Supporting the Design of Interoperable Information Systems in Clinical Research (3LGM2IHE)

3LGM代表医疗保健信息系统规划的建模范式和工具，已在医疗信息学的教育和项目中使用多年。在第一个建议中，阐述了与IHE（整合医疗保健企业）的关系。通过3LGM²工具为信息系统建模提供IT架构设计模式的方法在第一个资助阶段已经引起了极大的兴趣。因此，这个后续项目将进一步发展这种方法。除其他事项外，还将开发TMF数据保护概念的设计模式和生物银行的IT体系结构。在项目研讨会的范围内，在线调查问卷和来自TMF工作组IT基础设施和质量管理的反馈，收集了目前未在3级元模型中考虑的进一步需求。这尤其涉及到基于FHIR资源、CDA文档或openEHR的对象类型的引用。类似地，关于数据的来源和责任的信息（来源）、虚拟数据处理组件的映射和IT安全区域目前还不能充分建模。因此，应该在3LGM²工具中更新、扩展和实现3级元模型。还将研究如何改进3LGM²工具的可用性、用户体验和用户接受度。然后，利用扩展的3级元模型和改进的3LGM²工具，使用与DFG/TMF资助线和医学信息学倡议项目合作的三个场景，对新创建的设计模式进行评估。产生的模型将提供给合作伙伴进行分析，例如，关于标准的使用和计划IT体系结构的扩展。进一步的结果将以TMF教程和传播讲习班的形式发表。通过使用新的设计模式，为医学研究项目规划可互操作和低错误的IT体系结构将大大简化。

3LGM stands for a modeling paradigm and tool for the planning of information systems in health care, which has been used for many years in education and projects of medical informatics. In the first proposal, the relationship to IHE (Integrating the Healthcare Enterprise) was elaborated. The approach of providing design patterns of IT architectures for the modelling of information systems via the 3LGM² tool already met with great interest in the first funding period. Therefore, this approach will be further developed in this follow-up project. Among other things, design patterns for the TMF data protection concepts and the IT architecture of biobanks are to be developed. Within the scope of the project workshops, an online questionnaire and the feedback from the TMF working group IT Infrastructure and Quality Management, further requirements were collected which are currently not considered in the 3-level-metamodel. This concerns in particular the referencing of object types based on FHIR resources, CDA documents or openEHR. Similarly, information on the origin and responsibility of data (provenance), the mapping of virtual data processing components and IT security zones cannot currently be adequately modelled. Therefore, the 3-level-metamodel should be updated, extended and implemented in the 3LGM² tool. It will also be investigated how usability, user experience and user acceptance of the 3LGM² tool can be improved. The newly created design patterns will then be evaluated utilizing the extended 3-level-metamodel and the improved 3LGM² tool using three scenarios from collaborations with projects of the DFG/TMF funding line and the Medical Informatics Initiative. The resulting models will be made available to the partners for analyses, e.g. with regard to the use of standards and for planning extensions of the IT architecture. Further results will be published in the form of TMF tutorials and a dissemination workshop. By using the new design patterns, the planning of interoperable and low-error IT architectures for medical research projects will be considerably simplified.