This task involved the development of a comprehensive checklist to support developers and HTA agencies in assessing the cybersecurity of digital health devices. The approach was guided by a detailed analysis of existing standards, frameworks from EU member states, international guidelines, and emerging legislation. The resulting checklist consolidates essential requirements, applicable across the lifecycle of the DHT and designed for practical application by both DHT developers and HTA assessors. Its utility and effectiveness will be evaluated through case studies in WP5 of the Assess DHT project, with refinements based on user feedback.

This deliverable is sensitive.