EHDS, Article 78, DE

1. Datasets made available through health data access bodies may have a Union data quality and utility label applied by the health data holders.

2. Datasets with electronic health data collected and processed with the support of Union or national public funding shall have a data quality and utility label covering the elements set out in paragraph 3.

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: 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)

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