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The COVID-19 pandemic has highlighted the importance of digital health technologies and the role of effective surveillance systems. While recent events have accelerated progress towards the expansion of digital public health (DPH), there remains significant untapped potential in harnessing, leveraging, and repurposing digital technologies for public health. There is a particularly growing need for comprehensive action to prepare citizens for DPH, to regulate and effectively evaluate DPH, and adopt DPH strategies as part of health policy and services to optimise health systems improvement. As representatives of the European Public Health Association's (EUPHA) Digital Health Section, we reflect on the current state of DPH, share our understanding at the European level, and determine how the application of DPH has developed during the COVID-19 pandemic. We also discuss the opportunities, challenges, and implications of the increasing digitalisation of public health in Europe. Copyright (C) 2022 The Author(s). Published by Elsevier Ltd.

Background The 2020 COVID-19 pandemic led to a strict lockdown in France from March 17 to May 11, 2020. After the lockdown, the French strategy to mitigate the impact of SARS-CoV-2 relied partly on investigations of all confirmed cases. Monitoring collective settings is particularly important since SARS-CoV-2 seems prone to superspreading events (SSEs). Methods Our study is based on data gathered in Paris from May 11 to December 31, 2020, by the Ile-de-France Regional Health Agency (RHA) to investigate cases occurring in collective and high-risk settings. Specific events in high-risk settings were systematically transmitted to the RHA, and screenings were organized by the facilities, while other settings were reported when three cases were identified within a short period. These settings were more difficult to identify through the surveillance system since no systematic screening was organized by the facility, leaving screenings to rely on the national contact-tracing programme. No official superspreading threshold has been set for SARS-CoV-2. We defined a SSE as an event involving ten cases. Results We analysed 15,706 events associated with 38,670 cases, representing an average of 2.70 cases per event. Most clusters occurred in educational facilities, workplace environments, social care settings, and healthcare facilities. SSEs represented 3.4% but accounted for 28% of all cases reported. The highest number of SSEs occurred in college settings (12.6%), followed by hospitals and retirement homes. Educational facilities had the lowest number of SSEs, with around 1% in preschools and elementary schools. Conclusions We observed different SSE rates in each setting. Preschools and primary schools represented the majority of events but experiencing very few SSEs. Colleges were prone to SSEs and were associated with a high number of secondary cases. These findings provide some insights on contact tracing activities and SARS-CoV-2 transmission in different settings.

Objectives To investigate humoral responses and safety of mRNA SARS-CoV-2 vaccines in systemic autoimmune and autoinflammatory rheumatic disease (SAARD) patients subjected or not to treatment modifications during vaccination. Methods A nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis. Results Patients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls. Conclusions In SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.

Background and aims Despite concerns that liver transplant (LT) recipients may be at increased risk of unfavorable outcomes from COVID-19 due the high prevalence of co-morbidities, immunosuppression and ageing, a detailed analysis of their effects in large studies is lacking Methods Data from adult LT recipients with laboratory confirmed SARS-CoV2 infection were collected across Europe. All consecutive patients with symptoms were included in the analysis, Results Between March 1st and June 27th2020, data from 243 adult symptomatic cases from 36 centers and 9 countries were collected. Thirty-nine (16%) were managed as outpatients while 204 (84%) required hospitalization including admission to the ICU (39/204, 19.1%). Forty-nine (20.2%) patients died after a median of 13.5 (10-23) days, respiratory failure was the major cause. After multivariable Cox regression analysis, age > 70 (HR 4.16; 95%CI 1.78-9.73) had a negative effect and tacrolimus (TAC) use (HR 0.55; 95%CI 0.31-0.99) had a positive independent effect on survival. The role of co-morbidities was strongly influenced by the dominant effect of age where comorbidities increased with the increasing age of the recipients. In a second model excluding age, both diabetes (HR 1.95; 95%CI 1.06 - 3.58) and chronic kidney disease (HR 1.97; 95%CI 1.05 - 3.67) emerged as associated with death Conclusions Twenty-five per cent of patients requiring hospitalization for Covid-19 died, the risk being higher in patients older than 70 and with medical co-morbidities, such as impaired renal function and diabetes. Conversely, the use of TAC was associated with a better survival thus encouraging clinicians to keep TAC at the usual dose., Graphical abstract

Highlights • YOUth is a longitudinal cohort study in the Netherlands that aims to produce and safely store FAIR and high-quality data. • We share our experience and expertise in setting up a high-quality research data infrastructure for sensitive cohort data. • We describe our procedures and the technical aspects of our data and data infrastructure. • We highlight the importance of collaboration between organizations., The YOUth cohort study aims to be a trailblazer for open science. Being a large-scale, longitudinal cohort following children in their development from gestation until early adulthood, YOUth collects a vast amount of data through a variety of research techniques. Data are collected through multiple platforms, including facilities managed by Utrecht University and the University Medical Center Utrecht. In order to facilitate appropriate use of its data by research organizations and researchers, YOUth aims to produce high-quality, FAIR data while safeguarding the privacy of participants. This requires an extensive data infrastructure, set up by collaborative efforts of researchers, data managers, IT departments, and the Utrecht University Library. In the spirit of open science, YOUth will share its experience and expertise in setting up a high-quality research data infrastructure for sensitive cohort data. This paper describes the technical aspects of our data and data infrastructure, and the steps taken throughout the study to produce and safely store FAIR and high-quality data. Finally, we will reflect on the organizational aspects that are conducive to the success of setting up such an enterprise, and we consider the financial challenges posed by individual studies investing in sustainable science.

Today it is the norm that all relevant proteomics data that support the conclusions in scientific publications are made available in public proteomics data repositories. However, given the increase in the number of clinical proteomics studies, an important emerging topic is the management and dissemination of clinical, and thus potentially sensitive, human proteomics data. Both in the United States and in the European Union, there are legal frameworks protecting the privacy of individuals. Implementing privacy standards for publicly released research data in genomics and transcriptomics has led to processes to control who may access the data, so-called “controlled access” data. In parallel with the technological developments in the field, it is clear that the privacy risks of sharing proteomics data need to be properly assessed and managed. In our view, the proteomics community must be proactive in addressing these issues. Yet a careful balance must be kept. On the one hand, neglecting to address the potential of identifiability in human proteomics data could lead to reputational damage of the field, while on the other hand, erecting barriers to open access to clinical proteomics data will inevitably reduce reuse of proteomics data and could substantially delay critical discoveries in biomedical research. In order to balance these apparently conflicting requirements for data privacy and efficient use and reuse of research efforts through the sharing of clinical proteomics data, development efforts will be needed at different levels including bioinformatics infrastructure, policymaking, and mechanisms of oversight., Graphical Abstract, Highlights • Availability of proteomics data in public repositories (ProteomeXchange) has become the norm. • There are growing ethical issues and legal requirements related to human clinical proteomics data. • We review the current state of the art and provide our thoughts about some proteomics data types. • We make concrete recommendations to address these issues, summarized in four different points., In Brief Availability of proteomics data in the public domain has become the norm, as it has been the case in genomics and transcriptomics for many years. Analogously to sequencing data, there are increasing ethical issues and legal requirements related to sensitive human clinical proteomics data. We review the current state of the art and make concrete recommendations to address these issues in the proteomics field, which are summarized in four different areas.

The goal of clinical proteomics is to identify, quantify, and characterize proteins in body fluids or tissue to assist diagnosis, prognosis, and treatment of patients. In this way, it is similar to more mature omics technologies, such as genomics, that are increasingly applied in biomedicine. We argue that, similar to those fields, proteomics also faces ethical issues related to the kinds of information that is inherently obtained through sample measurement, although their acquisition was not the primary purpose. Specifically, we demonstrate the potential to identify individuals both by their characteristic, individual-specific protein levels and by variant peptides reporting on coding single nucleotide polymorphisms. Furthermore, it is in the nature of blood plasma proteomics profiling that it broadly reports on the health status of an individual—beyond the disease under investigation. Finally, we show that private and potentially sensitive information, such as ethnicity and pregnancy status, can increasingly be derived from proteomics data. Although this is potentially valuable not only to the individual, but also for biomedical research, it raises ethical questions similar to the incidental findings obtained through other omics technologies. We here introduce the necessity of—and argue for the desirability for—ethical and human-rights-related issues to be discussed within the proteomics community. Those thoughts are more fully developed in our accompanying manuscript. Appreciation and discussion of ethical aspects of proteomic research will allow for deeper, better-informed, more diverse, and, most importantly, wiser guidelines for clinical proteomics., Graphical Abstract, Highlights • Plasma proteomes can be reidentified based on protein expression levels. • Plasma proteomes can be reidentified based on variant peptides. • Plasma proteomes can contain actionable and nonactionable incidental findings. • Plasma proteomes can contain sensitive information such as pregnancy status., In Brief Due to its unbiased nature, proteomics may raise ethical and regulatory concerns. Plasma proteome samples can be reidentified given genomic information. Furthermore, plasma proteomes contain information of potential sensitive nature. Incidental findings can help diagnose unrelated but actionable disease states.

Recent advances in MS-based proteomics have vastly increased the quality and scope of biological information that can be derived from human samples. These advances have rendered current workflows increasingly applicable in biomedical and clinical contexts. As proteomics is poised to take an important role in the clinic, associated ethical responsibilities increase in tandem with impacts on the health, privacy, and well-being of individuals. We conducted and here report a systematic literature review of ethical issues in clinical proteomics. We add our perspectives from a background of bioethics, the results of our accompanying article extracting individual-sensitive results from patient samples, and the literature addressing similar issues in genomics. The spectrum of potential issues ranges from patient reidentification to incidental findings of clinical significance. The latter can be divided into actionable and unactionable findings. Some of these have the potential to be employed in discriminatory or privacy-infringing ways. However, incidental findings may also have great positive potential. A plasma proteome profile, for instance, could inform on the general health or disease status of an individual regardless of the narrow diagnostic question that prompted it. We suggest that early discussion of ethical issues in clinical proteomics can ensure that eventual health care practices and regulations reflect the considered judgment of the community and anticipate opportunities and problems that may arise as the technology matures., Graphical Abstract, Highlights • Principles of bioethics as they relate to clinical proteomics. • Systematic literature review of ethics in clinical proteomics. • Prospects for preventive proteomics profiling. • Importance of early discussion of ethical issues to ensure eventual regulations reflect the considered judgment of the community., In Brief We introduce bioethical principles and use these as operational definitions to carry out a systematic review of the literature on ethical issues in clinical proteomics. We identify 10 ethical themes across 16 studies, many of which are familiar from other fields. We therefore survey how genomics has dealt with ethical issues and regulation. We also add our own perspectives on the ethical aspects of study design and sample treatment as well as the ethical potential of preventive proteomics profiling.