Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery

Area of Science:

• Surgical Technology
• Medical Ethics
• Regulatory Science

Background:

• Artificial intelligence (AI) is increasingly integrated into craniofacial surgery for tasks like diagnostics, surgical planning, and outcome prediction.
• The clinical adoption of AI tools presents complex ethical and regulatory challenges, particularly concerning pediatric patient populations.

Purpose of the Study:

• To review and synthesize ethical principles for responsible AI adoption in craniofacial surgery.
• To examine the global regulatory landscape for AI in medical devices.
• To propose a framework for the safe and equitable implementation of AI in craniofacial care.

Main Methods:

• Literature review and synthesis of ethical principles related to AI in healthcare.
• Analysis of regulatory frameworks from the US FDA and European Union.
• Development of a pragmatic implementation framework for AI in craniofacial surgery.

Main Results:

• Key ethical considerations include informed consent, algorithmic bias, data privacy, transparency, and clinician accountability.
• Global regulations for AI/ML-based software as a medical device (SaMD) are evolving, with distinct approaches in the US and EU.
• A proposed framework emphasizes governance, validation, auditing, and equity-centered deployment for AI systems.

Conclusions:

• Establishing robust ethical guidelines and regulatory pathways is crucial for AI in craniofacial surgery.
• Specialty-specific governance is essential to harness AI's potential while ensuring patient safety and trust.
• Continuous monitoring and postmarket governance are vital for AI systems, especially those with learning capabilities.