The voyage data recorder (VDR) is a data recording system that aims to provide all navigational, positional, communicational, sensor, control and command information for data-driven investigation of accidents onboard ships. Due to the increasing dependence on interconnected networks, cybersecurity threats are one of the most severe issues and critical problems when it comes to safeguarding sensitive information and assets. Cybersecurity issues are extremely important for the VDR, considering that modern VDRs may have internet connections for data transfer, network links to the ship's critical systems and the capacity to record potentially sensitive data. Thus, this research adopted failure modes and effects analysis (FMEA) to perform a cybersecurity risk assessment of a VDR in order to identify cyber vulnerabilities and specific cyberattacks that might be launched against the VDR. The findings of the study indicate certain cyberattacks (false information, command injection, viruses) as well as specific VDR components (data acquisition unit (DAU), remote access, playback software) that required special attention. Accordingly, preventative and control measures to improve VDR cybersecurity have been discussed in detail. This research makes a contribution significantly to the improvement of ship safety management systems, particularly in terms of cybersecurity.

Responding to mistrust in the European agencies’ risk assessments in politically salient cases, the European Union (EU) legislator, the European Food Safety Authority and the European Medicines Agency alike have accelerated their efforts to foster EU regulatory science transparency. These simultaneous endeavours have, however, taken place in a fragmented legislative and administrative context, with each agency operating under a different legal framework. By focusing on authorisation procedures, from registration of studies to authorisation of novel foods, pesticides and human medicines, this article examines the resulting regimes governing the disclosure of scientific data by EU agencies to identify common trends and sectoral specificities. Against the background of an overall shift towards enhanced transparency, we shed light on, first, the circulation of institutional arrangements and practices among agencies and, second, the new dimensions of transparency emerging from these developments. We also highlight the remaining sectoral differences and argue that they could have potentially large impacts on the amount and type of information disclosed and on the level of transparency perceived by stakeholders and citizens. We argue that more coherence across the sectoral transparency regimes is needed, in particular in light of the agencies’ contested legitimacy and of their increasing cooperation on cross-cutting issues like antimicrobial resistance and medicine and pesticide residues in food.

The welfare of transgenic animals is often not considered prior to their generation. However, we demonstrate here how a welfare risk assessment can be carried out before transgenic animals are created. We describe a risk assessment identifying potential welfare problems in transgenic pigs generated for future xeno-donation of organs. This assessment is based on currently available information concerning transgenic animal models in which one or more transgenes relevant to future xeno-donation have been inserted. The welfare risk assessment reveals that future xeno-donor pigs may have an increased tendency toward septicaemias, reduced fertility and/or impaired vision. The transgenic animal models used in generating hypotheses about the welfare of xeno-donor pigs can also assist in the testing of these hypotheses. To ensure high levels of welfare of transgenic animals, analogous risk assessments can be used to identify potential welfare problems during the early stages of the generation of new transgenic animals. Such assessments may form part of the basis on which licenses to generate new transgenic animals are granted to research groups.

Risk is defined as a situation involving exposure to danger. Risk assessment by nature characterises the probability of a negative event occurring and quantifies the consequences of such an event. Risk assessment is increasingly being used in the field of animal welfare as a means of drawing comparisons between multiple welfare problems within and between species and identifying those that should be prioritised by policy-makers, either because they affect a large proportion of the population or because they have particularly severe consequences for those affected. The assessment of risk is typically based on three fundamental factors: intensity of consequences, duration affected by consequences and prevalence. However, it has been recognised that these factors alone do not give a complete picture of a hazard and its associated consequences. Rather, to get a complete picture, it is important to also consider information about the hazard itself: probability of exposure to the hazard and duration of exposure to the hazard. The method has been applied to a variety of farmed species (eg poultry, dairy cows, farmed fish), investigating housing, husbandry and slaughter procedures, as well as companion animals, where it has been used to compare inherited defects in pedigree dogs and horses. To what extent can we trust current risk assessment methods to get the priorities straight? How should we interpret the results produced by such assessments? Here, the potential difficulties and pitfalls of the welfare risk assessment method will be discussed: (i) the assumption that welfare hazards are independent; (ii) the problem of quantifying the model parameters; and (iii) assessing and incorporating variability and uncertainty into welfare risk assessments.

Science forms a vital part of animal welfare assessment. However, many animal welfare issues are more influenced by public perception and political pressure than they are by science. The discipline of epidemiology has had an important role to play in examining the effects that management, environment and infrastructure have on animal-based measures of welfare. Standard multifactorial analyses have been used to investigate the effects of these various inputs on outcomes such as lameness. Such research has thereby established estimates of the probability of occurrence of these adverse welfare outcomes (AWOs) and given exposure to particular management inputs (welfare challenges). Welfare science has established various measures of the consequences of challenges to welfare. In this paper, a method is proposed for comparing the likely impact of different welfare challenges, incorporating both the probability of AWOs resulting from that welfare challenge, and their impacts or consequences if they do, using risk assessment principles. The rationale of this framework is explained. Its scope lies within a science-based risk assessment framework. This method does not provide objective measures or score of welfare without some context of comparison and does not provide new welfare measures but only provides a framework enabling objective comparison. Possible applications of this method include comparing the effects of specific management inputs, assigning priority to welfare challenges in order to inform allocation of resources for addressing those challenges, and comparisons of the lifetime welfare effects of management inputs or systems. The use of risk assessment methods in the animal welfare field can facilitate objective comparisons of situations that are currently assessed with some level of subjectivity. This methodology will require significant validation to determine its most productive use. The risk assessment approach could have a productive role in advancing quantitative assessment in animal welfare science.

In Australia, flystrike can severely compromise sheep welfare. Traditionally, the surgical practice of mulesing was performed to alter wool distribution and breech conformation and thereby reduce flystrike risk. The aim of this study was to use published data to evaluate the effectiveness of an epidemiologically based risk assessment model in comparing welfare outcomes in sheep undergoing mulesing, mulesing with pain relief, plastic skin-fold clips, and no mulesing. We used four measures, based on cortisol, haptoglobin, bodyweight and behavioural change, across three farming regions in Australia. All data were normalised to a common scale, based on the range between the highest and lowest responses for each variable (‘welfare impact’; I). Lifetime severity of welfare challenge (SWC) was estimated by summing annual SWCs (SWC = I × P, where P = probability of that impact occurring). The severity of welfare challenge during the first year of life was higher for mulesed animals compared to unmulesed. However, over five years of life, the highest severity of welfare challenge was for unmulesed animals, and the lowest was for the plastic skin-fold clips. The model produced estimates of SWC that are in broad agreement with expert consensus that, although mulesing historically represented a welfare benefit for sheep under Australian conditions, the replacement of mulesing with less invasive procedures, and ultimately genetic selection combined with anti-fly treatments, will provide a sustainable welfare benefit. However, the primary objective of this work was to evaluate the use of the risk assessment framework; not to compare welfare outcomes from mulesing and its alternatives.

The Food and Drug Administration (FDA) warned against administering over-the-counter cough and cold medicines to children under 2. This study evaluated whether experienced parents show poorer adherence to the FDA warning, as safe experiences are predicted to reduce the impact of warnings, and how adherence can be improved. Participants included 218 American parents (mean age: 29.98 (SD = 6.16), 82.9% female) with children age ≤ 2 who were aware of the FDA warning. We compared adherence among experienced (N=142; with other children > age 2) and inexperienced parents (N=76; only children ≤2). We also evaluated potential moderating variables (amount of warning-related information received, prevalence of side effects, trust in the FDA, frequency of coughs and colds, trust in drug packaging) and quantified the impact of amount of information. Logistic regression assessed the ability of experience alone, and experience combined with amount of information, to predict adherence. 53.3% of inexperienced but 28.4% of experienced parents were adherent (p = 0.0003). The groups did not differ on potential moderating variables. Adherence was 39.5% among experienced parents receiving “a lot of information”, but 15.4% for those receiving less (p = 0.002); amount of information did not affect adherence in inexperienced parents (p = 0.22) but uniquely predicted adherence compared to a model with experience alone (p = 0.0005). Experienced parents were also less likely to mistrust drug packaging (p = 0.03). Targeting FDA information to experienced parents, particularly via drug packaging, may improve their adherence.

Digital psychiatry could empower individuals to navigate their context-specific experiences outside healthcare visits. This editorial discusses how leveraging digital health technologies could dramatically transform how we conceptualise mental health and the mental health professional's day-day practice, and how patients could be enabled to navigate their mental health with greater agency.

The strong, life-long association between epilepsy and intellectual disability means that psychiatric teams, and the services they exist in, have a need for significant competencies in the field of epilepsy. This article addresses these competencies through the pathway of care. It will focus on those areas most relevant to psychiatric care and, when possible, explore where technology has begun to influence practice. The pathway leads from diagnosis through, in some cases, to mortality and support of the bereaved in psychiatric care. We will approach the topic through showing how the intertwining themes of information, empowerment, access to care, assessment of risk and psychological support are important. Technological advances are supporting changes in most of these areas, and psychological support, a knowledge of the needs of people with epilepsy and intellectual disability and epilepsy skills remain the foundation in the application of these advances.

Risk assessment in clinical practice is often characterised as a process of analysing information so as to make a judgement about the likelihood of harmful behaviour occurring in the future. However, this characterisation is brought into question when the evidence does not support the current use of risk assessment approaches to predict, or provide probability estimates of, future behaviour in a way that is usable in single instances arising in individual cases. This article sets out a broader and more clinically applicable description of risk assessment which takes account of the wider influences on how this clinical activity takes place. In so doing, it provides a framework to guide clinicians, researchers and authors of practice guidance who are interested in improving approaches to risk assessment.