The successful project should bring together data-intensive EU health research initiatives to design an implementation roadmap /strategic agenda for a one-stop shop, a HRIC FAIR data portal respecting legal and ethics requirements. It should also define and promote, among research projects, procedures to make data FAIR as well as a standard way of communicating such data, so that any IT-system can easily provide metadata to the portal. This portal would serve as catalogue of all relevant publicly-funded health research databases, registries and infrastructures (e.g. ESFRI) and allow access to high quality health research data. The proposal is expected to build a community (i.e. a wider forum) in order to align strategies and capitalise on the work done by relevant European and international initiatives. The proposal should develop two use cases, where all the aforementioned aspects will be integrated and analysed. These use cases should link health research data, and if relevant, health research data with curated clinical data and health administrative data. The participation of experts in ethics and law as well as patient representatives is strongly recommended.
The proposal should also produce guidelines for researchers to contribute to the proper application of the GDPR regulation, taking into account the specific features of processing personal data in the area of health.
The HRIC should contribute to the European Open Science Cloud[[http://ec.europa.eu/research/openscience/index.cfm?pg=open-science-cloud]].
Project results should be widely disseminated to the relevant stakeholders across the Member States and Associated Countries.
The implementation roadmap of the HRIC FAIR data portal will define how to address the specific requirements of health research data. In this sense, the selected proposal is expected to collaborate with the projects funded under topics 'INFRAEOSC-04-2018' and 'INFRAEOSC-06-2019-2020: Enhancing the EOSC portal and connecting thematic clouds', in particular with those in the health field. Grants awarded under these topics will be complementary. The respective options of Article 2, Article 31.6 and Article 41.4 of the Model Grant Agreement will be applied.
The Commission considers that proposals requesting a contribution from the EU of between EUR 2 and 3 million would allow this topic to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Technological innovation has triggered an unprecedented increase in data production in health research and healthcare. The need to make EU health research data FAIR (i.e. Findable, Accessible, Interoperable and Re-usable) becomes more pressing than ever before if European health research is to reap the full benefits of this valuable resource. The stakes are high because making optimal use of this health data is expected to both accelerate research discoveries and bring them closer to clinical application for the benefit of EU citizens.
A wide range of challenges needs to be overcome before this vision becomes a reality. To be able to seamlessly integrate and analyse health data coming from different sources and different health sub-disciplines, individual research institutes and/or hospitals would need a potent IT infrastructure and interoperability solutions as well as powerful data analytics tools. Services in the Internet Cloud (i.e. Cloud Services) are a promising starting point to build these systems.
Properly addressing the security and privacy of health research data, and the compliance with various levels of legislations, in particular the General Data Protection Regulation (GDPR) together with the applicable National legislations in the EU Member States/Associated Countries and with different jurisdictions is a critical step for the design of a Health Research and Innovation Cloud (HRIC). These aspects need to be an integral part of the proposal so that the collection, governance, sharing, analysis and curation of health research data across different application domains can be achieved in ways that are technologically robust, scientifically reliable, and ethically and legally sound.
- A HRIC FAIR data portal respecting legal and ethics requirements. This portal should serve as catalogue of all relevant publicly-funded health research databases, registries and infrastructures (e.g. ESFRI) and allow access to high quality health research data.
- Through use cases, demonstrate the added value of close collaboration of health researchers with healthcare providers and other actors in health care systems.
- Guidelines on application of the GDPR and the EU Member States and Associated Countries national legislations. The developed guidelines should cover the processing and further processing of health research data.
- Contribute to the setup of a Health Research and Innovation Cloud, the Health thematic cloud of the European Open Science Cloud.
- Contribute to the Digital Single Market through piloting IT health research solutions.