Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 3, 2026
Open Peer Review Period: Jul 9, 2026 - Sep 3, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Regulating Generative AI in Healthcare: Protocol for a Scoping Review
ABSTRACT
Background:
Generative Artificial Intelligence (GenAI) is rapidly becoming an integral part of healthcare provision on a global scale. However, its unprecedented nature and fast paced transformation raises concerns around patient safety. With the global surge in health AI tools being developed and used, there is an urgent call on tighter and more robust regulatory oversight.
Objective:
We will conduct a scoping review to map and synthesise the current regulatory considerations of GenAI in healthcare. We will identify innovative approaches to regulating GenAI in health and characterise emerging challenges that regulators face, with the aim of supporting a needs-led approach to regulatory innovation.
Methods:
The proposed scoping review will be conducted in accordance with the JBI methodology for scoping reviews and follow the PRISMA-ScR reporting guidance. We will conduct a focussed regulatory website review complimented with a grey literature search using custom Google search and an academic literature search through Ovid Medline.
Results:
Preliminary searches and search strategy were conducted and refined in April 2026. The search strategy was executed in May 2026 with formal screening due to commence in June 2026. The final results are aimed to be submitted by November 2026.
Conclusions:
This review aims to provide an overview of the regulatory interventions currently being used in GenAI across the world, with the hope our findings will be able to inform regulators in the future.
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.