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Author(s)
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Aarestrup, F M (Denmark, Tech. U.) ; Albeyatti, A (Medicalchain, London ; NHS, UK) ; Armitage, W J (Bristol U.) ; Auffray, C (EISBM, Vourles) ; Augello, L (ARIA, Milan) ; Balling, R (Luxembourg U.) ; Benhabiles, N (U. Paris-Saclay) ; Bertolini, G (Bergamo U.) ; Bjaalie, J G (Oslo U.) ; Black, M (Ulster U.) ; Blomberg, N (ELIXIR, Welcome Genome Campus, Cambridge) ; Bogaert, P (Tilburg U.) ; Bubak, M (AGH-UST, Cracow) ; Claerhout, B (Gent U.) ; Clarke, L (Unlisted, GB) ; De Meulder, B (EISBM, Vourles) ; D'Errico, G (Fondazione Toscana Life Sciences, Siena) ; Di Meglio, A (CERN) ; Forgo, N (Vienna U.) ; Gans-Combe, C (INSEEC School of Business & Economics, Paris) ; Gray, A E (PwC, Oslo) ; Gut, I (Ctr. Genomic Regulations, Barcelona) ; Gyllenberg, A (Karolinska Hospital, Stockholm) ; Hemmrich-Stanisak, G (Kiel U.) ; Hjorth, L (Lund U.) ; Ioannidis, Y (Athens U.) ; Jarmalaite, S (Unlisted, LT) ; Kel, A (geneXplain GmbH, Wolfenbüttel) ; Kherif, F (Ctr. Hosp. Univ. Vaudois, Lausanne) ; Korbel, J O (EMBL, Heidelberg) ; Larue, C (Integrated Biobank of Luxembourg) ; Laszlo, M ; Maas, A (Antwerp U.) ; Magalhaes, L (Clinerion Ltd., Basel) ; Manneh-Vangramberen, I (European Cancer Patient Coalition, Brussels) ; Morley-Fletcher, E (Lynkeus, Rome) ; Ohmann, C (Heinrich Heine U., Dusseldorf) ; Oksvold, P (Royal Inst. Tech., Stockholm) ; Oxtoby, N P (U. Coll. London) ; Perseil, I (Inst. Natl. Santé Rech. Méd., Paris) ; Pezoulas, V (Ioannina U.) ; Riess, O (Inst. Med. Gen. Appl. Genomics, Tübingen) ; Riper, H (Vrije U., Amsterdam) ; Roca, J (Barcelona U.) ; Rosenstiel, P (Kiel U.) ; Sabatier, P (U. Grenoble Alpes) ; Sanz, F (Pompeu Fabra U.) ; Tayeb, M (Unlisted, GB) ; Thomassen, G (Oslo U.) ; Van Bussel, J (Sci. Inst. Public Health, Brussels) ; Van den Bulcke, M (Sci. Inst. Public Health, Brussels) ; Van Oyen, H (AGH-UST, Cracow) |
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Abstract
| 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. |