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MSCs products as well as their derived extracellular vesicles, are currently being explored as advanced biologics in cell-based therapies with high expectations for their clinical use in the next few years. In recent years, various strategies designed for improving the therapeutic potential of mesenchymal stromal cells (MSCs), including pre-conditioning for enhanced cytokine production, improved cell homing and strengthening of immunomodulatory properties, have been developed but the manufacture and handling of these cells for their use as advanced therapy medicinal products (ATMPs) remains insufficiently studied, and available data are mainly related to non-industrial processes. In the present article, we will review this topic, analyzing current information on the specific regulations, the selection of living donors as well as MSCs from different sources (bone marrow, adipose tissue, umbilical cord, etc.), in-process quality controls for ensuring cell efficiency and safety during all stages of the manual and automatic (bioreactors) manufacturing process, including cryopreservation, the use of cell banks, handling medicines, transport systems of ATMPs, among other related aspects, according to European and US legislation. Our aim is to provide a guide for a better, homogeneous manufacturing of therapeutic cellular products with special reference to MSCs.

Semantic legal metadata provides information that helps with understanding and interpreting legal provisions. Such metadata is therefore important for the systematic analysis of legal requirements. However, manually enhancing a large legal corpus with semantic metadata is prohibitively expensive. Our work is motivated by two observations: (1) the existing requirements engineering (RE) literature does not provide a harmonized view on the semantic metadata types that are useful for legal requirements analysis; (2) automated support for the extraction of semantic legal metadata is scarce, and it does not exploit the full potential of artificial intelligence technologies, notably natural language processing (NLP) and machine learning (ML). Our objective is to take steps toward overcoming these limitations. To do so, we review and reconcile the semantic legal metadata types proposed in the RE literature. Subsequently, we devise an automated extraction approach for the identified metadata types using NLP and ML. We evaluate our approach through two case studies over the Luxembourgish legislation. Our results indicate a high accuracy in the generation of metadata annotations. In particular, in the two case studies, we were able to obtain precision scores of 97,2% and 82,4%, and recall scores of 94,9% and 92,4%.

Europe is currently facing the potentially biggest energy crisis in history. There are many reasons for this, and the current geopolitical situation makes it clear that we are being forced to take immediate action to ensure sufficient energy supplies to consumers. Until recently, the European Union was dependent on Russian energy resources (mainly oil and gas). For many years, the EU countries had been shutting down their own production and importing much cheaper raw material from Russia. The threat of a blackout is becoming increasingly possible. European governments are preparing businesses and households for the energy crisis in various ways, but there is also a great deal of mobilization to accelerate the development of renewable energy sources (RES). The aim of this study was to identify the barriers and prospects for RES development in Poland in the current geopolitical conditions. The reasons for insufficient grid HC were analyzed. Additionally, the article aimed to assess the prospects for solar energy development in Poland. Wind power was discussed only in general terms because the development of wind farms is inhibited by the regulatory framework. Particular attention was paid to hosting capacity (HC) and the condition of the power infrastructure as the main determinants of RES development in Poland. Numerous documents developed by power companies and government agencies responsible for implementing and managing energy in Poland were analyzed. Special attention was paid to legal regulations and the need for legislative changes. As a country, Poland has one of the highest growth rates in photovoltaic (PV) installations. The forecasts for increasing HC, as a prerequisite for RES development in Poland, are not promising.

The future development of personalized medicine depends on a vast exchange of data from different sources, as well as harmonized integrative analysis of large-scale clinical health and sample data. Computational-modelling approaches play a key role in the analysis of the underlying molecular processes and pathways that characterize human biology, but they also lead to a more profound understanding of the mechanisms and factors that drive diseases; hence, they allow personalized treatment strategies that are guided by central clinical questions. However, despite the growing popularity of computational-modelling approaches in different stakeholder communities, there are still many hurdles to overcome for their clinical routine implementation in the future. Especially the integration of heterogeneous data from multiple sources and types are challenging tasks that require clear guidelines that also have to comply with high ethical and legal standards. Here, we discuss the most relevant computational models for personalized medicine in detail that can be considered as best-practice guidelines for application in clinical care. We define specific challenges and provide applicable guidelines and recommendations for study design, data acquisition, and operation as well as for model validation and clinical translation and other research areas.

Ensuring compliance of software systems with government regulations, policies, and laws is a complex problem. Generally speaking, solutions to the problem first identify rights and obligations defined in the law and then treat these as requirements for the system under design. This work examines the challenge of developing tool support for extracting such requirements from legal documents. To address this challenge, we have developed a tool called GaiusT. The tool is founded on a framework for textual semantic annotation. It semiautomatically generates elements of requirements models, including actors, rights, and obligations. We present the complexities of annotating prescriptive text, the architecture of GaiusT, and the process by which annotation is accomplished. We also present experimental results from two case studies to illustrate the application of the tool and its effectiveness relative to manual efforts. The first case study is based on the US Health Insurance Portability and Accountability Act, while the second analyzes the Italian accessibility law for information technology instruments.

The issue of safety in the use of machinery is an important issue for both manufacturers and employers. The current legislation imposes a number of obligations on manufacturers (essential requirements) and employers (minimum requirements) related to ensuring safety at every stage from design to operation. The study analyzes the possibility of applying selected Lean Manufacturing tools to improve occupational safety in the use of machinery (work equipment). The purpose of the study is to present the possibility of application of selected LM tools on operator safety, as well as to meet the requirements of legislators relating to safety related to the use of machinery. Implemented LM solutions improve communication and organization of work, and most importantly, reduce the risks associated with the operation of machinery and equipment.

Background This study aimed to reflect on scientific experts’ and executive stakeholders’ opinions on how charitable organizations can participate in the health care system properly and cope with problems, challenges, strategies, and executive requirements at three major levels of prevention, treatment, and rehabilitation. Methods A total number of 20 semi-structured interviews were conducted with scientific experts and executive stakeholders, selected for this qualitative study, based on an interview guide. Using the purposeful sampling method, we selected scientific experts with 5 years of experience in the health care system and executive stakeholders who had 5 years of experience in charitable activities. We applied a framework method for data analysis, and the main themes were extracted through MAXQDA software. Results Our findings revealed that charitable organizations at the major levels of the health care system, i.e., prevention, treatment, and rehabilitation, possessed the necessary capacities to provide services effectively. Nevertheless, charities encountered some problems, e.g., financial instability, non-recognition of donors’ legal status, non-involvement in policy-making, inadequate cooperation from other agencies, absence of transparent programs and goals, together with weaknesses in advertising and attracting donations. It was noted that the government should take more operational steps towards supporting such organizations, e.g., by granting special facilities and exemptions, engaging charities in policy-making and training processes, and empowering them in terms of the production of resources. Charitable organizations are also recommended to establish external communications with other bodies such as municipalities, secretaries of state, governorate offices, welfare organizations, relief committees, and medical sciences universities. Conclusions Charitable organizations have the potentials to provide health care services at prevention, treatment, and rehabilitation levels. Thus, it is of utmost importance to adopt strategies such as creating sustainable funding sources, training charity managers with a wide variety of scientific management techniques, and implementing their intellectual capacities in legislative and planning processes.

This work discusses the drivers and barriers (legal, chemical, biological, technical) related to implementing a circular economy model in the tire sector in Poland. The aim of this work was to identify and prioritize key factors determining the implementation of the circular economy business model, both among tire manufacturers and recyclers. The analysis of aspects facilitating the implementation of circular economy and the assessment of this type of project in organizations was the basis for identifying the most important factors in the development of eco-innovation in the tire industry. The research process used bibliometric analysis, empirical research based on a questionnaire and in-depth interviews of tire industry employees, and opinions of experts participating in a group interview. Research has indicated that the key to success in implementing the circular economy is to change actual business practices. The basic drivers of circular economy implementation in the tire sector are legal requirements and an organization’s profit associated with the use of circular economy actions. High environmental requirements and regulations that support a circular economy are key factors stimulating eco-innovative methods, but in most cases, these are more of a concern for recyclers than tire manufacturers. This study identified and hierarchized the determinants for implementing a circular economy model and indicated key factors influencing the development of eco-innovations among recyclers and tire manufacturers in Poland.

An important dimension of care and case managers is to support geriatric patients in obtaining social services in medical, nursing, therapeutic and social fields. To this, they advise and represent their patients. The documentation of patient contacts with case managers of a network of physicians was evaluated. In particular, activities involving legal advice were analysed in detail, compared with the current legal situation in Germany and evaluated. In addition, qualitative expert interviews were conducted. The content and the legal requirements of legal services law were determined by applying legal interpretation methods (esp. wording, telos, systematics). The results of the evaluation of the documentation were compared with legal requirements. Care and case management touches activities in some fields of action without having a legal basis in legal services law. This leads to the fact that these services may not be provided and to - uninsured and uninsurable - liability risks. With the introduction of care and case management into standard care, both social law and the Legal Services Act must be adapted to enable the legally compliant use of care and case managers. Otherwise, certain services that are useful for the care of patients may not be provided.

Valuable eco-innovations are emerging through increasingly close collaboration between the scientific community, industry, the energy sector, and public institutions supporting research, development, and the commercialization of new technologies that address specific market needs. Today, the implementation of eco-innovations is a key factor across many sectors and constitutes a significant barrier to market entry. This study identifies the key drivers of the implementation of eco-innovation in the Polish tire industry, which ranks among the lowest in the EU in terms of the adoption of eco-innovation. Legal regulations—particularly those related to the circular economy and Extended Producer Responsibility (EPR)—emerged as the strongest drivers, as indicated by over 60% of the companies surveyed. Financial support and incentives, such as tax relief, were emphasized by 70% of respondents as crucial for accelerating eco-innovation. This study also highlights significant barriers, including limited access to capital (cited by 65% of respondents) and the high costs associated with eco-innovative methods. Green public procurement and the certification status were recognized as important, albeit less impactful, factors. Expert interviews confirm these findings, underscoring the need for improved public funding mechanisms and stronger legislative support to overcome the current stagnation. This research concludes that without such measures, progress in eco-innovation within the sector may remain slow, thereby hindering the achievement of sustainable development goals.