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

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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.