Over the past year, the Digital Pathology Association’s Regulatory and Standards Task Force has made measurable strides in shaping the regulatory and technical landscape of digital pathology. This session will highlight key initiatives and cross-functional collaborations that are accelerating the field's readiness for clinical and real-world deployment at scale.

Structured around the Task Force’s four core working groups—FDA Collaboration, AI/ML Oversight, Interoperability, and Best Practices—this 50-minute session will feature multiple presenters offering rapid-fire updates on achievements and future objectives. Topics will include how the DPA is working with the FDA to clarify regulatory pathways, evolving consensus on validating AI-enabled workflows, progress toward plug-and-play interoperability, and the development of practical best practice guidelines to guide adoption.

Opening remarks from Task Force leaders Dr. John Groth and Dr. Laura Chang will set the stage with reflections on the regulatory momentum gained over the past year and the shared goals driving this multi-stakeholder effort. Attendees will leave with an up-to-date understanding of where standards are headed—and how they can contribute to shaping the next wave of digital pathology innovation.

Learning Objectives: 

1. Understand the Current Regulatory Landscape: Gain insight into how the Digital Pathology Association is collaborating with the FDA and other stakeholders to clarify and shape regulatory expectations for digital pathology platforms and AI-enabled tools.

2. Explore the Latest Standards Development Efforts: Learn about recent progress in interoperability frameworks, validation best practices, and data standards that support the scalable, reliable implementation of digital pathology in both clinical and research settings.

3. Identify Opportunities for Engagement and Adoption: Discover how you and your organization can contribute to or benefit from ongoing Task Force initiatives—whether by aligning with emerging best practices, participating in workgroup efforts, or preparing for regulatory trends.

The ESDIP Companion Meeting at Pathology Visions 2025 will feature Dr. Norman Zerbe, Dr. Mircea Sebastian-Serbanescu, Tom Bisson, and Dr. Joe Lennerz, who will share their expertise on advancing digital pathology. The session will start with an introduction from Dr. Norman Zerbe, ESDIP President, followed by Dr. Mircea-Sebastian Șerbănescu, whose talk will explain how legislation can accelerate (or hinder) the safe adoption of digital pathology and AI. The second presentation, made by Dr. Tom Bisson, will explore the advances and challenges in digital pathology from a European perspective, focusing on regulation-compliant data governance, real-world data for AI validation, and cross-border data exchange within a complex and evolving regulatory landscape. Lastly, Dr. Joe Lennerz will discuss how recently implemented frameworks such as the European Health Data Space (EHDS), US state-level AI regulations, and diverse regulatory requirements attempt to create relevant oversight and thereby generate both opportunities and challenges for digital pathology and AI.