Chair of Medical Informatics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Leipzig Medical Biobank, Leipzig University, Leipzig, Germany.
Stud Health Technol Inform. 2022 May 16;292:37-42. doi: 10.3233/SHTI220317.
ABIDE_MI is a complementary funded 18 months project within the German Medical Informatics Initiative (MII), which aims to align IT infrastructures and regulatory/governance structures between biobanks/biobanking IT and the MII data integration centres (DIC) at German university hospitals. A major task in 2021 was the systematic collection of all documents describing rules, as well as proposal/contract templates for data and biosample use and access at each of the participating 24 university hospitals and their comparison with MII-wide consented data sharing principles, documents and governance structures. This comparison revealed large heterogeneity across the ABIDE_MI sites and further, redundant structures/regulations currently established at the German university hospitals. A second task was the design and stepwise development of an IT network infrastructure with central components (data and biosample query portal) and decentralized standardized FHIR servers to capture the standardized FHIR-based core data set modules (resources) defined within the MII working group "Interoperability". Subsequent steps in the project are the harmonization of the data and biosample sharing governance/regulation frameworks at each ABIDE_MI site, creating synergies for the research infrastructures at the German university hospitals and to link those resources to the German Portal for Medical Research Data and with the BBMRI-ERIC Directory and Negotiator tools.
ABIDE_MI 是德国医学信息学倡议（MII）下的一个补充资助 18 个月的项目，旨在协调生物库/生物库 IT 与德国大学附属医院 MII 数据集成中心（DIC）之间的 IT 基础设施和监管/治理结构。2021 年的一项主要任务是系统收集所有描述规则的文件，以及每个参与的 24 所大学医院的数据和生物样本使用和访问的提案/合同模板，并将其与 MII 范围内同意的数据共享原则、文件和治理结构进行比较。该比较揭示了 ABIDE_MI 站点之间存在很大的异质性，并且德国大学医院目前建立的冗余结构/法规。第二项任务是设计和逐步开发具有中央组件（数据和生物样本查询门户）的 IT 网络基础设施和分散的标准化 FHIR 服务器，以捕获 MII 工作组“互操作性”中定义的基于标准化 FHIR 的核心数据集模块（资源）。该项目的后续步骤是协调每个 ABIDE_MI 站点的数据和生物样本共享治理/监管框架，为德国大学医院的研究基础设施创造协同效应，并将这些资源链接到德国医学研究数据门户以及 BBMRI-ERIC 目录和谈判工具。
