Ethical Responsibility in the Off-Label Use of AI in Medical Imaging

Area of Science:

• Medical Imaging
• Artificial Intelligence
• Bioethics

Background:

• Artificial intelligence in medical imaging (AI-MI) is regulated as Software as a Medical Device by the FDA.
• FDA approval (labeling) ensures AI-MI safety and efficacy for specific uses.
• Off-label use of AI-MI, outside approved indications, poses medical and ethical concerns.

Purpose of the Study:

• To review ethical responsibility frameworks for evaluating off-label AI-MI use.
• To propose a framework for navigating the complexities of off-label AI-MI applications.
• To ensure patient safety and ethical considerations in the evolving landscape of AI-MI.

Main Methods:

• Review of three distinct ethical responsibility models.
• Application of these models to the context of off-label AI-MI use.
• Analysis of stakeholder roles in ethical AI-MI deployment.

Main Results:

• Off-label AI-MI use can be problematic but may offer benefits if managed.
• A future-looking collective responsibility framework is identified as beneficial.
• This framework involves industry, healthcare organizations, clinicians, and patients.

Conclusions:

• A collective responsibility framework promotes proactive measures for safe off-label AI-MI use.
• Balancing innovation with safeguards is essential for patient-centered care.
• This ethical approach is critical as AI-MI integration in clinical decisions grows.