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Real4Reg assembles various data sources representing a valid RWD basis for the selected use cases in the regulatory and HTA context and can contribute to supportive or pivotal decision-making. National healthcare registers and claims data will provide information on demographic characteristics, medication use, diagnoses and treatments, and mortality.

The different types of data sources from the health sector used in this project derive from four countries: Denmark, Finland, Germany, and Portugal.

The project uses both very large data sets from the most populous European country (Germany) and data with great data depth from European countries with excellent data linkage resources (Denmark, Finland, Portugal).

Each data source will be accessed in a legally compliant and privacy-preserving manner. To maximise data privacy, each data-holding organisation will keep and be responsible for its data, i.e., no central data management. Real4Reg follow the paradigm of bringing algorithms to the data rather than the other way around.