Developing an AI Governance Framework for Safe and Responsible AI in Health Care Organizations: Protocol for a...

Area of Science:

• Health Informatics
• Artificial Intelligence Governance
• Healthcare Management

Background:

• Artificial intelligence (AI) offers significant potential to enhance healthcare diagnostics, operations, and predictive analytics.
• Healthcare organizations face challenges in safe and responsible AI implementation due to regulatory, ethical, and governance complexities.
• Existing theoretical AI governance frameworks often lack practical application in real-world healthcare settings.

Purpose of the Study:

• To develop and validate a practical AI governance framework for safe and responsible AI use in healthcare organizations.
• To identify specific governance requirements for AI in healthcare.
• To co-develop and refine a framework through real-world application and stakeholder input.

Main Methods:

• A multimethod research design involving a scoping review, document analysis, and in-depth interviews.
• Qualitative data analysis informed by grounded theory.
• Framework development through synthesis of findings, followed by validation via stakeholder workshops and case studies.

Main Results:

• The project received funding in October 2023, with ethics approval obtained from relevant committees.
• Data collection is underway, including a finalized scoping review and analysis, and 43 interviews completed as of March 2025.
• The AI governance framework is anticipated for completion and dissemination by June 2025.

Conclusions:

• This study will deliver a comprehensive, co-designed AI governance framework to address practical challenges in healthcare AI oversight.
• The framework will provide actionable guidance for healthcare organizations to adopt AI safely, ethically, and compliantly.
• Outcomes will inform global discussions and promote the responsible integration of AI in health systems.