Regulation of Substances of Human Origin (SoHO) is an important topic of Union health law both in the context of research and in the context of healthcare services and treatment of patients. When we observe Union SoHO law, we do not only observe a linear movement towards greater harmonisation and less differentiation between national laws. At the same time as the 'expected' harmonisation processes of an inexorable process of greater Union law coverage of a field, and less space for national difference, we also observe counter-processes in the opposite direction. Focusing on the role of the Court of Justice of the Union to understand the dynamics of Union regulation of the sector through the analysis of 19 SoHO cases, this article proposes two new legal analytical concepts to explain these processes: 'defragmentation' and 'fragmentation' which provide an explanatory model as a tool of legal science to use to promote greater understanding of Union law.
A collectively authored article, which (unusually in legal scholarship) makes explicit the processes and methodologies by which 'European Union health law' is conceptualised; the implications; and the strengths and weaknesses of the approach taken. Strengths include implied structural and systemic coherence; and the breadth of analysis that having a large team of authors permits, through holding their positionalities in creative interplay with each other. The authors argue that European Union health law - defined as transversal and distinctively European Union law that either directly or indirectly affects human health, in a broad sense - should be understood through a metaphor of growth and connectedness, specifically a 'tree'. The article seeks to initiate a discussion not only about European Union health law, but also about European law and health law.
BACKGROUND: Health literacy (HL) is the capacity to get, understand, assess, and use health information to prevent disease and improve health in day-to-day living. The study aimed to evaluate the validity and reliability of the Bangla version of the short form of the European Health Literacy Survey Questionnaire (HLS-EU-Q16) for university students. METHODS: This cross-sectional study was conducted from June 2023 to August 2023. A sample of 948 respondents was selected from three universities in Bangladesh (Jahangirnagar University, Dhaka University, and Ahshanullah University of Science and Technology) using a convenience sampling technique. A structured questionnaire was used to collect data from the respondents. IBM SPSS statistical software, version 25, and AMOS (Analysis of Moment Structure) were used to analyze the data. Scale’s validity and reliability were examined using Cronbach’s alpha coefficient and confirmatory factor analysis, respectively. The chi-square test was used to compare different variables. The level of significance is 0.05. RESULTS: The Kaiser-Meyer-Olkin coefficient was 0.826, and the Bartlett test of sphericity was statistically significant (χ² = 3064.93, df = 120, p < 0.001). Confirmatory factor analysis revealed that the three-factor model provided a good fit to the data, yielding better goodness-of-fit outcomes for the Bangla HLS-Q16 (GFI = 0.965, CFI = 0.926, TLI = 0.906, and RMSEA = 0.044) compared to a one-factor model. For the whole scale, Cronbach’s Alpha value was 0.808 within the acceptable limit. All domains had satisfactory internal consistency (Health Care = 0.71, Disease Prevention = 0.70, and Health Promotion = 0.70). In addition, the item-total correlation coefficient varies from r = 0.313 to r = 0.480. All correlations were significant, indicating that each item contributes to the scale score. CONCLUSION: The HLS-Q16 Bangla version is a reliable and valid instrument for evaluating health literacy.
This paper investigates the structural limitations of cross-border healthcare mobility under Directive 2011/24/EU, analysing whether the European Health Data Space (EHDS) could offer a constitutionally compatible solution to its limited practical effectiveness. Although the directive formally recognises patients' right to reimbursement for treatment abroad, organisational fragmentation and inadequate digital interoperability persistently constrain its effective exercise. Against this background, the article introduces the interpretative concept of 'non-immediate primary use' of electronic health data. This is defined as a professionally mediated and infrastructural process designed to identify appropriate cross-border treatment options when national systems are clearly inadequate. Using obesity as a case study of structural discrimination, the analysis argues that digital coordination under the EHDS could implement existing mobility rights without expanding the competences of the Union under Article 168(7) TFEU. The EHDS is therefore presented as an infrastructural instrument that can reinforce substantive equality within the current constitutional allocation of powers.
INTRODUCTION: Medication-related osteonecrosis of the Jaw (MRONJ) is a serious adverse drug reaction that can seriously affect the quality of life of patients if not promptly diagnosed and treated. To date, preventive measures have been the most effective strategy for reducing the incidence of MRONJ. The role of dental practitioners in managing patients treated with Bone Modifying Agents (BMAs) varies across countries, with some healthcare systems providing a more structured approach than others. This systematic review aims to investigate the knowledge and awareness of MRONJ among dentists, interpreting the findings from a medical and bioethical perspective. MATERIALS AND METHODS: The protocol for this study was designed following the PRISMA guideline and registered on PROSPERO (CRD420251015032). A systematic review search was conducted in PubMed, Scopus, Web of Science, and Cochrane Database to answer the PICo question: Are dentists well-informed and aware of the risk of MRONJ in patients receiving BMAs? Furthermore, to address potential geographic differences, a country-specific literature review was conducted to compare the level of MRONJ awareness between patients receiving BMAs and dental professionals within the same country. Studies published up to March 2025 were screened. RESULTS: Twenty-two studies were included in this systematic review. Among the 10,536 dentists involved, 62.8% were well-informed about MRONJ, but only 9.7% were aware of its risk factors. The most common sources of information were university education, followed by scientific journals and specific training courses or conferences. Studies performed in the same countries investigating MRONJ awareness among patients taking BMAs were analyzed. Country-based analysis revealed significant discrepancies between dentists’ (68.5%) and patients’ (19.5%) knowledge and awareness of MRONJ in the USA, Saudi Arabia, Bulgaria, and Brazil. Finally, a bioethical analysis of European legal frameworks on informed consent for pharmacological therapies revealed that adequately informing patients about treatment risks is both an ethical obligation and a legal duty, rooted in constitutional and legislative principles. CONCLUSION: This systematic review reveals a low level of awareness despite an acceptable level of knowledge among dentists, highlighting an alarming discrepancy. Beyond knowledge of the disease, awareness of its risk factors and preventive strategies is essential for dentists to adopt a personalized and safe workflow for these patient groups. Ensuring personalized therapy requires a structured and collaborative approach based on ethical principles and shared knowledge. Strengthening interprofessional training and teamwork is essential to improving prevention and patient empowerment. PROSPERO REGISTRATION CODE: CRD420251015032.
The REBECCA project taps into the potential of using real-world data (RWD) for supporting groundbreaking clinical research on complex chronic conditions as a complement to Randomised Controlled Trials. REBECCA moves beyond the analysis of clinical data from Electronic health records, by combining it with detailed monitoring data from multiple wearables, online behaviour and self-reported data to monitor patients's quality of life in terms of their functional and emotional status. The project focuses on the detection of cancer-related fatigue, developed during breast cancer recovery, using digital biomarker profiles for early detection of the disease and assessing the value of detailed and longitudinal patient monitoring as a means of improving patient care. The project also demonstrates the extensibility of REBECCA monitoring to other forms of cancer, such as prostate cancer. We describe the three clinical trials being conducted in Norway and the use of the REBECCA platform, capable of detailed monitoring and privacy preserving federated cross-country data analysis. The RWD will be analyzed in the context of data from questionnaires (Patient Reported Outcome Measures) and results from analysis of biological samples. Through this approach we expect that the REBECCA project will produce new knowledge on clinical management of cancer patients and contribute to new biological knowledge on cancer-related fatigue. Status and perspectives: The REBECCA project is ongoing, and patient follow-up will be completed during February 2026. The initial analyses of RWD, PROMs and biological samples have started together with the partners in the REBECCA consortium. The REBECCA trials are approved by the Regional Ethics Committee of the Western Health Authority (REK Vest) under the IDs 225,855 (REBECCA-1), 242,088 (REBECCA-2) and 619,903 (REBECCA-3). All trials have also been registered at clinicaltrials.gov (NCT05587777, NCT06120595 and NCT06435091). Trial registration: NCT05587777, Retrospectively registered 19th of October 2022, https://clinicaltrials.gov/study/ NCT05587777; NCT05587777, Retrospectively registered 6th of November 2023, https://clinicaltrials.gov/study/ NCT06120595; NCT05587777, Retrospectively registered 23rd of May 2024, https://clinicaltrials.gov/study/ NCT06435091.
This article analyses how the notion of health data under the GDPR has evolved through the legal instruments and provisions on health data sharing in the Data Governance Act (DGA) and the European Health Data Space (EHDS), aiming both legal sources to facilitate data access and governance, including electronic health data for its primary and secondary use, by establishing harmonised rules. These regulations open opportunities to enhance cross-border data access, the promotion of data altruism, and the development of data governance models facilitating biomedical research. In the specific context of rare diseases, however, significant challenges remain emerging from variations between EU Member States implementation of the EHDS. In particular, the EHDS's secondary use framework, the genomic and biobank data exception, and the coexistence with the DGA's consent‑based data altruism model create a complex legal landscape for rare disease research. This contribution intends to clarify the legal bases for secondary use to improve the capacity to protect data subjects' right to data protection, while preserving data value and utility in biomedical research within the context of rare diseases.
BACKGROUND: Sleep, physical activity, and diet are key determinants of health, each independently associated with chronic disease risk and mortality. These behaviors also interact: insufficient sleep can impair physical activity and dietary choices, while regular exercise and healthy diet promote better sleep. Although lifestyle interventions commonly target physical activity and diet, few simultaneously address sleep. Emerging evidence suggests that even small improvements across all three behaviors can reduce all-cause mortality, highlighting the potential of multi-behavior approaches. However, the effects of a lifestyle intervention simultaneously targeting sleep, physical activity, and diet on quality of life and physical activity levels in inactive adults remain largely unexplored. METHODS: The SPIRAL+ study is a single-center, randomized controlled trial conducted in France, among non-exercising adults aged 18–80 years. Participants (n = 201) will be randomized to one of three groups: (1) lifestyle intervention (physical activity and diet) (2), lifestyle plus sleep intervention, or (3) control. Assessments will be conducted at baseline, 6 months (post-intervention), and 12 months. The primary outcomes are health-related quality of life (EQ-5D-5 L) and daily step count (measured by accelerometer) assessed immediately after the 6-month intervention. Secondary outcomes include whether intervention effects are sustained at 12 months, along with markers of physical fitness (cardiorespiratory fitness, body composition, handgrip strength), physical activity and sedentary behavior (accelerometry), and sleep (home-based sleep test, actigraphy, and validated questionnaires). Additional self-reported outcomes will cover diet, mental wellbeing, motivation, quality of life, and psychological constructs related to health behavior change. A qualitative component will explore barriers and facilitators to adherence through semi-structured interviews. DISCUSSION: This trial will evaluate whether adding a sleep component to a lifestyle intervention improves quality of life and physical activity levels in inactive adults. If effective, the findings will support the integration of sleep into multi-behavior interventions to enhance health outcomes and inform future public health strategies. TRIAL REGISTRATION: Clinical Trials NCT06424847.
Could the emergence of a surrogacy market in France, despite its prohibition by the French Civil Code, be the tip of a social iceberg? This article aims to analyse the individualization of Law and society. Through innovative legal constructs, the possessors of rights provided by national Law are demanding changes to the law to suit their individual interests. By anchoring their desire in an existing subjective right, legal subjects situate the fulfillment of this desire within the legal domain, while raising the question of its normative dimension. Beyond traditional questions of legal agility, optimization and discursive dimension of the use of available rights, the consequences are crucial: because individualization is growing, the law is no longer a collective and social phenomenon, but a tool that the judge adjusts according to the desired result. What is at stake here is the meaning of Law, Justice and, ultimately, society itself.
OBJECTIVE: Depressive symptoms are prevalent, heterogeneous conditions involving physical and psychological manifestations, and are associated with impairment of health-related quality of life (HRQoL). We aimed to estimate the association between depressive symptoms, lung function trajectories, and HRQoL in aging individuals, and explore whether lung function trajectory explains part of the association between depressive symptoms and HRQoL in ageing population. METHODS: This study used data from waves 2, 4, 6, and 7 of the Survey of Health, Ageing and Retirement in Europe (SHARE), comprising 7848 observations from participants aged 50 years and older across multiple European countries. Group-based trajectory modelling identified distinct longitudinal trajectories of lung function by sex. Multinomial logistic regression was used to examine the associations of depressive symptoms and lung function trajectories with HRQoL. To assess whether the association between depressive symptoms and HRQoL could be explained by an indirect pathway involving lung function trajectory, a parallel-process latent growth curve model was performed. RESULTS: A strong dose-response relationship was observed between the cumulative exposure level of depressive symptoms, lung function trajectories, and HRQoL. The longitudinal analysis revealed that the association between depressive symptoms and HRQoL was partially accounted for by an indirect association involving lung function trajectory. A statistically significant indirect effect of depressive symptoms on HRQoL through the intercept of lung function was observed in both males and females. CONCLUSIONS: The findings underscore that depressive symptoms, lung function decline, and HRQoL are interrelated in the aging population. This suggests that strategies addressing depressive symptoms could be relevant for comprehensive care aimed at preserving lung health and HRQoL.
ChatGPT Health and other health-focused generative AI chatbots increasingly function as alternative first points of contact that may mediate-and in some cases substitute-engagement with regulated healthcare systems. At scale, these systems can shape care-seeking behavior, system capacity, trust in clinical expertise, and health equity. We describe this development as the emergence of shadow health systems: privately governed infrastructures that perform health-system functions without being subject to healthcare-specific safeguards. EU law currently regulates such tools based on declared medical purpose rather than their real-world effects, creating gaps in legal protection. This Policy Brief examines the public health implications and regulatory positioning of health-focused generative AI chatbots in Europe and proposes targeted reforms to address emerging governance gaps.
BACKGROUND: The EORTC Sexual Health Questionnaire (EORTC QLQ-SH22) assesses sexual health-related quality of life in adult cancer patients. However, it may not fully address age-dependent issues in young adults aged 18–39 at diagnosis. This study aimed to explore the questionnaire’s relevance and comprehensibility for young adults with cancer and identify topics needing elaboration or missing. METHODOLOGY: IN: this cross-sectional study 60 young adults with cancer across treatment stages rated item relevance on a Likert scale and gave qualitative feedback through a “think-aloud” process and semi-structured interviews. Quantitative analyses examined item relevance using mean scores and predefined thresholds. Qualitative data were analysed using reflexive thematic analysis. RESULTS: Twenty-one of the 22 items were rated relevant. Participants suggested refining wording to improve comprehensibility. Interviews indicated a need to expand coverage of intimacy, communication with professionals, body changes and body image, and partnership. Missing topics included singlehood, cancer before sexual debut, contraception and fertility, and gender diversity. CONCLUSIONS: The EORTC QLQ-SH22 is relevant for young adults with cancer but may be improved through clearer wording, elaboration of key topics, and inclusion of missing items. An international content validity study in this population is recommended to guide future development.
Adjuvant immunotherapies have transformed lung cancer management by improving survival and patient-reported quality of life. However, their high acquisition costs and uncertainty around real-world economic value raise concerns regarding health system affordability and long-term sustainability. This study assessed the cost-effectiveness of adjuvant immunotherapies and evaluated their projected budget impact under plausible real-world adoption scenarios. We systematically reviewed published economic evaluations of adjuvant immunotherapies in lung cancer from 2010 to 2024. Eligible studies included cost-effectiveness and cost-utility analyses comparing immune checkpoint inhibitors with standard chemotherapy or best supportive care. Data on costs, quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and willingness-to-pay (WTP) thresholds were extracted and narratively synthesised. For therapies judged cost-effective, we conducted a five-year (2025-2029) budget impact analysis using ISPOR-consistent methods, with costs standardised to 2024 US dollars. Three adoption scenarios were modelled: a base-case phased adoption (10 %-50 %), an accelerated uptake scenario (30 %-50 %), and a restricted uptake scenario (10 %-30 %), to examine the sensitivity of affordability to alternative implementation pathways. Thirty-five economic evaluations of adjuvant immunotherapies for lung cancer were included (33 NSCLC and 2 SCLC studies). Frequently evaluated agents were pembrolizumab (n = 11), nivolumab (n = 8), atezolizumab (n = 6), and durvalumab (n = 5), alongside emerging agents including icotinib, sintilimab, sugemalimab and camrelizumab. Overall, adjuvant immunotherapies were associated with improved health outcomes compared with standard chemotherapy, with incremental gains of ∼0.3-0.5 QALYs in several US/European models and gains of ≥ 1.0 QALY in selected biomarker-defined population or Chinese cohorts. However, per-patient costs were substantially higher, ranging from modest increases (∼US$4000 with icotinib) to totals >US$230,000-390,000 for PD-1/PD-L1 based regimens and > 10-fold higher than standard care in some middle-income settings. ICERs ranged from highly favourable estimates (e.g. icotinib ∼US$3440/QALY; selected pembrolizumab, sintilimab, sugemalimab, squamous-specific nivolumab and CAD strategies within local WTP thresholds) to clearly non-cost-effective values (>US$300,000-600,000/QALY) for broad, unselected use, combination regimens, and several SCLC indications. Fo interventions judged cost-effective, five-year dudget impact estimates for cost-effective options indicated substantial 5-year incremental spending (from low millions up to >US$400 million), while a small subset of regimens were cost-saving or near budget-neutral, underscoring the need for targeted adoption and price negotiation in the adjuvant setting. Under the base-case phased uptake scenario, budget impact increased steadily over time, with high-cost regimens such as pembrolizumab- and durvalumab-based strategies generating the largest cumulative five-year expenditure. Accelerated uptake substantially intensified short-term fiscal pressure, with first-year spending approximately tripling and over half of total five-year costs incurred within the first three years for several therapies. In contrast, restricted uptake reduced cumulative five-year budget impact by approximately one-third to nearly one-half, depending on the agent. Adjuvant immunotherapies for lung cancer deliver meaningful clinical benefits, but their economic value and affordability are highly context-specific. While several strategies are cost-effective at the individual patient level, health system affordability is strongly influenced by the pace and scale of adoption. Scenario-based budget impact analyses demonstrate that accelerated uptake can impose substantial short-term fiscal pressure, whereas phased or restricted implementation markedly improves affordability without altering cost-effectiveness conclusions. These findings underscore the importance of integrating cost-effectiveness evidence with explicit consideration of budget impact, adoption strategies, and managed entry mechanisms to support sustainable and equitable scale-up of adjuvant immunotherapies in routine clinical practice. CRD420251127115.
The Carer Experience Scale (CES) measures the caring experience, focusing on caregiver-related quality of life (QoL) rather than health-related QoL. We aimed to validate the Danish language version of CES in family caregivers of people with dementia in Denmark by assessing CES discriminative and convergent validity. Further, we aimed to establish the internal consistency and test-retest reliability of CES. A baseline questionnaire from the Danish DemTool intervention trial, including CES and five other measures of QoL and wellbeing was completed by 375 family caregivers of people with dementia. Discriminative validity was assessed by the ability of CES to discriminate between different caring contexts and levels of caregiver strain, as determined by Mann-Whitney U and Kruskal-Wallis H tests. Convergent validity was assessed by analyzing correlations using Spearman's rank correlation coefficients between the CES index and domain scores, and the 5-level EQ-5D version (EQ-5D-5L), European Quality of life visual analog scale (EQ VAS), Neuropsychiatric Inventory Caregiver Distress Scale (NPI-D), World Health Organization Wellbeing Index (WHO-5), and the University of California, Los Angeles Three-Item Loneliness Scale (UCLA 3-item). Internal consistency was assessed using Cronbach's α and test-retest reliability was assessed using intraclass correlation coefficient (ICC) between two different time points. The CES effectively distinguished between different levels of caregiver strain. Further, the CES was not affected by different caregiver and care recipient characteristics. Supporting convergent validity, the CES index was moderately correlated with NPI-D (ρ=-0.42), WHO-5 (ρ = 0.44), and UCLA 3-item (ρ=-0.40). The CES index was weakly correlated with EQ-5D-5L (ρ = 0.27), and EQ-VAS (ρ = 0.26). The CES showed low internal consistency (α = 0.53), but high test-retest reliability (ICC = 0.76). The Danish version of CES demonstrated discriminative validity and acceptable psychometric properties, providing further evidence for its use in family caregivers of people with dementia.
Pulmonary hypertension (PH) is a common sequela of interstitial lung diseases (ILDs) and is associated with poor prognosis and quality of life. The diagnosis and management of PH associated with ILD (ILD-PH) are challenging, due in part to the heterogeneity of ILD subtypes, difficulty distinguishing symptoms and signs of ILD progression from manifestations of PH, lack of specific biomarkers, and the requirement of invasive right heart catheterisation (RHC) to diagnose and assess the severity of PH. This state-of-the-art review provides a comprehensive overview of the clinical characteristics, pathophysiology, diagnosis, prognosis and treatment of ILD-PH. It also identifies promising areas for future research, such as the development and validation of novel biomarkers and imaging techniques and further evaluation of the efficacy and safety of pharmacological therapies for PH in patients with ILD. Given the inherent complexity of diagnosing and managing heterogeneous ILD subtypes, there is a clear need for multidisciplinary and personalised care strategies for ILD-PH. Dedicated attention and further research to improve diagnostic and treatment interventions are warranted to help develop much-needed, evidence-based guidelines and to improve outcomes that are meaningful for patients with ILD-PH.
In this paper, we document a tension in the European Code of Conduct for Research Integrity: the Code seeks to limit the influence of non-epistemic values, and yet, it recognizes that such values play a legitimate role in research. By comparing various versions of the Code, we argue that, over time, there has been less explicit recognition of the complexity of the relation between research and societal values. Currently, the Code does not give guidance on what value influence count as undesirable or as "undue pressure," and conflates the issues of value-freedom and scientific freedom. As the impact of non-epistemic values is becoming increasingly evident, we recommend that future codes start by explicitly acknowledging the challenges inherent in the relation between science and societal values, and we offer an example of how the ECoC could be revised to meet this recommendation.
Artificial intelligence (AI) offers opportunities for more efficient care, improved communication, and support in diagnostics and clinical decision-making. The transition to safe application in practice, however, requires AI literacy: the ability to understand the functioning, limitations, and risks of systems and to use them critically. The European Regulation on artificial intelligence (AI Act) obliges providers, deployers, and users to ensure an appropriate level of AI literacy. This article outlines the core aspects of AI literacy, with specific attention to predictive models and generative AI, including their pitfalls such as bias, confounding, hallucinations, and automation bias. The distribution of responsibilities is also addressed: providers are expected to ensure transparency and validation, deployers to establish governance and training, and healthcare professionals to apply contextual interpretation. Education and assessment of both basic knowledge and application are essential, from initial training to specialist practice. Only through early and structural investment in AI literacy can human oversight be safeguarded and patient safety maintained.
BACKGROUND: Anaemia is a common condition associated with increased morbidity, mortality, and health resource utilization. Early detection and timely treatment are essential to improve prognosis and quality of life. The aim of this study was to evaluate the effect of point-of-care haemoglobinometry combined with activation of a hospital transfusion circuit compared with usual care in patients with transfusion-dependent chronic anaemia managed in primary care settings in Catalonia, Spain. METHODS: A randomized controlled clinical trial was conducted between 2018 and 2021 in primary care centres of the Catalan Institute of Health. Patients were randomly assigned to an intervention group (monthly capillary haemoglobin monitoring using a haemoglobinometer and activation of a transfusion circuit) or a control group (standard venous blood monitoring according to usual practice). Descriptive statistics were calculated, and between-group comparisons were performed using appropriate statistical tests. RESULTS: Patients in the intervention group had shorter hospital stay (median = 2 vs. 12.5 days; p = 0.319), although these differences were not statistically significant. Median values of emergency room visits were significantly lower in the intervention group (1) compared to the control group (4), p < 0.001, as was total emergency room time in hours (4 vs. 70; p < 0.001). At 12 months, quality of life scores were significantly higher in the intervention group (15 vs. -2; p < 0.001). CONCLUSIONS: Point-of-care haemoglobinometry combined with an organized transfusion circuit improves quality of life and reduces emergency service utilization in patients with transfusion-dependent anaemia, with important implications for clinical practice and healthcare resource optimization. TRIAL REGISTRATION: ClinicalTrials.gov NCT04757909. Submitted February 16, 2021.
Up to 30% of individuals infected with COVID-19 experience persistent symptoms, known as post-COVID-19 condition (PCC), which can impair health-related quality of life (HRQoL). While post-COVID-19 condition (PCC) is known to affect health-related quality of life (HRQoL), the specific contribution of individual symptoms remains underexplored. This study examined how specific symptoms affect HRQoL in individuals with PCC compared to those who had COVID-19 without PCC and those never infected. A cross-sectional survey was conducted among a nationally representative sample of 1,813 French adults through telephone and online interviews. Participants were grouped according to WHO PCC criteria, based on infection status and 31 persistent symptoms. HRQoL was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29), and impairment was defined as having at least two affected domains. Logistic regressions adjusted for confounders were used to assess associations. Among 1,813 participants (365 with PCC, 1,270 previously infected without PCC, 178 never infected), impaired HRQoL was significantly more frequent in with PCC (36%) than in those previously infected without PCC or never infected (adjusted odds ratio: 2.02; 95% CI 1.19-3.42]). The symptoms most strongly associated with HRQoL impairment in PCC were anxiety (OR 3.75; 95% CI: 1.80-7.80), joint pain (OR 2.31; 95% CI: 1.15-4.65), and sleep disturbances (OR 2.14; 95% CI 1.08-4.25), whereas fatigue, shortness of breath, and memory issues had a weaker association with impaired HRQoL in PCC than in other groups. PCC, and particularly joint pain, anxiety and sleep disturbance, are associated with impaired HRQoL. Targeted interventions for these symptoms may improve well-being in affected individuals.
During the COVID-19 pandemic, government-to-business (G2B) data sharing became a vital practice, exemplified by the 2021 Israeli Ministry of Health-Pfizer agreement. This established a large-scale data sharing operation outside of research and data protection regulations and oversight. This paper explores two related questions: (i) whether an EU Member State could replicate this scenario, and (ii) whether EU data legislation provides sufficient protection against excessive G2B data sharing. The analysis of the General Data Protection Regulation, Data Governance Act, and European Health Data Space shows that (i) despite the uncertain definitions of research and personal data, it would be difficult for an EU Member State to replicate this scenario; and (ii) despite its many grey areas and flexibilities, EU data legislation offers protection against excessive G2B data sharing. This highlights the need to explore alternative strategies to facilitate data sharing that can address public health emergencies promptly while safeguarding fundamental rights.