HL7 Europe Foundation
HL7 Europe
Founded in 1987, Health Level Seven International (HL7) is a not-for-profit standards developing organization (SDO) and a founding member of the JIC for Global Health Informatics Standardization.
ID: 717892419762-76
Lobbying Activity
Response to EU cardiovascular health plan
15 Sept 2025
The EU Plan for Cardiovascular Health has the potential to transform prevention, detection, and treatment while driving innovation and strengthening the EU health industry. To achieve this equitably, however, cardiovascular research must confront a persistent challenge: the lack of diversity in data and study design. Underserved populations, including women, ethnic minorities, people with severe mental illness (SMI), and those in low-resource settings, remain systematically underrepresented in cardiovascular research. For instance, women are underrepresented in clinical trials, whereas pre-clinical studies tend toward the disproportional use of male animals or cell models. Similarly, SMI, although a known cardiovascular disease risk factor, is seldom considered in trial design or the analysis of data. There is emerging awareness of this important issue. The European Health Data Space (EHDS), through Article 78, requires that the forthcoming data quality and utility label explicitly examine biases. Yet, it is essential to recognize that there is no single, universal metric of diversity, what counts as meaningful representation varies with the purpose and context of each study. As the Global Alliance for Genomics and Health (GA4GH) notes, diversity in datasets is often desired in order to achieve, or at least make progress towards, equitable health outcomes (Diversity in Datasets Policy v2.4). For this purpose, appropriate extensions to HealthDCAT-AP need to be created. Furthermore, an API based on HL7-FHIR would facilitate the interaction between researchers and data-holders to establish the utility of a dataset for a particular research purpose from a diversity perspective. Additionally, a composite diversity index, highlighting multiple diversity aspects, such as health-related socioeconomic factors, could augment the utility label of federated multimodal datasets. Two EU funded projects where HL7 Europe is participating are addressing this pressing priority: These are: Research in Europe and Diversity Inclusion (READI) project whose mission is to make clinical studies in Europe more inclusive, especially for populations that are underserved and underrepresented in research, https://ihi-readi.org/ and NextGen Genome-Centric Multimodal Data Integration in Personalised Cardiovascular Medicine, whose mission is to develop next-generation tools for secure and federated data analysis that can ensure more equitable health research, https://www.nextgentools.eu/. By embedding robust standards for diversity and bias assessment into the Plan, Europe can lead the way toward a future where cardiovascular innovation not only reduces disparities but also delivers truly equitable care, improves outcomes across all communities, and strengthens a resilient, people-centered health system for generations to come. ------------ HL7 Europe Foundation addresses European standardization requirements for HL7 standards in digital health, serving as the European Office of HL7 International. The mission of HL7 is to provide standards that empower global health data interoperability to realize its vision of a world in which everyone can securely access and use the right health data when and where they need it. HL7 Europe supports the European Health Data Space with HL7 FHIR IGs for priority health data categories. Contact: press-contact@HL7europe.org
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