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1. Pārskats

,
Article 78 1

1.   Datasets made available through health data access bodies may have a Union data quality and utility label applied by the health data holders.
Article 78 2

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.
Article 78 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)

for information on data modifications: merging and adding data to an existing dataset, including links with other datasets.
Article 78 4

4.   Where a health data access body has reason to believe that a data quality and utility label might be inaccurate, it shall assess whether the dataset covered by the label meets the quality requirements forming part of the elements of the data quality and utility label as referred to in paragraph 3 and, in the event the dataset does not meet the quality requirements, shall revoke the label.
Article 78 5

5.   The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend this Regulation by modifying, adding or removing elements to be covered by the data quality and utility label provided for in paragraph 3 of this Article.
Article 78 6

6.   By 26 March 2027, the Commission shall, by means of implementing acts, set out the visual characteristics and technical specifications of the data quality and utility label, based on the elements referred to in paragraph 3 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2) of this Regulation. Those implementing acts shall take into account the requirements in Article 10 of Regulation (EU) 2024/1689 and any adopted common specifications or harmonised standards supporting those requirements, where applicable.

1.1 Atsauces

1.2 Identificētās prasības

1.3 Saistītie standarti

2. Identificētās prasības

Prasības

3. Saistītie standarti

Standarti
  • Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
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