User consent at the interface of the DMA and the GDPR : a privacy-setting solution to ensure compliance with ART. 5(2) DMA

The Digital Markets Act (DMA) is fully applicable since 2nd May 2023; the EU Commission has recently designated six firms having the status of ‘digital gatekeepers’ and thus subject to the DMA obligations. By imposing asymmetric regulation on ‘large’ digital platforms (i.e., gatekeepers), the new EU Regulation aims at improving the ‘fairness’ and ‘contestability’ of digital markets. In line with its goals, Art. 5(2) DMA prohibits gatekeepers from combining and cross using the end user’s data collected from different sources within its own eco-system. However, Art. 5(2) DMA offers some exceptions to this general prohibition: data combination, in fact, is possible if the end-user provides his/her ‘consent’ to such data combination, to benefit from more personalized services/advertisement from the gatekeeper. In particular, the users’ consent should comply with the requirements of Article 7 of the General Data Protection Regulation (GDPR). The paper discusses the relationship between the DMA and the GDPR, focusing on the users’ consent as a lawful basis to the processing activities of data combination and cross-use under Art. 5(2) DMA. The paper argues in favor of a ‘privacy setting’ solution, introduced by the gatekeeper within its platform service: at the first log in, the user would face on her/his screen a cookie wall, asking her/him to opt-in to specific types of data combination activities by the gatekeeper. Cookie walls have generally been considered not compatible with the GDPR requirement in terms of ‘free’ consent. However, in the online world, the emphasis on repeated, individual consent requests for every data processing has generated the so-called ‘consent fatigue’. In the paper, we argue that the DMA anti-circumvention provision addresses the consent fatigue issue: in our view, if the gatekeeper had to ask for the user’s consent every time before engaging in a data combination activity, this would represent a breach of Art. 13(6) DMA. Secondly, the paper argues that the DMA represents a lex specialis in comparison to the GDPR. Therefore, while respecting the general criteria indicated by Art. 7 GDPR, the user’s consent under Art. 5(2) DMA should be ‘adjusted’ to the peculiarities of the Digital Markets Act

News deserts in Europe : assessing risks for local and community media in the 27 EU member states

Published online: July 2023. Preliminary report - Literature review and methodologyThis preliminary report consists of a literature review of the existing research on EU countries regarding the state of local and community media, with the final aim of identifying the relevant theoretical and practical dimensions for understanding the phenomenon of “news deserts” in a European context. This report anticipates a wider study that will be published in January 2024 in the context of the project “Local Media for Democracy” (LM4D), which aims at supporting local, regional and community media in emerging ‘news deserts’ in Europe.The production and publication of this report is co-funded by the European Union as part of the Local Media for Democracy project. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union can be held responsible for them

Position statement on the Joint ITA–NIST–USPTO collaboration initiative regarding standards : notice of public listening and request for comments

On 11th September 2023, the US Patent and Trademark Office (USPTO), the International Trade Administration (ITA), and the National Institute for Standards and Technology (NIST) called for stakeholder input on the current state of U.S. firm participation in standard-setting, and the ability of U.S. industry to readily adopt standards to grow and compete, especially as they relate to the standardisation of critical and emerging technologies. The Centre for a Digital Society (CDS) of the European University Institute (EUI) is thankful for the opportunity to offer its comments. We would like to express our view on the legislative proposal of the European Commission (EC) for a Regulation on Standard Essential Patents (hereinafter, the Regulation) as it relates to question no. 1 of the Request for Comments on the impact of foreign IPR policies on US leadership and participation in international standard setting. Furthermore, concerning question no. 9 on possible standard-essential patents (SEP) transparency measures, we highlight the possibility of improving the USPTO patent register already in place

Monitoring media pluralism in the digital era : application of the media pluralism monitor in the European member states and in candidate countries in 2023

Published: 27 June 2024This report presents the results of the implementation of the Media Pluralism Monitor for the year 2023 (MPM2024). The MPM is a holistic tool geared at assessing the risks to media pluralism in EU member states and selected candidate countries (32 European countries in total, including Albania, Montenegro, the Republic of North Macedonia, Serbia, and Turkey). The MPM takes into account legal, political and economic variables that are relevant to analysing the levels of plurality of media systems in a democratic society. The Media Pluralism Monitor has been implemented, on a regular basis, by the Centre for Media Pluralism and Media Freedom, since 2013/2014.Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EACEA. Neither the European Union nor the granting authority can be held responsible for them

Position statement on the European Commission’s proposal for a SEPs regulation

On 27th April 2023, the European Commission published a proposal for a Regulation on Standard Essential Patents (hereinafter, SEPs Regulation) and allowed the public to provide feedback. The Centre for a Digital Society (CDS) of the European University Institute (EUI) is thankful for the opportunity to offer its comments and make suggestions on the proposed Regulation. Our team of researchers has significant research, policy and training experience in the areas of intellectual property, telecommunications regulation, standardisation and EU competition policy. In this Position Statement, we caution against adopting the proposed SEPs Regulation in its current form and suggest adopting guidance under Arts. 101 and 102 TFEU to clarify how SEP licensing should occur not to breach EU competition law. In the sub-optimal scenario where EU institutions would continue to pursue an immediate regulatory intervention, we provide substantial suggestions in an attempt to improve the current proposal of SEPs Regulation and limit certain negative consequences. Our constructive criticism aims to be a catalyst for the debate in the legislative process about the appropriate SEP licensing framework

Manifestações psiquiátricas na reumatologia: uma revisão sistemática / Psychiatric manifestations in rheumatology: a systematic review

Doenças reumatológicas, são doenças crônicas que geralmente apresentam múltiplas causas. São representadas principalmente pela artrite reumatoide e lúpus eritematoso sistêmico. Sabe-se, no entanto, que existe uma ligação entre os processos autoimunes subjacentes às doenças reumáticas e aos transtornos mentais. O objetivo desta revisão foi avaliar as manifestações psiquiátricas em pacientes com condições reumatológicas. Uma busca sistemática na literatura foi realizada, nos portais BIREME e PubMed de estudos publicados nos últimos 10 anos. A busca foi realizada utilizando descritores em português e seus correspondentes em inglês: “artrite reumatoide”, “lúpus eritematoso sistêmico”, “esclerose sistêmica” e “síndrome de Sjögren” e “manifestações psiquiátricas”. Os artigos que foram incluídos após leitura na íntegra, tiveram seus dados coletados em instrumento padronizado e elaborado antes do início da busca. foram identificados e adicionados através da estratégia de busca 14 artigos. Ansiedade, depressão, incapacidade cognitiva e insônia estão entre as manifestações psiquiátricas mais prevalentes. A frequente presença de manifestações psiquiátricas na reumatologia acende um alerta entre os profissionais para priorizar a qualidade de vida de seus pacientes, reduzindo suas limitações

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030