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Somatic Genome Editing with the Use of AI: Big Promises but Doubled Legal Issues
European Journal of Health Law Pub Date : 2022-04-08 , DOI: 10.1163/15718093-bja10079
Anastasiya Kiseleva 1, 2
Affiliation  

Both Artificial Intelligence (‘AI’) and genome editing are technologies that on their own promise to revolutionise healthcare. But their common application can facilitate progress in the field even more. Multiplied benefits go along with increased risks. In this article, I identify and analyse legal challenges associated with applying AI facilities in medicinal products based on somatic genome editing. These challenges are caused by several factors. First, the two technologies share the characteristics that create and facilitate common risks. Second, each of the technologies is subject to very complex regulatory frameworks. These frameworks are not substantially connected to control the safety and quality of the common product. The main argument of this paper is that the management of common risks is only possible through common procedures. I discover the gaps in the current legislation that prevent from establishing these common procedures and provide recommendations to fill them in.



中文翻译:

使用人工智能进行体细胞基因组编辑:前景广阔,但法律问题成倍增加

人工智能(“ AI ”)和基因组编辑技术本身就有望彻底改变医疗保健。但它们的共同应用可以进一步促进该领域的进步。收益成倍增加,风险也随之增加。在本文中,我识别并分析了在基于体细胞基因组编辑的医药产品中应用人工智能设施相关的法律挑战。这些挑战是由多种因素造成的。首先,这两种技术具有产生和促进共同风险的特征。其次,每一项技术都受到非常复杂的监管框架的约束。这些框架与控制通用产品的安全和质量没有实质性联系。本文的主要论点是,只有通过共同程序才能管理共同风险。我发现现行立法中存在阻碍建立这些共同程序的缺陷,并提出填补这些缺陷的建议。

更新日期:2022-04-08
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