Currently submitted to: JMIR Research Protocols
Date Submitted: Apr 9, 2025
Open Peer Review Period: Apr 9, 2025 - Jun 4, 2025
(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Warning: This is an author submission that is not peer-reviewed or edited.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.
Developing an AI Governance Framework for Safe and Responsible AI in Healthcare Organisations: A Protocol for a Multimethod Study
ABSTRACT
Background:
Artificial intelligence (AI) has significant potential for improving healthcare delivery through enhanced diagnostics, streamlined operations, and predictive analytics. However, healthcare organisations face substantial challenges in implementing AI safely and responsibly. This is due to regulatory complexity, ethical considerations, and a lack of practical governance frameworks. While many theoretical frameworks exist, few have been tested or adapted for real-world application in healthcare settings.
Objective:
This study aims to develop and validate a practical AI governance framework to support the safe and responsible use of AI in healthcare organisations. The specific objectives are to: (1) identify governance requirements for AI in healthcare; (2) examine existing AI governance processes and best practices; (3) co-develop an AI governance framework to meet the needs of healthcare organisations; and (4) test and refine the framework through real-world application.
Methods:
A multimethod research design will be used, comprising four key stages (1) a scoping review and document analysis to identify governance needs and current processes; (2) in-depth interviews with healthcare stakeholders as well as national and international AI governance experts; (3) development of a draft AI governance framework through synthesis of findings; and (4) validation and refinement of the framework through stakeholder workshops and application to case studies of AI tools. Data will be analysed using qualitative methods informed by grounded theory.
Results:
The project received funding in October 2023. Ethics approval was obtained from the Alfred Health Human Research Ethics Committee (HREC) (Project ID: 171/24) and the Macquarie University HREC (Project ID: 16508). Data collection commenced in April 2024, with the scoping review and document analysis being finalised. As of March 2025, 43 interviews have been completed. The final AI governance framework is expected to be completed and ready for dissemination by June 2025.
Conclusions:
This study will deliver a comprehensive AI governance framework co-designed with healthcare stakeholders to address real-world challenges in AI oversight. The framework will offer practical guidance to support healthcare organisations in adopting AI technologies safely, ethically, and in alignment with regulatory requirements. Outcomes from this study will inform local and international discussions on AI governance and promote the responsible integration of AI in health systems.
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