed that these devices could improve not only their own health but also that of their patients through positive behavior changes; and (4) despite this optimism, participants emphasized that their ability to modify sleep and activity patterns was constrained by social and occupational determinants, with sleep improvements being particularly challenging.</p><p><strong>Conclusions: </strong>Our findings suggest that appropriately designed personal tracking interventions could offer a promising approach to supporting positive health-related changes in this historically overlooked wor","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e77510"},"PeriodicalIF":6.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146052584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ye-Eun Park, Minsu Ock, Jae-Ho Lee, Dae-Hyun Ko, Hak-Jae Lee, Taezoon Park, Junsang Yoo, Yura Lee
Background: Artificial intelligence (AI)-enabled clinical decision support systems (CDSSs) are increasingly embedded within electronic health record (EHR) environments; however, their introduction can disrupt existing workflows and raise patient safety concerns, particularly in high-stakes settings such as surgical transfusion. Limited qualitative evidence exists regarding how frontline professionals anticipate the clinical, organizational, and workflow implications of such systems before wider deployment.
Objective: This study aims to qualitatively examine the anticipated clinical, organizational, and workflow-level implications of implementing personalized Maximum Surgical Blood Order Schedule-Thoracic Surgery (pMSBOS-TS), an AI-enabled CDSS for personalized surgical blood ordering, before large-scale deployment.
Methods: We conducted a consensual qualitative study with 14 multidisciplinary health care professionals involved in transfusion-related tasks at a large tertiary hospital. Following 1 pilot focus group to refine the interview guide and workflow diagram, 2 semistructured focus group discussions were held with 14 participants (5 physicians, 6 nurses, and 3 blood bank staff). Transcripts were analyzed using the Systems Engineering Initiative for Patient Safety (SEIPS) 101 framework, focusing on People, Environment, Tools, and Tasks, and were supported by task- and workflow-based analyses of transfusion processes. Member checking was conducted with participants and external clinicians to enhance validity.
Results: A total of 189 semantic units and 61 core ideas were identified across 18 subdomains and 7 overarching domains. Participants anticipated that pMSBOS-TS could reduce unwarranted variation in blood ordering and planning, provided that algorithmic performance is reliable and the interface is tightly integrated into existing EHR workflows. At the same time, they expressed concerns regarding increased verification burden, system limitations in unexpected clinical scenarios, and potential communication bottlenecks between clinical units and the blood bank. Organizational culture, governance structures, and local transfusion logistics were viewed as critical determinants of whether the system would reduce or inadvertently increase workload and blood product waste.
Conclusions: This preimplementation, SEIPS-based qualitative evaluation suggests that the successful adoption of an AI-enabled transfusion CDSS depends not only on predictive performance but also on sociotechnical readiness, including user trust, workflow fit, and organizational support. These findings provide practice-based insights to inform staged implementation, training, and governance strategies aimed at safely integrating predictive transfusion CDSSs into EHR-supported surgical workflows.
{"title":"Assessing Health Care Professionals' Perceptions of a New System in Clinical Workflows: Systems Engineering Initiative for Patient Safety-Based Consensual Qualitative Research.","authors":"Ye-Eun Park, Minsu Ock, Jae-Ho Lee, Dae-Hyun Ko, Hak-Jae Lee, Taezoon Park, Junsang Yoo, Yura Lee","doi":"10.2196/86166","DOIUrl":"10.2196/86166","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI)-enabled clinical decision support systems (CDSSs) are increasingly embedded within electronic health record (EHR) environments; however, their introduction can disrupt existing workflows and raise patient safety concerns, particularly in high-stakes settings such as surgical transfusion. Limited qualitative evidence exists regarding how frontline professionals anticipate the clinical, organizational, and workflow implications of such systems before wider deployment.</p><p><strong>Objective: </strong>This study aims to qualitatively examine the anticipated clinical, organizational, and workflow-level implications of implementing personalized Maximum Surgical Blood Order Schedule-Thoracic Surgery (pMSBOS-TS), an AI-enabled CDSS for personalized surgical blood ordering, before large-scale deployment.</p><p><strong>Methods: </strong>We conducted a consensual qualitative study with 14 multidisciplinary health care professionals involved in transfusion-related tasks at a large tertiary hospital. Following 1 pilot focus group to refine the interview guide and workflow diagram, 2 semistructured focus group discussions were held with 14 participants (5 physicians, 6 nurses, and 3 blood bank staff). Transcripts were analyzed using the Systems Engineering Initiative for Patient Safety (SEIPS) 101 framework, focusing on People, Environment, Tools, and Tasks, and were supported by task- and workflow-based analyses of transfusion processes. Member checking was conducted with participants and external clinicians to enhance validity.</p><p><strong>Results: </strong>A total of 189 semantic units and 61 core ideas were identified across 18 subdomains and 7 overarching domains. Participants anticipated that pMSBOS-TS could reduce unwarranted variation in blood ordering and planning, provided that algorithmic performance is reliable and the interface is tightly integrated into existing EHR workflows. At the same time, they expressed concerns regarding increased verification burden, system limitations in unexpected clinical scenarios, and potential communication bottlenecks between clinical units and the blood bank. Organizational culture, governance structures, and local transfusion logistics were viewed as critical determinants of whether the system would reduce or inadvertently increase workload and blood product waste.</p><p><strong>Conclusions: </strong>This preimplementation, SEIPS-based qualitative evaluation suggests that the successful adoption of an AI-enabled transfusion CDSS depends not only on predictive performance but also on sociotechnical readiness, including user trust, workflow fit, and organizational support. These findings provide practice-based insights to inform staged implementation, training, and governance strategies aimed at safely integrating predictive transfusion CDSSs into EHR-supported surgical workflows.</p>","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e86166"},"PeriodicalIF":6.0,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12881895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"When Lived Experience Designs the Intervention.","authors":"Trevor van Mierlo","doi":"10.2196/91371","DOIUrl":"10.2196/91371","url":null,"abstract":"","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e91371"},"PeriodicalIF":6.0,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12829630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146040939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Farhad Abtahi, Fernando Seoane, Ivan Pau, Mario Vega-Barbas
<p><strong>Background: </strong>Health care artificial intelligence (AI) systems are increasingly integrated into clinical workflows, yet remain vulnerable to data-poisoning attacks. A small number of manipulated training samples can compromise AI models used for diagnosis, documentation, and resource allocation. Existing privacy regulations, including the Health Insurance Portability and Accountability Act and the General Data Protection Regulation, may inadvertently complicate anomaly detection and cross-institutional auditing, thereby limiting visibility into adversarial activity.</p><p><strong>Objective: </strong>This study provides a comprehensive threat analysis of data poisoning vulnerabilities across major health care AI architectures. The goals are to (1) identify attack surfaces in clinical AI systems, (2) evaluate the feasibility and detectability of poisoning attacks analytically modeled in prior security research, and (3) propose a multilayered defense framework appropriate for health care settings.</p><p><strong>Methods: </strong>We synthesized empirical findings from 41 key security studies published between 2019 and 2025 and integrated them into an analytical threat-modeling framework specific to health care. We constructed 8 hypothetical yet technically grounded attack scenarios across 4 categories: (1) architecture-specific attacks on convolutional neural networks, large language models, and reinforcement learning agents (scenario A); (2) infrastructure exploitation in federated learning and clinical documentation pipelines (scenario B); (3) poisoning of critical resource allocation systems (scenario C); and (4) supply chain attacks affecting commercial foundation models (scenario D). Scenarios were aligned with realistic insider-access threat models and current clinical deployment practices.</p><p><strong>Results: </strong>Multiple empirical studies demonstrate that attackers with access to as few as 100-500 poisoned samples can compromise health care AI systems, with attack success rates typically ≥60%. Critically, attack success depends on the absolute number of poisoned samples rather than their proportion of the training corpus, a finding that fundamentally challenges assumptions that larger datasets provide inherent protection. We estimate that detection delays commonly range from 6 to 12 months and may extend to years in distributed or privacy-constrained environments. Analytical scenarios highlight that (1) routine insider access creates numerous injection points across health care data infrastructure, (2) federated learning amplifies risks by obscuring attribution, and (3) supply chain compromises can simultaneously affect dozens to hundreds of institutions. Privacy regulations further complicate cross-patient correlation and model audit processes, substantially delaying the detection of subtle poisoning campaigns.</p><p><strong>Conclusions: </strong>Health care AI systems face significant security challenges that curre
{"title":"Data Poisoning Vulnerabilities Across Health Care Artificial Intelligence Architectures: Analytical Security Framework and Defense Strategies.","authors":"Farhad Abtahi, Fernando Seoane, Ivan Pau, Mario Vega-Barbas","doi":"10.2196/87969","DOIUrl":"10.2196/87969","url":null,"abstract":"<p><strong>Background: </strong>Health care artificial intelligence (AI) systems are increasingly integrated into clinical workflows, yet remain vulnerable to data-poisoning attacks. A small number of manipulated training samples can compromise AI models used for diagnosis, documentation, and resource allocation. Existing privacy regulations, including the Health Insurance Portability and Accountability Act and the General Data Protection Regulation, may inadvertently complicate anomaly detection and cross-institutional auditing, thereby limiting visibility into adversarial activity.</p><p><strong>Objective: </strong>This study provides a comprehensive threat analysis of data poisoning vulnerabilities across major health care AI architectures. The goals are to (1) identify attack surfaces in clinical AI systems, (2) evaluate the feasibility and detectability of poisoning attacks analytically modeled in prior security research, and (3) propose a multilayered defense framework appropriate for health care settings.</p><p><strong>Methods: </strong>We synthesized empirical findings from 41 key security studies published between 2019 and 2025 and integrated them into an analytical threat-modeling framework specific to health care. We constructed 8 hypothetical yet technically grounded attack scenarios across 4 categories: (1) architecture-specific attacks on convolutional neural networks, large language models, and reinforcement learning agents (scenario A); (2) infrastructure exploitation in federated learning and clinical documentation pipelines (scenario B); (3) poisoning of critical resource allocation systems (scenario C); and (4) supply chain attacks affecting commercial foundation models (scenario D). Scenarios were aligned with realistic insider-access threat models and current clinical deployment practices.</p><p><strong>Results: </strong>Multiple empirical studies demonstrate that attackers with access to as few as 100-500 poisoned samples can compromise health care AI systems, with attack success rates typically ≥60%. Critically, attack success depends on the absolute number of poisoned samples rather than their proportion of the training corpus, a finding that fundamentally challenges assumptions that larger datasets provide inherent protection. We estimate that detection delays commonly range from 6 to 12 months and may extend to years in distributed or privacy-constrained environments. Analytical scenarios highlight that (1) routine insider access creates numerous injection points across health care data infrastructure, (2) federated learning amplifies risks by obscuring attribution, and (3) supply chain compromises can simultaneously affect dozens to hundreds of institutions. Privacy regulations further complicate cross-patient correlation and model audit processes, substantially delaying the detection of subtle poisoning campaigns.</p><p><strong>Conclusions: </strong>Health care AI systems face significant security challenges that curre","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e87969"},"PeriodicalIF":6.0,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12881903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146029966","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p><strong>Background: </strong>Artificial intelligence-enhanced imaging techniques have demonstrated promising diagnostic potential for carotid plaques, a key cardiovascular and cerebrovascular risk factor. However, previous studies did not systematically synthesize their diagnostic accuracy.</p><p><strong>Objective: </strong>This study aimed to quantitatively explore the diagnostic efficacy of deep learning (DL) and radiomics for extracranial carotid plaques and establish a standardized framework for improving plaque detection.</p><p><strong>Methods: </strong>We searched the PubMed, Embase, Cochrane, Web of Science, and Institute of Electrical and Electronics Engineers databases to identify studies involving the use of radiomics or DL models to diagnose extracranial carotid artery plaques from inception up to September 24, 2025. The quality of the studies was determined using Quality Assessment of Diagnostic Accuracy Studies for Artificial Intelligence (QUADAS-AI). A meta-analysis was conducted using StataMP (version 17.0; StataCorp) with a bivariate mixed-effects model to calculate pooled sensitivity and specificity, generate summary receiver operating characteristic (SROC) curves, assess Cochran Q statistic and I²-based heterogeneity, and conduct subgroup analyses and regression analysis.</p><p><strong>Results: </strong>Among 40 studies comprising 17,246 patients, 34 integrated independent test sets or validation sets in the quantitative statistical analysis. Among them, 24 focused on DL models, 10 on machine learning models based on radiomics. The combined sensitivity, specificity, and area under the SROC curve were 0.88 (95% CI 0.85-0.91; P<.001; I2=93.58%), 0.89 (95% CI 0.85-0.92; P<.001; I2=91.38%), and 0.95 (95% CI 0.92-0.96), respectively. Compared with the machine learning models based on radiomics algorithms, DL models achieved comparable improvements in specificity and area under the SROC curve. It was observed that transfer learning and a large sample size enhanced the diagnostic performance of models. Models used to identify plaque stability and presence had similar diagnostic performances, both of which were more effective in identifying symptomatic plaque models. A total of 7 studies demonstrated that the models that combined clinical features exhibited comparable diagnostic capability to pure DL and radiomics models. Additionally, 7 studies performed external validation, obtaining lower diagnostic performance than in testing groups. Limited regression analysis failed to identify significant sources of heterogeneity, and the limited number of eligible studies restricted more comprehensive subgroup analyses. The high heterogeneity in the study results may be due to different scanning parameters, model architecture, image segmentation, and algorithms.</p><p><strong>Conclusions: </strong>Radiomics algorithms and DL models can effectively diagnose extracranial carotid plaque. However, there are concerns regarding irregularities in re
背景:人工智能增强成像技术已经证明了对颈动脉斑块(一种关键的心脑血管危险因素)的诊断潜力。然而,以往的研究并没有系统地综合其诊断准确性。目的:本研究旨在定量探讨深度学习(deep learning, DL)和放射组学对颈动脉颅外斑块的诊断效果,建立提高斑块检测的标准化框架。方法:我们检索了PubMed、Embase、Cochrane、Web of Science和美国电气与电子工程师协会的数据库,以确定从成立到2025年9月24日使用放射组学或DL模型诊断颅外颈动脉斑块的研究。使用人工智能诊断准确性研究质量评估(QUADAS-AI)确定研究的质量。采用StataMP (version 17.0; StataCorp)软件进行meta分析,采用双变量混合效应模型计算合并敏感性和特异性,生成总受试者工作特征(SROC)曲线,评估Cochran Q统计量和基于I²的异质性,并进行亚组分析和回归分析。结果:40项研究共17246例患者,在定量统计分析中有34个综合独立试验集或验证集。其中,24个专注于深度学习模型,10个专注于基于放射组学的机器学习模型。综合敏感性、特异性和SROC曲线下面积为0.88 (95% CI 0.85-0.91)。结论:放射组学算法和DL模型可有效诊断颈动脉颅外斑块。然而,人们对研究设计的不规则性和缺乏多中心研究和外部验证感到担忧。未来的研究应以降低偏倚风险、增强模型的普遍性和临床导向为目标。
{"title":"Diagnostic Performance of Deep Learning and Radiomics in Extracranial Carotid Plaque Detection: Systematic Review and Meta-Analysis.","authors":"Lingjie Ju, Yongsheng Guo, Haiyong Guo, Ruijuan Liu, Yiyang Wang, Siyu Wang, Na Ma, Junhong Ren","doi":"10.2196/77092","DOIUrl":"10.2196/77092","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence-enhanced imaging techniques have demonstrated promising diagnostic potential for carotid plaques, a key cardiovascular and cerebrovascular risk factor. However, previous studies did not systematically synthesize their diagnostic accuracy.</p><p><strong>Objective: </strong>This study aimed to quantitatively explore the diagnostic efficacy of deep learning (DL) and radiomics for extracranial carotid plaques and establish a standardized framework for improving plaque detection.</p><p><strong>Methods: </strong>We searched the PubMed, Embase, Cochrane, Web of Science, and Institute of Electrical and Electronics Engineers databases to identify studies involving the use of radiomics or DL models to diagnose extracranial carotid artery plaques from inception up to September 24, 2025. The quality of the studies was determined using Quality Assessment of Diagnostic Accuracy Studies for Artificial Intelligence (QUADAS-AI). A meta-analysis was conducted using StataMP (version 17.0; StataCorp) with a bivariate mixed-effects model to calculate pooled sensitivity and specificity, generate summary receiver operating characteristic (SROC) curves, assess Cochran Q statistic and I²-based heterogeneity, and conduct subgroup analyses and regression analysis.</p><p><strong>Results: </strong>Among 40 studies comprising 17,246 patients, 34 integrated independent test sets or validation sets in the quantitative statistical analysis. Among them, 24 focused on DL models, 10 on machine learning models based on radiomics. The combined sensitivity, specificity, and area under the SROC curve were 0.88 (95% CI 0.85-0.91; P<.001; I2=93.58%), 0.89 (95% CI 0.85-0.92; P<.001; I2=91.38%), and 0.95 (95% CI 0.92-0.96), respectively. Compared with the machine learning models based on radiomics algorithms, DL models achieved comparable improvements in specificity and area under the SROC curve. It was observed that transfer learning and a large sample size enhanced the diagnostic performance of models. Models used to identify plaque stability and presence had similar diagnostic performances, both of which were more effective in identifying symptomatic plaque models. A total of 7 studies demonstrated that the models that combined clinical features exhibited comparable diagnostic capability to pure DL and radiomics models. Additionally, 7 studies performed external validation, obtaining lower diagnostic performance than in testing groups. Limited regression analysis failed to identify significant sources of heterogeneity, and the limited number of eligible studies restricted more comprehensive subgroup analyses. The high heterogeneity in the study results may be due to different scanning parameters, model architecture, image segmentation, and algorithms.</p><p><strong>Conclusions: </strong>Radiomics algorithms and DL models can effectively diagnose extracranial carotid plaque. However, there are concerns regarding irregularities in re","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e77092"},"PeriodicalIF":6.0,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12826653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146029958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"UnitedXR Europe 2025: Aligning Health Care Extended Reality.","authors":"Jose Ferrer Costa","doi":"10.2196/90727","DOIUrl":"10.2196/90727","url":null,"abstract":"","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e90727"},"PeriodicalIF":6.0,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12822546/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jose M Palomares, Rafael Molina-Luque, Fernando León-García, Irene Casares-Rodríguez, María García-Rodríguez, María Pilar Villena Esponera, Guillermo Molina-Recio
<p><strong>Background: </strong>Developing user-centered digital health hardware requires systematic design methods applicable across clinical contexts. As diabetes mellitus continues to rise globally and contributes to morbidity, mortality, and costs, effective nutritional management remains essential-yet adherence is often poor. Digital health interventions grounded in human-centered design may enhance adherence by better aligning solutions with patients' real needs.</p><p><strong>Objective: </strong>This tutorial aims to provide replicable guidance on applying the design thinking approach to health care hardware development, illustrated through the design, development, and preliminary usability evaluation of SMARTCLOTH (GA-16: Lifestyles, Innovation, and Health), a smart tablecloth prototype intended to facilitate dietary management and support adherence to nutritional recommendations among individuals with diabetes.</p><p><strong>Methods: </strong>We demonstrate a systematic design thinking approach adaptable to other hardware contexts, using the Double Diamond model. In mapping, we performed a structured preassessment to define project scope and feasible functionalities. To characterize end user needs, we conducted 6 in-depth interviews with health care professionals and applied persona, empathy map, and customer journey map tools. In exploring, 5 focus groups (patients and diabetes educators) identified barriers, facilitators, and desired functionalities for dietary self-management. In building, we created low- and high-fidelity wireframes and interactive web prototypes using Phaser 3 (HTML5/JS) to simulate a kitchen workspace for meal assembly. In testing, 7 patients with different diabetes profiles participated in 3 iterative usability sessions. Using think-aloud, video analysis, and structured tasks, we documented completion times, errors, and the level of required assistance, enabling refinements. Development progressed through 15 internal versions and 3 user-tested prototypes with real-time adjustments when feasible.</p><p><strong>Results: </strong>Interviews and focus groups yielded three user profiles guiding design: (1) adolescents with type 1 diabetes navigating social and dietary challenges, (2) working-age adults with type 2 diabetes who were motivated but inconsistent, and (3) older adults with type 2 diabetes showing low adherence due to entrenched habits. Iterative usability testing indicated that the system was intuitive, with improvements in layout, labeling, and navigation. Quantitative metrics showed refinement, with simple tasks being completed in under 1 minute in later iterations, while complex meal simulations took longer. Error rates and required guidance decreased as prototypes evolved. Qualitative feedback highlighted clarity, motivational value, and educational potential, while older participants requested larger text and simplified controls. Despite usability gains, motivational barriers persisted among low-adhere
{"title":"SMARTCLOTH Prototype for Dietary Management in Patients With Diabetes Mellitus: Tutorial on Human-Centered Design Methodology for Health Care Hardware Development.","authors":"Jose M Palomares, Rafael Molina-Luque, Fernando León-García, Irene Casares-Rodríguez, María García-Rodríguez, María Pilar Villena Esponera, Guillermo Molina-Recio","doi":"10.2196/75744","DOIUrl":"10.2196/75744","url":null,"abstract":"<p><strong>Background: </strong>Developing user-centered digital health hardware requires systematic design methods applicable across clinical contexts. As diabetes mellitus continues to rise globally and contributes to morbidity, mortality, and costs, effective nutritional management remains essential-yet adherence is often poor. Digital health interventions grounded in human-centered design may enhance adherence by better aligning solutions with patients' real needs.</p><p><strong>Objective: </strong>This tutorial aims to provide replicable guidance on applying the design thinking approach to health care hardware development, illustrated through the design, development, and preliminary usability evaluation of SMARTCLOTH (GA-16: Lifestyles, Innovation, and Health), a smart tablecloth prototype intended to facilitate dietary management and support adherence to nutritional recommendations among individuals with diabetes.</p><p><strong>Methods: </strong>We demonstrate a systematic design thinking approach adaptable to other hardware contexts, using the Double Diamond model. In mapping, we performed a structured preassessment to define project scope and feasible functionalities. To characterize end user needs, we conducted 6 in-depth interviews with health care professionals and applied persona, empathy map, and customer journey map tools. In exploring, 5 focus groups (patients and diabetes educators) identified barriers, facilitators, and desired functionalities for dietary self-management. In building, we created low- and high-fidelity wireframes and interactive web prototypes using Phaser 3 (HTML5/JS) to simulate a kitchen workspace for meal assembly. In testing, 7 patients with different diabetes profiles participated in 3 iterative usability sessions. Using think-aloud, video analysis, and structured tasks, we documented completion times, errors, and the level of required assistance, enabling refinements. Development progressed through 15 internal versions and 3 user-tested prototypes with real-time adjustments when feasible.</p><p><strong>Results: </strong>Interviews and focus groups yielded three user profiles guiding design: (1) adolescents with type 1 diabetes navigating social and dietary challenges, (2) working-age adults with type 2 diabetes who were motivated but inconsistent, and (3) older adults with type 2 diabetes showing low adherence due to entrenched habits. Iterative usability testing indicated that the system was intuitive, with improvements in layout, labeling, and navigation. Quantitative metrics showed refinement, with simple tasks being completed in under 1 minute in later iterations, while complex meal simulations took longer. Error rates and required guidance decreased as prototypes evolved. Qualitative feedback highlighted clarity, motivational value, and educational potential, while older participants requested larger text and simplified controls. Despite usability gains, motivational barriers persisted among low-adhere","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e75744"},"PeriodicalIF":6.0,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12826948/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"WHOOP, There It Is: Lessons From WHOOP's FDA Warning Letter.","authors":"Blythe Karow","doi":"10.2196/90882","DOIUrl":"10.2196/90882","url":null,"abstract":"","PeriodicalId":16337,"journal":{"name":"Journal of Medical Internet Research","volume":"28 ","pages":"e90882"},"PeriodicalIF":6.0,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12822547/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010809","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}