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In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern market access are often evolving slowly, sometimes creating market barriers. This article gives a brief overview of the existing clinical studies regarding the use of smart wearables in cardiac monitoring and provides insight into the main regulatory and legal aspects that need to be considered when such products are intended to be used in a health care setting. Based on this brief overview, the article elaborates on the specific requirements in the main areas of authorization/certification and reimbursement/compensation, as well as data protection and data security. Three case studies are presented as examples of specific market access procedures: the USA, Germany, and Belgium. This article concludes that, despite the differences in specific requirements, market access pathways in most countries are characterized by a number of similarities, which should be considered early on in product development. The article also elaborates on how regulatory and legal requirements are currently being adapted for digitally driven wearables and proposes an ongoing evolution of these requirements to facilitate market access for beneficial medical technology in the future.
The educational sector currently faces a massive digital transformation with various digital offerings entering the market. To provide some orientation in this transforming space, a national digital education platform (NDEP) is under development in Germany as part of a nationwide flagship project. On the one hand, in efficiently connecting the relevant stakeholders to each other and to value-adding education-related offerings, various benefits emerge. On the other hand, monopolising the educational sector and influencing the respective market through a state-controlled platform bears potential regulatory risks from misuse of power by the platform to malpractice by the users. Against this background, we aim to identify and systematise these potential drawbacks prior to the platform’s actual development and implementation. We pursue a qualitative, interpretivist approach for policy analysis, based on ten elite interviews and two workshops. Our results are threefold: (1) We capture the consolidated NDEP architecture; (2) We categorise the range of relevant functions and value propositions of the NDEP; (3) We derive 23 regulatory areas of conflict across the three building blocks that result from the potential ecosystem and function scope configurations of the NDEP. As a contribution to research, we shed new interdisciplinary light on the governance and infrastructure of public-private platforms that enable innovation and collaboration while integrating respective market segments. As a contribution to practice, we provide clear guidance for policy-makers in strategizing the development and governance of and through national digital platforms in education.
High-growth firms (HGFs) are important for job creation and productivity growth. We investigate the relationship between product and labour market regulations, as well as the quality of regional governments that implement these regulations, and the development of HGFs across European regions. Using data from Eurostat, the Organisation for Economic Co-operation and Development (OECD), World Economic Forum (WEF), and Gothenburg University, we show that both regulatory stringency and the quality of the regional government relate to the regional shares of HGFs. In particular, we find that the effect of labour and product market regulations is moderated by the quality of regional government. Depending on the quality of regional governments, regulations may have a ‘good, bad or ugly’ influence on the development of HGFs. Our findings contribute to the debate on the effects of regulations and offer important building blocks to develop tailored policy measures that may influence the development of HGFs in a region.
In this study, we investigated the cognitive-emotional interplay by measuring the effects of executive competition (Pessoa, 2013), i.e., how inhibitory control is influenced when emotional information is encountered. Sixty-three children (8 to 9 years of age) participated in an inhibition task (central task) accompanied by happy, sad, or neutral emoticons (displayed in the periphery). Typical interference effects were found in the main task for speed and accuracy, but in general, these effects were not additionally modulated by the peripheral emoticons indicating that processing of the main task exhausted the limited capacity such that interference from the task-irrelevant, peripheral information did not show (Pessoa, 2013). Further analyses revealed that the magnitude of interference effects depended on the order of congruency conditions: when incongruent conditions preceded congruent ones, there was greater interference. This effect was smaller in sad conditions, and particularly so at the beginning of the experiment. These findings suggest that the bottom-up perception of task-irrelevant emotional information influenced the top-down process of inhibitory control among children in the sad condition when processing demands were particularly high. We discuss if the salience and valence of the emotional stimuli as well as task demands are the decisive characteristics that modulate the strength of this relation.
The limitations and possibilities of the state in solving societal problems are perennial issues in the political and policy sciences and increasingly so in studies of environmental politics. With the aim of better understanding the role of the state in addressing environmental degradation through policy making, this article investigates the nexus between the environmental policy outputs and the environmental performance. Drawing on three theoretical perspectives on the state and market nexus in the environmental dilemma, we identify five distinct pathways. We then examine the extent to which these pathways are manifested in the real world. Our empirical investigation covers up to 37 countries for the period 1970–2010. While we see no global pattern of linkages between policy outputs and performance, our exploratory analysis finds evidence of policy effects, which suggest that the state can, under certain circumstances, improve the environment through policy making.
On 21 April 2021, the European Commission presented its long-awaited proposal for a Regulation “laying down harmonized rules on Artificial Intelligence”, the so-called “Artificial Intelligence Act” (AIA). This article takes a critical look at the proposed regulation. After an introduction (1), the paper analyzes the unclear preemptive effect of the AIA and EU competences (2), the scope of application (3), the prohibited uses of Artificial Intelligence (AI) (4), the provisions on high-risk AI systems (5), the obligations of providers and users (6), the requirements for AI systems with limited risks (7), the enforcement system (8), the relationship of the AIA with the existing legal framework (9), and the regulatory gaps (10). The last section draws some final conclusions (11).
Equity crowdfunding
(2021)
In this study, we explore the development of equity crowdfunding (ECF) over the next 5 to 10 years by conducting an international Delphi study. Our results indicate that the ECF market is expected to grow significantly. However, it is unlikely to disrupt other forms of financing and will not cover all SME financing needs. ECF will remain a funding technique for SMEs and small investors; it is unlikely to attract large corporations or institutional investors. Platforms will impose stricter requirements for capital raisers, expand their services, and innovate their business models. National governments will probably partly liberalize the ECF market.
Plasticity of human growth
(2020)
Background:
This systematic review aimed at collecting, analyzing and summarizing scientific studies focusing on psychosocial factors that influence linear growth among humans.
Methods:
The online database "PubMed" was used in order to acquire suitable scientific studies. These studies were evaluated based on clearly defined criteria that determine whether a study was to be excluded or included in the literature review. In the end, a total sum of 36 studies remained, which were carefully analyzed and used to generate an overview of the association between psychosocial factors and linear growth.
Results:
In the 36 reviewed studies, different social and psychological factors, such as socioeconomic status, parental education or emotional deprivation were set in relation to physical growth among humans. The studies were listed and summarized, depending on the investigated psychosocial factor. A clear association between psychosocial factors and growth could be observed in most of the reviewed studies. Discussion: Based on the results of the reviewed studies it could be concluded that the regulation of linear growth is also subject to different psychosocial factors. The way in which the developing human and the specific social environment interact seemed to have a major impact on linear growth. Statusspecific stress was discussed as one possible explanation for the regulating mechanism of human linear growth.
The availability of high-throughput data from transcriptomics and metabolomics technologies provides the opportunity to characterize the transcriptional effects on metabolism. Here we propose and evaluate two computational approaches rooted in data reduction techniques to identify and categorize transcriptional effects on metabolism by combining data on gene expression and metabolite levels. The approaches determine the partial correlation between two metabolite data profiles upon control of given principal components extracted from transcriptomics data profiles. Therefore, they allow us to investigate both data types with all features simultaneously without doing preselection of genes. The proposed approaches allow us to categorize the relation between pairs of metabolites as being under transcriptional or post-transcriptional regulation. The resulting classification is compared to existing literature and accumulated evidence about regulatory mechanism of reactions and pathways in the cases of Escherichia coil, Saccharomycies cerevisiae, and Arabidopsis thaliana.
Nitrogen lipid regulator (NlpR) is a pleiotropic regulator that positively controls genes associated with both nitrogen and lipid metabolism in the oleaginous bacterium Rhodococcus jostii RHA1. In this study, we investigated the effect of nlpR disruption and overexpression on the assimilation of C-13-labeled glucose as carbon source, during cultivation of cells under nitrogen-limiting and nitrogen-rich conditions, respectively. Label incorporation into the total lipid extract (TLE) fraction was about 30% lower in the mutant strain in comparison with the wild type strain under low-nitrogen conditions. Moreover, a higher C-13 abundance (similar to 60%) into the extracellular polymeric substance fraction was observed in the mutant strain, nlpR disruption also promoted a decrease in the label incorporation into several TLE-derivative fractions including neutral lipids (NL), glycolipids (GL), phospholipids (PL), triacylglycerols (TAG), diacylglycerols (DAG), and free fatty acids (FFA), with the DAG being the most affected. In contrast, the nlpR overexpression in RHA1 cells under nitrogen-rich conditions produced an increase of the label incorporation into the TLE and its derivative NL and PL fractions, the last one being the highest C-13 enriched. In addition, a higher C-13 enrichment occurred in the TAG, DAG, and FFA fractions after nlpR induction, with the FFA fraction being the most affected within the TLE. Isotopic-labeling experiments demonstrated that NlpR regulator is contributing in oleaginous phenotype of R. jostii RHA1 to the allocation of carbon into the different lipid fractions in response to nitrogen levels, increasing the rate of carbon flux into lipid metabolism.