How are surgical and clinical innovations in medical practice defined for the purpose of determining regulatory jurisdiction and oversight responsibility?: A scoping review

Q3 Medicine

Ethics, Medicine and Public Health Pub Date : 2025-01-01 DOI:10.1016/j.jemep.2025.101044

A. Zarzeczny , C. Bradley , L. Ge

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引用次数: 0

Abstract

Background

Various jurisdictions such as the US, Canada, and the UK have regulatory frameworks overseeing pharmaceuticals, medical devices, and medical research, with categorization determining authority and responsibility for oversight. Unclear categorization poses health policy concerns, potentially hindering progress in fields like regenerative medicine.

Methodology

This scoping review aims to clarify how surgical and clinical innovations, as well as medical practices, are defined for regulatory purposes. It maps current literature, clarifies key concepts, and provides a descriptive analysis.

Results

The review elucidates key concepts related to the characterization and oversight of new medical interventions, highlighting inconsistencies, and identifying gaps needing clarity in regulation and characterization in medical practices.

Conclusion

Addressing ambiguity in oversight is crucial. Clarifying definitions can enhance governance, advance medical interventions, promote innovation, and ensure patient safety in emerging biomedical fields.

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如何定义医疗实践中的外科和临床创新，以确定监管管辖权和监督责任？范围审查

不同的司法管辖区，如美国、加拿大和英国，都有监管药品、医疗器械和医学研究的监管框架，其分类决定了监管的权力和责任。不明确的分类引起了卫生政策方面的担忧，可能会阻碍再生医学等领域的进展。方法本综述旨在阐明外科和临床创新以及医疗实践是如何为监管目的而定义的。它描绘了当前的文献，澄清了关键概念，并提供了描述性的分析。结果本综述阐明了与新医疗干预的表征和监督相关的关键概念，突出了不一致之处，并确定了医疗实践中需要明确监管和表征的差距。结论解决监管中的歧义是至关重要的。澄清定义可以加强治理，推进医疗干预，促进创新，并确保新兴生物医学领域的患者安全。

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

Ethics, Medicine and Public Health Medicine-Health Policy

CiteScore

2.20

自引率

0.00%

发文量

107

审稿时长

42 days

期刊介绍： This review aims to compare approaches to medical ethics and bioethics in two forms, Anglo-Saxon (Ethics, Medicine and Public Health) and French (Ethique, Médecine et Politiques Publiques). Thus, in their native languages, the authors will present research on the legitimacy of the practice and appreciation of the consequences of acts towards patients as compared to the limits acceptable by the community, as illustrated by the democratic debate.