Deliverable 3.2 Guidelines and specifications for the implementation of the QUANTUM labelling mechanism

Executive Summary This Deliverable aims to broach sustainability and transferability topics of the developed QUANTUM Data Quality, Utility and Data Holder Maturity label, issuing recommendations for the major stakeholders involved in its implementation (Data Holders, Health Data Access Bodies and the European Commission). These recommendations were developed and validated via consensus methods, built upon previous work from Tasks 3.1-3.3, and surveys sent to HDABs and Data Holders in Task 3.4. From the consensus exercises performed by Task 3.4 (Section 4), a comprehensive list of recommendations was drafted for each stakeholder group (Section 5) and then further condensed into condensed into its key ideas, omitting more granular implementation details, and set to a timeline in accordance with the EHDS implementation timeline (Section 6): Short-term – Until March 2027 Mid-term – Until March 2029 Long-term – After March 2029 A list of these key ideas and their timing for implementation is presented below for ease of consultation: Short-term: Recognition of the label as a de facto standard – full introduction of the developed label specifications and related recommendations in the Article 78 implementing act Integration of the tool into the HealthData@EU Central Services metadata tool suite Establishment of a knowledge base collating all the Academies’ work, ready for use by all stakeholders Establishing the mechanism for a structured update of the quality and utility specification Mid-term: Extended controlled implementations along the whole data life cycle Procedures in place for the improvement of the QUANTUM specification, tool and supporting materials Development and testing of the fitness-for-purpose (F4P) technical specifications Implementation of the F4P assessment Setting up a community of practice for the adequate implementation of the data quality and utility and Data Holders’ (DHs) maturity label Data intermediation entities set up to support DHs duties DHs should have data governance, data quality and assessment frameworks in place, aligned with QUANTUM specification. This will support them issuing the label. Clear roles and responsibilities for quality, utility and maturity assessments. HDABs or data quality agencies nominated at national level and following harmonised national supervision and oversight frameworks for QUANTUM DQ&U and maturity assessments HDABs or data quality agencies nominated at national level must support DHs implementing QUANTUM label procedures Long-term: Continuously improve the QUANTUM tool and update related materials Establishing a culture of continuous improvement utilizing F4P, regular audits, etc Promoting the adoption of the QUANTUM label for non-mandatory datasets Fostering harmonisation of data quality and utility assessment practices across datasets and organisations Support integration with DCAT to standardise DQ and maturity assessments across data spaces