Europe needs to step up its efforts and strengthen its very own security capacities to secure its digital society, economy, and democracy. It is time to reconquer Europe’s digital sovereignty. The vision for Europe can only be to join forces across Europe’s research, industry and public sector and to include all talents not just those that have representation in the EU mainstream or are within big organizations. Diversity and inclusion are keys for success. Europe has incredible coverage and talent in the area of IT and cybersecurity. The area of cybersecurity is geographically fragmented across Europe for competences, and often also technically fragmented with problem-specific development of security solutions. There is no doubt that excellent research exists in Europe. Nevertheless, it is a fact that this research does not result in IT products and solutions that contribute to the European Single Digital Market. On contrary, a lot of research, also financed by EU ERC grants, is tested on real data in large US companies that cooperate with them. Europe has to and is already rethinking this strategy. CONCORDIA addresses the current fragmentation of security competence by networking diverse competences into a leadership role via a synergistic agglomeration of a pan-European Cybersecurity Center. The vision of CONCORDIA is to build a community a strong cooperation between all stakeholders, understanding that all stakeholders have their KPIs, bridging among them, and fostering the development of IT products and solutions along the whole supply chain. Technologically, it projects a broad and evolvable data-driven and cognitive E2E Security approach for the ever-complex ever-interconnected compositions of emergent data-driven cloud, IoT and edge-assisted ICT ecosystems.

For the EU health industry to be competitive and to sustainably deliver internationally leading care quality, it is important that EU regulation, guidelines and standards enable effective and interoperable digital health innovation and promote a vibrant entrepreneurial EU sector. Safety and competitiveness are not mutually exclusive. To deliver on them requires a pace and intensity of technological innovation that is matched by intensive regulatory innovation. Smarter, adaptive, dynamic, and evidence-based regulatory approaches are needed, based on real world experience in representative use scenarios. CYMEDSEC has been designed with an optimum consortium of regulatory, cybersecurity, technology, evaluation, and clinical EU experts to address exactly this challenge. It provides close feedback loops between new technological paradigms and recommendation of regulatory approaches, fostering regulatory science fresh thinking. It will deliver novel security-by-design solutions for the oversight of ‘Internet of Medical Things’ (IoMT) devices, including connected in vitro diagnostics. IoMT ‘fleet’ cybersecurity oversight systems will be developed. Use cases explored include remote patient monitoring and critical care scenarios, for which the project will develop novel and highly secure gateway middleware. Our technological and methodological advancement will go hand-in-hand with detailed review of regulations and guidelines, the formal creation of a new IoMT cybersecurity standard, and evidence collection from representative case studies. These objectives are holistically interlinked, with learnings form each work area feeding into development and proposals in other areas. Key to this is the in-project development of a cybersecurity benefit-risk toolbox, which will further develop the state of the art, using qualitative and quantitively approaches, and will make these available as easily usable and findable Open-Source resources for manufactures and regulatory bodies.