Agent · helsodata-2025-327-78

EHDS artikel 78: Data quality and utility label

Structural tree: the article's own paragraphs, verbatim.

CELEX 32025R0327 · 2026-08-31 · Weight 62 · minimal-risk

OpenOpen reading. No metering is planned for this class.

EHDSOfficial source

Inputs

• in_scopeThe article applies to the situationboolean
• punktParagraph of the articleenum (1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14)

Rule tree

1. If: alla(in_scope = true, punkt = 1)

   Paragraph 1 applies

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

   Paragraph 1

2. If: alla(in_scope = true, punkt = 2)

   Paragraph 2 applies

   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.

   Paragraph 2

3. If: alla(in_scope = true, punkt = 3)

   Paragraph 3 applies

   3. The data quality and utility label shall cover the following elements, where applicable:

   Paragraph 3

4. If: alla(in_scope = true, punkt = 4)

   Paragraph 4 applies

   (a)

   Paragraph 4

5. If: alla(in_scope = true, punkt = 5)

   Paragraph 5 applies

   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;

   Paragraph 5

6. If: alla(in_scope = true, punkt = 6)

   Paragraph 6 applies

   (b)

   Paragraph 6

7. If: alla(in_scope = true, punkt = 7)

   Paragraph 7 applies

   for assessment of technical quality: the completeness, uniqueness, accuracy, validity, timeliness and consistency of the data;

   Paragraph 7

8. If: alla(in_scope = true, punkt = 8)

   Paragraph 8 applies

   (c)

   Paragraph 8

9. If: alla(in_scope = true, punkt = 9)

   Paragraph 9 applies

   for data quality management processes: the level of maturity of the data quality management processes, including review and audit processes, and bias examination;

   Paragraph 9

10. If: alla(in_scope = true, punkt = 10)

    Paragraph 10 applies

    (d)

    Paragraph 10

11. If: alla(in_scope = true, punkt = 11)

    Paragraph 11 applies

    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;

    Paragraph 11

12. If: alla(in_scope = true, punkt = 12)

    Paragraph 12 applies

    (e)

    Paragraph 12

13. If: alla(in_scope = true, punkt = 13)

    Paragraph 13 applies

    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;

    Paragraph 13

14. If: alla(in_scope = true, punkt = 14)

    Paragraph 14 applies

    (f)

    Paragraph 14

If no rule matches: The article is not stated to apply, or no paragraph is selected. The agent abstains rather than guesses.

The article text as read

1. 11. Datasets made available through health data access bodies may have a Union data quality and utility label applied by the health data holders.
2. 22. 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. 33. The data quality and utility label shall cover the following elements, where applicable:
4. 4(a)
5. 5for data documentation: metadata, support documentation, the data dictionary, the format and standards used, the source of the data and, where applicable, the data model;
6. 6(b)
7. 7for assessment of technical quality: the completeness, uniqueness, accuracy, validity, timeliness and consistency of the data;
8. 8(c)
9. 9for data quality management processes: the level of maturity of the data quality management processes, including review and audit processes, and bias examination;
10. 10(d)
11. 11for 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;
12. 12(e)
13. 13for 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;
14. 14(f)

No legal advice. Deterministisk regeluppslagning. Ingen juridisk rådgivning, inget efterlevnadsbeslut, ingen bedömning av ett enskilt ärende.

Citation: 32025R0327 art. 78, Data quality and utility label. ExploreWorld Legal, https://legal.exploreworldai.com/agent/helsodata-2025-327/artikel-78 (hämtad 2026-08-31, bevis sha256:9163174297800a66, bygge legal-2026-08-25).