Dataset description and dataset catalogue
1. Health data access bodies shall, through a publicly available and standardised machine-readable dataset catalogue, provide a description in the form of metadata of the available datasets and their characteristics. The description of each dataset shall include information concerning the source, scope, main characteristics, and nature of the electronic health data in the dataset and the conditions for making those data available.
2. The dataset descriptions in the national dataset catalogue shall be available in at least one official language of the Union. The dataset catalogue for Union institutions, bodies, offices and agencies provided by the Union health data access service shall be available in all official languages of the Union.
3. The dataset catalogue shall be made available to single information points established or designated under Article 8 of Regulation (EU) 2022/868.
4. By 26 March 2027, the Commission shall, by means of implementing acts, set out the minimum elements health data holders are to provide for datasets and the characteristics of those elements. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Data quality and utility label
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)
for information on data modifications: merging and adding data to an existing dataset, including links with other datasets.
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.
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.
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.
EU dataset catalogue
1. The Commission shall establish an EU dataset catalogue connecting the national dataset catalogues established by the health data access bodies in each Member State as well as the dataset catalogues of authorised participants in HealthData@EU.
2. The EU dataset catalogue, the national dataset catalogues and the dataset catalogues of authorised participants in HealthData@EU shall be made publicly available.
Minimum specifications for datasets of high impact
The Commission may, by means of implementing acts, determine the minimum specifications for datasets of high impact for secondary use, taking into account existing Union infrastructures, standards, guidelines and recommendations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
