This DPA R&STF special session convenes FDA and industry leaders to advance digital pathology regulatory science and consensus standards. The session opens with a review of R&STF’s annual achievements by Chair Dr. John Groth (Endeavor Health), followed by a presentation from Dr. Aldo Badano (FDA) on the FDA/DPA collaboration exploring scientific approaches for technical performance assessment. A multidisciplinary panel, moderated by Cheng Cui (AstraZeneca), will then explore three key themes: evaluation approaches for WSI systems, the establishment of robust validation methods for computational pathology-based devices, and strategies for AI-enabled biomarker and companion diagnostic validation to align with current FDA considerations for data strategy and clinical validation in premarket applications.

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This session brings together the digital pathology community to review progress in interoperability and discuss priorities for the years ahead. The session will provide background and updates on Digital Imaging and Communications in Medicine (DICOM) and the Integrating the Healthcare Enterprise (IHE) Digital Pathology Workflow–Image Acquisition (DPIA) profile. Results and lessons learned from the 2026 Global Digital Pathology Connectathon will inform discussion of current capabilities, remaining challenges, and potential next steps for advancing standards-based integration in clinical practice.

Learning objectives

By the end of this session, participants will be able to:

1. Describe the complementary roles of DICOM and IHE DPIA in digital pathology interoperability, including recent developments.
2. Discuss results and lessons learned from the 2026 Global Digital Pathology Connectathon, including demonstrated capabilities and remaining gaps.
3. Identify priorities and opportunities for collaboration, interoperability testing, and clinical adoption in the coming year.