This critical review looks at the assessment of the application of artificial intelligence in handling legal documents with specific reference to medical negligence cases with a view of identifying its transformative ...This critical review looks at the assessment of the application of artificial intelligence in handling legal documents with specific reference to medical negligence cases with a view of identifying its transformative potentialities, issues and ethical concerns. The review consolidates findings that show the impact of AI in improving the efficiency, accuracy and justice delivery in the legal profession. The studies show increased efficiency in speed of document review and enhancement of the accuracy of the reviewed documents, with time efficiency estimates of 60% reduction of time. However, the review also outlines some of the problems that continue to characterize AI, such as data quality problems, biased algorithms and the problem of the opaque decision-making system. This paper assesses ethical issues related to patient autonomy, justice and non-malignant suffering, with particular focus on patient privacy and fair process, and on potential unfairness to patients. This paper’s review of AI innovations finds that regulations lag behind AI developments, leading to unsettled issues regarding legal responsibility for AI and user control over AI-generated results and findings in legal proceedings. Some of the future avenues that are presented in the study are the future of XAI for legal purposes, utilizing federated learning for resolving privacy issues, and the need to foster adaptive regulation. Finally, the review advocates for Legal Subject Matter Experts to collaborate with legal informatics experts, ethicists, and policy makers to develop the best solutions to implement AI in medical negligence claims. It reasons that there is great potential for AI to have a deep impact on the practice of law but when done, it must do so in a way that respects justice and on the Rights of Individuals.展开更多
目的:研究当前国内电子递交制度在药品注册全生命周期管理中的应用现状,分析面临的挑战,提出完善我国电子递交制度的建议。方法:采用文献研究和比较研究等方法,回顾并对比分析国内电子递交制度的发展历程及实施现状,结合我国实际情况,...目的:研究当前国内电子递交制度在药品注册全生命周期管理中的应用现状,分析面临的挑战,提出完善我国电子递交制度的建议。方法:采用文献研究和比较研究等方法,回顾并对比分析国内电子递交制度的发展历程及实施现状,结合我国实际情况,提出针对性的改进建议。结果与结论:我国的电子递交存在电子通用技术文档(electronic common technical document,eCTD)递交与非eCTD递交2种形式,目前处于两者并行的过渡阶段。但在实施过程中仍面临申请事项递交格式标准不统一、省级药品监管机构接收和审阅eCTD能力不足等问题。针对这些问题,本文提出了以下具体措施:①深化eCTD改革的进程,扩大实施范围。②强化药品从上市前到上市后管理的有效衔接。③加速药品全生命周期文件递交的标准化。通过这些措施的实施,以期加速推进我国药品注册申报全面电子化的进程,从而提升审评审批的效率与质量。展开更多
文摘This critical review looks at the assessment of the application of artificial intelligence in handling legal documents with specific reference to medical negligence cases with a view of identifying its transformative potentialities, issues and ethical concerns. The review consolidates findings that show the impact of AI in improving the efficiency, accuracy and justice delivery in the legal profession. The studies show increased efficiency in speed of document review and enhancement of the accuracy of the reviewed documents, with time efficiency estimates of 60% reduction of time. However, the review also outlines some of the problems that continue to characterize AI, such as data quality problems, biased algorithms and the problem of the opaque decision-making system. This paper assesses ethical issues related to patient autonomy, justice and non-malignant suffering, with particular focus on patient privacy and fair process, and on potential unfairness to patients. This paper’s review of AI innovations finds that regulations lag behind AI developments, leading to unsettled issues regarding legal responsibility for AI and user control over AI-generated results and findings in legal proceedings. Some of the future avenues that are presented in the study are the future of XAI for legal purposes, utilizing federated learning for resolving privacy issues, and the need to foster adaptive regulation. Finally, the review advocates for Legal Subject Matter Experts to collaborate with legal informatics experts, ethicists, and policy makers to develop the best solutions to implement AI in medical negligence claims. It reasons that there is great potential for AI to have a deep impact on the practice of law but when done, it must do so in a way that respects justice and on the Rights of Individuals.
文摘目的:研究当前国内电子递交制度在药品注册全生命周期管理中的应用现状,分析面临的挑战,提出完善我国电子递交制度的建议。方法:采用文献研究和比较研究等方法,回顾并对比分析国内电子递交制度的发展历程及实施现状,结合我国实际情况,提出针对性的改进建议。结果与结论:我国的电子递交存在电子通用技术文档(electronic common technical document,eCTD)递交与非eCTD递交2种形式,目前处于两者并行的过渡阶段。但在实施过程中仍面临申请事项递交格式标准不统一、省级药品监管机构接收和审阅eCTD能力不足等问题。针对这些问题,本文提出了以下具体措施:①深化eCTD改革的进程,扩大实施范围。②强化药品从上市前到上市后管理的有效衔接。③加速药品全生命周期文件递交的标准化。通过这些措施的实施,以期加速推进我国药品注册申报全面电子化的进程,从而提升审评审批的效率与质量。
