IMI 116026 HARMONY; IMI 945406 HARMONY PLUS - HARMONY Big Data Platform

The data provider prepares the “Data Dictionary” that describes the data to be submitted, listing and defining all fields with all possible values. Common data dictionaries exist in some HMs, to facilitate this process. The data providers then prepare the data itself, ensuring all fields are fully defined, and subjecting it to a first stage of pseudonymisation. The pseudonymized data are submitted through a Trusted Third Party (TTP), following required file names and formats. The TTP takes the data through another pseudonymisation process before uploading to the HARMONY Platform. Then, a Data Quality Supervision Committee (DQSC) verify and check the quality of the data from a clinical and technical point of view to guarantee compliance with different quality levels. After pseudonymisation and quality control, the data are standardised to a common model to address the heterogeneity of incoming data from different sources: OMOP CDM and custom concepts created by HARMONY when they are absent in OMOP. The approach consists of transforming the information from the origin databases into a common representation in terms of vocabularies, terminologies, or coding schemes. If necessary, the data provider and clinicians will validate the harmonisation process to ensure completeness and trustworthiness of the data. After harmonisation is complete, the data are deposited in the HARMONY Platform.
Custom HARMONY OMOP concepts are subject to validadation from OHDSI relevant workgroups (https://www.ohdsi.org/workgroups/)
Currently the HARMONY Platform is mainly based on secondary used of anonymized data and not includes EHR. Therefore, there is not an specific way to creating a record (pregunta 34), to register a person (pregunta 35) o to de-register a person (pregunta 36) and it is not linked to another data sources (pregunta 37). Pilot projects to include EHR information are foreseen in Q4 2023.