B1MGplus MS17 Regulatory Sandbox Workshop - Report

Context and aim of this workshop is to support the governmental 1+ Million Genomes initiative (1+MG), which aims to enable cross-border secondary use of harmonised genomic and associated health data under harmonised, GDPR-compliant rules. Secondary use is restricted to scientific research, healthcare support, quality management in healthcare, and health system policy development. The implementation is to take place through a European Digital Infrastructure Consortium, Genome EDIC, with Member States as members and sovereign decision-makers.

A key feature is a single common data access policy: one application, one contract, harmonised conditions. Following the finding in the 2024 workshop that the legal basis through a public-interest task with Article 9.2 exemption through the founding legislation is not possible, processing will now be based on consent. This change of the legal basis has further led to the decision that, under these circumstances, the access decisions could be kept at national level. The approach of Genome EDIC as the legal responsible for the access decision was therefore changed to establishing 1+MG Data Holders at the national level who are in charge of the access decision.