Freeman Sam, Wang Amy, Saraf Sudeep, Potts Erica, McKimm Amy, Coiera Enrico, Magrabi Farah
Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.
Alfred Health, Melbourne, Australia.
JMIR Res Protoc. 2025 Jul 28;14:e75702. doi: 10.2196/75702.
Artificial intelligence (AI) has the potential to improve health care delivery through enhanced diagnostics, streamlined operations, and predictive analytics. However, health care organizations 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 health care settings.
This study aims to develop and validate a practical AI governance framework to support the safe and responsible use of AI in health care organizations. The specific objectives are to identify governance requirements for AI in health care, examine existing AI governance processes and best practices, codevelop an AI governance framework to meet the needs of health care organizations, and test and refine the framework through real-world application.
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 health care stakeholders as well as national and international AI governance experts, (3) development of a draft AI governance framework through a 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 analyzed using qualitative methods informed by grounded theory.
The project received funding in October 2023. Ethics approval was obtained from the Alfred Health Human Research Ethics Committee (project 171/24) and the Macquarie University Human Research Ethics Committee (project 16508). Data collection commenced in April 2024, with the scoping review and document analysis being finalized. As of March 2025, a total of 43 interviews have been completed. The final AI governance framework is expected to be completed and ready for dissemination by June 2025.
This study will deliver a comprehensive AI governance framework co-designed with health care stakeholders to address real-world challenges in AI oversight. The framework will offer practical guidance to support health care organizations 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.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/75702.
人工智能（AI）有潜力通过增强诊断、简化操作和预测分析来改善医疗服务的提供。然而，医疗保健组织在安全且负责任地实施人工智能方面面临重大挑战。这是由于监管的复杂性、伦理考量以及缺乏实用的治理框架。虽然存在许多理论框架，但很少有经过测试或适用于医疗保健环境中的实际应用。
本研究旨在开发并验证一个实用的人工智能治理框架，以支持医疗保健组织安全且负责任地使用人工智能。具体目标是确定医疗保健领域人工智能的治理要求，审视现有的人工智能治理流程和最佳实践，共同开发一个满足医疗保健组织需求的人工智能治理框架，并通过实际应用对该框架进行测试和完善。
将采用多方法研究设计，包括四个关键阶段：（1）进行范围审查和文件分析，以确定治理需求和当前流程；（2）对医疗保健利益相关者以及国家和国际人工智能治理专家进行深入访谈；（3）通过综合研究结果制定人工智能治理框架草案；（4）通过利益相关者研讨会以及将其应用于人工智能工具的案例研究来验证和完善该框架。将使用基于扎根理论的定性方法对数据进行分析。
该项目于2023年10月获得资金。已获得阿尔弗雷德健康人类研究伦理委员会（项目171/24）和麦考瑞大学人类研究伦理委员会（项目16508）的伦理批准。数据收集于2024年4月开始，范围审查和文件分析已完成。截至2025年3月，共完成了43次访谈。最终的人工智能治理框架预计将于2025年6月完成并准备好进行传播。
本研究将提供一个与医疗保健利益相关者共同设计的全面人工智能治理框架，以应对人工智能监管中的实际挑战。该框架将提供实用指导，以支持医疗保健组织安全、符合伦理且符合监管要求地采用人工智能技术。本研究的结果将为关于人工智能治理的国内外讨论提供参考，并促进人工智能在卫生系统中的负责任整合。
国际注册报告标识符（IRRID）：DERR1-10.2196/75702。
