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Coordination and Support to better data and secure cross-border digital infrastructures building on European capacities for genomics and personalised medicine

This action should aim to support the identification of common standards, cross-border digital infrastructures and coordination mechanisms to advance personalised medicine in Europe. It should build on existing initiatives, projects and resources at national, regional and European level.

This CSA should consolidate knowledge from existing initiatives and projects to identify the most appropriate practices, standards and governance models for establishing cross-border digital infrastructures supporting genomics research and personalised medicine in Europe.

In a coordinated effort with national initiatives, Research & Innovation projects, and other stakeholders (among them national authorities, health institutions, standardisation bodies, ICT industry), the action should develop coordination mechanisms for sharing expertise and for securely linking genomic and other health data (eg electronic health records, registries, including rare disease registries etc), respecting legal (including but not limited to similarities and differences in EU Member states and associated countries, standardisation, type approval etc.) and ethics requirements. This CSA should identify and facilitate the exchange of best practices between relevant R&I projects, initiatives and other stakeholders. It should provide an overview of relevant standards for data quality, security, interoperability, privacy and ethics. It should identify critical elements of a system of transparent governance of a digital infrastructure enabling the cross-border linking of genomic and other health data in Europe. It should also develop a quality risk management concept for sustainability and further development.

For grants awarded under this topic, beneficiaries may provide support to third parties as described in General Annex K of the Work Programme either in form of grants or prizes. The respective options of Article 15 of the Model Grant Agreement will be applied.

The Commission considers that proposals requesting from the EU up to EUR 4 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Personalised medicine uses data generated by new technologies to better understand the individual characteristics in order to deliver the right care to the right person at the right time. This approach has substantial potential for tackling major health challenges, such as cancer and rare diseases, helping to deliver better and more effective health outcomes. In order to seize this potential, there is a need to support the large scale pooling of expertise and of genomic and other health data, as well as to identify common standards for the generation, analysis and sharing of this data.

Coordination and support is needed to develop cross-border solutions for sharing expertise and linking genomic and other health data. This should be achieved by identifying relevant initiatives and projects, discerning best practice emerging from clinical implementation and engaging with relevant stakeholders. It is critical to identify common standards for data quality, security, interoperability, privacy, ethical guidelines and governance models underpinning the establishment of sustainable cross-border digital infrastructures and networks for genomics and personalised medicine in Europe.

The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas:

  • Agreed standards and mechanisms for the cross-border linking and analysis of genomic and other health data with potential for wide-spread adoption across Europe.
  • Adequate basis for developing a cross-border digital infrastructure for linking genomic and other health data in Europe.
  • Best possible and secure use of genomic and other health data for personalized medicine.
  • Adequate basis for investment decisions in personalized medicine (both private and public) based on expected returns.
  • Support Europe’s global leadership in personalized medicine.