Description

The B1MGplus project supports the creation of a European cross-border network of genomic and clinical data to improve healthcare. The project provides coordination and support to the 1+ Million Genomes (1+MG) initiative, the commitment of 23 EU countries and Norway to enable secure access to genomic and corresponding clinical data across Europe.

The project enables the sustainability of the 1+MG initiative by supporting signatory countries in creating a federated European genomic data infrastructure to provide secure access to genomic and related health data and enable the development of personalised healthcare that will benefit society.

To support the 1+MG initiative, the B1MGplus project will focus on delivering implementation tracks on the 1+MG Roadmap 2023-2027 with four objectives:

• Support preparatory work for the creation and operation of a European Digital Infrastructure Consortium (EDIC);
• Facilitate the strategic orientation of the 1+MG initiative;
• Support expert work to enable the uptake of genomics for healthcare and public health purposes;

Develop data quality aspects of the 1+MG Framework.

Smartlex’s role

Smartlex will actively participate in the establishment of a Genome European Digital Infrastructure Consortium (EDIC), defining its legal framework and taking part in the drafting of its statutes. In addition, Smartlex will look after the implementation profiles of a cross-border data infrastructure for secondary use of health and genomic data according to a common data governance.

In addition, Smartlex contributes to the regulatory sandboxes, the analysis of the regulatory framework, in particular related to cybersecurity and will contribute to the recommendations on ethical and legal implementation derived from the other tasks.

Partners

• Sciensano (Sciensano)
• Ruđer Bošković Institute (RBI)
• Masarykova Univerzita (MU)
• Nationalt Genom Center (NGC)
• Ministry of Social Affairs Estonia (MSAE)
• Helsingin Yliopisto (UH)
• Institut National de la Sante et de la Recherche Medicale (INSERM)
• Ministère de la Recherche et de l’Enseignement supérieur (MESR)
• Ruprecht-Karls-Universität Heidelberg (UHEI)
• Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
• Ruprecht-Karls-Universität Heidelberg (UHEI)
• Ethniko Kentro Ereunas Kai Technologikis Anaptyxis (CERTH)
• Istituto Giannina Gaslini (IGG)
• Università Vita-Salute San Raffaele (UNISR)
• Consiglio Nazionale delle Ricerche (CNR)
• Smartlex s.r.l. (SLEX)
• ELIXIR and EMBL
• Latvijas Biomedicinas Petijumu un Studiju Centrs (LBMC)
• Vilnius University Hospital Santaros Klinikos (VUHSK)
• Stichting Health-RI (Health-RI)
• University of Bergen (UiB)
• Helsedirektoratet (HDIR)
• Országos Onkológiai Intézet (National Institute of Oncology) (OOI)
• Associação BIP4DAB (BioData.pt)
• Instituto Nacional de Saúde Doutor Ricardo Jorge (INSA)
• Institutul de Cercetare-Dezvoltare in Genomica (Genomics Research and Development Institute) (GRDI)
• Univerza v Ljubljani (UL)
• Centro Nacional de Supercomputacion (BSC)
• Consorcio para la Explotacion del Centro Nacional de Analisis Genomico (CNAG)
• Instituto de Salud Carlos III (ISCIII)
• Fundacio Centre de Regulacio Genomica (CRG)
• Karolinska Institutet (KI)
• Verket för Innovation (Sweden’s Innovation Agency) (Vinnova)
• Uppsala Universitet (UU)
• SIB Swiss Institute of Bioinformatics (SIB)