HealthData@EU pilot project - Milestone 7.1 Legal landscape analysis

This document is a milestone of the HealthData@EU pilot project, part of Work Package 7 "Regulatory and legal compliance" (WP7). Prepared by BBMRI-ERIC, this document provides an overview of the legal and regulatory similarities and differences observed within the network of the project. The analysis identifies common elements and key differences among national health data access bodies, research infrastructures, and EU agencies involved in the project, which are responsible for gathering and providing health data (nodes) and associated documentation (e.g., data application forms, data use policies).

The findings have supported the activities of WP7, including the development of a common data application form and aligned conditions for data use. The analysis is based on a questionnaire completed by the following nodes: BBMRI-ERIC (European Research Infrastructure), Health Data Lab (Germany), Danish Health Data Authority (Denmark), Findata (Finland), Health Data Hub (France), Sciensano (Belgium), Norwegian Directorate of eHealth (Norway), and Croatian Institute of Public Health (Croatia).