How are surgical and clinical innovations in medical practice defined for the purpose of determining regulatory jurisdiction and oversight responsibility

A scoping review

Bibliographic Data

ID19570979
AuthorsAmy Zarzeczny (0000-0002-7570-3515, University of Regina, corresponding author), Chris Bradley (0000-0003-4042-867X, University of Regina), Lixin Ge (0000-0002-8554-1054, University of Regina)
Year2025
Volume33
Pages101044
Publication date2025-01-01
Open AccessYes
TypeARTICLE
VenueEthics Medicine and Public Health (JOURNAL)
Journal identifiersISSN: 2352-5525 • E-ISSN: 2352-5533
PublisherElsevier BV (PUBLISHER)
DOI10.1016/j.jemep.2025.101044
OpenAlexW4406367797
LanguageEN
References cited31

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

Business · Engineering ethics · Jurisdiction · Political science · Biomedical Ethics and Regulation · Engineering · Ethics in Clinical Research · Health Systems, Economic Evaluations, Quality of Life · Law · Medicine · Accounting

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