The mission of the Digital Pathology Association (DPA) Regulatory and Standards Task Force is to advance digital pathology by clarifying the regulatory pathway, raising awareness of its evolution, and working toward the development and adoption of standards while promoting interoperability for clinical use. This session will provide a comprehensive update on the task force's four key initiatives: developing responses and educational materials for the FDA’s Laboratory Developed Tests (LDT) Rule, creating guidelines for AI and ML-based technologies, advancing interoperability, and collaborating with the FDA.

Attendees will gain valuable insights into the task force's efforts, particularly the implications of the European Union Artificial Intelligence Act (EU AIA) for digital pathology. The session will also cover the ongoing collaboration with the FDA, focusing on addressing regulatory challenges for digital pathology devices, interoperability issues, and key updates from the regulatory landscape.

This session is more than just an information update—it’s a call to action. Pathologists, industry leaders, and innovators are encouraged to actively participate in shaping the future of digital pathology by contributing to regulatory and standards development. Your involvement is crucial to ensure that the digital pathology ecosystem can thrive in a rapidly evolving regulatory environment. Together, we can drive innovation, enhance patient care, and shape the next generation of pathology practices.

Learning Objectives

1. Provide an overview of the DPA Regulatory & Standards Task Force's key initiatives.
2. Explore the impact of the European Union Artificial Intelligence Act (EU AIA) on digital pathology innovation, including risk classifications, compliance, and real-world use cases.
3. Highlight ongoing collaboration with the FDA to address current regulatory challenges related to digital pathology devices, issues surrounding interoperability, and provide a regulatory update.