The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.

This paper presents an extract from our works on a software engineering method for avionic real-time systems [3], the C-Method, which covers the whole software lifecycle thanks to a seamless process, and integrates formal methods in its process. Because distributed, real-time and embedded (DRE) systems have safety critical concerns, they require the use of formal languages (that allow non-ambiguous and rigorous specifications) in order to be able to prove their non-functional properties. Therefore, the "C-Method" relies on the use of formal languages in the earliest steps of the system specification and on the use of semi-formal languages in the analysis, design and programming steps. The fundamental question is how to integrate several languages with different levels of formalization and abstraction. The previous software engineering methods were based on a single language or notation, so they did not address this issue. In order to make the transitions more continuous between semi-formal and formal specifications, we have introduced in the development process what we call "intermediate" languages (+CAL and Why), that are easy to manipulate but directly linked to a formal language (TLA+ for +CAL, Why for PVS).

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