The European legislator has included the fulfilment service provider (FSP) in European product safety legislation as a new responsible economic operator (EO) in e-commerce for instances where no other EO is based in the European Union. As a matter of coherency, this adjusted personal scope of product safety law will likely be mirrored in a revised product liability directive. This article explores to what extent the aims and expectations of European legislator with respect to these legal changes (law in the books) align with the perceptions of FSPs and legal advisors in the field (law in action). This is done by means of a legal analysis of the goals and envisioned effects of these changes as well as a semi-structured interview study on how FSPs and legal advisors in the field perceive this new role, responsibility, and liability. The findings provide indications that product safety law currently in force might not (yet) lead to the desired effects. The findings also make us question the extent to which victim compensation is actually improved by the proposed adjustment of the personal scope of the product liability directive.

The robots of tomorrow should be endowed with the ability to adapt to drastic and unpredicted changes in their environment and interactions with humans. Such adaptations, however, cannot be boundless: the robot must stay trustworthy. So, the adaptations should not be just a recovery into a degraded functionality. Instead, they must be true adaptations: the robot must change its behaviour while maintaining or even increasing its expected performance and staying at least as safe and robust as before. The RoboSAPIENS project will focus on autonomous robotic software adaptations and will lay the foundations for ensuring that they are carried out in an intrinsically trustworthy, safe and efficient manner, thereby reconciling open-ended self-adaptation with safety by design. RoboSAPIENS will transform these foundations into ‘first time right’-design tools and platforms and will validate and demonstrate them.

While clozapine has risks, relative risk of fatality is overestimated. The UK pharmacovigilance programme is efficient, but comparisons with other drugs can mislead because of reporting variations. Clozapine actually lowers mortality, partly by reducing schizophrenia-related suicides, but preventable deaths still occur. Clozapine should be used earlier and more widely, but there should be better monitoring and better management of toxicity.

In vitro maturation of oocytes (IVM) represents an assisted reproductive technique that involves the minimal or absence of ovarian stimulation and is beneficial to specific groups of patients. These may include women with polycystic ovarian syndrome and/or patients who need a fertility preservation option before undergoing gonadotoxic treatment. However, when IVM is applied in cases where it is not recommended, it can be considered as an add-on technique, as described by the ESHRE Guideline Group on Female Fertility Preservation. Interestingly, IVM has not been proven yet to be as effective as conventional IVF in the laboratory, in terms of clinical pregnancy and live birth rates, while concerns have been raised for its long-term safety. As a result, both safety and efficacy of IVM remain still questionable and additional data are needed to draw conclusions.

The creation of a more sustainable economy is one of the main targets of the European Green Deal and the new Circular Economy Action Plan. Technological innovation is needed, among other things, to render materials, products, and production processes more sustainable. Given the goals of the European Green Deal, the regulatory concept of “Safe and Sustainable by Design” is increasingly receiving attention. The concept is (arguably) a precautionary and preventative measure that is implemented at the early stages of the design of a technology. Therefore, it is often described as a tool for lowering the risks that follow from efforts to create a more circular economy. The concept was included in the European Chemicals Strategy of the European Commission. The aim of the strategy is to accelerate progress towards the discovery of more sustainable chemicals and towards a toxicity-free environment. In this paper, we will explore the benefits and disadvantages of integrating the “Safe and Sustainable by Design” concept into the regulation of technology. As a form of regulation by technology, this concept can enhance sustainability. We will first describe the origins of the concept and its current use. Then, we will analyse its implications for the circular economy.

In recent issues of the Journal of the Society for Cardiovascular Angiography and Interventions and the Journal of the American College of Cardiology: Cardiovascular Interventions, Holzer and colleagues presented an Expert Consensus Document titled: “PICS / AEPC / APPCS / CSANZ / SCAI / SOLACI: Expert consensus statement on cardiac catheterization for pediatric patients and adults with congenital heart disease.” This Expert Consensus Document is a massively important contribution to the community of paediatric and congenital cardiac care. This document was developed as an Expert Consensus Document by the Pediatric and Congenital Interventional Cardiovascular Society, the Association for European Paediatric and Congenital Cardiology, the Asia-Pacific Pediatric Cardiac Society, the Cardiac Society of Australia and New Zealand, the Society for Cardiovascular Angiography and Interventions, and the Latin American Society of Interventional Cardiology, as well as the Congenital Cardiac Anesthesia Society and the American Association of Physicists in Medicine.

As perfectly stated in the Preamble of this Expert Consensus Document, “This expert consensus document is intended to inform practitioners, payors, hospital administrators and other parties as to the opinion of the aforementioned societies about best practices for cardiac catheterisation and transcatheter management of paediatric and adult patients with congenital heart disease, with added accommodations for resource-limited environments.” And, the fact that the authorship of this Expert Consensus Document includes global representation is notable, commendable, and important.

This Expert Consensus Document has the potential to fill an important gap for this patient population. National guideline documents for specific aspects of interventions in patients with paediatric heart disease, including training guidelines, do exist. However, this current Expert Consensus Document authored by Holzer and colleagues provides truly globally applicable standards on cardiac catheterisation for both paediatric patients and adults with congenital heart disease (CHD).

Our current Editorial provides different regional perspectives from senior physicians dedicated to paediatric and congenital cardiac care who are practicing in Europe, the Asia-Pacific region, Latin America, Australia/New Zealand, and North America. Establishing worldwide standards for cardiac catheterisation laboratories for children and adults with CHD is a significant stride towards improving the quality and consistency of care. These standards should not only reflect the current state of medical knowledge but should also be adaptable to future advancements, ultimately fostering better outcomes and enhancing the lives of individuals affected by CHD worldwide.

Ensuring that these standards are accessible and adaptable across different healthcare settings globally is a critical step. Given the variability in resources and infrastructure globally, the need exists for flexibility and tailoring to implement recommendations.

The potential impact of the Expert Consensus Document and its recommendations is likely significant, but heterogeneity of healthcare systems will pose continuing challenges on healthcare professionals. Indeed, this heterogeneity of healthcare systems will challenge healthcare professionals to finally close the gap between acceptable and ideal in the catheterisation of patients with paediatric and/or congenital heart disease.

Bentonites are readily available clays used in the livestock industry as feed additives to reduce aflatoxin (AF) exposure; their potential interaction with nutrients is the main concern limiting their use, however. The objective of the present study was to determine the safety of a dietary sodium-bentonite (Na-bentonite) supplement as a potential AF adsorbent, using juvenile Sprague Dawley (SD) rats as a research model. Animals were fed either a control diet or a diet containing Na-bentonite at 0.25% and 2% (w/w) inclusion rate. Growth, serum, and blood biochemical parameters, including selected serum vitamins (A and E) and elements such as calcium (Ca), potassium (K), iron (Fe), and zinc (Zn) were measured. The mineral characteristics and the aflatoxin B1 sorption capacity of Na-bentonite were also determined. By the end of the study, males gained more weight than females in control and Na-bentonite groups (p ≤ 0.0001); the interaction between treatment and sex was not significant (p = 0.6780), however. Some significant differences between the control group and bentonite treatments were observed in serum biochemistry and vitamin and minerals measurements; however, parameters fell within reference clinical values reported for SD rats and no evidence of dose-dependency was found. Serum Na and Na/K ratios were increased, while K levels were decreased in males and females from Na-bentonite groups. Serum Zn levels were decreased only in males from Na-bentonite treatments. Overall, results showed that inclusion of Na-bentonite at 0.25% and 2% did not cause any observable toxicity in a 3-month rodent study.

Social media is not a neutral channel. How visible information posted online is depends on many factors such as the network structure, the emotional volatility of the content, and the design of the social media platform. In this paper, we use formal methods to study the visibility of agents and information in a social network, as well as how vulnerable the network is to exploitation. We introduce a modal logic to reason about a social network of agents that can follow each other, post, and share information. We show that by imposing some simple rules on the system, a potentially malicious agent can take advantage of the network construction to post an unpopular opinion that may reach many agents. The network is presented both in static and dynamic forms. We prove completeness, expressivity, and model checking problem complexity results for the corresponding logical systems.

Available data suggest that the immunogenicity of COVID-19 vaccines might decrease in the immunocompromised population, but data on vaccine immunogenicity and safety among people living with HIV (PLWH) are still lacking. The purpose of this meta-analysis is to compare the immunogenicity and safety of COVID-19 vaccines in PLWH with healthy controls. We comprehensively searched the following databases: PubMed, Cochrane Library, and EMBASE. The risk ratio (RR) of seroconversion after the first and second doses of a COVID-19 vaccine was separately pooled using random-effects meta-analysis. Seroconversion rate was lower among PLWH compared with healthy individuals after the first (RR = 0.77, 95% confident interval (CI) 0.64–0.92) and second doses (RR = 0.97, 95%CI 0.95–0.99). The risk of total adverse reactions among PLWH is similar to the risk in the healthy group, after the first (RR = 0.87, 95%CI 0.70–1.10) and second (RR = 0.83, 95%CI 0.65–1.07) doses. This study demonstrates that the immunogenicity and safety of SARS-CoV-2 vaccine in fully vaccinated HIV-infected patients were generally satisfactory. A second dose was related to seroconversion enhancement. Therefore, we considered that a booster dose may provide better seroprotection for PLWH. On the basis of a conventional two-dose regimen for COVID-19 vaccines, the booster dose is very necessary.