Albashiti Fady, Thasler Reinhard, Wendt Thomas, Bathelt Franziska, Reinecke Ines, Schreiweis Björn
Zentrum für Medizinische Datenintegration und -analyse (MeDICLMU), LMU Klinikum, München, Deutschland.
Zentrum für Medizinische Datenintegration und -analyse, LMU Klinikum, Fraunhoferstr. 20, 82152, Martinsried (Planegg), Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2024 Jun;67(6):629-636. doi: 10.1007/s00103-024-03879-5. Epub 2024 Apr 25.
As part of the Medical Informatics Initiative (MII), data integration centers (DICs) have been established at 38 university and 3 non-university locations in Germany since 2018. At DICs, research and healthcare data are collected. The DICs represent an important pillar in research and healthcare. They establish the technical, organizational, and (ethical) data protection requirements to enable cross-site research with the available routine clinical data.This article presents the three main pillars of DICs: ethical-legal framework, organization, and technology. The organization of DICs and their organizational embedding and interaction are presented, as well as the technical infrastructure. The services that a DIC provides for its own location and for external researchers are explained, and the role of the DIC as an internal and external interface for strengthening cooperation and collaboration is outlined.Legal conformity, organization, and technology form the basis for the processes and structures of a DIC and are decisive for how it is integrated into the healthcare and research landscape of a location, but also for how it can react to national and European requirements and act and function as an interface to the outside world. In this context and with regard to national developments (e.g., introduction of the electronic patient file-ePA), but also international and European initiatives (e.g., European Health Data Space-EHDS), the DIC will play a central role in the future.
作为医学信息学倡议(MII)的一部分,自2018年以来,德国已在38个大学地点和3个非大学地点设立了数据集成中心(DIC)。在数据集成中心,研究和医疗数据被收集。数据集成中心是研究和医疗领域的重要支柱。它们制定技术、组织和(伦理)数据保护要求,以便利用现有的常规临床数据开展跨站点研究。本文介绍了数据集成中心的三大主要支柱:伦理法律框架、组织和技术。介绍了数据集成中心的组织架构及其组织嵌入和互动情况,以及技术基础设施。解释了数据集成中心为其自身所在地和外部研究人员提供的服务,并概述了数据集成中心作为加强合作与协作的内部和外部接口的作用。法律合规性、组织和技术构成了数据集成中心流程和结构的基础,对于其如何融入所在地的医疗和研究格局具有决定性意义,对于其如何应对国家和欧洲的要求以及作为与外部世界的接口发挥作用和履行职能也具有决定性意义。在这种背景下,考虑到国家层面的发展(如引入电子患者档案-ePA),以及国际和欧洲层面的倡议(如欧洲健康数据空间-EHDS),数据集成中心在未来将发挥核心作用。