art_78__para_3

3. The data quality and utility label shall cover the following elements, where applicable: for data documentation: metadata, support documentation, the data dictionary, the format and standards used, the source of the data and, where applicable, the data model; for assessment of technical quality: the completeness, uniqueness, accuracy, validity, timeliness and consistency of the data; for data quality management processes: the level of maturity of the data quality management processes, including review and audit processes, and bias examination; for assessment of coverage: the period, population coverage and, where applicable, representativity of the population sampled, and the average timeframe in which a natural person appears in a dataset; for information on access and provision: the time between the collection of the electronic health data and their addition to the dataset and the time needed to provide electronic health data following the issuing of a data permit or a health data request approval; for information on data modifications: merging and adding data to an existing dataset, including links with other datasets.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.