Report: Bigpicture Digital Pathology and AI Interaction Platform at ECDP 2025

The platform aims to foster interaction between scientific experts, regulators, and health authorities, a dialogue that the IVDR does not explicitly facilitate. The third meeting centered on two key themes: the ongoing development of an ISO standard for the full digital pathology + AI image analysis workflow, and the implications of the AI Act for digital pathology.

Developing an ISO standard for digital pathology and AI

The new ISO standard, “Digital pathology and artificial intelligence (AI)-based image analysis,” is being drafted by Working Group 4 of ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems). As project lead, Kurt Zatloukal explained the drafting process, which includes broad expert input to ensure the final standard is state of the art. He acknowledged several implementation challenges: the cost of acquiring the standard, limited familiarity with standards in the field, and the additional effort and resources needed. Discussions at the workshop stressed the importance of interoperability within the standard, ensuring compatibility across systems, and the definition of quality parameters.

Navigating the AI Act

Regarding the AI Act, one challenge is its requirement for precisely described training data (unlike broader FDA requirements), which places constraints on defining the intended use. Another critical issue is the mandatory human oversight and how this can be demonstrated.

Building momentum through collaboration

To increase stakeholder engagement, participants suggested leveraging public–private partnerships like the Innovative Health Initiative (IHI), benefiting from their established links with regulators, policymakers, and other actors. Future efforts will build upon these foundations.