Opening Up Opportunities in 2023

"The ongoing journey to standardization on more aspects of submission and data exchange will continue to have an impact," he notes. lan Crone, business unit director Europe-fme Life Sciences, which provides business and technology services, points out that the web-based human variations electronic application form (eAF) for centrally authorized products (CAPs) has been available for use since 4 Nov. 2022 on the European Medicines Agency's (EMA's) new product lifecycle management (PLM) portal. Renato Rjavec, Amplexor Life Sciences "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/software as a service environment platform that brings foundational benefit to individual functions," states Steve Gens managing partner. Internal productivity and external regulatory requirements are both driving this data connectivity within industry, he adds, which "requires a clear cross functional digitization strategy and focus on cross-functional data governance, master data management, and ensuring all data from these various authoritative systems [are] at the same high level. " "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/ software as a service environment platform that brings foundational benefit to individual functions." -

The effects of tie strength and data integration with supply base on supply disruption ambiguity and its impact on inventory turnover

PurposeIn this paper, the authors introduce supply disruption ambiguity as the inability of a sourcing firm to attach probability point estimates to the occurrence of and to the magnitude of loss from supply disruptions. The authors drew on the "ambiguity in decision-making” literature to define this concept formally, connected it to relevant supply disruption information deficit, positioned it relative to supply chain risk assessment and hypothesized and tested its negative associations with both supply base ties and inventory turnover.Design/methodology/approachThe authors analysed survey data from 171 North American manufacturers and archival data for a subset (88 publicly listed) of these manufacturers via Ordinary Least Squares (OLS) estimation after ensuring that methodological concerns with survey research have been addressed. They used appropriate controls and employed the heteroskedasticity-based instrumental variable (HBIV) approach to ensure that inferences from our results are not unduly influenced by endogeneity.FindingsStrong supply base ties decrease supply disruption ambiguity, which, in turn, increases inventory turnover. Moreover, strong supply base ties and data integration with the supply base have indirect and positive effects on inventory turnover. As sourcing firms strengthen ties and integrate data exchange with their supply base, their inventory turnover improves from access to information relevant to detect and diagnose supply disruptions effectively.Originality/valueResearch on supply disruption management has paid more attention to the "disruption recovery” stage than to the "disruption discovery” stage. In this paper, the authors add novel insights regarding the recognition and diagnosis aspects of the "disruption discovery” stage. These novel insights reveal how and why sourcing firms reduce their overall ambiguity associated with detecting and assessing losses from supply disruptions through establishing strong ties with their supply base and how and why reducing such ambiguity improves inventory turnover performance.

Influence Mechanism of Construction Supply Chain Information Collaboration Based on Structural Equation Model

The construction supply chain has many stakeholders and complex and diverse information, which cause various information exchange problems that diminish project management efficiency. Thus, information collaboration is an important factor in the construction supply chain. This study aims to improve the efficiency of project management by analyzing the factors hindering information collaboration in the construction supply chain in order to determine their internal influencing mechanisms. The relevant data of 281 construction employees is collected by questionnaire survey. The relationship among stakeholders (SH), information technology (IT), external stability mechanism (ESM), and information collaboration is then quantitatively evaluated based on the structural equation model (SEM). The results show that stakeholders, information technology, and the external stability mechanism have an influence on information collaboration, while stakeholders do not have a significant influence. Information technology and the external stability mechanism significantly influence information collaboration and provide a mediation role between stakeholders and information collaboration. The innovation of this work is the quantification of information collaboration influencing factors in the construction supply chain and the analysis of its potential path relationship according to the mediating effect test. Its theoretical contribution is to address the research gap in construction supply chain information collaboration and expand the research scope of construction project collaborative management regarding information collaboration. Finally, this work has a practical contribution by providing suggestions for improving the efficiency of building supply information collaboration.

Editorial: Science, data and society

Quality data remain elusive while data access freedoms disappear. Serious mis-matches between data availability and human need should attract societal attention.

Externalization of Unexplored Data with Data Origination: Case Analysis of Person-to-Object Contact Data During COVID-19 Pandemic

Various industries worldwide have been severely affected by the COVID-19 pandemic, highlighting the gaps between social systems and forcing major transformations of our lives. To understand and mitigate the phenomena related to the unprecedented danger of COVID-19, we have become acutely aware of the importance of data distribution, exchange, and sharing across fields;indeed, various data are published and used in decision-making processes. However, although many international organizations and companies have been publishing data and adopting relevant measures, data sharing regarding the question of what data are required for any purpose is insufficient;that is, data are principally provided by organizations who publish the data unilaterally;currently, data-related needs are not shared or leveraged. To address this issue, we introduce the concept of “data origination.” Data origination is the act of designing/acquiring/utilizing data that considers the subjective knowledge and diversity of perspectives of humans, and that aims to elucidate and support this process. We also discuss a case study of data needs and unexplored data externalization conducted during the COVID-19 pandemic, based on data origination. © 2023, Springer Nature Switzerland AG.

Den Patienten wirklich verstehen lernen: Real-world-Evidenz aus der „patient journey“

Background The coronavirus disease 2019 (COVID-19) pandemic has underscored the importance of real world data in everyday clinical practice and has highlighted some long-standing problems of our healthcare system such as gaps in primary data collection, hurdles in the evaluation of patient data, and complexity regarding the data exchange between different institutions. In addition, changes in physician-patient relationships such as transitions from a paternalistic to a partnership-based relationship model as well as increasing digitalization have shaped our modern understanding of healthcare, emphasizing the issue of patient autonomy and self-efficacy and highlighting the need for innovative, patient-centered approaches. Methods Using the patient journey as a theoretical construct, we describe the collection of different types of real world data, their meaning and handling. Conclusion Mapping the patient journey process combined with a widely used data standard can lead to the acquisition of primary data in the healthcare sector which can be used by all medical treatment institutions. This will lead to an exchange of valuable data between institutions and circuit the current problem of proprietary formats. Furthermore, the evaluation of patient-reported outcomes as a standard in the clinical routine could enhance patients' autonomy and optimize treatment. Thus, the overall treatment effectiveness and survival of patients can be improved by creating a common data language and using a holistic, human-centered care approach through integrating perspectives of patients and their loved ones.

Integrated care with digital health innovation: pressing challenges: Managing Community Care

Purpose>Digital health care has emerged as one of the most important means to deliver integrated care by care providers in recent years. As the use of digital health increases, there are some pressing issues such as interoperability of data across different healthcare information systems, regulatory environment and security and privacy of patient’s information which need to be discussed and addressed in order to reduce information silos and to ensure efficient and seamless use of digital health technologies. The purpose of this paper is to address these issues.Design/methodology/approach>In this paper the authors outline the key concepts of interoperability, key challenges pertaining in achieving interoperability and concepts of security and privacy in context of digital health models of integrated care.Findings>The study suggests that standardization of digital health information systems and connecting existing systems to health network, addressing privacy and security related issues through a comprehensive but supportive regulatory environment and educating citizens and healthcare providers are some of the ways to achieve effective use of digital health in models of integrated care.Originality/value>Although the concepts of privacy and interoperability are not new, however, as per best of the authors’ knowledge, this is the first attempt to discuss the challenges and possible actions to meet the objective of achieving integrated care through digital innovation.

Design and Implementation of OPC UA-Based VR/AR Collaboration Model Using CPS Server for VR Engineering Process

In order to cope with the changing era of the innovative management paradigm of the manufacturing industry, it is necessary to advance the construction of smart factories in the domestic manufacturing industry, and in particular, the 3D design and manufacturing content sector is highly growthable. In particular, the core technologies that enable digital transformation VR (Virtual Reality)/AR (Augmented Reality) technologies have developed rapidly in recent years, but have not yet achieved any particular results in industrial engineering. In the manufacturing industry, digital threads and collaboration systems are needed to reduce design costs that change over and over again due to the inability to respond to various problems and demands that should be considered when designing products. To this end, we propose a VR/AR collaboration model that increases efficiency of manufacturing environments such as inspection and maintenance as well as design simultaneously with participants through 3D rendering virtualization of facilities or robot 3D designs in VR/AR. We implemented converting programs and middleware CPS (Cyber Physical System) servers that convert to BOM (Bill of Material)-based 3D graphics models and CPS models to test the accuracy of data and optimization of 3D modeling and study their performance through robotic arms in real factories.

Dans un monde à la fois connecté et en tension, quels enjeux et quelles approches pour assurer valorisation et protection des données ?

La révolution numérique intervenue au cours des trente dernières années est à l'origine de très nombreuses mutations au plan économique et dans notre vie quotidienne. Internet qui en est le socle s'est bâti sur l'échange de données toujours plus importantes, mais surtout sur leur valorisation dans tous les champs : scientifique, sociétal, politique, artistique, ludique... L'information et la connaissance qu'elles rendent possibles constituent un actif qu'il s'agit aujourd'hui de protéger au regard de leur valeur intrinsèque, mais aussi des conséquences que peut induire, directement ou indirectement, leur utilisation. À l'image du numérique et comme toute autre innovation, l'émergence des données n'est pas neutre, représentant tour à tour un risque ou une opportunité, un remède ou un « poison ». La cybersécurité est une pratique et un champ industriel qui peuvent permettre de mesurer et de canaliser ces différentes alternatives, mais qu'il faut aussi appréhender sur le plan politique, au niveau national comme international, pour tenter d'en réguler les équilibres.Alternate :Digital revolution has induced massive economical transformations, since the last thirty years. Data exchange, thanks to the Internet has been cornerstone to this revolution, enhanced by their valuation in all domains: science, health, society, politics, arts, entertainment... Information and knowledge they produce become actual assets, to protect for their own value, as well as for consequences they can cause, directly or indirectly. Data emergence is not neutral, like other aspects of Digital and any innovation: as much a cure as a poison, they can lead to both risks and opportunities. Cybersecurity is a practice and an industrial sector that can allow gauging and marshalling such routes. In this context, political regulation and balances are needed, at both national and international.

A Taxonomy on Smart Healthcare Technologies: Security Framework, Case Study, and Future Directions

There is a massive transformation in the traditional healthcare system from the specialist-centric approach to the patient-centric approach by adopting modern and intelligent healthcare solutions to build a smart healthcare system. It permits patients to directly share their medical data with the specialist for remote diagnosis without any human intervention. Furthermore, the remote monitoring of patients utilizing wearable sensors, Internet of Things (IoT) technologies, and artificial intelligence (AI) has made the treatment readily accessible and affordable. However, the advancement also brings several security and privacy concerns that poorly maneuvered the effective performance of the smart healthcare system. An attacker can exploit the IoT infrastructure, perform an adversarial attack on AI models, and proliferate resource starvation attacks in smart healthcare system. To overcome the aforementioned issues, in this survey, we extensively reviewed and created a comprehensive taxonomy of various smart healthcare technologies such as wearable devices, digital healthcare, and body area networks (BANs), along with their security aspects and solutions for the smart healthcare system. Moreover, we propose an AI-based architecture with the 6G network interface to secure the data exchange between patients and medical practitioners. We have examined our proposed architecture with the case study based on the COVID-19 pandemic by adopting unmanned aerial vehicles (UAVs) for data exchange. The performance of the proposed architecture is evaluated using various machine learning (ML) classification algorithms such as random forest (RF), naive Bayes (NB), logistic regression (LR), linear discriminant analysis (LDA), and perceptron. The RF classification algorithm outperforms the conventional algorithms in terms of accuracy, i.e., 98%. Finally, we present open issues and research challenges associated with smart healthcare technologies.

Hybrid Cryptographic Scheme for Secure Communication in Mobile Ad Hoc Network-Based E-Healthcare System

The COVID-19 pandemic has affected people’s lives in all aspects. This pandemic has raised the usage of ubiquitous networks such as mobile ad hoc networks (MANETs) for information exchange in various domains. MANET is a group of versatile nodes that communicates with each other without relying on a fixed physical framework. One of the prominent features of MANET is its versatile topology. Because of this striking feature, MANETs are employed in various domains like defense and combat operations, disaster management, healthcare, and environmental monitoring. In this paper, we enlighten the significance of MANET in the smart healthcare system. The COVID-19 pandemic outbreak demanded the reshaping of the healthcare systems to combat the pandemic and similar cataclysms. Existing healthcare systems are proved inefficient in dealing with pandemic situations, because they are not fully automated and also vulnerable to various security attacks. Therefore, it is vital to empower the healthcare sectors by integrating ubiquitous networks and other emerging technologies. In this paper, we proposed a MANET-based secure healthcare system to exchange medical data among portable nodes. Ensuring secure communication in the MANET-based healthcare system is one of the challenging issues. Healthcare system demands the sharing of confidential medical data among mobile nodes. So it is essential to provide secure information exchange in healthcare system by using strong cryptographic schemes. In this paper, we proposed a hybrid cryptographic algorithm for secure medical information exchange among mobile healthcare nodes. The proposed cryptographic scheme uses logistic map for key generation. Logistic map exhibits high security with less computational power. Our simulation results show that the proposed hybrid cryptographic scheme exhibits better security against various attacks in MANET-based healthcare systems.

The impact of operational disruptions on performance in surgical settings: moderating roles of risk management infrastructure and information exchange

Purpose>Drawing on normal accident and high-reliability organizational theories, this study examines the impact of magnitude and likelihood of disruptions on surgical procedure performance. More importantly, the authors investigate the moderating role played by information exchange and risk management infrastructure in mitigating the negative effect of disruption on performance.Design/methodology/approach>A nationwide multi-respondent survey was administered to operating room personnel to collect information on their experiences with disruptions experienced in surgeries. The survey data are analyzed to examine the relationship between operational disruptions and procedure performance. Additionally, the moderating roles of risk management infrastructure and information exchange on the relationship between disruptions and performance are investigated. The results obtained from the empirical analysis are validated using data from an ethnographic investigation of surgeries at a major hospital.Findings>The results show that both the magnitude and the likelihood of a disruption adversely impact procedure performance. Interestingly, the authors find that risk management infrastructure and information exchange play different roles in mitigating the effect of disruptions on performance. The authors find that while risk management infrastructure helps mitigate the effect of magnitude of service disruptions, information exchange helps reduce the effects of likelihood of disruptions. The findings lend strong support to the theoretical assertions. By means of the participant–observer data collected from over 100 surgeries as part of the ethnographic investigation, the authors validate the key findings. The findings suggest that disruptions are common occurrences in surgical settings, but their performance impact may be lessened or altogether avoided with the proper information and risk management mechanisms in place.Originality/value>This survey research extends the understanding of risk management by considering a context that is highly prone to disruptions. The authors adopt existing constructs pertaining to supply chain disruptions within this context and find new insights. The findings of the study show differential roles played by information exchange and risk management infrastructure in mitigating disruptions. This nuanced understanding provides directions for aligning efforts towards risk mitigation in surgical settings in a more focused way. This study supplements findings from survey data analysis with an examination of data collected by means of ethnographic investigation.

Research of an Influence of a Traffic Flow Movement Intensity Change on the Possibility of Nonstop Passage of the Traffic Lights Objects

There were examined the problems of passage of the regulated parts of a road. There were investigated the changes of a traffic movement intensity in Lutsk (Ukraine) during the spread of Covid-19 pandemic. The graphic dependences of the drivers' actions estimation while passing the traffic lights objects on a chosen movement route at the beginning of quarantine measures, during the least movement intensity and at the increasing of movement intensity, were obtained. A method of increasing of a possibility of the traffic lights objects nonstop passage was offered. © 2022 Pavlo Mazyliuk et al., published by Sciendo.

SEMRES - A Triple Security Protected Blockchain Based Medical Record Exchange Structure.

BACKGROUND AND OBJECTIVE: COVID-19, a serious infectious disease outbreak started in the end of 2019, has caused a strong impact on the overall medical system, which reflects the gap in the volume and capacity of medical services and highlights the importance of clinical data ex-change and application. The most important concerns of medical records in the medical field include data privacy, data correctness, and data security. By realizing these three goals, medical records can be made available to different hospital information systems to achieve the most complete medical care services. The privacy and protection of health data require detailed specification and usage requirements, which is particularly important for cross-agency data exchange. METHODS: This research is composed of three main modules. "Combined Encryption and Decryption Architecture", which includes the hybrid double encryption mechanism of AES and RSA, and encrypts medical records to produce "Secured Encrypted Medical Record". "Decentralize EMR Repository", which includes data decryption and an exchange mechanism. After a data transmission is completed, the content verification and data decryption process will be launched to confirm the correctness of the data and obtain the data. A blockchain architecture is used to store the hash value of the encrypted EMR, and completes the correctness verification of the EMR after transmission through the hash value. RESULTS: The results of this study provide an efficient triple encryption mechanism for electronic medical records. SEMRES ensures the correctness of data through the non-repudiation feature of a blockchain open ledger, and complete integrated information security protection and data verification architecture, in order that medical data can be exchanged, verified, and applied in different locations. After the patient receives medical services, the medical record is re-encrypted and verified and stored in the patient's medical record. The blockchain architecture is used to ensure the verification of non-repudiation of medical service, and finally to complete the payment for medical services. CONCLUSIONS: The main aim of this study was to complete a security architecture for medical data, and develop a triple encryption authentication architecture to help data owners easily and securely share personal medical records with medical service personnel.

Growing Process of Communities on Data Platforms: Case Analysis of a COVID-19 Dataset

In recent years, there have been growing expectations for the creation of new businesses and the improvement of the value of existing services by exchanging data in different fields. Data stored in-house within organizations have become a new source of innovation. While there is a high need for the value creation of data, determining the data value is not an easy task, as there is a wide range of factors to be considered, such as data pricing, acquisition cost, usage value, and update frequency. In this study, we observe communication, such as the sharing of know-hows in data exchange and analysis, and discuss the growing process of a community on the data platform. For the experiment, we focused on the data community in the COVID-19 disaster and used a unique dataset from the data platform Kaggle, which is the data analysis competition service. The results suggest that user actions differ in the discussion of the dataset and analysis. Moreover, providing topics, user participation, and activating actions in the early stages after the dataset is released are essential for forming a data community. We argue that the actions on the data analysis, such as comments and votes, are also crucial for fostering a common understanding of the data value. © 2021 IEEE.

2020 Crisis Preparedness Exercise with EFSA Focal Points & Observers

In September 2020, the European Food Safety Authority (EFSA) facilitated an online workshop on crisis preparedness and procedures with Members and Observers of EFSA's Focal Point Network. The overall aims of the event were, in the context of a food or feed safety incident,(i) to establish the most appropriate ways to improve collaboration—and exchange data & information—between EFSA and Focal Points, in EU Member States and Pre‐Accession Countries;(ii) identify gaps and frustrations in the current system and look for ways to improve;and (iii) share best practice and knowledge to improve ways of working. Content for the workshop was jointly developed between EFSA and Instinctif Partners. Sixty‐three (63) participants attended plenary and/or working group activity sessions configured within an agenda extending across two days.During Day One, four plenary activities (including presentations and structured discussions) aimed to clarify the role played by Focal Point Network members during incident response, plus the frustrations and challenges arising from fulfilling that role. A working group activity focused on finding solutions and workarounds to the problems and challenges identified. The Day One afternoon session was a two‐hour discussion exercise designed to elaborate the real‐world incident response activities potentially undertaken by Focal Points in the case of a fast‐evolving, large‐scale foodborne disease outbreak. The fictional scenario for the exercise was based on a hypothetical situation where a novel pathogenic virus (similar to SARS‐CoV‐2) turned out to be transmissible in certain food products. Day Two of the event included a 1.5‐hour facilitated plenary debrief of the Day One discussion exercise. The objectives of the event were achieved, based on the recorded outcomes and feedback provided by participants in an online evaluation survey. In addition, discussions during the event generated eighteen (18) practical recommendations for future enhancements and improvements.

Centers for Disease Control and Prevention 2019 novel coronavirus disease (COVID-19) information management: addressing national health-care and public health needs for standardized data definitions and codified vocabulary for data exchange.

OBJECTIVE: The 2019 novel coronavirus disease (COVID-19) outbreak progressed rapidly from a public health (PH) emergency of international concern (World Health Organization [WHO], 30 January 2020) to a pandemic (WHO, 11 March 2020). The declaration of a national emergency in the United States (13 March 2020) necessitated the addition and modification of terminology related to COVID-19 and development of the disease's case definition. During this period, the Centers for Disease Control and Prevention (CDC) and standard development organizations released guidance on data standards for reporting COVID-19 clinical encounters, laboratory results, cause-of-death certifications, and other surveillance processes for COVID-19 PH emergency operations. The CDC COVID-19 Information Management Repository was created to address the need for PH and health-care stakeholders at local and national levels to easily obtain access to comprehensive and up-to-date information management resources. MATERIALS AND METHODS: We introduce the clinical and health-care informatics community to the CDC COVID-19 Information Management Repository: a new, national COVID-19 information management tool. We provide a description of COVID-19 informatics resources, including data requirements for COVID-19 data reporting. RESULTS: We demonstrate the CDC COVID-19 Information Management Repository's categorization and management of critical COVID-19 informatics documentation and standards. We also describe COVID-19 data exchange standards, forms, and specifications. CONCLUSIONS: This information will be valuable to clinical and PH informaticians, epidemiologists, data analysts, standards developers and implementers, and information technology managers involved in the development of COVID-19 situational awareness and response reporting and analytics.