Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance.

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-09-27 DOI:10.1007/s40264-024-01483-9
Ashish Jain, Maribel Salas, Omar Aimer, Zahabia Adenwala
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Abstract

Artificial intelligence is increasingly being used in pharmacovigilance. However, the use of artificial intelligence in pharmacovigilance raises ethical concerns related to fairness, non-discrimination, compliance, and responsibility as the central ethical principles in risk assessment and regulatory requirements. This paper explores these concerns and provides a roadmap to how to address these challenges by considering data collection, privacy protection, transparency and accountability, model training, and explainability in artificial intelligence decision making for drug safety surveillance. A number of responsible approaches have been identified including an ethics framework and best practices to enhance artificial intelligence use in healthcare. The document also recognizes some initiatives that have demonstrated the importance of ethics in artificial intelligence pharmacovigilance. Nevertheless, the major needs mentioned in this paper are transparency, accountability, data protection, and fairness, which stress the necessity of collaboration to construct a cognitive framework aimed at integrating ethical artificial intelligence into pharmacovigilance. In conclusion, innovation should be balanced with ethical responsibility to enhance public health outcomes as well as patient safety.

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在人工智能时代保护患者:药物警戒最前沿的伦理。
人工智能正越来越多地应用于药物警戒领域。然而,在药物警戒中使用人工智能会引发与公平、非歧视、合规和责任有关的伦理问题,而这些是风险评估和监管要求的核心伦理原则。本文探讨了这些问题,并通过考虑药物安全监控人工智能决策中的数据收集、隐私保护、透明度和问责制、模型训练和可解释性,为如何应对这些挑战提供了路线图。文件提出了一些负责任的方法,包括伦理框架和最佳实践,以加强人工智能在医疗保健领域的应用。该文件还认可了一些表明伦理在人工智能药物警戒中重要性的倡议。不过,本文提到的主要需求是透明度、问责制、数据保护和公平性,这强调了合作构建认知框架的必要性,旨在将符合伦理的人工智能纳入药物警戒。总之,创新应与伦理责任相平衡,以提高公共卫生成果和患者安全。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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