Technical University of Denmark, Kongens Lyngby, Denmark.
Medicalchain, York Road, London, SQ1 7NQ, UK.
Genome Med. 2020 Feb 19;12(1):18. doi: 10.1186/s13073-020-0713-z.
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.
欧盟（EU）的数字健康与医疗保健转型倡议（Digicare）旨在为构建安全、灵活和分散的数字医疗基础设施提供必要条件。在此环境中创建一个欧洲健康研究与创新云（HRIC），应该能够在符合数据保护法规的前提下，在整个欧盟范围内进行健康研究的数据共享和分析，同时保留参与者的充分信任。这样的 HRIC 应该借鉴和利用现有的数据基础设施，整合最佳实践，并关注社区在技术、治理、管理、法规和道德要求方面的具体需求。在这里，我们描述了数字数据共享在健康研究活动中的愿景和预期收益，并提出了一份路线图，以促进实施 HRIC 的机会，同时应对挑战。为此，我们提出了五项具体建议和行动要点，以确保：i）欧洲 HRIC 建立在既定标准和指南之上，通过开放和分散的基础设施提供云技术；ii）按照最高的互操作性和数据安全性标准进行开发和认证，这些标准能够得到所有利益相关者的信任；iii）得到一个强大的伦理和法律框架的支持，该框架符合欧盟通用数据保护条例（GDPR）；iv）为新一代数据和医学科学家的培训创造适当的环境；v）通过欧盟通过 Horizon 2020 和 Horizon Europe 资助的公共和私人举措以及合作伙伴关系，激发跨国合作中的研究和创新。
