The use of AI in healthcare has sparked much debate among philosophers, ethicists, regulators and policymakers who raised concerns about the implications such technologies. presented scoping review captures progression ethical legal proposed frameworks available concerning AI-based medical technologies, capturing key themes across a wide range contexts. dimensions are synthesised order to produce coherent framework for highlighting how transparency, accountability, confidentiality, autonomy,...

Abstract COVID-19 pandemic is plaguing the world and representing most significant stress test for many national healthcare systems services, since their foundation. The supply-chain disruption unprecedented request intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions prevention, treatment management this disease which involving large amount people. Every day, new Do-It-Yourself (DIY) regarding...

To date (April 2021), medical device (MD) design approaches have failed to consider the contexts where MDs can be operationalised. Although most of global population lives and is treated in Low- Middle-Income Countries (LMCIs), over 80% MD market share high-resource settings, which set de facto standards that cannot taken for granted lower resource settings. Using a designed settings LMICs may hinder its safe efficient operationalisation. In literature, many criteria frameworks support...

Abstract Purpose European Extended Reality (XR) industry is expected to significantly increase by 2025 with an extreme impact on the Healthcare scenario. Considering that transition period for Medical Device Regulation 2017/745 (MDR 2017/745) will end in May 2024, purpose of this study assess whether Regulatory Compliance ready cope inclusion XR and its possible social economic world medical device software (MDSW). Methods publications patterns were evaluated since MDR release different...

Abstract Purpose The aim of this paper is to present and validate a framework for assessing healthcare facilities in low-resource settings collect evidence inform policies on the harmonisation, regulation contextualised design medical devices. Methods A literature review focus groups with several experts device design, clinical engineering, health technology assessment management, allowed creation protocol, comprising two parts: semi-structured interview electrical safety measures. Results...

Abstract Background Identifying individual and contextual factors that influence adolescent well-being is a research priority. This study aimed to assess the prevalence of symptoms mental health problems some related in Italian adolescents 2017–2018. Methods The present was cross-sectional survey among 3002 students aged 15–16 years who resided two provinces, North South Italy. Symptoms were assessed using SDQ CES-DC, students’ risk-taking behaviors school climate perception assessed. All...

Regulatory frameworks surrounding medical devices (MDs) and locations are of utter importance for safeguarding patients users, granting a universal access to healthcare. Currently, as the main existing regulatory drafted by high-income countries, they pretend be general applicable globally, but fail understand particular contexts, specifically those in low-resource settings (LRSs), resulting, therefore, inapplicable. In particular, LRSs present varied situation, with legal transplants...

L'une des stratégies clés retenues pour la lutte contre COVID-19 au Bénin a consisté en vaccination progressive populations. Mais campagne de déployée n'a pas emporté l'adhésion populations cibles point faire émerger problématique l'acceptabilité vaccinale. Cet article objectif d'appréhender les controverses suscitées à cet effet, partant l'analyse données d'entretiens collectées auprès ces dernières. Il s'ensuit que politiques mises place manquent d'efficacité parce qu'elles sont peu...

Background: Pandemic management and preparedness are more needed than ever before there is widespread governmental interest in learning from the COVID-19 pandemic order to ensure availability of evidence-based Infection Prevention Control measures. Contact tracing integral Control, facilitating breaks chain transmission a targeted way, identifying individuals who have come into contact with an infected person, providing them instruction/advice relating testing, medical advice and/or...

In March 2019, the World Health Organization (WHO) declared that humanity was entering a global pandemic phase. This unforeseen situation caught everyone unprepared and had major impact on several professional categories found themselves facing important ethical dilemmas. The article revolves around category of biomedical clinical engineers, which were among those most involved in dealing with finding solutions to pandemic. hindsight, issues brought attention engineers have raised...

This project aims to assess and analyse the perception impact of COVID-19 pandemic in Benin. The applied research methodology was interdisciplinary combined field studies that used ethnographic social methods with coding data analysis, leading theoretical dilemmas, which were analysed from viewpoint bioethical reflection. Furthermore, biomedical engineering approaches preparedness COVID-19. Despite due promoted governmental measures, a peculiar management emerged. latter, although...

Introduction This article aims at investigating social engagement in the fight against COVID-19 pandemic low-resource settings (LRSs). In particular, it focuses on Benin (Sub-Saharan Africa), and reports results of a field study that investigated local people's acceptance vaccine tracking program. Methods project is product collaboration between ABSPIE (Applied Biomedical Signal Processing E-Health) Lab University Warwick (UK) LAMA (Laboratoire d'Antropologie Medical Appliqué) Abomey Calavi...

Abstract Purpose From previous studies, we had observed that the number of biomedical engineers and technicians (BMETs) skilled in maintenance medical devices (MDs) were limited sub-Saharan Africa (SSA) a likely parallelism existed between BME maintenance-related tasks house chores mainly carried out by women daily life. Our objective carrying this study was to understand underlying local cultural social factors domestic traditions interfering with inclusion field clinical engineering (BME),...

Abstract Purpose This manuscript presents a parallel among important EU legal frameworks, such as the Medical Device Regulations and General Data Protection Regulation economic-historical challenges faced by European citizens. offers prospective for understanding direction taken policymakers forthcoming regulations, Health Space AI-Act. Method The paper describes key commonalities differences those which may help scholars working with AI in medicine, navigating this articulated framework....

Abstract This paper examines the ethical and legal challenges encountered during GATEKEEPER Project how these informed development of a comprehensive framework for future Large-Scale Pilot (LSP) projects. is LSP with 48 partners conducting 30 implementation studies across Europe 50,000 target participants grouped into 9 Reference Use Cases. The project underscored complexity obtaining approval various jurisdictions divergent regulations procedures. Through detailed analysis issues faced...

Post-partum haemorrhage is among the main causes of (preventable) mortality for women in low-resource settings (LRSs), where, 2017, ratio was 462 out every 100 000 live births, over 10 times higher than high-resource settings. There are different treatments available post-partum haemorrhage. The intrauterine balloon tamponade a medical device that proved to be simple and cost-effective approach. Currently, there several tamponades available, with design working principles. However, all these...