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A Blueprint for Clinical-Driven Medical Device Development: The Feverkidstool Application to Identify Children With Serious Bacterial Infection 临床驱动的医疗设备开发蓝图:识别严重细菌感染儿童的 Feverkidstool 应用程序
Pub Date : 2024-10-30 DOI: 10.1016/j.mcpdig.2024.10.003
Evelien B. van Kempen MD , Sanne E.W. Vrijlandt MD , Kelly van der Geest MSc , Sophie Lotgering MSc , Tom A. Hueting PhD , Rianne Oostenbrink MD, PhD
Clinical decision rules (CDRs) integrated into applications enhance diagnostic and treatment prediction support for clinicians, necessitating Confirmité Europeenne (CE)-mark certification to enter the European market. We describe the development of a CDR as a medical device, focusing on challenges from a physician’s perspective exemplified by the Feverkidstool (FKT), a validated CDR for febrile children. We pursued a local process, aligned with the CE-marking process, to develop the FKT as in-house developed device. We aimed to provide a blueprint for colleagues. Medical device development, conforming the medical device regulation and performed by a multidisciplinary team, encompassed 5 stages: market scan, design, production, verification and validation and conformity assessment. Regulatory processes were continuously updated. The market scan identified a need for the FKT compared with existing applications. A prototype was designed in stage 2, further adjusted and improved based on the qualitative and quantitative results of stages 2-4. Lastly, stage 5 confirmed FKT’s performance and safety. Medical device development presents challenges for physicians, requiring collaboration for technical, regulatory, and financial expertise. Multidisciplinary teamwork also poses challenges, including uncertainties regarding responsibility and timelines. After CE certification, adapting to evolving needs and ensuring data privacy highlights the ongoing nature of medical device development.
集成到应用程序中的临床决策规则(CDR)为临床医生提供了更多诊断和治疗预测支持,因此必须获得欧洲认证(CE)标志认证才能进入欧洲市场。我们介绍了作为医疗设备的 CDR 的开发过程,重点从医生的角度分析了 Feverkidstool (FKT) 所面临的挑战,FKT 是经过验证的发热儿童 CDR。我们采用了与 CE 标识流程相一致的本地流程,将 FKT 开发为自主研发的设备。我们的目标是为同行提供一个蓝图。医疗器械开发符合医疗器械法规,由一个多学科团队完成,包括 5 个阶段:市场扫描、设计、生产、验证和确认以及合格评估。监管流程不断更新。与现有应用相比,市场扫描确定了对 FKT 的需求。在第 2 阶段设计了原型,并根据第 2-4 阶段的定性和定量结果进一步调整和改进。最后,第五阶段确认了 FKT 的性能和安全性。医疗设备的开发给医生带来了挑战,需要技术、监管和财务专业知识方面的合作。多学科团队合作也带来了挑战,包括责任和时间表方面的不确定性。获得 CE 认证后,如何适应不断变化的需求并确保数据隐私突出了医疗设备开发的持续性。
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引用次数: 0
Cost-Effectiveness of Artificial Intelligence-Enabled Electrocardiograms for Early Detection of Low Ejection Fraction: A Secondary Analysis of the Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction Trial 人工智能心电图早期检测低射血分数的成本效益:心电图人工智能辅助筛查低射血分数试验二次分析
Pub Date : 2024-10-26 DOI: 10.1016/j.mcpdig.2024.10.001
Viengneesee Thao PhD, MS , Ye Zhu MD, MPH, PhD , Andrew S. Tseng MD, MPH , Jonathan W. Inselman MS , Bijan J. Borah PhD , Rozalina G. McCoy MD, MS , Zachi I. Attia PhD , Francisco Lopez-Jimenez MD, MBA , Patricia A. Pellikka MD , David R. Rushlow MD, MBOE , Paul A. Friedman MD , Peter A. Noseworthy MD, MBA , Xiaoxi Yao MPH, MS, PhD

Objective

To investigate the cost-effectiveness of using artificial intelligence (AI) to screen for low ejection fraction (EF) in routine clinical practice using a pragmatic randomized controlled trial (RCT).

Patients and Methods

In a post hoc analysis of the electrocardiogram (ECG) AI-guided screening for low ejection fraction trial, we developed a decision analytic model for patients aged 18 years and older without previously diagnosed heart failure and underwent a clinically indicated ECG between August 5, 2019, and March 31, 2020. In the previously published RCT, the intervention arm underwent an AI-guided targeted screening program for low EF with a workflow embedded into routine clinical practice—AI was applied to the ECG to identify patients at high-risk and recommended clinicians to order an ECG and the control arm received usual care without the screening program. We used results from the RCT for rates of low EF diagnosis and a lifetime Markov model to project the long-term outcomes. Quality-adjusted life years (QALYs), costs of intervention and treatment, disease event costs, incremental cost-effectiveness ratio (ICER), and cost for the number needed to screen. Multiple scenario and sensitivity analyses were performed.

Results

Compared with usual care, AI-integrated ECG was cost effective, with an incremental cost-effectiveness ratio of $27,858/QALY. The program remained cost effective even with a change in patient age and follow-up time duration, although the specific ICER values varied for these parameters. The program was more cost effective in outpatient settings (ICER $1651/QALY) than in inpatient or emergency room settings.

Conclusion

Implementing AI-guided targeted screening for low EF in routine clinical practice was cost effective.
患者和方法在心电图(ECG)人工智能指导的低射血分数筛查试验的事后分析中,我们为年龄在18岁及18岁以上、既往未确诊心力衰竭且在2019年8月5日至2020年3月31日期间接受了有临床指征的心电图检查的患者开发了一个决策分析模型。在之前发表的 RCT 中,干预组接受了人工智能指导的低 EF 靶向筛查计划,并将工作流程嵌入到常规临床实践中--人工智能应用于心电图以识别高风险患者,并建议临床医生进行心电图检查;对照组接受常规护理,不接受筛查计划。我们利用 RCT 的低 EF 诊断率结果和终身马尔可夫模型来预测长期结果。结果显示了质量调整生命年 (QALY)、干预和治疗成本、疾病事件成本、增量成本效益比 (ICER) 以及筛查所需人数的成本。结果与常规护理相比,人工智能整合心电图具有成本效益,增量成本效益比为 27,858 美元/QALY。即使患者年龄和随访时间发生变化,该方案仍具有成本效益,尽管这些参数的具体 ICER 值有所不同。结论在常规临床实践中实施人工智能指导的低 EF 目标筛查具有成本效益。
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引用次数: 0
Real-World Assessment of the Efficacy of Computer-Assisted Diagnosis in Colonoscopy: A Single Institution Cohort Study in Singapore 结肠镜检查中计算机辅助诊断功效的真实世界评估:新加坡单一机构队列研究
Pub Date : 2024-10-26 DOI: 10.1016/j.mcpdig.2024.10.002
Gabrielle E. Koh MBBS , Brittany Ng MBBS , Ronja M.B. Lagström MSc , Fung-Joon Foo FRCS , Shuen-Ern Chin MBBS , Fang-Ting Wan MBBS , Juinn Huar Kam FRCS , Baldwin Yeung PhD, FRCS , Clarence Kwan MRCP , Cesare Hassan MD, PhD , Ismail Gögenur MD, DMSc , Frederick H. Koh FRCS, PhD

Objective

To review the efficacy and accuracy of the GI Genius Intelligent Endoscopy Module Computer-Assisted Diagnosis (CADx) program in colonic adenoma detection and real-time polyp characterization.

Patients and Methods

Colonoscopy remains the gold standard in colonic screening and evaluation. The incorporation of artificial intelligence (AI) technology therefore allows for optimized endoscopic performance. However, validation of most CADx programs with real-world data remains scarce. This prospective cohort study was conducted within a single Singaporean institution between April 1, 2023 and December 31, 2023. Videos of all AI-enabled colonoscopies were reviewed with polyp-by-polyp analysis performed. Real-time polyp characterization predictions after sustained polyp detection were compared against final histology results to assess the accuracy of the CADx system at colonic adenoma identification.

Results

A total of 808 videos of CADx colonoscopies were reviewed. Out of the 781 polypectomies performed, 543 (69.5%) and 222 (28.4%) were adenomas and non-adenomas on final histology, respectively. Overall, GI Genius correctly characterized adenomas with 89.4% sensitivity, 61.7% specificity, a positive predictive value of 85.4%, a negative predictive value of 69.8%, and 81.5% accuracy. The negative predictive value for rectosigmoid lesions (80.3%) was notably higher than for colonic lesions (54.2%), attributed to the increased prevalence of hyperplastic rectosigmoid polyps (11.4%) vs other colonic regions (5.4%).

Conclusion

Computer-Assisted Diagnosis is therefore a promising adjunct in colonoscopy with substantial clinical implications. Accurate identification of low-risk non-adenomatous polyps encourages the adoption of “resect-and-discard” strategies. However, further calibration of AI systems is needed before the acceptance of such strategies as the new standard of care.
患者和方法 结肠镜检查仍然是结肠筛查和评估的黄金标准。因此,人工智能(AI)技术的应用可以优化内窥镜检查的效果。然而,大多数 CADx 程序在实际数据中的验证仍然很少。这项前瞻性队列研究是在 2023 年 4 月 1 日至 2023 年 12 月 31 日期间在新加坡一家机构内进行的。研究人员观看了所有人工智能结肠镜检查的视频,并逐个息肉进行分析。将持续息肉检测后的实时息肉特征预测与最终组织学结果进行比较,以评估 CADx 系统识别结肠腺瘤的准确性。在进行的 781 例息肉切除术中,最终组织学结果为腺瘤和非腺瘤的分别为 543 例(69.5%)和 222 例(28.4%)。总体而言,消化道天才能正确定性腺瘤,灵敏度为 89.4%,特异性为 61.7%,阳性预测值为 85.4%,阴性预测值为 69.8%,准确率为 81.5%。直肠乙状结肠病变的阴性预测值(80.3%)明显高于结肠病变(54.2%),这是因为增生性直肠乙状结肠息肉的发病率(11.4%)高于其他结肠区域(5.4%)。对低风险非腺瘤性息肉的准确识别有助于采用 "切除-丢弃 "策略。不过,在将这种策略作为新的治疗标准之前,还需要对人工智能系统进行进一步校准。
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引用次数: 0
Evaluating Large Language Model–Supported Instructions for Medication Use: First Steps Toward a Comprehensive Model 评估大语言模型支持的用药指导:迈向综合模式的第一步
Pub Date : 2024-10-19 DOI: 10.1016/j.mcpdig.2024.09.006
Zilma Silveira Nogueira Reis MD, PhD , Adriana Silvina Pagano MA, PhD , Isaias Jose Ramos de Oliveira MSc , Cristiane dos Santos Dias MD, PhD , Eura Martins Lage MD, PhD , Erico Franco Mineiro PhD , Glaucia Miranda Varella Pereira PhD , Igor de Carvalho Gomes MSc , Vinicius Araujo Basilio MS , Ricardo João Cruz-Correia PhD , Davi dos Reis de Jesus BCS , Antônio Pereira de Souza Júnior MS , Leonardo Chaves Dutra da Rocha PhD

Objective

To assess the support of large language models (LLMs) in generating clearer and more personalized medication instructions to enhance e-prescription.

Patients and Methods

We established patient-centered guidelines for adequate, acceptable, and personalized directions to enhance e-prescription. A dataset comprising 104 outpatient scenarios, with an array of medications, administration routes, and patient conditions, was developed following the Brazilian national e-prescribing standard. Three prompts were submitted to a closed-source LLM. The first prompt involved a generic command, the second one was calibrated for content enhancement and personalization, and the third one requested bias mitigation. The third prompt was submitted to an open-source LLM. Outputs were assessed using automated metrics and human evaluation. We conducted the study between March 1, 2024 and September 10, 2024.

Results

Adequacy scores of our closed-source LLM’s output showed the third prompt outperforming the first and second one. Full and partial acceptability was achieved in 94.3% of texts with the third prompt. Personalization was rated highly, especially with the second and third prompts. The 2 LLMs showed similar adequacy results. Lack of scientific evidence and factual errors were infrequent and unrelated to a particular prompt or LLM. The frequency of hallucinations was different for each LLM and concerned prescriptions issued upon symptom manifestation and medications requiring dosage adjustment or involving intermittent use. Gender bias was found in our closed-source LLM’s output for the first and second prompts, with the third one being bias-free. The second LLM’s output was bias-free.

Conclusion

This study demonstrates the potential of LLM-supported generation to produce prescription directions and improve communication between health professionals and patients within the e-prescribing system.
目的评估大型语言模型(LLM)在生成更清晰、更个性化的用药指导以提高电子处方水平方面的支持情况。我们根据巴西国家电子处方标准开发了一个数据集,其中包括 104 个门诊场景,涉及一系列药物、给药途径和患者状况。向封闭源 LLM 提交了三个提示。第一个提示涉及一个通用命令,第二个提示经过内容增强和个性化校准,第三个提示要求减少偏差。第三个提示提交给了开源 LLM。我们使用自动度量和人工评估对输出结果进行了评估。我们在 2024 年 3 月 1 日至 2024 年 9 月 10 日期间进行了这项研究。结果闭源 LLM 输出的适当性评分显示,第三条提示优于第一条和第二条提示。94.3%的文本在使用第三条提示时达到了完全或部分可接受性。个性化评分很高,尤其是第二和第三个提示。两份法律文件的适当性结果相似。缺乏科学证据和事实错误并不常见,而且与特定的提示或 LLM 无关。出现幻觉的频率在每个 LLM 中都有所不同,涉及到症状表现时开具的处方以及需要调整剂量或间歇性使用的药物。在我们的封闭源 LLM 中,第一个和第二个提示的输出存在性别偏差,第三个提示则没有性别偏差。结论这项研究表明,在电子处方系统中,LLM 支持生成处方指示并改善医疗专业人员与患者之间的沟通具有潜力。
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引用次数: 0
Application of Federated Learning in Cardiology: Key Challenges and Potential Solutions 联合学习在心脏病学中的应用:关键挑战与潜在解决方案
Pub Date : 2024-10-11 DOI: 10.1016/j.mcpdig.2024.09.005
Md Saifur Rahman PhD , Chandan Karmarkar PhD , Sheikh Mohammed Shariful Islam MBBS, PhD
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引用次数: 0
Assessments of Generative Artificial Intelligence as Clinical Decision Support Ought to be Incorporated Into Randomized Controlled Trials of Electronic Alerts for Acute Kidney Injury 急性肾损伤电子警报的随机对照试验中应纳入对作为临床决策支持的生成性人工智能的评估
Pub Date : 2024-10-10 DOI: 10.1016/j.mcpdig.2024.09.004
Donal J. Sexton MD, PhD , Conor Judge MB, PhD
{"title":"Assessments of Generative Artificial Intelligence as Clinical Decision Support Ought to be Incorporated Into Randomized Controlled Trials of Electronic Alerts for Acute Kidney Injury","authors":"Donal J. Sexton MD, PhD ,&nbsp;Conor Judge MB, PhD","doi":"10.1016/j.mcpdig.2024.09.004","DOIUrl":"10.1016/j.mcpdig.2024.09.004","url":null,"abstract":"","PeriodicalId":74127,"journal":{"name":"Mayo Clinic Proceedings. Digital health","volume":"2 4","pages":"Pages 606-610"},"PeriodicalIF":0.0,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142592645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Deep Learning Model for Predicting Neurodevelopmental Outcome in Very Preterm Infants Using Cerebral Ultrasound 利用脑超声波预测极早产儿神经发育结果的深度学习模型
Pub Date : 2024-10-09 DOI: 10.1016/j.mcpdig.2024.09.003
Tahani M. Ahmad MD, ABR , Alessandro Guida PhD , Sam Stewart PhD , Noah Barrett MSc , Michael J. Vincer MD , Jehier K. Afifi MD, MSc

Objective

To develop deep learning (DL) models applied to neonatal cranial ultrasound (CUS) and clinical variables to predict neurodevelopmental impairment (NDI) in very preterm infants (VPIs) at 3 years of corrected age.

Patients and Methods

This is a retrospective study of a cohort of VPI (220-306 weeks’ gestation) born between 2004 and 2016 in Nova Scotia, Canada. Clinical data at hospital discharge and CUS images at 3 time points were used to develop DL models using elastic net (EN) and convolutional neural network (CNN). The models’ performances were compared using precision recall area under the curve (PR-AUC) and area under the receiver operation characteristic curve (ROC-AUC) with their 95% ci.

Results

Of 665 eligible VPIs, 619 (93%) infants with 4184 CUS images were included. The CNN model combining CUS and clinical variables reported better performance (PR-AUC, 0.75; 95% CI, 072-0.79; ROC-AUC, 0.71; 95% CI, 0.67-0.74) in the prediction of positive NDI outcome compared with the traditional models based solely on clinical predictors (PR-AUC, 0.60; 95% CI, 0.52-0.68; ROC-AUC, 0.72; 95% CI, 0.68-0.75). When analyzed by the CUS plane and acquisition time point, the model using the anterior coronal plane at 6 weeks of age provided the highest predictive accuracy (PR-AUC, 0.81; 95% CI, 0.77-0.91; ROC-AUC, 0.78; 95% CI, 0.66-0.87).

Conclusion

We developed and internally validated a DL prognostic model using CUS and clinical predictors to predict NDI in VPIs at 3 years of age. Early and accurate identification of infants at risk for NDI enables referral to targeted interventions, which improves functional outcomes.
目的开发应用于新生儿头颅超声(CUS)和临床变量的深度学习(DL)模型,以预测极早产儿(VPI)在 3 岁矫正年龄时的神经发育障碍(NDI)。患者和方法这是一项回顾性研究,研究对象是 2004 年至 2016 年期间在加拿大新斯科舍省出生的一组 VPI(妊娠 220-306 周)。出院时的临床数据和 3 个时间点的 CUS 图像被用于使用弹性网(EN)和卷积神经网络(CNN)开发 DL 模型。使用精确召回曲线下面积(PR-AUC)和接收者操作特征曲线下面积(ROC-AUC)及其 95% ci 比较了模型的性能。与仅基于临床预测因子的传统模型(PR-AUC,0.60;95% CI,0.52-0.68;ROC-AUC,0.72;95% CI,0.68-0.75)相比,结合 CUS 和临床变量的 CNN 模型在预测 NDI 阳性结果方面表现更好(PR-AUC,0.75;95% CI,072-0.79;ROC-AUC,0.71;95% CI,0.67-0.74)。当按 CUS 平面和采集时间点进行分析时,6 周龄时使用前冠状面的模型具有最高的预测准确性(PR-AUC,0.81;95% CI,0.77-0.91;ROC-AUC,0.78;95% CI,0.66-0.87)。早期准确识别有 NDI 风险的婴儿可转诊接受有针对性的干预,从而改善功能预后。
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引用次数: 0
Medication Extraction and Drug Interaction Chatbot: Generative Pretrained Transformer-Powered Chatbot for Drug-Drug Interaction 药物提取和药物相互作用聊天机器人:生成式预训练变换器驱动的药物交互聊天机器人
Pub Date : 2024-10-09 DOI: 10.1016/j.mcpdig.2024.09.001
Won Tae Kim MD, PhD , Jaegwang Shin , In-Sang Yoo , Jae-Woo Lee MD, PhD , Hyun Jeong Jeon MD, PhD , Hyo-Sun Yoo MD , Yongwhan Kim MD , Jeong-Min Jo , ShinJi Hwang , Woo-Jeong Lee , Seung Park PhD , Yong-June Kim MD, PhD

Objective

To assist individuals, particularly cancer patients or those with complex comorbidities, in quickly identifying potentially contraindicated medications when taking multiple drugs simultaneously.

Patients and Methods

In this study, we introduce the Medication Extraction and Drug Interaction Chatbot (MEDIC), an artificial intelligence system that integrates optical character recognition and Chat generative pretrained transformer through the Langchain framework. Medication Extraction and Drug Interaction Chatbot starts by receiving 2 drug bag images from the patient. It uses optical character recognition and text similarity techniques to extract drug names from the images. The extracted drug names are then processed through Chat generative pretrained transformer and Langchain to provide the user with information about drug contraindications. The MEDIC responds to the user with clear and concise sentences to ensure the information is easily understandable. This research was conducted from July 1, 2022 to April 30, 2024.

Results

This streamlined process enhances the accuracy of drug-drug interaction detection, providing a crucial tool for health care professionals and patients to improve medication safety. The proposed system was validated through rigorous evaluation using real-world data, reporting high accuracy in drug-drug interaction identification and highlighting its potential to benefit medication management practices considerably.

Conclusion

By implementing MEDIC, contraindicated medications can be identified using only medication packaging, and users can be alerted to potential drug adverse effects, thereby contributing to advancements in patient care in clinical settings.
患者和方法在本研究中,我们介绍了药物提取和药物相互作用聊天机器人(MEDIC),这是一种人工智能系统,通过 Langchain 框架集成了光学字符识别和聊天生成预训练变换器。药物提取和药物交互聊天机器人首先接收患者提供的 2 张药物袋图像。它使用光学字符识别和文本相似性技术从图像中提取药物名称。然后,通过聊天生成预训练变换器和 Langchain 对提取的药物名称进行处理,为用户提供药物禁忌信息。MEDIC 会用简洁明了的句子回复用户,确保信息通俗易懂。这项研究从 2022 年 7 月 1 日开始,到 2024 年 4 月 30 日结束。结果这一简化流程提高了药物相互作用检测的准确性,为医护人员和患者提高用药安全提供了重要工具。通过使用真实世界的数据进行严格评估,验证了所提议的系统,报告了药物相互作用识别的高准确性,并强调了该系统对药物管理实践大有裨益的潜力。结论通过实施 MEDIC,可以仅使用药物包装识别禁忌药物,并提醒用户潜在的药物不良反应,从而促进临床环境中患者护理的进步。
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引用次数: 0
Use of a Head-Mounted Assisted Reality, High-Resolution Telemedicine Camera and Satellite Communication Terminal in an Out-of-Hospital Cardiac Arrest 在院外心脏骤停中使用头戴式辅助现实系统、高分辨率远程医疗摄像机和卫星通信终端
Pub Date : 2024-10-09 DOI: 10.1016/j.mcpdig.2024.09.002
Christopher S. Russi DO , Sarayna S. McGuire MD , Aaron B. Klassen MD , Kate M. Skeens MD , Kate J. Arms NREMT-P , Lindsey D. Kaczmerick NREMT-P , Patrick J. Fullerton DO, MHCM , Louis M. Radnothy DO , Anuradha Luke MD
Mayo Clinic Ambulance Service is testing a novel combination of technologies to enhance the ability to provide prehospital telemedicine connecting physicians with paramedics. Mayo Clinic Ambulance Service partnered with start-up company OPTAC-X to field test a novel head-mounted video camera connected with a satellite communications terminal to bring medical control emergency medicine physicians to the patient and paramedic by video. The authors believe this is the first report of a physician providing medical guidance to paramedics resuscitating an out-of-hospital cardiac arrest using these technologies.
梅奥诊所救护车服务公司正在测试一种新颖的技术组合,以提高提供院前远程医疗的能力,将医生与护理人员连接起来。梅奥诊所救护车服务公司与初创公司 OPTAC-X 合作,实地测试了一种新型头戴式摄像机,该摄像机与卫星通信终端相连,可通过视频将医疗控制急诊科医生带到病人和救护人员身边。作者认为,这是首次报道医生利用这些技术为急救人员抢救院外心脏骤停患者提供医疗指导。
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引用次数: 0
Challenges and Limitations of Human Oversight in Ethical Artificial Intelligence Implementation in Health Care: Balancing Digital Literacy and Professional Strain 在医疗保健领域实施合乎伦理的人工智能时,人工监督所面临的挑战和局限性:兼顾数字素养和专业压力
Pub Date : 2024-09-07 DOI: 10.1016/j.mcpdig.2024.08.004
Roanne van Voorst PhD
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引用次数: 0
期刊
Mayo Clinic Proceedings. Digital health
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