NFDI4Health T2.2: Data and metadata standards and integration

To achieve data “FAIRification by standardisation” and enable the user community to integrate heterogeneous and complex data, recommendations and guidelines will be developed for the consistent use of domain-specific standards for data formats, as well as for consistent data descriptions based on established metadata standards and terminologies. This standardisation concept will be based on existing standards, such as ISO 20691 and will include the definition of a minimal metadata set for discovering, specifying and assessing data in the NFDI4Health services (implemented in nfdi4health TA3). (1) To develop a data standardisation roadmap for clinical trial, public health and epidemiological data, domain-specific data standardisation requirements derived from the nfdi4health use cases will be aligned with existing data and metadata standards. (2) To adapt and customise existing standards for the user communities and use cases of NFDI4Health, co-applicants will intensify their engagement in international standardisation organisations (ISO/TC 276, ISO/TC 215 and CEN/TC 251), nationally supported in Germany by DIN, and in standardisation initiatives (e.g. HL7, CDISC, SNOMED, GA4GH, openEHR, COMBINE, DICOM, etc.). Relevant standards of these and other standardisation efforts will be bundled and made available to the user community in a FAIRsharing collection for clinical and health research. (3) To create an NFDI4Health core metadata set, a synopsis of overarching metadata elements in these domain-specific standards will be elaborated and aligned with the requirements of the user communities in the use cases. This will be used to formulate a generalised set of common metadata in the served communities, as preparation of a joint metadata repository (MDR). (4) All recommendations and documents will be bundled for the preparation of guidelines for FAIR data sharing and integration (T4.2) and for the data publication guidelines (T2.1), as well as to prepare a final NFDI4Health standardisation and quality recommendation document.