Ethical considerations

伦理考虑
  • 文章类型: Journal Article
    背景:癌症治疗和生存的进步依赖于参与研究和获取健康记录。
    方法:本研究在42个社区成员的14个研讨会上探讨了数据访问和共享的偏好,其中大多数是癌症幸存者或照顾者。介绍和讨论了数据访问和共享的各种场景,使用描述性统计数据汇总参与者的偏好。通过对讲习班笔录的专题分析,确定了这些偏好的原因。
    结果:大多数参与者表示,研究人员愿意将他们的自我报告数据和当前的健康记录用于特定的研究项目(86%)。许多人还愿意将他们的自我报告数据和当前(62%)或所有未来(44%)的健康记录与其他研究人员共享,以便在意识到这一点的情况下用于其他研究。同意在癌症研究中访问和共享数据的意愿受到以下因素的影响:(i)数据共享促进医学发现并使未来受癌症影响的人们受益的潜力,(Ii)围绕研究人员的可信度及其数据共享意图的透明度,(iii)对数据共享的所有权和控制水平,和(iv)数据共享中的隐私和保密协议。
    结论:基于这些主题,我们提出了在癌症研究中优化数据访问和共享的实用策略.
    BACKGROUND: Advancements in cancer treatment and survivorship rely on participation in research and access to health records.
    METHODS: This study explored preferences for data access and sharing in 14 workshops with 42 community members, most of whom were a cancer survivor or carer. Various scenarios for data access and sharing were presented and discussed, with participants\' preferences summarized using descriptive statistics. Reasons underlying these preferences were identified through a thematic analysis of workshop transcripts.
    RESULTS: Most participants indicated a willingness for researchers to use their self-report data and current health records for a specific research project (86%). Many were also willing for their self-report data and current (62%) or all future (44%) health records to be shared with other researchers for use in other studies if made aware of this. Willingness to consent to data access and sharing data in cancer research was influenced by: (i) the potential for data sharing to advance medical discoveries and benefit people impacted by cancer in the future, (ii) transparency around researchers\' credibility and their intentions for data sharing, (iii) level of ownership and control over data sharing, and (iv) protocols for privacy and confidentiality in data sharing.
    CONCLUSIONS: Based on these themes, we present practical strategies for optimizing data access and sharing in cancer research.
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  • 文章类型: Journal Article
    数字化转型迅速改变了我们在大流行后世界的生活方式。不幸的是,数字技术不仅限于守法组织和公民。犯罪组织和个人迅速发现新技术的新机会,数字化转型正在极大地改变犯罪的性质,恐怖,和其他威胁。人工智能等颠覆性技术带来的可能性促进了新犯罪的快速出现,物联网,无人机,和加密货币可能成为罪犯手中的灾难性工具。因此,我们的社会需要更好的能力来预防和调查犯罪行为,以保护组织和公民。这迫切需要积极改革数字取证,以显著提高我们的能力,以应对数字转型时代不断演变的犯罪给社会带来的压力。法医学的未来已经到来,其特点是机遇与挑战并存。必须加大有效利用数字技术进行犯罪活动的难度,在利用受影响者使用数字技术的可能性的同时,执法机构,商业和组织。随着数字技术的不断发展,我们需要及时了解最新发展,以有效调查和起诉数字时代的犯罪。人们越来越依赖数字证据,刑事案件中的异构数字证据数量不断增加。因此,法医科学技术变得更加复杂,并发挥着越来越重要的作用。然而,科学领域极其广泛,超出了大多数法医学实验室跟上技术前沿发展速度的能力。除了迫切需要把这个话题提到政治舞台上,讨论了我们如何应对挑战的例子,例如通过扩大我们的合作,鼓励和促进培训和教育合作,以应对极其广泛和快速的发展,制定解释和可视化证据的方法,以说明起诉中数字证据的处理和法律价值,以及产品开发人员和犯罪调查人员之间的合作,以迅速创新数字取证工具和方法,以应对快速出现的威胁。本文将重点介绍使用现代数字技术来解决物理世界中的犯罪以及数字领域中的犯罪的具体示例,并讨论如何使用“良好的AI”来打击“邪恶的AI”,并最终触及新的数字取证工具的增强功能与私人诚信之间的敏感平衡。
    Digital transformation rapidly changes how we live our lives in the post pandemic world. Unfortunately, digital technology is not limited to law abiding organisations and citizens. Criminal organisations and individuals are quick to identify new opportunities with new technologies, and digital transformation is dramatically changing the character of crimes, terror, and other threats. The fast emergence of new crimes is facilitated by possibilities brought by disruptive technologies such as AI, Internet of Things, drones, and cryptocurrencies that can be disastrous tools in the hands of criminals. Consequently, our society needs far better capacity to prevent and investigate criminal acts to protect organisations and citizens. This brings an urgent need to proactively reform digital forensics to significantly increase our capability to meet the strain on society brought by crimes evolving in the digital transformation era. The future of forensic science is already here, characterized by a mix of opportunities and challenges. It is essential to make it harder to effectively use digital technologies for criminal activities, while leveraging the possibilities of digital technologies by those affected, law enforcement agencies, business and organisations. As digital technologies continue to evolve, we need to stay up to date with the latest developments to effectively investigate and prosecute crimes in the digital age. There is an increased reliance on digital evidence, and the amount of heterogeneous digital evidence in criminal cases keep increasing. The forensic science techniques thus become more sophisticated and play an increasingly important role. However, the scientific area is extremely broad, and beyond the capability of most forensic science labs to keep up with the technology forefront development speed. Besides an urgent need to bring up the subject to the political arena, examples of how we can meet the challenges are discussed such as by extending our cooperation, encourage and facilitate cooperation for training and education to handle the extremely broad and rapid development, working out methods for explaining and visualising evidence for the treatment and legal values of digital evidence in prosecution, and cooperation between product developers and crime investigators for swift innovation of digital forensics tools and methodologies for quickly emerging threats. This paper will highlight specific examples where modern digital techniques are used to solve crimes in the physical world as well as crimes committed in the digital domain and discuss how \"good AI\" can be used to fight \"evil AI\" and finally touch on the sensitive balance between the increased power of the new digital forensic tools and private integrity.
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  • 文章类型: Journal Article
    标准的血管内主动脉修复术(EVAR)已成为治疗具有良好解剖结构的患者的肾下腹主动脉瘤(AAAs)的护理标准。而具有挑战性的AAA解剖结构的患者,那些有肾上或胸腹动脉瘤的人,仍然需要替代,更复杂,解决方案,包括定制的分支或开窗移植物,受到生产延误和成本的制约。解决紧迫的需要和复杂的案件,医生建议通过手动创建移植物开窗来修改标准内移植物。这允许有效的动脉瘤排除和内脏血管的令人满意的通畅。尽管医师改良的移植物(PMEG)已经证明了很高的技术成功,仍然缺乏标准化的创建流程和长期安全数据,需要进一步研究以验证其临床和法律地位。本文的目的是说明有关这种手术技术的最新技术,总结它的起源,进化,以及支持其有效性的主要临床证据。本文还旨在讨论与使用PMEGs有关的主要医学法律问题,特别提到与外科技术标准化相关的安全问题,医疗责任简介,知情同意。
    Standard endovascular aortic repair (EVAR) has become the standard of care for treating infrarenal abdominal aortic aneurysms (AAAs) in patients with favorable anatomies, while patients with challenging AAA anatomies, and those with suprarenal or thoraco-abdominal aneurysms, still need alternative, more complex, solutions, including custom-made branched or fenestrated grafts, which are constrained by production delay and costs. To address urgent needs and complex cases, physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory patency of visceral vessels. Although physician-modified grafts (PMEGs) have demonstrated high technical success, standardized creation processes and long-term safety data are still lacking, necessitating further study to validate their clinical and legal standing. The aim of this article is to illustrate the state of the art with regard to this surgical technique, summarizing its origin, evolution, and the main clinical evidence supporting its effectiveness. The paper also aims to discuss the main medico-legal issues related to the use of PMEGs, with particular reference to the issue of safety related to the standardization of the surgical technique, medical liability profiles, and informed consent.
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  • 文章类型: Journal Article
    本文试图强调在根据伦理原则评估人类医学研究时,必须将研究可持续性纳入其中的重要性。使用对最近文献的范围界定回顾,研究可持续性的复杂性得到了强调,围绕这一重要主题的关键主题和概念得到了认可和讨论。确定了总体上缺乏指导文件,并提出了实际解决这一缺陷的建议。目前正在试行的研究可持续性评估工具的一个例子已经提供,供伦理委员会和机构审查委员会可能进行调整和使用,以在研究批准过程中加强可持续性的概念和纳入。
    This article attempts to highlight the importance of including research sustainability as imperative when assessing human medical research in terms of ethical principles. Using a scoping review of recent literature, the complexity of research sustainability is highlighted with key themes and concepts surrounding this important topic being recognized and discussed. An overall paucity of guidance documents was identified and recommendations have been made to practically address this deficiency. An example of a research sustainability evaluation tool which is currently being piloted has been provided for possible adaptation and use by Ethics Committees and Institutional Review Boards to bolster the concept and inclusion of sustainability during the research approval process.
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  • 文章类型: Journal Article
    过去十年来,人们对更精确和有效的医疗技术,特别强调诊断技术的兴趣增加了。人工智能已被证明有助于各种此类技术的发展。像ML这样的各种类型的AI,NLP,RPA等.正在使用,它简化和组织了电子健康记录(EHR),并帮助医疗保健提供者进行决策,样本和数据分析。本文还讨论了3大类诊断技术-基于成像,基于病理学和预防性诊断技术,以及所有变化和修改都给它们带来了什么,由于使用AI。由于如此高的需求,对基于人工智能的医疗保健技术的投资大幅增加,到2030年,预计市场规模将接近188亿美元。在印度本身,预计到2028年,医疗保健领域的人工智能将使国内生产总值增加250亿美元。但也有一些与之相关的挑战,比如质量数据的不可用,黑匣子问题等。主要挑战之一是使用医疗记录期间的伦理考虑和问题,因为它是一个非常敏感的文件。由于这个原因,许多组织采用人工智能存在几个信任问题。本文也讨论了这些挑战。本文还需要进一步开发基于AI的诊断技术。旁边,这些技术和设备的生产是易于使用和简单地纳入日常工作流程在即将到来的时代有巨大的范围。临床决策支持系统的范围越来越大,远程医疗等.使AI在医疗保健和诊断领域成为一个有前途的领域。结束文章,可以说,尽管实施和使用面临各种挑战,人工智能在医疗保健领域的未来前景是巨大的,需要做工作,以确保同样的资源的可用性,以便实现高水平的准确性,并为患者提供更好的健康结果。需要解决道德问题,以便顺利实施并减轻开发人员的负担,这在这篇叙事综述文章中已经讨论过了。
    Since the past decade, the interest towards more precise and efficient healthcare techniques with special emphasis on diagnostic techniques has increased. Artificial Intelligence has proved to be instrumental in development of various such techniques. The various types of AI like ML, NLP, RPA etc. are being used, which have streamlined and organised the Electronic Health Records (EHR) along with aiding the healthcare provider with decision making and sample and data analysis. This article also deals with the 3 major categories of diagnostic techniques - Imaging based, Pathology based and Preventive diagnostic techniques and what all changes and modifications were brought upon them, due to use of AI. Due to such a high demand, the investment in AI based healthcare techniques has increased substantially, with predicted market size of almost 188 billon USD by 2030. In India itself, AI in healthcare is expected to raise the GDP by 25 billion USD by 2028. But there are also several challenges associated with this like unavailability of quality data, black box issue etc. One of the major challenges is the ethical considerations and issues during use of medical records as it is a very sensitive document. Due to this, there is several trust issues associated with adoption of AI by many organizations. These challenges have also been discussed in this article. Need for further development in the AI based diagnostic techniques is also done in the article. Alongside, the production of such techniques and devices which are easy to use and simple to incorporate into the daily workflows have immense scope in the upcoming times. The increasing scope of Clinical Decision Support System, Telemedicine etc. make AI a promising field in the healthcare and diagnostics arena. Concluding the article, it can be said that despite the presence of various challenges to the implementation and usage, the future prospects for AI in healthcare is immense and work needs to be done in order to ensure the availability of resources for same so that high level of accuracy can be achieved and better health outcomes can be provided to patients. Ethical concerns need to be addressed for smooth implementation and to reduce the burden of the developers, which has been discussed in this narrative review article.
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  • 文章类型: Journal Article
    语音作为使用人工智能(AI)的健康生物标志物正在获得研究的动力。通过可访问技术(如智能手机、远程医疗,和环境记录)或在临床环境中意味着语音AI可能有助于解决健康差异并促进边缘化社区的包容。然而,开发无偏见和歧视的AI就绪语音数据集是一项复杂的任务。这项研究的目的是更好地理解参与和感兴趣的利益相关者对道德和值得信赖的语音AI的观点。为进一步的伦理调查和技术创新提供信息。
    对语音AI专家进行了问卷调查,临床医生,学者,病人,学员,和政策制定者参加了由Bridge2AI-VoiceAI联盟组织的2023年语音AI研讨会。调查使用了李克特量表的组合,排名和开放式问题。共有27个利益相关者参与了这项研究。
    这项研究的主要结果是在伦理问题方面确定了优先事项,语音AI的道德来源数据的初始定义,对合成语音数据使用的见解,以及对语音人工智能可信度采取行动的建议。该研究显示了观点的多样性,并为道德和值得信赖的语音AI的规划和开发增加了细微差别。
    这项研究代表了迄今为止发表的与语音作为健康生物标志物有关的第一项利益相关者调查。这项研究揭示了道德和可信赖性在语音AI技术在健康应用开发中的至关重要性。
    UNASSIGNED: Voice as a health biomarker using artificial intelligence (AI) is gaining momentum in research. The noninvasiveness of voice data collection through accessible technology (such as smartphones, telehealth, and ambient recordings) or within clinical contexts means voice AI may help address health disparities and promote the inclusion of marginalized communities. However, the development of AI-ready voice datasets free from bias and discrimination is a complex task. The objective of this study is to better understand the perspectives of engaged and interested stakeholders regarding ethical and trustworthy voice AI, to inform both further ethical inquiry and technology innovation.
    UNASSIGNED: A questionnaire was administered to voice AI experts, clinicians, scholars, patients, trainees, and policy-makers who participated at the 2023 Voice AI Symposium organized by the Bridge2AI-Voice AI Consortium. The survey used a mix of Likert scale, ranking and open-ended questions. A total of 27 stakeholders participated in the study.
    UNASSIGNED: The main results of the study are the identification of priorities in terms of ethical issues, an initial definition of ethically sourced data for voice AI, insights into the use of synthetic voice data, and proposals for acting on the trustworthiness of voice AI. The study shows a diversity of perspectives and adds nuance to the planning and development of ethical and trustworthy voice AI.
    UNASSIGNED: This study represents the first stakeholder survey related to voice as a biomarker of health published to date. This study sheds light on the critical importance of ethics and trustworthiness in the development of voice AI technologies for health applications.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    家族性高胆固醇血症(FH)由于发病率高和诊断不足而构成了全球健康挑战。导致早发性动脉粥样硬化和心血管疾病的风险增加。FH的早期发现和治疗对于降低心血管事件的风险和改善受影响的个人及其家人的长期结果和生活质量至关重要。传统的治疗方法围绕降脂干预,然而挑战依然存在,特别是在准确和及时的诊断。当前的诊断环境严重依赖于特定LDL-C代谢基因的基因检测,通常仅限于专业中心。这种限制导致FH诊断采用替代临床评分。然而,人工智能(AI)和机器学习(ML)的快速发展为这些诊断挑战提供了有希望的解决方案。这篇综述探讨了FH的复杂性,强调在疾病诊断和管理中遇到的挑战。ML的革命性潜力,特别是在大规模人群筛查中,突出显示。ML在FH筛查中的应用,诊断,并讨论了风险分层,展示其超越传统标准的能力。然而,挑战和道德考虑,包括算法稳定性,数据质量,隐私,和同意问题,是需要关注的关键领域。审查最后强调了AI和ML在FH管理中的重要前景,同时强调了道德和实践警惕的必要性,以确保负责任和有效地整合到医疗保健实践中。
    Familial hypercholesterolemia (FH) poses a global health challenge due to high incidence rates and underdiagnosis, leading to increased risks of early-onset atherosclerosis and cardiovascular diseases. Early detection and treatment of FH is critical in reducing the risk of cardiovascular events and improving the long-term outcomes and quality of life for affected individuals and their families. Traditional therapeutic approaches revolve around lipid-lowering interventions, yet challenges persist, particularly in accurate and timely diagnosis. The current diagnostic landscape heavily relies on genetic testing of specific LDL-C metabolism genes, often limited to specialized centers. This constraint has led to the adoption of alternative clinical scores for FH diagnosis. However, the rapid advancements in artificial intelligence (AI) and machine learning (ML) present promising solutions to these diagnostic challenges. This review explores the intricacies of FH, highlighting the challenges that are encountered in the diagnosis and management of the disorder. The revolutionary potential of ML, particularly in large-scale population screening, is highlighted. Applications of ML in FH screening, diagnosis, and risk stratification are discussed, showcasing its ability to outperform traditional criteria. However, challenges and ethical considerations, including algorithmic stability, data quality, privacy, and consent issues, are crucial areas that require attention. The review concludes by emphasizing the significant promise of AI and ML in FH management while underscoring the need for ethical and practical vigilance to ensure responsible and effective integration into healthcare practices.
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  • 文章类型: Journal Article
    一个目标,使用医疗设备进行的生理测量可以通过在视觉迹象出现之前早期检测到问题迹象来降低压疮的发生率。该领域的研究受到临床实践和患者水平混杂因素的影响。
    作者概述了设计一项研究方案的关键考虑因素,以评估预后医疗设备在降低医院压疮发生率方面的有效性和安全性。包括比较器,随机化,样本量,道德和实际问题。
    与方法和道德相关的关键问题与理论协议一起考虑,这可以支持未来的研究人员进行伤口护理试验。
    预期,三臂,多中心,提出了分层整群随机对照试验。建议使用第三臂,因为预计需要移动患者以使用医疗设备,并且重新定位是一种预防策略。至少需要招募33个病房的16200名患者才能达到统计学意义。需要考虑同意或同意方面的道德考虑。
    旨在评估诊断或预后医疗设备在降低二级保健中的压疮发生率方面的有效性的假设研究,在考虑偏见的同时,将需要大样本量,并涉及运营商间和设备间可靠性的风险,用户的异质性和设备结果的模糊临床解释。该领域的强大研究有可能影响或改变与预防二级保健中的压疮有关的政策和实践。
    UNASSIGNED: An objective, physiological measurement taken using a medical device may reduce the incidence of pressure ulcers through earlier detection of problems signs before visual signs appear. Research in this field is hampered by variations in clinical practice and patient-level confounders.
    UNASSIGNED: The authors outline key considerations for designing a protocol for a study to assess the efficacy and safety of a prognostic medical device in reducing pressure ulcer incidence in a hospital, including comparators, randomisation, sample size, ethics and practical issues.
    UNASSIGNED: Key issues relating to methodology and ethics are considered alongside a theoretical protocol, which could support future researchers in wound care trials.
    UNASSIGNED: A prospective, three-armed, multi-centre, stratified cluster-randomised controlled trial is proposed. The third arm is recommended as it is expected that patients will need to be moved for the medical device to be used and repositioning is a preventive strategy. A minimum of 16 200 patients in 33 wards would needed to be recruited to achieve statistical significance. Ethical considerations in terms of consent or assent need to be considered.
    UNASSIGNED: The hypothetical study designed to evaluate the effectiveness of a diagnostic or prognostic medical device in reducing pressure ulcer incidence in secondary care, while accounting for biases, would require large sample sizes and involves risks of inter-operator and inter-device reliability, heterogeneity of users and the vague clinical interpretation of device results. Robust research in this field has the potential to influence or change policy and practice relating to the prevention of pressure ulcers in secondary care.
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  • 文章类型: Journal Article
    背景:利用人工智能(AI)和机器学习(ML)的创新工具正在迅速开发用于医学,随着预测中出现的新应用,诊断,以及一系列疾病的治疗,患者群体,和临床程序。成功创新的一个障碍是当前文献中缺乏寻求和分析AI或ML研究人员和医生的观点以支持伦理指导的研究。
    目的:本研究旨在描述,使用定性的方法,AI或ML研究人员和专业接触AI或ML工具的医生在AI和ML在医学中的开发和使用中观察或预期的道德问题景观。
    方法:使用半结构化访谈来促进深入,开放式讨论,并使用有目的的抽样技术来识别和招募参与者。我们对AI和ML研究人员(n=10)和医生(n=11)的有目的样本进行了21次半结构化访谈。我们询问了受访者对与在医学中采用AI和ML有关的道德考虑的看法。我们的研究小组成员对访谈进行了转录和鉴定。数据分析遵循定性内容分析的原则。这种方法,其中转录的数据被分解为描述性单位,这些单位根据其内容进行命名和排序,允许直接从数据集中归纳出现代码。
    结果:值得注意的是,研究人员和医生都表达了对人工智能和机器学习创新在早期发展中如何形成的担忧(即,问题制定阶段)。考虑因素包括评估研究重点和动机,临床需求的清晰度和中心性,研究团队的专业和人口多样性,以及跨学科的知识生成和协作。受访者确定的第一阶段伦理问题在本质上是跨学科的,并邀请了关于如何调整跨学科的优先事项和价值观,并在整个医学AI和ML的开发和实施过程中确保临床价值的问题。相关地,受访者建议跨学科解决这些问题,例如,更多资源来支持开发人员和医生之间的知识生成和协作,与更广泛的利益相关者接触,并努力在广泛的研究和个人团队内部增加研究的多样性。
    结论:这些定性发现有助于阐明AI和ML在医疗保健方面预期或遇到的一些伦理挑战。我们的研究是独一无二的,因为它使用开放式问题允许受访者探索他们的情绪和观点,而不会过度依赖关于AI和ML目前是什么或不是什么的隐含假设。这个分析,然而,不包括其他相关利益相关者团体的观点,如患者,伦理学家,行业研究人员或代表,或医生以外的其他医疗保健专业人员。需要额外的定性和定量研究来重现和建立这些发现。
    BACKGROUND: Innovative tools leveraging artificial intelligence (AI) and machine learning (ML) are rapidly being developed for medicine, with new applications emerging in prediction, diagnosis, and treatment across a range of illnesses, patient populations, and clinical procedures. One barrier for successful innovation is the scarcity of research in the current literature seeking and analyzing the views of AI or ML researchers and physicians to support ethical guidance.
    OBJECTIVE: This study aims to describe, using a qualitative approach, the landscape of ethical issues that AI or ML researchers and physicians with professional exposure to AI or ML tools observe or anticipate in the development and use of AI and ML in medicine.
    METHODS: Semistructured interviews were used to facilitate in-depth, open-ended discussion, and a purposeful sampling technique was used to identify and recruit participants. We conducted 21 semistructured interviews with a purposeful sample of AI and ML researchers (n=10) and physicians (n=11). We asked interviewees about their views regarding ethical considerations related to the adoption of AI and ML in medicine. Interviews were transcribed and deidentified by members of our research team. Data analysis was guided by the principles of qualitative content analysis. This approach, in which transcribed data is broken down into descriptive units that are named and sorted based on their content, allows for the inductive emergence of codes directly from the data set.
    RESULTS: Notably, both researchers and physicians articulated concerns regarding how AI and ML innovations are shaped in their early development (ie, the problem formulation stage). Considerations encompassed the assessment of research priorities and motivations, clarity and centeredness of clinical needs, professional and demographic diversity of research teams, and interdisciplinary knowledge generation and collaboration. Phase-1 ethical issues identified by interviewees were notably interdisciplinary in nature and invited questions regarding how to align priorities and values across disciplines and ensure clinical value throughout the development and implementation of medical AI and ML. Relatedly, interviewees suggested interdisciplinary solutions to these issues, for example, more resources to support knowledge generation and collaboration between developers and physicians, engagement with a broader range of stakeholders, and efforts to increase diversity in research broadly and within individual teams.
    CONCLUSIONS: These qualitative findings help elucidate several ethical challenges anticipated or encountered in AI and ML for health care. Our study is unique in that its use of open-ended questions allowed interviewees to explore their sentiments and perspectives without overreliance on implicit assumptions about what AI and ML currently are or are not. This analysis, however, does not include the perspectives of other relevant stakeholder groups, such as patients, ethicists, industry researchers or representatives, or other health care professionals beyond physicians. Additional qualitative and quantitative research is needed to reproduce and build on these findings.
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