3.
The data quality and utility label shall cover the following elements, where
applicable:
- (a) 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;
- (b) for assessment of technical quality: completeness, uniqueness, accuracy,
validity, timeliness and consistency of the data;
- (c) for data quality management processes: the level of maturity of the data quality
management processes, including review and audit processes, and bias
examination;
- (d) 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;
- (e) 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;
- (f) for information on data modifications: merging and adding data to an existing
dataset, including links with other datasets.
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