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Detangling AI Transparency in the Medical Regulation Space
Tatiana Aranovich1, Rita Matulionyte2, Farah Magrabi3
1PhD Researcher, Macquarie Law School, Macquarie University.
Journal of Law and Medicine
|August 25, 2025
Summary
Artificial Intelligence (AI) in healthcare requires transparency for quality and trust. Achieving this requires clarity on what information to share and how, especially for AI medical devices.
Area of Science:
- Health Informatics
- Artificial Intelligence
- Medical Device Regulation
Background:
- Artificial Intelligence (AI) is rapidly advancing in healthcare, raising concerns about transparency.
- Transparency is crucial for ensuring the quality, safety, and trustworthiness of AI technologies in medical applications.
- The meaning of AI transparency in healthcare is often ambiguous and requires clear definition.
Purpose of the Study:
- To examine the concept of AI transparency in healthcare.
- To differentiate AI transparency from related concepts like AI explainability.
- To explore challenges in enhancing transparency for users of AI-based medical devices.
Main Methods:
- Literature review of AI transparency in healthcare.
- Analysis of policy documents to identify emerging consensus on AI transparency.
- Stakeholder analysis of rationales for AI transparency.
Main Results:
- AI transparency in healthcare is essential but lacks a universally agreed-upon definition.
- Emerging consensus distinguishes AI transparency from AI explainability.
- Key challenges exist in providing appropriate information to users of AI medical devices.
Conclusions:
- While AI transparency in medical devices is recognized as vital, a significant hurdle is the lack of clarity.
- Defining the appropriate level of information for different contexts and stakeholders is critical.
- Effective methods for delivering information to achieve transparency goals are yet to be fully established.
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