Generative Artificial Intelligence-Enabled (GenAI) Digital Mental Health Medical Devices

AGENDA

2025 FDA Perspective: Generative Artificial Intelligence-Enabled (GenAI) Digital Mental Health Medical Devices

FDA Perspective: Regulatory Considerations for Digital Mental Health Therapeutics

Topic 1: Large Language Models in digital mental health medical devices

Topic 2: The impact of GenAI on digital mental health medical devices development

Topic 3: Developer Perspective on GenAI digital mental health medical devices

Topic 4: Clinical trial evaluation of GenAI digital mental health medical devices

Topic 5: Best practices and lessons learned from other fields of AI

Topic 6: Patient-provider considerations in the use of GenAI-enabled digital mental health medical devices

Topic 7: Payer perspectives on digital mental health technologies

Topic 8: Health technology assessment perspective of GenAI digital mental health medical devices

Committee Discussion of the FDA Question

Closing Remarks