Institute for Medical Informatics, Statistics and Epidemiology (IMISE), University of Leipzig, Leipzig, Germany.
Stud Health Technol Inform. 2024 Aug 30;317:59-66. doi: 10.3233/SHTI240838.
To support research projects that require medical data from multiple sites is one of the goals of the German Medical Informatics Initiative (MII). The data integration centers (DIC) at university medical centers in Germany provide patient data via FHIR® in compliance with the MII core data set (CDS). Requirements for data protection and other legal bases for processing prefer decentralized processing of the relevant data in the DICs and the subsequent exchange of aggregated results for cross-site evaluation.
Requirements from clinical experts were obtained in the context of the MII use case INTERPOLAR. A software architecture was then developed, modeled using 3LGM2, finally implemented and published in a github repository.
With the CDS tool chain, we have created software components for decentralized processing on the basis of the MII CDS. The CDS tool chain requires access to a local FHIR endpoint and then transfers the data to an SQL database. This is accessed by the DataProcessor component, which performs calculations with the help of rules (input repo) and writes the results back to the database. The CDS tool chain also has a frontend module (REDCap), which is used to display the output data and calculated results, and allows verification, evaluation, comments and other responses. This feedback is also persisted in the database and is available for further use, analysis or data sharing in the future.
Other solutions are conceivable. Our solution utilizes the advantages of an SQL database. This enables flexible and direct processing of the stored data using established analysis methods. Due to the modularization, adjustments can be made so that it can be used in other projects. We are planning further developments to support pseudonymization and data sharing. Initial experience is being gathered. An evaluation is pending and planned.
支持需要从多个站点获取医学数据的研究项目是德国医学信息学倡议（MII）的目标之一。德国大学医学中心的数据集成中心（DIC）通过 FHIR®提供符合 MII 核心数据集（CDS）的患者数据。数据保护和其他处理的法律依据要求在 DIC 中对相关数据进行分散式处理，并随后交换汇总结果以进行跨站点评估。
在 MII 用例 INTERPOLAR 的背景下，从临床专家那里获得了要求。然后开发了一个软件架构，使用 3LGM2 对其进行建模，最后在 github 存储库中实现和发布。
使用 CDS 工具链，我们基于 MII CDS 创建了用于分散式处理的软件组件。CDS 工具链需要访问本地 FHIR 端点，然后将数据传输到 SQL 数据库。DataProcessor 组件访问该数据库，该组件使用规则（输入存储库）进行计算，并将结果写回数据库。CDS 工具链还具有前端模块（REDCap），用于显示输出数据和计算结果，并允许验证、评估、评论和其他响应。此反馈也保存在数据库中，可用于将来进一步使用、分析或数据共享。
其他解决方案是可以想象的。我们的解决方案利用了 SQL 数据库的优势。这使得可以使用既定的分析方法灵活且直接地处理存储的数据。由于模块化，可以进行调整，以便可以在其他项目中使用。我们计划进一步开发以支持假名化和数据共享。正在收集初步经验。评估正在进行中并计划进行。
