The B1MG project has three main objectives. For an overview of the Work Packages (WPs) mentioned here, see the Work Packages section.
To define the requirements for cross-border access to genomics and personalised medicine data, B1MG will establish a Stakeholder Coordination Group (SGC) to gather input at regular intervals from all relevant stakeholders. These requirements will be fed into Objectives 2 and 3. The group will include national-level representatives from the 1+MG initiative and beyond, experts from the public and private sectors, policy-makers, and patients and citizens more generally.
Using personalised medicine Use Cases, we will outline the benefits that can be derived for patients. At least one open event - the ‘B1MG Summit’ - will be organised (in addition to the annual general assembly meeting), to ensure that all stakeholders have an opportunity to contribute and be informed about B1MG progress.
Addressed by WP1 and WP6.
To create a common framework to make genomic and health data findable, accessible, interoperable and reusable (FAIR), we will solve technical and infrastructure challenges regarding quality, data standards, interoperability and harmonisation, whilst developing privacy-preserving access procedures and computing. We will also need to solve legal and ethical challenges surrounding the use of genomics and healthcare data across borders – privacy and cross-border legal and ethical issues.
Legal and ethical
Addressed by WP2, WP3 and WP4.
During the course of B1MG, we will propose the governance and models for engagement and participation (e.g. for accessing/giving access to data). We will consider training requirements for infrastructure users, risk management, IP models and sustainability. Continuous reflection on Use Cases (i.e. cancer and rare diseases) will ensure that the recommended infrastructure will have value and impact.
It will be essential to map the maturity of healthcare system systems and develop a roadmap to implementation of genomic information in healthcare (considering the specificities of each country), using a stepwise framework and a B1MG maturity level model tool for healthcare systems. A harmonised methodology for economic evaluation of the cost and benefits of implementing Personalised Medicine, including a societal perspective, will be key for informing sustainability options, as well as the establishment of national mirror groups to coordinate implementation at a national level.
Addressed by WP5 and WP6.