Applied EEG-AI Use Case to Support ERA Uptake, Standards, and Training for Emerging NAMs

Risorius Co., Ltd. is a deep learning–based neurotechnology company developing EEG/PSG-driven biomarkers to quantify brain-state changes in psychiatry and neurology. We are currently conducting more than 10 retrospective clinical EEG/PSG studies in collaboration with tertiary hospitals in Korea, to establish feasibility and build reproducible end-to-end analysis pipelines with explainable AI.

For HORIZON-HLTH-2026-01-TOOL-06 (CSA), Risorius positions itself as an applied use-case contributor supporting the European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs). We do not aim to lead policy coordination; rather, we provide a concrete example of an emerging, human-derived, AI-enabled methodology that can inform prioritisation, harmonisation, and capacity-building activities across stakeholders.

Within the action, Risorius can contribute to the ERA themes and Working Groups by:

• WG1 (Development & infrastructures): sharing practical requirements and lessons learned for scalable, reproducible pipelines for human EEG/PSG-based functional readouts, including data workflow considerations relevant to infrastructure needs.

• WG2 (Validation, acceptance & uptake): providing input on realistic validation steps, performance metrics, and explainability expectations for AI-enabled NAM components, to support regulator confidence-building discussions.

• WG3 (Education & training): contributing to training content/case materials on EEG/PSG analytics, quality control, and interpretability for researchers and non-technical stakeholders.

• WG4 (Openness & awareness): supporting best-practice discussions on protocol transparency, documentation, and sharing approaches (within legal/ethical constraints), helping strengthen trust and harmonised awareness of AI-enabled NAMs.

By contributing a real-world, developing NAM-relevant use case and implementation insights, Risorius supports the CSA objective of accelerating NAM development, harmonisation, and uptake—while maintaining a credible, stepwise technology maturity pathway aligned with the ERA action’s scope.