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.

As digital pathology systems gain momentum in clinical diagnostics, the importance of interoperability between systems from different vendors is paramount. This session will explore the evolution and significance of the Connectathon for digital pathology, highlighting key milestones, recent breakthroughs, and future developments. Participants will learn about the use of the Digital Imaging and Communications in Medicine (DICOM) standard for whole slide imaging and the importance of requesting DICOM features in pathology solutions. We will discuss lessons learned from recent Connectathon events, focusing on annotations, regulatory considerations, and the roadmap for expanded functionality and broader vendor participation. A joint initiative with the IHE Pathology and Laboratory Medicine (PaLM) group will also be introduced, aiming to resolve workflow issues and improve integration. By attending this session, pathologists will better understand how Connectathons are shaping the future of digital pathology. 

This is not just a discussion—it's a call to action! Learn how you join the next Connectathon and be at the forefront of advancing digital pathology! As vendors, you can showcase your commitment to interoperability by actively participating in these events and demonstrating that your solutions meet the standards required for clinical workflows. Pathologists, now is the time to require standards-based interoperability from the very beginning of every procurement process. Ensure that DICOM and IHE PaLM compliance is a requirement in your contracts to guarantee seamless integration, enhanced flexibility, and future-proofing of your pathology practice.

Together, we can drive the widespread adoption of standards that will benefit the entire field of digital pathology, ensuring that both systems and workflows are not only interoperable but also scalable and ready for future innovations. Let's make standards-based interoperability the norm, not the exception.

Learning Objectives:

1. Understand the History and Significance of Connectathons in Digital Pathology
2. Explore the Latest Connectathon Results and Annotation Advancements
3. Learn about the Future of Connectathons and Vendor Participation as part of a Global Digital Pathology Initiative

In this talk we will explore how the fusion of digital transformation and direct patient care in pathology is reshaping patient journeys and redefining our roles as pathologists. Through real-world cases, as told by a patient, a lead for training, educational and public/patient involvement and a pathologist, we will unveil how patient interactions with their pathology images through direct visualization, guide these journeys. Discover actionable insights to navigate the balance between innovation and compassionate care, all centered on enhancing the patient and pathologist experience.

Learning Objectives

1. Illustrate how direct visualization and interaction with pathology images empowered the patient's understanding of their condition, leading to a more informed and involved role in their own care journey.       
2. Discuss the development and implementation of educational programs that bridge the gap between patients and digital pathology, emphasizing the role of training in enhancing patient engagement and understanding.
3. Examine the evolving role of pathologists in the digital age, focusing on how integrating direct patient interactions and digital tools can improve diagnostic accuracy, patient trust, and overall healthcare outcomes.