IDEA-FAST is developing novel digital endpoints to assess fatigue, sleep quality, and impact of sleep disturbances in patients with neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the project’s consortium met with the European Medicines Agency (EMA) to get advice on its plans for regulatory qualification of the measures.This paper reviews the IDEA-FAST view on developing digital measures for multiple diseases and the advice provided by the EMA.