Background Mass gatherings (MGs) such as music festivals and sports events have been associated with a high risk of SARS-CoV-2 transmission. On-site research can foster knowledge of risk factors for infections and improve risk assessments and precautionary measures at future MGs. We tested a web-based participatory disease surveillance tool to detect COVID-19 infections at and after an outdoor MG by collecting self-reported COVID-19 symptoms and tests. Methods We conducted a digital prospective observational cohort study among fully immunized attendees of a sports festival that took place from September 2 to 5, 2021 in Saxony-Anhalt, Germany. Participants used our study app to report demographic data, COVID-19 tests, symptoms, and their contact behavior. This self-reported data was used to define probable and confirmed COVID-19 cases for the full "study period" (08/12/2021 - 10/31/2021) and within the 14-day "surveillance period" during and after the MG, with the highest likelihood of an MG-related COVID-19 outbreak (09/04/2021 - 09/17/2021). Results A total of 2,808 of 9,242 (30.4%) event attendees participated in the study. Within the study period, 776 individual symptoms and 5,255 COVID-19 tests were reported. During the 14-day surveillance period around and after the MG, seven probable and seven PCR-confirmed COVID-19 cases were detected. The confirmed cases translated to an estimated seven-day incidence of 125 per 100,000 participants (95% CI [67.7/100,000, 223/100,000]), which was comparable to the average age-matched incidence in Germany during this time. Overall, weekly numbers of COVID-19 cases were fluctuating over the study period, with another increase at the end of the study period. Conclusion COVID-19 cases attributable to the mass gathering were comparable to the Germany-wide age-matched incidence, implicating that our active participatory disease surveillance tool was able to detect MG-related infections. Further studies are needed to evaluate and apply our participatory disease surveillance tool in other mass gathering settings.

One of the most challenging difficulties for incumbent organisations, especially small- and medium-sized enterprises (SMEs), is to manage digital transformation driven by technological change. Incumbent organisations' responses to digital transformation have been extensively studied in the current literature. However, most research neglects digital transformation in SMEs. There are hardly any valid developed measures for the maturity of digital transformation. We present a holistic digital transformation maturity model based on an extensive literature review, qualitative computer-assisted data analysis, and empirical findings. The digital transformation maturity model focuses on small- and medium-sized enterprises' unique features and characteristics. We proved the practical applicability and relevance of the digital transformation maturity model in an extensive study involving various organisations, particularly German SMEs (n = 310). Organisations can use this model to assess themselves initially and, through this process, gain a comprehensive understanding of the multiple forms of digital transformation.

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.

Objective: Hypertension has long been recognized as one of the most important predisposing factors for cardiovascular diseases and mortality. In recent years, machine learning methods have shown potential in diagnostic and predictive approaches in chronic diseases. Electronic health records (EHRs) have emerged as a reliable source of longitudinal data. The aim of this study is to predict the onset of hypertension using modern deep learning (DL) architectures, specifically long short-term memory (LSTM) networks, and longitudinal EHRs. Materials and Methods: We compare this approach to the best performing models reported from previous works, particularly XGboost, applied to aggregated features. Our work is based on data from 233 895 adult patients from a large health system in the United States. We divided our population into 2 distinct longitudinal datasets based on the diagnosis date. To ensure generalization to unseen data, we trained our models on the first dataset (dataset A "train and validation") using cross-validation, and then applied the models to a second dataset (dataset B "test") to assess their performance. We also experimented with 2 different time-windows before the onset of hypertension and evaluated the impact on model performance. Results: With the LSTM network, we were able to achieve an area under the receiver operating characteristic curve value of 0.98 in the "train and validation" dataset A and 0.94 in the "test" dataset B for a prediction time window of 1 year. Lipid disorders, type 2 diabetes, and renal disorders are found to be associated with incident hypertension. Conclusion: These findings show that DL models based on temporal EHR data can improve the identification of patients at high risk of hypertension and corresponding driving factors. In the long term, this work may support identifying individuals who are at high risk for developing hypertension and facilitate earlier intervention to prevent the future development of hypertension.