German Federal Authorities Research Articles

Critical success factors for creating sustainable digital health applications: A systematic review of the German case.

The Covid-19 pandemic has accelerated the adoption of digital technologies to address social needs, leading to increased investments in digital healthcare applications. Germany implemented a special law called the "Digitales Versorgungsgesetz" (DVG-Digital Supply Act) in 2019, which enables the reimbursement of digital health applications, including digital therapeutics (DTx), through a fast-track process. The Federal Institute for Drugs and Medical Devices (BfArM), the German federal authority responsible for overseeing digital health applications, has implemented legislative adjustments since the law's introduction, which have increased requirements for these applications and potentially led to the removal of some from the directory as well as a slowdown in the addition of new ones. To counteract this trend, this work aimed to identify key success factors for digital health applications (DiGAs). This research identifies critical success factors through a structured literature review for developing sustainable digital health applications within the European healthcare systems, specifically DiGAs. The study aims to support the ongoing digital transformation in healthcare. The identified success factors that significantly impact the sustainability of DiGAs include patient-centered design, application effectiveness, user-friendliness, and adherence to data protection and information security regulations using standardized approaches. These factors are crucial in preventing the failure of DiGA manufacturers in European countries. By considering and implementing these critical success factors, DiGA manufacturers can enhance their chances of long-term success and contribute to the digital transformation of the healthcare system in Europe.

A Paradigm Change in Energy Cooperation between Germany and Russia

Germany’s transition to a climate-neutral economy, the main parameters of which were determined by the European Green Exchange Rate (December 2019) and clarified in the updated Law on Climate Protection of Germany (June 2021) and the EU Fit-for-55 program (July 2021), leads to the abandonment of the use of primary energy sources, including their importation from Russia. The energy transformation of the German market economy presumed a gradual restructuring of the existing model of German–Russian cooperation in the energy sector, including its transfer to priority cooperation in the field of energy efficiency and renewable energy sources. Brussels and Berlin responded to the special military operation of the Russian Federation on the territory of Ukraine with large-scale economic and political sanctions, which included significant restrictions on the import of Russian coal and oil. At the same time, the German federal authorities outlined the necessity to abandon Russian pipeline gas and petroleum products, as well as the deprivation of ownership of the two main players from the Russian Federation in the German oil and gas market—Gazprom and Rosneft. Their German partners have frozen participation in Russian projects. At the end of February, the certification of the Nord Stream-2 offshore gas pipeline was stopped. Interdepartmental state interaction and scientific and technical cooperation in the energy sector have been terminated. These events indicated the readiness of the government coalition in the short term to replace the previous model of energy cooperation, which has performed well for half a century, and to move to independence from Russian fossil resources and their derivatives. The author analyzes the reasons and content of the current measures taken by Berlin, as well as their medium- and long-term consequences for German–Russian cooperation.

POSB189 Mental Health in COVID Times: A Quasi-Experimental Analysis of the Impact of Lockdown Measures on Mental Healthcare Use in Germany

On March 22, 2020, German federal authorities announced lockdown measures to contain the spread of COVID-19. There are concerns that these measures reduced the use of health services. Using a quasi-experimental approach, we investigated the impact that the enactment of lockdown measures had on mental healthcare utilization in Germany.

Reporting practices in situations of conflicting institutional logics: the case of a German federal authority

PurposeThis study aims to understand how reporting practices act as drivers of change in situations of conflicting institutional logics in a public sector organisation.Design/methodology/approachThe findings are based on a case study of a German federal authority, where management accounting reports were introduced as part of a “new” managerial logic of control.FindingsIn the case organisation, management accounting reports were intended to change the behaviour of executives but were still guided by an “old” logic of justification. Nevertheless, over time, the addressees of the reports used the reports and reconciled different logics. This documents a process from decoupling to compromising and, finally, reconciling different institutional logics.Originality/valueBy examining the practices of management accounting reporting, this study elaborates the tensions placed on individuals by conflicting institutional logics and provides insights into how organisational practices are used to handle and reconcile conflicting logics in a public sector organisation. Therefore, this paper contributes to the discussion on how organisational practices act as drivers of organisational change.

Strukturprobleme des Glücksspielrechts

Comprised of a plurality of legal actors and powered by a highly polarised social and legal discourse, German gambling law provides a framework for the ever booming gambling market. It is challenged by digitalization and by the internationalization of gambling. In addition, it faces adverse regulatory impulses, ranging from liberalization to a firm regulatory grasp within a couple of years. On the one hand, it purports to offer a sufficiently attractive supply of gambling products in order to draw the public into legal forms and away from illegal forms of gambling. On the other hand, its regulatory objective seeks to fence in and suppress the gambling urges of the population. On the whole, German gambling law is characterized by three, legally and factually interdependent problems. First, it needs to come up with a practical, inclusive and dynamic legal definition of its subject-matter, i. e.: what counts as legally relevant gambling? Second, it needs to define, maintain and implement larger objectives in regard to a target audience that do not overburden the executive und judicial branch with the need to reconcile contradicting regulatory impulses. Finally, it needs to guarantee a sufficient degree of implementation, which is achieved by combination of rational and high-quality legislation, adequate resources, and the necessary political will. Gambling law in Germany lacks these features to varying degrees. It, therefore, increasingly falls prey to mere legal symbolism that pretends to govern the gambling market much more than it actually does. The constitutional distribution of legislative and executive competencies in favor of the German Länder (“states”) is largely insufficient. Governing gambling in an international and highly digitalized market requires federal legislation and execution. The German federal authorities should consider federalizing gambling law by means of Art. 72 II GG and creating a federal gambling agency on the basis of Art. 87 III GG.

Prognostic significance and economic burden of hepatic encephalopathy in liver cirrhosis in German hospitals based on G-DRG data

Hepatic encephalopathy (HE) represents a frequent complication of liver cirrhosis with negative effects on patients' lives. The prevalence of clinical HE is estimated to be between 30-45 %. Regardless of its clinical and prognostic relevance HE is considered to be underdiagnosed. Beyond a systematic analysis of mortality of HE, we investigated the economic impact and reimbursement situation for HE in patients with liver cirrhosis in Germany. For the retrospective analysis, anonymized data (2011-2015) concerning expenses and diagnoses (§ 21-4 KHEntgG) were obtained from 74 participating hospitals of the Diagnosis Related Groups (DRG) Project of the German Gastroenterological Association (DGVS). Furthermore, results were compared with case data from all German hospitals provided by the German Federal Authority on Statistics (Statistische Bundesamt (Destatis), Wiesbaden). In participating hospitals 59 093 cases with liver cirrhosis were identified of which 14.6 % were coded as having HE. Hospital mortality was threefold increased compared to cirrhosis-patients without HE (20.9 versus 7.5 %). Cases with cirrhosis as well as the proportion with HE increased over time. Compared to all patients with cirrhosis, reimbursement for HE patients produced a deficit (of up to 634 € for HE grade 4). Mortality is threefold increased in patients with cirrhosis when an additional HE is diagnosed. Hospitals participating in the DGVS-DRG-project coded 2 % more HE cases among their cirrhosis cases than the rest of hospitals either because of a selection bias for greater disease severity or because of better coding quality. At present, reimbursement for HE patients on the basis of F-DRG-system produced a deficit.

The ‘Responsibility to Prosecute’ Core International Crimes? The Case of German Universal Jurisdiction and the Syrian Government

Arguably, more than any other state or interstate actor, German federal authorities, including the German Federal Public Prosecutor General (Generalbundesanwalt, gba) and German Federal Criminal Police Office (Bundeskriminalamt), have been at the forefront of issuing arrest warrants for senior members of the Syrian government suspected of atrocity crimes in the wake of the Arab Spring. This includes German federal authorities making the first arrest of a senior member of the Syrian government in February 2019 for crimes against humanity. This article argues that in relation to core international crimes, Germany’s concept of law reflects one based on a ‘standard’ and international rule of law. Moreover, German federal authorities have demonstrated a willingness to use international humanitarian and criminal law (ichl) in relation to those most responsible for core international crimes. In this way, Germany’s current investigations into alleged crimes against humanity in Syria since 2011 provides for an illuminating case for extending universal jurisdiction, as well as the ‘responsibility to prosecute’ as a legal obligation. It also indicates how a multiplicity of actors – including state and non-state actors – can extend the reach of international criminal law, when the International Criminal Court (icc) cannot act.

Rapid Mapping for German Federal Authorities

Abstract. The Federal Agency for Cartography and Geodesy (BKG) in Germany is a technical agency under the Federal Ministry of the Interior, Building and Community (BMI). The organization consists of three departments namely Geoinformation, Geodesy and a Business Operations/Support department. Each department has multiple units which carry out their own respective duty in their field of subject. Tasks related to providing and homogenizing spatial data are located inside the geoinformation department. The main focus lies here on uniting the data collected by the federal states to form different types of nationwide datasets. The geodesy department focusses on real time satellite navigation systems, very long baseline interferometry and geodetic reference systems.A recent development in the federal authorities has been the demand for quick maps and spatial data to support fast decision making processes. The BKG has established a complete workflow which allows for rapid data processing and the distribution to the respective customers. It is split into six sub processes with several branching options, processing and backpropagation steps. This allows for a systematic approach to covering the customer’s demand for spatial data and for the internal production chain. The workflow is backed up by a project management system, a quality management system and a production management system each covered in a handbook specially prepared to ensure consistency along the workflow.The workflow gets started by the customer posing their request either via the service center (SC) unit, via mail or phone or through the controlling institution as a decree or an executive order. The first contact is crucial as important information is being exchanged and a rough concept of the demand is shaped. Once the actual task has reached the BKG a ticket number and an internal processing identifier will be assigned by the SC and the resource manager (RM) respectively. These unique keys will be used for the communication with the customer and additionally utilized as a tool for the administrative actions being carried out in the background. This action involves querying the license status of the customer which in addition determines the maximum cost of the task and the authorization of the data being used. In parallel the task, now referred to as a ticket, is being implemented in the project management system. Certain additional information will be assigned to the ticket like the project manager (PM) and the project processor. Once this step has been completed the working directory for the ticket will be created by using a predefined folder structure. This structure is composed of a data, export, communications and documentation folder. Depending on the nature of the ticket various preconfigured templates are at hand and will be used to ensure uniformity of the final products. If needed further communication with the customer is carried out. Data research is the last step in this part of the workflow (see figure 1).The processing of the actual data makes up most of the workflow regarding time. Aspects like a uniform styleguide and quality controls by colleagues are performed alongside the work progress. If any non comforming aspect is found, the feedback is given directly to the person in charge of the ticket while also being mirrored in the project management system. Once the product is ready for deployment, final communication with the customer is executed. Additional changes stated by the customer can be implemented whereby an extra iteration of the quality process will be necessary. The data deployment is either carried out as a print product, a DVD, an OGC service or via a download option (see figure 2).The final steps of the workflow involve the report of delivery to the service center, the creation of the cost report and the closure of the ticket in the project management system. The cost report is created in a semi-automatic process from data stored in the project management system and combined with the material cost report. It is then send via e-mail to the service center which will carry out any necessary invoice collections. Furthermore the internal data folder structure is cleaned up and a screenshot is taken of the product to use it as a subsidiary product in the dedicated online gallery of created products. Finally the closing information is relayed to the service center and the ticket gets closed (see figure 3). This whole workflow can be executed within several hours, days or weeks, depending on the deadline imposed by the customer or the event. Actual rapid mapping activations are done by multiple people simultaneously working on different steps of the previously explained workflow. This allows for fast response times and the accomplishment of the activation in time.

Study protocol: COmparison of the effect of treatment with Nonsteroidal anti-inflammatory drugs added to anti-tumour necrosis factor a therapy versus anti-tumour necrosis factor a therapy alone on progression of StrUctural damage in the spine over two years in patients with ankyLosing spondylitis (CONSUL) – an open-label randomized controlled multicenter trial

IntroductionThere is some evidence that non-steroidal anti-inflammatory drugs (NSAIDs), in particular celecoxib, might possess not only a symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis (AS), retarding the progression...

Stomatin‐domain protein interactions with acid‐sensing ion channels modulate nociceptor mechanosensitivity

Acid-sensing ion channels (ASICs) and their interaction partners of the stomatin family have all been implicated in sensory transduction. Single gene deletion of asic3, asic2, stomatin, or stoml3 all result in deficits in the mechanosensitivity of distinct cutaneous afferents in the mouse. Here, we generated asic3−/−:stomatin−/−, asic3−/−:stoml3−/− and asic2−/−:stomatin−/− double mutant mice to characterize the functional consequences of stomatin–ASIC protein interactions on sensory afferent mechanosensitivity. The absence of ASIC3 led to a clear increase in mechanosensitivity in rapidly adapting mechanoreceptors (RAMs) and a decrease in the mechanosensitivity in both Aδ- and C-fibre nociceptors. The increased mechanosensitivity of RAMs could be accounted for by a loss of adaptation which could be mimicked by local application of APETx2 a toxin that specifically blocks ASIC3. There is a substantial loss of mechanosensitivity in stoml3−/− mice in which ∼35% of the myelinated fibres lack a mechanosensitive receptive field and this phenotype was found to be identical in asic3−/−:stoml3−/− mutant mice. However, Aδ-nociceptors showed much reduced mechanosensitivity in asic3−/−:stoml3−/− mutant mice compared to asic3−/− controls. Interestingly, in asic2−/−:stomatin−/− mutant mice many Aδ-nociceptors completely lost their mechanosensitivity which was not observed in asic2−/− or stomatin−/− mice. Examination of stomatin−/−:stoml3−/− mutant mice indicated that a stomatin/STOML3 interaction is unlikely to account for the greater Aδ-nociceptor deficits in double mutant mice. A key finding from these studies is that the loss of stomatin or STOML3 in asic3−/− or asic2−/− mutant mice markedly exacerbates deficits in the mechanosensitivity of nociceptors without affecting mechanoreceptor function.

Reduction of nitrate concentration in drinking water by a hybrid process with zero discharge based on reverse osmosis

As a consequence of the heavy utilization of artificial fertilizers, the nitrate concentration of certain well waters has increased to figures above the standards set by the German Federal authorities. If such well water cannot be diluted by corresponding amounts of nitrate-free-water, the nitrate has to be removed, at least partially. In principle, reverse osmosis is capable of reducing the nitrate concentration. There will be however a brine with high nitrate content amounting to about 10% of the feed flow which cannot be discharged into a river or a deep well. This paper discusses a hybrid process based on reverse osmosis which solves the problem of the concentrate-disposal by treating this concentrate in a zero discharge system utilizing selective ion-exchange, electrodialysis and thin-film-evaporation. A pilot-plant with a capacity of 50 m 3/d permeate is under construction on the premises of a municipal waterworks. Special factors of interest are the reliability as well as the actual costs of such a process, the possibility of utilizing brine for the regeneration of the ion-exchanger and the optimal concentration factors for every step of the process.