MDCG 2019-16 is intended to assist practitioners in compliance with the Medical Device Regulation and the In-Vitro Device Regulation. This paper presents a gap analysis of MDCG 2019-16, identifying key gaps and proposing a robust set of recommendations to enhance the IoMT regulatory framework. This work has been undertaken by a selection of current (2023-2025) projects, all funded under the Horizon Europe call "Enhancing cybersecurity of connected medical devices": HORIZON-HLTH-2022-IND-13-01, and this paper summarizes observations and recommendations from across these projects. There is considerable consensus across the projects in many recommendation themes, notably; linking cybersecurity with patient safety and privacy; keeping the guidelines current; and usage recipes for the guidelines. The paper also suggests toolkit solutions to address some of the recommendations.

Global environmental and social change are pushing wildfire activity and impact beyond known trajectories. Here, we conducted a targeted review to distill five wildfire challenges that we argue form opportunities for their governance (research aim 1). We exemplified our arguments by drawing from the case of Cyprus (research aim 2), a small island country in the south-east European Mediterranean Basin at risk of extreme wildfire impact. Findings indicate that burning for social and ecological resource benefits, innovative management paradigms and anticipatory governance systems offer actionable solutions to the wildfire paradox and the limits of suppression. Local adaptive institutions and a reconceptualisation of wildfire as a risk and process beyond technocratic interpretations are necessary to account for broader social conditions shaping wildfire regimes and community impact. Governance systems that accommodate collective action have proven suitable to address multiple wildfire complexities linked with different socio-economic systems and values. A systematic literature review, policy review, and qualitative data collection on wildfire management in Cyprus track back to the initial framing. Our case study offers insights for tackling wildfires with actionable steps through overarching governance systems, and illustrates the potential for change in thinking of and acting on wildfire in flammable landscapes globally.

This paper investigates the views of practitioners on the decision-making influences and the transnational considerations affecting risk assessment (RA) for critical infrastructure (CI) and its protection (CIP). The investigation is based on a thematic analysis of the interviews of twelve RA practitioners. The analysis identified an overarching theme supporting the view that the team approach is the one true remedy to RA process shortcomings as well as five other themes: (1) the value of the human influence in RA; (2) transnationalism - an unfathomable notion; (3) consistency is no panacea to performance; (4) CI organizational RA-influencing forces; and (5) CI RA-enablers and impediments. The investigation suggests that the team approach to effective RA for CIP is considered as the absolute panacea in the eyes of practitioners although both insights from the current industry RA practice through the interviews themselves, and an investigation of relevant literature suggests that although this is warmheartedly recommended (a) there are no set rules and guidelines in its application, (b) it is not coordinated nor applied consistently, and (c) it is not an integral part of RA processes. Notwithstanding the reality that a team approach to RA for CIP is being contemplated by practitioners, albeit with lagging consistency and coordination, it is evident that additional research is necessary to broaden the understanding of its value.

Fire and explosion are one of the fatal causalities frequently encountered in maritime transportation. Due to technical or/and human error, fire and explosion can be occurred either in the cargo hold or deck of bulk carriers. According to the EMSA report (2022), fire and explosion causalities were ranked 4th on the top. Fire and explosion accidents onboard may pose hazards for human life and the maritime environment. In this context, performing a comprehensive risk assessment is of paramount importance for safer navigation, cargo operation, and the marine environment. This study aims to assess the risks, including human errors, of fire and explosion accidents in cargo holds and decks of bulk carriers under the fuzzy Bayesian networks (BN) approach. Since BN provides a robust tool for calculating the conditional probability of risk, fuzzy sets deal with uncertainty and ambiguity during expert judgments. The outcomes of the paper are expected to contribute to bulk carrier ship owners, safety superintendents, HSEQ managers, Master, Chief officers, and crew on-board ships to understand basic events that may cause fire and explosion and to improve safety at the operational level.

There is currently insufficient evidence of a beneficial effect to recommend vitamin D supplementation for optimizing glycemic status in patients with type 2 diabetes mellitus (T2DM). Taking into consideration the significant extra-skeletal effect of vitamin D on pancreatic β-cell function and insulin secretion and the large number of scientific evidence supporting the inverse association between vitamin D status and hyperglycemia, this review article aims to examine whether vitamin D supplementation therapies are beneficial to patients with T2DM considering specific factors through randomized controlled trials (RCTs). EBSCOhost and Medline databases were searched from the beginning of 2009 until the end of 2014 for RCTs in patients with T2DM. Parameters, such as baseline vitamin D levels, frequency/dosage of supplementation, length of the study and type of supplementation, were independently assessed, based on their effect on glycemic status. Although all different types of supplementation were safe and effective in the achievement of vitamin D sufficiency in a dose-dependent way, the impact on glycemic status was different. 14 RCTs were included with daily supplementations ranging from 400-11.200 IU/daily, 40.000-50.000 IU/weekly and 100.000-300.000 IU/intramuscularly or once given, for a period from 8 to 24 weeks. Daily supplementation of vitamin D (up to 11.200 IU) showed no effect, whereas combined supplementation, with calcium (≥300 mg), and with vitamin D doses similar to the RDA, showed positive effects. Additionally, high weekly doses of vitamin D (40.000-50.000 IU) were effective on glycemic outcomes but available data are limited.

Various anatomic structures including bone, muscle, or fibrous bands may entrap and potentially compress branches of the mandibular nerve (MN). The infratemporal fossa is a common location for MN compression and one of the most difficult regions of the skull to access surgically. Other potential sites for entrapment of the MN and its branches include, a totally or partially ossified pterygospinous or pterygoalar ligament, a large lamina of the lateral plate of the pterygoid process, the medial fibers of the lower belly of the lateral pterygoid muscle and the inner fibers of the medial pterygoid muscle. The clinical consequences of MN entrapment are dependent upon which branches are compressed. Compression of the MN motor branches can lead to paresis or weakness in the innervated muscles, whereas compression of the sensory branches can provoke neuralgia or paresthesia. Compression of one of the major branches of the MN, the lingual nerve (LN), is associated with numbness, hypoesthesia, or even anesthesia of the tongue, loss of taste in the anterior two thirds of the tongue, anesthesia of the lingual gums, pain, and speech articulation disorders. The aim of this article is to review, the anatomy of the MN and its major branches with relation to their vulnerability to entrapment. Because the LN expresses an increased vulnerability to entrapment neuropathies as a result of its anatomical location, frequent variations, as well as from irregular osseous, fibrous, or muscular irregularities in the region of the infratemporal fossa, particular emphasis is placed on the LN.

The education of Roma children presents many challenges throughout the world because of poverty, issues of isolation and discrimination. In many countries where Roma reside, laws exist that prohibit discrimination against this minority group. A variety of conflicting issues exist for Roma children. On one hand, the Roma communities practice cultural norms that are in conflict with a typical schooling environment that requires significant structure and lack of independent support. Conversely, schools fail to provide appropriate bilingual instruction for Roma children who usually do not speak the local language. In most countries discrimination attitudes create segregated schools and insufficient social services. Many efforts and organizations are in place to positively impact these challenges to provide quality education for all Roma children.

Με δεδομένη την έλλειψη καταλογισμού ποινικών ευθυνών στα νομικά πρόσωπα στην ελληνική έννομη τάξη, η συγκεκριμένη μελέτη αναδεικνύει συγκεκριμένα προβλήματα που αφορούν την ατομική ποινική ευθύνη των διευθυνόντων/ διοικητών, αλλά και των εκπροσώπων επιχειρήσεων, σε περιπτώσεις που με τις πράξεις των τελευταίων τελείται άδικη ποινική πράξη. Μετά την παρουσίαση κάποιων βασικών στοιχείων που αφορούν το ποινικό δίκαιο της επιχείρησης, γίνεται μία παρουσίαση κάποιων συγκεκριμένων ζητημάτων που ανακύπτουν κατά την απόδοση ατομικών ποινικών ευθυνών στα φυσικά αυτά πρόσωπα των επιχειρήσεων. Ακολουθεί μία προσπάθεια θεμελίωσης αυτών με τη βοήθεια των παγιωμένων κανόνων του Ποινικού Δικαίου, τόσο αυτών της ελληνικής, όσο και αυτών της γερμανικής θεωρίας και νομολογίας, παραθέτοντας κάθε φορά τις απαιτούμενες προϋποθέσεις για την πλήρωση της νομοτυπικής υπόστασης κάθε μηχανισμού απόδοσης ποινικών ευθυνών. Γενικότερος στόχος στη συγκεκριμένη μελέτη είναι να γίνει όσο το δυνατόν πιο σαφές για το αν και με ποιο τρόπο ευθύνονται τα παραπάνω πρόσωπα σε περιπτώσεις, που η επιχείρηση αναπτύσσει εγκληματική δραστηριότητα.