Enhanced Role of EMA in EU Crisis Response

The regulation also sets out obligations on marketing authorization holders (MAHs) and medical devices manufacturers, authorized representatives, importers, distributors, and notified bodies duties to: * Provide information that will assist with the monitoring by the MSSG/MDSSG of shortages of medicinal products and devices contained in the critical medicines list and updating this when necessary * Provide a justification for any failure to provide the requested information by the established deadlines * Immediately provide any evidence of an actual or potential shortage of medicinal products or devices * Provide information to EMA by 2 Sep. 2022 that will enable the establishment of a Single Point of Contact (SPOC) network, and the industry Single Point of Contact (iSPOC) network, with mandates to updating this when necessary (7). Enhanced advisory role In addition to the measures designed to address medicinal and medical device shortages, an Emergency Task Force (ETF) will also be established within EMA to provide scientific advice and review evidence on medicines that have the potential to address public health emergencies, offer scientific support to facilitate clinical trials, and support existing EMA committees with their authorization and safety monitoring of medicines (8). According to the document published by EMA on Crisis Preparedness and Management, the key benefits for EMA of having these responsibilities include: * Accelerated evaluation and access to safe and effective medicines which could treat or prevent a disease causing, or likely to cause, a public health emergency * Improved quality of data and the effective use of resources through increased support at EU level towards the conducting of clinical trials in preparation for, and during a public health emergency * Improved coordination and harmonization at EU level in preparation for and during a public health emergency (7).

Healthcare costs vis-à-vis economic growth in pandemic crisis with technology adoption

COVID-19 pandemic brought up issues with healthcare costs, national economic development and welfare of the society in forefront. Nations across the globe followed different approaches to deal with COVID-19, such as zero tolerance, herd immunity, containment to build treatment capability. National healthcare became a contentious sociopolitical issue involving healthcare costs, technologies and societal health. In the United States even during the COVID-19 pandemic, the government approach was pursuing a sustainable improvement in patient care through adoption of medical and information technologies. The national healthcare policies are framed around technological interventions with the assumption that deployment of technologies could keep healthcare costs under control and at the same time improve health outcomes. However, evidences show that the healthcare costs are in the rise even with impressive progress in technological deployment. This article highlights some of the recent trends in healthcare costs, technological preparedness, medical technology developments in managing COVID-19 pandemic. The US government mandated electronic health record (EHR) systems implementation and assess its impact on healthcare costs and health outcomes. This article emphasizes the need for understanding the interconnectedness of costs, technology and societal health.

Efficiency of Levilimab in patients with moderate and severe COVID-19.

Objective: evaluation of the clinical and economic efficiency of using Levilimab in the treatment of moderate and severe COVID-19 based on real world data (RWD). Material and methods. A single-center observational retrospective case-control study was performed. According to the matching algorithm, 834 pairs of patients with moderate and 347 pairs with severe infection were selected, similar in gender, age, vaccination status, severity of the disease and the level of C-reactive protein. Results. The clinical efficiency of Levilimab with respect to in-hospital mortality was demonstrated both for the moderate course (6% in the Levilimab group and 10% in the standard therapy group;odds ratio (OR) 1.71;95% confidence interval (CI) 1.19-2.47;p<0.01) and for the severe course of COVID-19 (63% and 82%, respectively;OR 2.70;95% CI 1.90-3.82;p<0.01). The costs per 1 treated patient were also higher in the Levilimab therapy groups: the difference in costs compared to the standard therapy group for patients with moderate disease was 54 665.30 rubles, with severe disease - 91 285.85 rubles. The estimated cost of the additional effectiveness of Levilimab for the moderate course of the disease was 13, 666.32 rubles, for the severe course - 4, 804.51 rubles. Conclusion. The use of Levilimab for the treatment of moderate and severe COVID-19 is feasible both from a clinical and economic points of view. Conducting RWD trials is an important tool to understand the effectiveness of medical technologies in real clinical practice.Copyright © 2023 IRBIS LLC. All Rights Reserved.

Moving into the Future of Clinical Trials

Every delay, from equipment not arriving at a clinical site on time to patients unable to arrive for an onsite visit, creates an avalanche of effects, from decreased patient retention to increased time to market. [...]extending beyond logistical complexities, data compliance regulations, such as HI PA A or GDPR, expand further back in the supply chain as partners need to handle patient data that enables home delivery of equipment as well as labeling for sample collections. Delivering training in a decentralized clinical trial Logistics is more than the movement of people and products;it's also about the movement of information. [...]hybrid and virtual trials require partners to ship directly to or pick up directly from patients, requiring partners to have access to a range of personal information, from the patient's name and address to the study type to the serial number of the equipment used. Data that is not properly secured can create cybersecurity risks that potentially expose confidential patient information as well as violate regulatory standards.

Regulating Digital Therapeutics

Conversely, in Italy DTx are classed as medical devices and must pass International Organization for Standardization (ISO) standards to ensure they are compliant with safety requirements. The new EU MDR should help to simplify the exchange of data on medical devices and improve data collection and post-market surveillance to reinforce end-user confidence in DTx solutions. In Germany, Ireland, and the Netherlands, DTx manufacturers have directly targeted self-insured employer health plans, whereas in France, Belgium, and the United Kingdom, a B2P reimbursement model has proven successful.

Performing Remote Audits During a Pandemic

For medical devices, FDA has published a "Remote Auditing Pilot Program" document outlining a voluntary pilot programme for remote auditing of processes, the Medical Device Single Audit Program (MDSAP) as part of the audit of a medical device organization (2). An important aspect of this pilot is the use of technology that facilitates remote audits, including: * Videoconferencing * Web-based meeting systems with screen sharing capability * Teleconferencing in conjunction with e-mail * Smart glasses or optical mounted head displays * Secure fileshare repositories * Remote 'read only' access to automated systems, such as electronic quality management systems (e.g., to view standard operating procedures [SOPs], deviations, electronic batch records, video recordings from the operational area, etc.). The meeting, which was moderated by Janet Woodcock, the US Food and Drug Administration's (FDA')s director of the Center for Drug Evaluation and Research, was conducted to align global regulations and approaches to clinical trial management, drug supply issues, and pharmacovigilance during the pandemic (1).

The Development of a Chatbot Technology to Disseminate Post-COVID-19 Information: Descriptive Implementation Study.

BACKGROUND: Post-COVID-19, or long COVID, has now affected millions of individuals, resulting in fatigue, neurocognitive symptoms, and an impact on daily life. The uncertainty of knowledge around this condition, including its overall prevalence, pathophysiology, and management, along with the growing numbers of affected individuals, has created an essential need for information and disease management. This has become even more critical in a time of abundant online misinformation and potential misleading of patients and health care professionals. OBJECTIVE: The RAFAEL platform is an ecosystem created to address the information about and management of post-COVID-19, integrating online information, webinars, and chatbot technology to answer a large number of individuals in a time- and resource-limited setting. This paper describes the development and deployment of the RAFAEL platform and chatbot in addressing post-COVID-19 in children and adults. METHODS: The RAFAEL study took place in Geneva, Switzerland. The RAFAEL platform and chatbot were made available online, and all users were considered participants of this study. The development phase started in December 2020 and included developing the concept, the backend, and the frontend, as well as beta testing. The specific strategy behind the RAFAEL chatbot balanced an accessible interactive approach with medical safety, aiming to relay correct and verified information for the management of post-COVID-19. Development was followed by deployment with the establishment of partnerships and communication strategies in the French-speaking world. The use of the chatbot and the answers provided were continuously monitored by community moderators and health care professionals, creating a safe fallback for users. RESULTS: To date, the RAFAEL chatbot has had 30,488 interactions, with an 79.6% (6417/8061) matching rate and a 73.2% (n=1795) positive feedback rate out of the 2451 users who provided feedback. Overall, 5807 unique users interacted with the chatbot, with 5.1 interactions per user, on average, and 8061 stories triggered. The use of the RAFAEL chatbot and platform was additionally driven by the monthly thematic webinars as well as communication campaigns, with an average of 250 participants at each webinar. User queries included questions about post-COVID-19 symptoms (n=5612, 69.2%), of which fatigue was the most predominant query (n=1255, 22.4%) in symptoms-related stories. Additional queries included questions about consultations (n=598, 7.4%), treatment (n=527, 6.5%), and general information (n=510, 6.3%). CONCLUSIONS: The RAFAEL chatbot is, to the best of our knowledge, the first chatbot developed to address post-COVID-19 in children and adults. Its innovation lies in the use of a scalable tool to disseminate verified information in a time- and resource-limited environment. Additionally, the use of machine learning could help professionals gain knowledge about a new condition, while concomitantly addressing patients' concerns. Lessons learned from the RAFAEL chatbot will further encourage a participative approach to learning and could potentially be applied to other chronic conditions.

Medical-engineering Cross-innovation Postgraduate Talent Training

At the beginning of the new year of 2020, the new coronavirus swept across the motherland. Scientific researchers throughout the country overcame scientific difficulties and wrote papers for the motherland. Under the challenge of the epidemic situation, medical workers in the front saved the dying and healed the wounded, while the scientific researchers in the rear tackled scientific and technological problems. The two sides cooperated sincerely to unify medical practice and theoretical development, and effectively improved the scientific and technological level of China's medical industry. Health care is closely related to human survival, development and quality of life. At present, mankind is still facing the threat of major diseases, and the development of medical and health services has increasingly shown strategic significance to national security, social stability and even national survival. This article introduces a new model of talent cultivation at the graduate level. The cross-dissolution of clinical medicine and manufacturing engineering produces novel ideas and new technologies.

Accessing isotopically labeled proteins containing genetically encoded phosphoserine for NMR with optimized expression conditions

Phosphoserine (pSer) sites are primarily located within disordered protein regions, making it difficult to experimentally ascertain their effects on protein structure and function. Therefore, the production of 15N- (and 13C)-labeled proteins with site-specifically encoded pSer for NMR studies is essential to uncover molecular mechanisms of protein regulation by phosphorylation. While genetic code expansion technologies for the translational installation of pSer in Escherichia coli are well established and offer a powerful strategy to produce site-specifically phosphorylated proteins, methodologies to adapt them to minimal or isotope-enriched media have not been described. This shortcoming exists because pSer genetic code expansion expression hosts require the genomic DELTAserB mutation, which increases pSer bioavailability but also imposes serine auxotrophy, preventing growth in minimal media used for isotopic labeling of recombinant proteins. Here, by testing different media supplements, we restored normal BL21(DE3) DELTAserB growth in labeling media but subsequently observed an increase of phosphatase activity and mis-incorporation not typically seen in standard rich media. After rounds of optimization and adaption of a high-density culture protocol, we were able to obtain >=10 mg/L homogenously labeled, phosphorylated superfolder GFP. To demonstrate the utility of this method, we also produced the intrinsically disordered serine/arginine-rich region of the SARS-CoV-2 Nucleocapsid protein labeled with 15N and pSer at the key site S188 and observed the resulting peak shift due to phosphorylation by 2D and 3D heteronuclear single quantum correlation analyses. We propose this cost-effective methodology will pave the way for more routine access to pSer-enriched proteins for 2D and 3D NMR analyses. GCE4All Biomedical Technology Development and Dissemination Center was supported by National Institute of General Medical Science, OSU NMR Facility funded in part by the National Institutes of Health, the Medical Research Foundation at OHSU and the Collins Medical Trust, National Science Foundation EAGER, and by the M. J. Murdock Charitable Trust.Copyright © 2023 The American Society for Biochemistry and Molecular Biology, Inc.

Correlations between Social Determinants of Health and Technology Access among Rural African American Alabamians

Certain populations have been excluded from the benefits of telehealth and the recent advances and widespread use of technology in health promotion due to limited technology access. Although research has identified these specific groups, none has explored these issues using the social determinants of health (SDH) framework. This exploratory study aimed 1) to investigate technology access and 2) to identify associated SDHs. A cross-sectional research design was implemented, and participants were recruited from rural Alabama (N=185). Binary logistic regressions were conducted. Only 60% of participants had technology access. People with food insecurity and health illiteracy were less likely to have internet and PC/tablet access. In addition, older age was associated with a lower likelihood of access to a smartphone. This study provided insights into SDH correlates of the digital divide, particularly among rural African Americans, and indicated that addressing affordability could be a partial solution.

WORKING PRINCIPLE AND INTELLIGENCE OF SMART INFUSION PUMP

There is a tremendous demand on the critical care resources due to the extensive spread of the ongoing coronavirus pandemic and the large number of patients requiring critical care. The efficacy of a device directly influences how long a patient lives since patients are often receiving critical care. Smart infusion pump is a medical device that can drip fluids into the patient's body. This device is considered as one of the most safety-critical medical devices due to the way it functions and the risks it presents. The main objective of this work is to develop an affordable infusion pump usin g embedded technology. The main tactic is to develop equipment that can identify air bubbles in infusion pump tubing since even a little one might obstruct blood flow and result in mortality. This method may provide consumers an accurate result, making it the greatest method for identifying bubbles and saving lives.

Psychosocial effects of COVID-19 in Ecuadorian university professors

The objective of this work is to analyze the psychosocial effects of COVID-19 on Ecuadorian university professors, for which a quantitative research of descriptive and correlational nature was developed. Two instruments were applied, based on the Depression, Anxiety and Stress Scales and the Burnout questionnaire to the selected sample, in three public universities of easy access and linkage with the researchers. The population consisted of professors with appointment: 682 from the Technical University of Manabí, 678 from the Lay University Eloy Alfaro de Manabí, and 131 from the State University of Southern Manabí, from which a sample of 246, 246 and 98 professors was selected respectively. From the results it is derived that depression, anxiety, and stress were configured in psychosocial effects, which have had an impact during the COVID-19 pandemic on the professors of the universities studied, due to the pressure originated by new emerging methodological structures, the acquisition of other competences associated to technology, health and the risks of contagion, death and by the pedagogical attention through virtuality, unexpectedly arisen in times of pandemic.

The El Dorado Pandemic

Recent experiences with COVID-19 has been a sobering reminder of how, despite advanced medical knowledge and technology- disease can scramble a society, from its economic trajectory to when and how its citizens should leave their houses. As the coronavirus's qualifying adjective notes, the experience has been novel in one sense, but in a wider context it is not. Microbes and pandemics have shaped the history of the US from its start. Early contagions opened the way to the first colonial settlements by devastating Native peoples along the Atlantic coast. In the 1780s, the smallpox that raged from Boston to the Pacific Northwest helped secure the American Revolution and open the far West to the US exploration and colonization. The global influenza pandemic of 1918 began in Kansas and claimed an estimated hundred million lives worldwide. The nineteenth century saw other pandemics. Arguably, the most dreadful was Asiatic cholera. It originated in India and spread to Europe and the US in three deadly doses--in 1832-34, in 1848-52, and in 1866-68.

Glycemic Control in Type 1 Diabetes Mellitus During COVID-19 Quarantine and the Role of In-Home Physical Activity

Background: To limit the spread of coronavirus disease 2019 (COVID-19), governments have ordered a series of restrictions that may affect glycemic control in individuals with type 1 diabetes mellitus (T1DM), since physical activity (PA) was not allowed outside home. Methods: We retrospectively evaluated glycemic control of individuals with T1DM using hybrid closed loop (HCL) system in the period before the SARS-CoV-2 outbreak in Italy (February 10–23, 2020–Time 1), when movements were only reduced (February 24–March 8, 2020–Time 2) and during complete lockdown (March 9–22, 2020–Time 3). Information about regular PA (at least 3 h per week) prior and during the quarantine was collected. Results: The study included 13 individuals with a median age of 14.2 years and a good glycemic control at baseline (glucose management indicator of 7%, time in range [TIR] of 68%, time below range [TBR] of 2%). All individuals continued to show good glycemic control throughout the study period. There was an increase in TIR during the study period (+3%) and TIR was significantly higher during Time 3 (72%) than during Time 2 (66%). TBR was significantly lower during Time 3 (1%) both compared with Time 1 and Time 2 (2%). A meaningful variance in TIR at Time 3 between individuals who performed or not PA during quarantine and a significant increase in TIR between Time 2 and Time 3 in individuals both doing PA at baseline and during quarantine was found. At logistic regression, only the presence of PA during quarantine significantly predicted a TIR >70%. Conclusions: Glycemic control of T1DM in adolescents using HCL system did not worsen during the restrictions due to COVID-19 pandemics and further improved in those who continued PA during the quarantine. Maintaining regular PA in a safe home environment is an essential strategy for young individuals with T1DM during the COVID-19 crisis.

The Relationship between Digital Technology and the Development of the Entrepreneurial Competencies of Young People in the Medical Field

Digital technology is an important tool that influences employees from the healthcare sector to manifest their intention to become an entrepreneur. Furthermore, the last pandemic crisis underlined the importance of digitalizing the relationship between medical staff and patients. The research aims to evaluate how digital technology influences the development of the entrepreneurial spirit of young people working in the medical field. The data were gathered from a sample of 395 young people with medical studies and analyzed with SMARTPLS4 using the PLS-SEM method. The motivation of young people with a background in the medical field to become entrepreneurs is strongly influenced by the objective assessment of the level of digitalization of the medical field. The usability and availability of new technology give people with a background in the medical field the desire to become an entrepreneur in this domain. The young people perceive their entrepreneurial potential in complementarity with the level of digitalization of the medical field. The research's theoretical and practical contributions are underlined by the features of the young people that consider new technology as an omnipresent tool in their life. In the medical field, there are few theoretical papers and studies on the entrepreneurial spirit of young people with a background in healthcare, and our research underlines the importance of training the entrepreneurial competencies of young people in the medical field. The COVID-19 pandemic underlined the relevance of entrepreneurial competencies in building sustainable healthcare practices and identifying the deficiencies of healthcare systems to find timely solutions for the benefit of the patients. Therefore, the challenges related to the medical services market require a new approach to doctors' entrepreneurial competencies.

Estonian Men Over 65 Are More Willing to Use Digital Technology

Digital technology offers older people an excellent opportunity to cope independently, which has become particularly apparent now in times of the COVID-19 crisis. Computers and smart devices provide additional access to a variety of online health-related information and communication with healthcare professionals, as well as digital health-related applications. Research suggests that while men are interested in digital solutions, women are more likely to seek online health information and exhibit better health behavior. The article aims to critically examine gender differences in digital technology acceptance for health purposes, online health information seeking, and COVID-19 vaccine readiness among older adults living in the small Eastern European country of Estonia. Data on the 65+ age group (65 men and 116 women) were derived from a larger survey, which contained a representative sample in terms of gender, age, and nationality and was conducted among Estonian older adults in 2020. In light of the findings of earlier research, it was surprising to learn that 65+ men in Estonia take a slightly greater interest in health information compared to their female peers, which could result from men's poorer health status. Although it was more important for women to have access to a doctor from a distance, men expressed more avid interest in various digital health gadgets and services. As it happens, they were also more willing to get vaccinated against COVID-19. Thus, this study positively dispels the myth that men are dismissive about their health and information regarding it. The results of the study imply that older people in Estonia, well-educated men in particular, are enthusiastic digital technology users for health purposes which could prove to be valuable insight to those responsible for should be taken into account when developing digital services and health campaigns.

Exploring the challenges for medical tourism in the United Arab Emirates during the Covid-19 pandemic era: a stakeholder perspective

PurposeThis paper explores medical tourism development challenges in the United Arab Emirates (UAE) pre- and during Covid-19. Medical tourism is becoming a dynamic, rapid growth area and an engine of economic development.Design/methodology/approachIn-depth interviews were conducted with medical tourism professionals. Fourteen medical tourism stakeholders were interviewed from 1 January to 31 January 2020. Qualitative thematic analysis was applied on medical tourism challenges before and during the pandemic.FindingsThe major themes indicated concerns for medical tourism in the UAE and they included higher medical services costs and a shortage of highly qualified medical expertise. The emerging themes related to the challenges of coping with Covid-19 and strategies to attract medical tourists.Originality/valueThis study contributes towards (1) the theory of medical tourism, (2) the related limited prior published work on this topic relating to the UAE and (3) the importance of medical tourism in today's tourism industry. Additionally, there are theoretical and practical implications for medical tourism stakeholders in terms of attracting inbound medical tourists to the UAE from other countries during the Covid-19 crisis and in the post-pandemic situation.

Understanding the Digital Resilience of Physicians during the COVID-19 Pandemic: An Empirical Study

The COVID-19 pandemic has underscored the urgent need for healthcare entities to develop resilient strategies to cope with disruptions caused by the pandemic. This study focuses on the digital resilience of certified physicians who adopted an online healthcare community (OHC) to acquire patients and conduct telemedicine services during the pandemic. We synthesize the resilience literature and identify two effects of digital resilience-the resistance effect and the recovery effect. We use a proprietary dataset that matches online and offline data sources to study the digital resilience of physicians. A difference-in-differences (DID) analysis shows that physicians who adopted an OHC had strong resistance and recovery effects during the pandemic. Remarkably, after the COVID-19 outbreak, these physicians had 35.0% less reduction in medical consultations in the immediate period and 31.0% more bounce-back in the subsequent period as compared to physicians who did not adopt the OHC. We further analyze the sources of physicians' digital resilience by distinguishing between new and existing patients from both online and offline channels. Our subgroup analysis shows that, in general, digital resilience is more pronounced when physicians have a higher online reputation rating or have more positive interactions with patients on the OHC platform, providing further support for the mechanisms underlying digital resilience. Our research has significant theoretical and managerial implications beyond the context of the pandemic.