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Are EU member states ready for the European Health Data Space? Lessons learnt on the secondary use of health data from the TEHDAS Joint Action
No full textThe proposal for a regulation on the European Health Data Space (EHDS) contains provisions that would significantly change health data management systems in European member states (MS). This article presents results of a country mapping exercise conducted during the Joint Action ‘Towards the European Health Data Space’ (TEHDAS) in 2022. It presents the state-of-play of health data management systems in 12 MS and their preparedness to comply with the EHDS provisions. The country mapping exercise consisted of virtual or face-to-face semi-structured interviews to a selection of key stakeholders of the health information systems. A semi-quantitative analysis of the reports was conducted and is presented here, focusing on key aspects related to the user journey through the EHDS. This article reveals a heterogenous picture in countries’ readiness to comply with the EHDS provisions. There is a need to improve digitalization and quality of health data at source across most countries. Less than half of the countries visited have or are developing a national datasets catalogue. Although the process to access health data varies, researchers can analyse health data in secure processing environments in all countries visited. Most of the countries use a unique personal identifier for health to facilitate data linkage. The study concluded that the current landscape is heterogeneous, and no member state is fully ready yet to comply with the future regulation. However, there is general political will and ongoing efforts to align health data management systems with the provisions in the EHDS legislative proposal.</p
COVID-19 vaccine effectiveness against hospitalisation and death using electronic health records in eight European countries in the VEBIS monitoring network - October 2023 to April 2024
No full textRepeated point prevalence surveys of healthcare-associated infections and antimicrobial use in Belgian nursing homes
No full textImpact of environmental nitrogen enrichment on birch pollen allergy
No full textBackground:
The prevalence of allergy to aeroallergens is rising and attributed to lifestyle- and environmental changes such as nitrogen pollution, although causality is often difficult to infer. Despite its known ecological impact, the impact on pollen allergenicity of environmental nitrogen pollution remains poorly circumscribed. We hypothesize that soil nitrogen pollution may directly affect pollen production and/or properties, resulting in pollen collected from different environmental nitrogen deposition conditions exhibiting different allergenicity in sensitized patients.
Methods:
Fresh Betula pollen samples were collected throughout Europe (e.g. Belgium, Sweden, Ireland, Poland, Ukraine, Spain, France). In 2022, 66 samples were collected in a paired design in Belgium. Groups of birch trees close to each other but with different environmental nitrogen conditions (natural vs agricultural land) were sampled. In 2023, samples from Belgium (n = 35) and Europe (n = 63) were collected over a gradient of environmental nitrogen based on nitrogen deposition map data (Eutrophication caused by atmospheric nitrogen deposition in Europe, European Environment Agency, EEA). Nitrogen deposition values were extracted from modeled air concentrations and depositions from the European Monitoring and Evaluation Program (EMEP). Fresh pollen, leaf nitrogen and carbon content were measured (CHNS elemental analyzer, EA1108 by Carlo Erba). Soluble proteins were extracted and normalized for protein concentration (Bradford). A selection of good quality pollen (10/66 for 2022 and 20/98 for 2023) extracts representing the nitrogen gradient, was used to determine their allergenicity in pollen-allergic adult patients (n = 60 in total) using ex vivo basophil activation testing (BAT) and specific IgE (sIgE) determination (ImmunoCAP, Phadia). For BAT, area under the curve (AUC), half maximal effective concentration (EC50), and maximal reactivity were compared.
Results:
No difference in BAT reactivity was observed in a subset of 20 patients. Also no difference in sIgE titer was seen in the natural vs. agricultural group (mean 12.51 vs. 12.47 kUA/mL, paired t-test, p = 0.9075). For pollen obtained in 2023 in Europe (10/63) and Belgium (10/35) over a nitrogen deposition gradient, a significantly higher estimated reactivity was observed in samples with lower predicted nitrogen deposition (BAT AUC estimated effect for total N-deposition -402.631 (EU, p = 0.041) and -539.178 (BE, p = 0.014)), linear mixed model analysis). We are awaiting results that correlate sIgE with nitrogen deposition values. We did observe a significant positive estimated effect of initial pollen protein concentration on BAT reactivity (AUC 25.053 (EU, p < 0.001) and 8.213 (BE, p < 0.001)), despite our correction for this in our experimental setup. Initial protein concentrations did not correlate with nitrogen deposition estimates or measurements (total N-deposition, n = 41, ρ = -0.3078, p = 0.0503).
Conclusion:
Betula pollen collected during two consecutive sampling rounds in Belgium and across Europe from sites with varying levels of environmental nitrogen deposition did not consistently impact pollen allergenicity. Further analysis will assess how environmental nitrogen enrichment affects pollen production capacity and its protein characteristics.</p
EU Oncology Decision Support Tool concept (CAN.HEAL Deliverable 10.1)
No full textThis deliverable, titled D10.1 EU-oncDST, is one of the outcomes of Work Package 10 (WP10) on oncology decision support tools (oncDSTs) within the CAN.HEAL project under the EU4Health Programme. It introduces the EU-oncDST concept, a digital framework that facilitates the implementation and interoperability of oncDSTs to support the management of oncological processes and drive further advancements in the field. The framework aims to support Molecular Tumor Board (MTB) operations across institutional, national, and European levels. The concept was developed based on consultations within CAN.HEAL, insights from a European survey, and a mapping exercise of oncDST solutions, encompass contributions from the private sector as well as national and European initiatives.</p
Unlocking the Power of Transcriptomic Biomarkers in Qualitative and Quantitative Genotoxicity Assessment of Chemicals.
No full textTo modernize genotoxicity assessment and reduce reliance on experimental animals, new approach methodologies (NAMs) that provide human-relevant dose-response data are needed. Two transcriptomic biomarkers, GENOMARK and TGx-DDI, have shown a high classification accuracy for genotoxicity. As these biomarkers were extracted from different training sets, we investigated whether combining the two biomarkers in a human-derived metabolically competent cell line (i.e., HepaRG) provides complementary information for the classification of genotoxic hazard identification and potency ranking. First, the applicability of GENOMARK to TempO-Seq, a high-throughput transcriptomic technology, was evaluated. HepaRG cells were exposed for 72 h to increasing concentrations of 10 chemicals (i.e., eight known genotoxicants and two nongenotoxicants). Gene expression data were generated using the TempO-Seq technology. We found a prediction performance of 100%, confirming the applicability of GENOMARK to TempO-Seq. Classification using TGx-DDI was then compared to GENOMARK. For the chemicals identified as genotoxic, benchmark concentration modeling was conducted to perform potency ranking. The high concordance observed for both hazard classification and potency ranking by GENOMARK and TGx-DDI highlights the value of integrating these NAMs in a weight of evidence evaluation of genotoxicity.</p
EU Calls - Call for Proposals on radiation safety and quality of computed tomography imaging of children and young (EU4H-2024-PJ-03-3)
No full textOne Pager
For evaluating the relevance and feasibility of belgian participation in EU calls</p
be.Prepared: An architecture to increase Belgian integration of health data as a way of strengthening preparedness for infectious diseases
No full textThe Belgian Preparedness Architecture for Infectious Diseases (be.Prepared) is an overarching Belgian infrastructure that facilitates the integration of health data from different sources in order to strengthen preparedness for infectious diseases. The initial microbial study cases are: Listeria, Mycobacterium tuberculosis, Neisseria meningitidis, Salmonella, Influenza and SARS-CoV-2. Here, we present an overview of the components of the be.Prepared architecture: the central bioinformatics (BioIT) platform, the central National Reference Centre (NRC) platform and the healthdata.be platform</p