Article 78 3

(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: the 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.