The European Union and some of its institutions have taken significant steps to address the challenges posed by the development and use of Artificial Intelligence (AI) in various contexts. The ubiquity of AI applications in everyday life, affecting both citizens and professionals, has made AI a common topic of discussion. However, as is evident from the documents analyzed here, concerns have been raised about the possible negative social consequences of AI, in particular discriminatory bias, making it a particularly relevant issue if people-centred, rights-based AI is to be implemented. This article aims to examine the challenges of defining, identifying and mitigating discriminatory bias in AI systems from two perspectives: (1) to conduct an ethical and normative review of European Commission documents from the last 8 years (from GDPR to AI Act regulation); and (2) to expose recommendations for key stakeholders, including designers, end-users and public authorities, to minimize/mitigate this risk. The document review was carried out on 21 EU regulatory and ethical guidelines in the field of AI, from which 152 measures were extracted, differentiated between design, governance and organizational measures. It has also been observed that there is no clear conceptual framework on the issue at the European level, showing a clear problem in providing definitions of algorithmic bias and discrimination, but not in assessing their potential negative impact on individuals. Secondly, these gaps may affect the concreteness and detail of the possible mitigation/minimization measures proposed and, subsequently, their application in different contexts. Finally, the last section of this paper presents a brief discussion and conclusions on possible issues related to the implementation of the measures extracted and certain limitations of the study.

UNASSIGNED: A radical shift in energy production is underway worldwide, replacing fossil fuels with renewable sources and causing structural changes in power generation systems.
UNASSIGNED: Photovoltaic installations for self-consumption have experienced a steep increase in recent years. They have reached a significant installed capacity to cause a noticeable reduction in consumption from the national grid, which can cause serious management problems.
UNASSIGNED: In this work, the evolution of the Spanish demand in the last years is analyzed to identify the influence of self-consumption in the overall demand. In addition, a mathematical model is defined to estimate this influence.
UNASSIGNED: The demand curves of equivalent days in years with high and low installed self-consumption photovoltaic systems have been compared. Then, an estimation of the electricity generated with this source is proposed, with a mathematical model that takes into account data on solar radiation, installed photovoltaic power for self-consumption and other relevant factors.
UNASSIGNED: The analysis of the demand has shown a significant reduction of the electricity demand in daylight hours when the number of self-consumption photovoltaic systems increases. Moreover, the proposed model has been able to provide an estimation of the electricity generated with this source. The addition of these estimates to the actual consumption curves of years with a high number of self-consumption installations gives profiles close to those obtained when self-consumption was low.
UNASSIGNED: New storage systems need to be implemented and grid management need to be improved to take advantage of the surpluses produced by photovoltaic systems.

The management and reconstruction of critical-sized segmental bone defects remain a major clinical challenge for orthopaedic clinicians and surgeons. In particular, regenerative medicine approaches that involve incorporating stem cells within tissue engineering scaffolds have great promise for fracture management. This narrative review focuses on the primary components of bone tissue engineering-stem cells, scaffolds, the microenvironment, and vascularisation-addressing current advances and translational and regulatory challenges in the current landscape of stem cell therapy for critical-sized bone defects. To comprehensively explore this research area and offer insights for future treatment options in orthopaedic surgery, we have examined the latest developments and advancements in bone tissue engineering, focusing on those of clinical relevance in recent years. Finally, we present a forward-looking perspective on using stem cells in bone tissue engineering for critical-sized segmental bone defects.

Patch testing is the only clinically applicable diagnostic method for Type IV allergy. The availability of Type IV patch test (PT) allergens in Europe, however, is currently scarce. This severely compromises adequate diagnostics of contact allergy, leading to serious consequences for the affected patients. Against this background, the European Society of Contact Dermatitis (ESCD) has created a task force (TF) (i) to explore the current availability of PT substances in different member states, (ii) to highlight some of the unique characteristics of Type IV vs. other allergens and (iii) to suggest ways forward to promote and ensure availability of high-quality patch testing substances for the diagnosis of Type IV allergies throughout Europe. The suggestions of the TF on how to improve the availability of PT allergens are supported by the ESCD, the European Academy of Allergy and Clinical Immunology, and the European Academy of Dermatology and Venereology and intend to provide potential means to resolve the present medical crisis.

A modular strategy is described for the testing and assessment (MoSt) of non-genotoxic carcinogenicity (NGTxC) that is suitable for regulatory applications. It utilizes and builds upon work conducted by the OECD expert group on NGTxC. The approach integrates relevant test methods from the molecular- to cellular- and further to tissue level, many of which have been recently reviewed. Six progressive modules are included in the strategy. Advice is provided for the iterative selection of the next appropriate test method within each step of the strategy. Assessment is completed by a weight of evidence conclusion, which integrates the different streams of modular information. The assessment method gives higher weight to findings that are mechanistically linked with biological relevance to carcinogenesis. With a focus on EU-REACH, and pending upon successful test method validation and acceptance, this will also enable the MoSt for NGTxC to be applied for regulatory purposes across different regulatory jurisdictions.

Feed costs present a major burden in animal production for human consumption, representing a key opportunity for cost reduction and profit improvement. Nanotechnology offers potential to increase productivity by creating higher-quality and safer products. The feed sector has benefited from the use of nanosystems to improve the stability and bioavailability of feed ingredients. The development of nanotechnology products for feed must consider the challenges raised by biological barriers as well as regulatory requirements. While some nanotechnology-based products are already commercially available for animal production, the exponential growth and application of these products requires further research ensuring their safety and the establishment of comprehensive legislative frameworks and regulatory guidelines. Thus, this article provides an overview of the current state of the art regarding nanotechnology solutions applied in feed, as well as the risks and opportunities aimed to help researchers and livestock producers.

Seeds, as the initial products in agricultural systems, play a pivotal role in ensuring quality, fundamental to national food security and sustainable agricultural development. This study introduces a concept integrating public governance and evolutionary game theory to construct a quadripartite evolutionary game model involving seed companies, certification agencies, farmers, and governmental departments. It considers the strategic choices of these stakeholders under varying economic motivations and market mechanisms, as well as the influence of external regulation and incentives on game strategies. The existence conditions for evolutionarily stable strategy combinations are determined using the Lyapunov first method, and MATLAB is employed for numerical simulation analysis to validate the game analysis under initial conditions. The simulation results reveal two potential equilibrium points corresponding to different strategic choices among stakeholders. The study finds that producing high-quality seeds and the refusal of certification agencies to engage in rent-seeking are crucial for ensuring seed quality. Additionally, the cost-benefit ratio of seed companies, the speculative cost of certification agencies, and the rights-protection cost of farmers are key determinants in the evolution of seed quality assurance strategies. This research also holds practical significance in enhancing seed quality assurance mechanisms and fostering sustainable development in agriculture.

Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increased safety and clinical effectiveness. The emergence of innovative CPs poses new challenges for regulatory agencies in assigning jurisdiction for premarket review and oversight. In US, the 1990 Safe Medical Devices Act defines and provides classification criteria for CPs, and the US government has developed a regulatory process through multiple acts, including the 21st Century Cures Act of 2016. Meanwhile, regulators in the European Union (EU) and the Republic of Korea have recently recognized the importance of premarket pathways for CPs. The European Medicines Agency (EMA) has issued guidelines and explanations on compliance issues related to drug-device CPs under MDR. EMA doesn\'t have the definitions of CPs, but uses the term drug-device combination products (drug-device CPs). CPs are categorized as drugs or medical devices, which follow their relevant regulatory framework. The Ministry of Food and Drug Safety (MFDS) in Korea has legal definitions of CPs under the Notice of the MFDS. CPs are designated as drugs or medical devices according to their primary mode of actions (PMOA) and follow regulatory processes through the framework of drugs or medical devices. This study aims to comprehensively summarize the regulatory oversight of CPs by analyzing the regulatory policies and legal frameworks in the US, the EU, and Korea. The regulatory challenges encountered when developing CPs are also discussed. With specific emphasis on the combination of drugs and devices, this study provides in-depth insights into the regulatory landscape, shedding light on the unique challenges associated with the development of CPs for this particular intersection of drugs and devices.

In an organization with highly specialized and changing services over the course of a working life, such as health services managed directly by public administrations (DM-NHS) are, the issues related to the recruitment, selection and retention of professionals should receive special attention. much larger than what is provided. For too long, the DM-NHS has mainly been working to resolve the problems that affect the organization, with enormous disregard for those suffer by the recipients of its services, the real population to which it provides assistance. In the DM-NHS, its administration (rather than management) of human resources is circumscribed by the contours of the Framework Statute and its implementing regulations and rulings. This is an inadequate instrument, both empirically in view of the results obtained (50% temporary employment among professionals working in the NHS), and conceptually, since it fails to comply with the reasons that normatively justify its existence: \"that its legal regime is adapts to the specific characteristics of the practice of health professions, as well as the organizational peculiarities of the National Health System\". The text describes the characteristics of statutory regulation and reviews how regulatory restrictions affect recruitment, selection and retention policies. Finally, possible alternatives are proposed to have coherent and rational permanent staffing policies that cover the real needs of the health services.

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. Methods: The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.