Articles of the European Health Data Space (EHDS), Article 56, Data quality and utility label

Article 56, Data quality and utility label, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Datasets made available through health data access bodies may have a Union data quality and utility label provided by the 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, in accordance with the principles set out in paragraph 3.

3. The data quality and utility label shall comply with the following elements:

(a) for data documentation: meta-data, support documentation, data model, data dictionary, standards used, provenance;

(b) technical quality, showing the completeness, uniqueness, accuracy, validity, timeliness and consistency of the data;

(c) for data quality management processes: level of maturity of the data quality management processes, including review and audit processes, biases examination;

(d) coverage: representation of multi-disciplinary electronic health data, representativity of population sampled, average timeframe in which a natural person appears in a dataset;

(e) information on access and provision: time between the collection of the electronic health data and their addition to the dataset, time to provide electronic health data following electronic health data access application approval;

(f) information on data enrichments: merging and adding data to an existing dataset, including links with other datasets;

4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of principles for data quality and utility label. Such delegated acts may also amend the list set out under paragraph 3 by adding, modifying or removing requirements for data quality and utility label.

5. 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. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). Those implementing acts shall take into account the requirements in Article 10 of Regulation […] [AI Act COM/2021/206 final] and any adopted common specifications or harmonised standards supporting those requirements.