COVlD-19 vaccine Distribution: Preparing for the Unexpected

In December 2020, two shipments of the vaccine experienced temperature excursions in which product was actually kept at overly cold temperatures (3). Urgent need to protect data One problem that vaccine developers and regulatory agencies need to address is the urgent need to protect data, says Nigel Thorpe, technology director with Secure Age, which specializes in enterprise data encryption using a public key infrastructure platform. For operators on the plant floor, the efforts required are fraught with potential error, especially during shift changes, says Jim Evans, director of Verista, Inc.'s vision, connectivity, and automation division. Raw materials The speed with which vaccines have been developed and are being distributed pose important questions centred around variability. If we're having a raw materials shortage when the vaccines haven't even been scaled up, what will happen when they get full approval?" he asks.

Advances in Dissolution Testing

With everything from real-time release testing to automated regulatory audit trail software continuing to gain prominence in the sector, an in-depth look toward the future of dissolution testing is needed for those seeking comprehensive understanding of the industry. [...]things like remote instrument monitoring, maintenance, validation, and possibly repair, software as a service, etc. start becoming subjects of discussion. Together with the move to software control discussed previously, this may make these concepts palatable and applicable to pharma the way they are accepted as de facto in many other industries.

Protecting the NHS from Cyber Attacks

Given that cyber security underwrites public trust in digital services and technologies, the new cyber strategy sets out a vision for reducing the cyber security risk to health and social care organizations across the Department of Health and Social Care (DHSC), National Health Service (NHS) organizations, local authorities, independent social care providers, and suppliers-which includes pharmaceutical manufacturers. [...]attacks can cause a complete loss of access to clinical and administrative information technology (IT) systems, resulting in significant disruption in day-to-day operations. According to the NCSC, ransomware attacks are increasingly seen to include data theft and extortion with a threat of data leaks (3). According to the UK government's recently published policy paper outlining the new cyber security strategy, "all these threats pose risk not just to patient and staff safety, but also to public trust in a health and social care system that can and must safeguard people's data" (2).

Securing Europe's Critical Entities from Cyber Attacks

The revised NIS-2 Directive has been assigned to the Committee on Industry, Research, and Energy (ITRE), within the European Parliament, and is intended to form one of the baselines for the European cybersecurity framework, as well as act as a central tool in advancing Europe's strategic autonomy and the Digital Europe Programme (3). The intention is that cyber resilience must be considered a priority at board and senior management level rather than be confined to the remit of technical teams. European Parliament Adopts New Draft Directive," Technology Law Dispatch, Reed Smith LLP, 20 Jan. 2022.

Driving Consistency in Validation Management

FDA also explained that system designs and controls should allow for detecting errors, omissions, and unusual results-outcomes that cannot be easily identified with paper-based processes. Because the guidance requirements for record retention and review don't differ between paper or electronic, this update supports the shift to a digital model. Using paper to check and mark things off is a normal practice in life sciences, even if it is not a very good process for error detection, data collection, or metrics, says Bryony Borneo, quality assurance director at global contract research organization (CRO) Emmes. Building a solid data foundation and gaining more experience with remote ways of working are driving positive change and making it easier for quality teams to remain compliant with regulations. According to Sanjeev Kumar, senior director, data integrity and technology at Vertex Pharmaceuticals, there is greater awareness of data standardization to identify developing trends and insights from information.

Why Centralized Monitoring and RBQM are Here to Stay

Suddenly, concepts such as remote and centralized monitoring along with the broader RBQM paradigm, which have long been lingering at the side lines of clinical trial management, were brought into sharp focus. The approach allows study leaders to use the risk assessment process to first identify and then focus on the most critical data-the safety and endpoint data that matters most to each individual trial. RBQM has proved its worth during the pandemic, especially in the race to find a vaccine References 1.https://www.outsourcing-pharma.com/Article/2020/12/07/How-has-COVID-19-impacted clinical-trial-data-collection 2.<https://www.ema.europa.eu/en/human-regula tory/overview/public-health-threats/coronavirus disease-covid-19/guidance-medicine-developers> other-stakeholders-covid-19 3.<https://globalforum.diaglobal.org/issue/septem ber-2020/looking-to-the-future-with-rbqm/ 4. https://www.centerwatch.com/articles/24898 remote-monitoring-wont-require-post-pandem ic-re-monitoring-fda-says

ePRO and Ensuring Data Integrity

An increased focus on patient engagement and the 21st Century Cures Act, regulatory authorities, i.e., the FDA, are embracing the need for more patient-centric drug development and wider access to assure accurate data collection as trials become more decentralized. The focus on improved visibility and oversight of data collection, faster trial implementation, sharing of real-time data and patient comfort and collaboration has led to a variety of eClinical applications. ePRO and other eCOA approaches can transform trials to make them more pragmatic, patient-centric and efficient by maximizing the potential to quickly access data through electronic health records, and especially to assist trial managers to make reliable data-driven decisions, and to mitigate risks. In the area of event prediction, a trial manager can look into a company's historical clinical trial data and provide data guidance when for example, writing new protocols, i.e., for dosages that may need to be increased/ reduced for trials in different geographic areas or age groups.

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.

Adoption of blockchain technology enabled healthcare sustainable supply chain to improve healthcare supply chain performance

PurposeThe COVID-19 pandemic has had a significant and worldwide influence on healthcare delivery, and it has significantly increased the pace at which digital technology is being used. Blockchain, one of these developing digital technologies, is distinguished by a number of properties. This study focuses on a blockchain-enabled healthcare supply chain. The purpose of this work is to investigate how blockchain technology (BCT) benefits the performance of healthcare supply chain management (HSCM).Design/methodology/approachThe present study is based on the empirical research. Blockchain Technology (BCT), Healthcare Sustainable Supply Chain Practices (HSSCP), Healthcare Supply Chain Performance (HSCP) and Stakeholders' Involvement (SI) practices are identified from the literature review and hypotheses are framed to check their interrelationship. For testing of hypothesis, a questionnaire was developed. Data collection was done by healthcare professionals via Google docs. The IBM SPSS version 22.0 was used to analyze the data and IBM SPSS AMOS 22.0 software was used for the development of structural modal. The data was collected through the Google form from the stakeholders of healthcare sector and analyzed through Structural Equation Modelling.FindingsThis research is focused on adoption of BCT enabled Healthcare Sustainable Supply Chain to improve HSCP. From the result, it had been found that BCT is positively effecting the stakeholder's involvement (SI) and HSSCP practices. Cumulatively, they positively impact the performance of HSCP. From this study, it is found that adoption of BCT enabled Healthcare Sustainable Supply Chain succours to combat COVID-19 situation.Originality/valueThis study attempts to show the potential benefits of the adoption of BCT enabled HSSCP to improve HSCP.

ONLINE PARTICIPATION AND PERCEPTION OF ONLINE PRIVACY AND SECURITY IN THE UNITED STATES DURING THE GLOBAL PANDEMIC

The global pandemic changed many things from the way we do business to how we consume services. This article examines participation in various online activities before and during the COVID-19 pandemic. In addition, participant opinions about security and privacy opinions are compared in survey results before and after pandemic lockdowns. Responses to questions covering online activities and perceptions about privacy and security from the NTIA Computer and Internet Use Survey from November 2019 and 2021 were analyzed using Chi Square tests. Findings indicate that participation in online activities increased across most categories and that opinions of online security and privacy changed as well. Participants were less concerned about security risks like identity theft and banking fraud and were more concerned with privacy issues of data tracking by online services and the government.

Digital Transformation in Vietnam: Policies, Results and Recommendations

This paper attempts to elucidate Vietnam's strategies and policies for fostering digital transformation. Vietnam has made some progress in the digital transformation of its economy but there are challenges to achieving further progress. Business enterprises struggle to adopt digital technologies due to technical, financial and regulatory constraints. These constraints include conversion costs, internal infrastructure resources, data leakages and ineffective regulations. The government has provided support for the digital transformation of enterprises through improvements in its å framework for the digital economy, promotion of science and technology, taxation regime and SME assistance. The government should undertake further legal reforms to support digital transformation, strengthen digital human resources and enhance e-government capabilities.

Blockchain-Based Trusted Federated Learning with Pre-Trained Models for COVID-19 Detection

COVID-19 is a serious epidemic that not only endangers human health, but also wreaks havoc on the development of society. Recently, there has been research on using artificial intelligence (AI) techniques for COVID-19 detection. As AI has entered the era of big models, deep learning methods based on pre-trained models (PTMs) have become a focus of industrial applications. Federated learning (FL) enables the union of geographically isolated data, which can address the demands of big data for PTMs. However, the incompleteness of the healthcare system and the untrusted distribution of medical data make FL participants unreliable, and medical data also has strong privacy protection requirements. Our research aims to improve training efficiency and global model accuracy using PTMs for training in FL, reducing computation and communication. Meanwhile, we provide a secure aggregation rule using differential privacy and fully homomorphic encryption to achieve a privacy-preserving Byzantine robust federal learning scheme. In addition, we use blockchain to record the training process and we integrate a Byzantine fault tolerance consensus to further improve robustness. Finally, we conduct experiments on a publicly available dataset, and the experimental results show that our scheme is effective with privacy-preserving and robustness. The final trained models achieve better performance on the positive prediction and severe prediction tasks, with an accuracy of 85.00% and 85.06%, respectively. Thus, this indicates that our study is able to provide reliable results for COVID-19 detection.

Digital Workplaces and Information Security Behavior of Business Employees: An Empirical Study of Saudi Arabia

In the post pandemic era, the telecommuting of business employees has widely become acceptable in organizations, which demands extensive dependence on digital technologies. In addition, this poses additional security threats for business employees as well as organizations. In order to better respond to security threats, business employees must have a higher level of awareness of the potential threats that are relevant to digital infrastructure used within the workplace. In this paper, we present a quantitative study conducted in line with the theory of planned behavior to gain insight into employee behavior toward information security within different business sectors in Saudi Arabia. The key factors chosen for our model were password management, infrastructure security management, email management, organizational security policy, organizational support and training, and the perception of the level of security. We have applied structured equation modelling to identify most of the relevant factors based on the respondents' feedback. The results based on the business employee behavior showed that they respondents did not perceive all of the constructs of our model as relevant security factors, which can potentially result in security lapses. This indicates that more security-related measures should be put in place and that business employees should be updated periodically about potential security threats. To this effect, we divided the studied security measures into those which should be implemented at organizational and individual levels. The results will potentially help business managers to design appropriate security trainings, guidelines, and policies for their employees to ensure more information security awareness and protect their technological infrastructure, especially within home office environments.

Future of Drug Discovery: The Synergy of Edge Computing, Internet of Medical Things, and Deep Learning

The global spread of COVID-19 highlights the urgency of quickly finding drugs and vaccines and suggests that similar challenges will arise in the future. This underscores the need for ongoing efforts to overcome the obstacles involved in the development of potential treatments. Although some progress has been made in the use of Artificial Intelligence (AI) in drug discovery, virologists, pharmaceutical companies, and investors seek more long-term solutions and greater investment in emerging technologies. One potential solution to aid in the drug-development process is to combine the capabilities of the Internet of Medical Things (IoMT), edge computing (EC), and deep learning (DL). Some practical frameworks and techniques utilizing EC, IoMT, and DL have been proposed for the monitoring and tracking of infected individuals or high-risk areas. However, these technologies have not been widely utilized in drug clinical trials. Given the time-consuming nature of traditional drug- and vaccine-development methods, there is a need for a new AI-based platform that can revolutionize the industry. One approach involves utilizing smartphones equipped with medical sensors to collect and transmit real-time physiological and healthcare information on clinical-trial participants to the nearest edge nodes (EN). This allows the verification of a vast amount of medical data for a large number of individuals in a short time frame, without the restrictions of latency, bandwidth, or security constraints. The collected information can be monitored by physicians and researchers to assess a vaccine's performance.

PbDinEHR: A Novel Privacy by Design Developed Framework Using Distributed Data Storage and Sharing for Secure and Scalable Electronic Health Records Management

Privacy in Electronic Health Records (EHR) has become a significant concern in today's rapidly changing world, particularly for personal and sensitive user data. The sheer volume and sensitive nature of patient records require healthcare providers to exercise an intense quantity of caution during EHR implementation. In recent years, various healthcare providers have been hit by ransomware and distributed denial of service attacks, halting many emergency services during COVID-19. Personal data breaches are becoming more common day by day, and privacy concerns are often raised when sharing data across a network, mainly due to transparency and security issues. To tackle this problem, various researchers have proposed privacy-preserving solutions for EHR. However, most solutions do not extensively use Privacy by Design (PbD) mechanisms, distributed data storage and sharing when designing their frameworks, which is the emphasis of this study. To design a framework for Privacy by Design in Electronic Health Records (PbDinEHR) that can preserve the privacy of patients during data collection, storage, access and sharing, we have analysed the fundamental principles of privacy by design and privacy design strategies, and the compatibility of our proposed healthcare principles with Privacy Impact Assessment (PIA), Australian Privacy Principles (APPs) and General Data Protection Regulation (GDPR). To demonstrate the proposed framework, ‘PbDinEHR', we have implemented a Patient Record Management System (PRMS) to create interfaces for patients and healthcare providers. In addition, to provide transparency and security for sharing patients' medical files with various healthcare providers, we have implemented a distributed file system and two permission blockchain networks using the InterPlanetary File System (IPFS) and Ethereum blockchain. This allows us to expand the proposed privacy by design mechanisms in the future to enable healthcare providers, patients, imaging labs and others to share patient-centric data in a transparent manner. The developed framework has been tested and evaluated to ensure user performance, effectiveness, and security. The complete solution is expected to provide progressive resistance in the face of continuous data breaches in the patient information domain.

RETHINKING STRATEGIC AUTONOMY IN TIMES OF NEXT GENERATION EU: NEW DIGITAL AGENDA

The digital transformation of the global economy and society has accelerated after the Covid-19 pandemic. The European Union (EU), compared to China and the United States, is losing its capacity for innovation and control over data and fundamental raw materials and could even lose ground in the regulatory power it has in the digital realm. This paper pays special attention to the situation and progress toward a new European policy to achieve digital strategic autonomy. It also briefly outlines the Recovery Plan for Europe as a possible incentive for its promotion. Both descriptive and analytical methods were employed to gather the data from secondary sources and provide reliable research results. The major findings of this article are that strategic autonomy is an imperative requirement for sustaining and encouraging European integration, forcing the EU to advance faster toward developing critical digital technologies. There is also an urgent need to secure critical parts of supply chains and data protection, intellectual property, and defense against disinformation. Finally, the European Union must improve its resilience to face new crises and lead the digitalization of its economy.

The Utilization of Blockchain Technology on Remote Audit to Ensure Audit Data Integrity in Detecting Potential Fraudulent Financial Reporting

The rapid evolution of technology has massively changed and shaped audit work culture. At the same time, the COVID-19 pandemic outbreak significantly changed audit and control activities, encouraging auditors to audit clients remotely and forcing auditors to adopt advanced digital technology, especially blockchain-based technology. Blockchain is one decentralized, transparent, and immutable technology that plays an essential role and has an aggressive impact in the audit field. The implementation and adoption of cognitive technologies such as blockchain in the remote audit process allow auditors to access various client data and information in real-time, ensure audit data integrity, review and process data documentation quickly, obtaining data directly without third parties that make it easier for auditors to obtain audit evidence instantly and accurately in detecting any anomalies. This research aims to identify and navigate how blockchain assists auditors in performing remote audits, ensuring data integrity, detecting fraudulent financial reporting, elaborating on factors that influence the auditor's success in using blockchain, and identifying challenges auditors face during blockchain utilization in their remote audits. This research used a descriptive qualitative approach by obtaining primary data from profound interview results with several auditors experienced in using blockchain. We also used secondary data from journals, papers, articles, books, and relevant websites. The research findings showed that blockchain's unique characteristics greatly assist auditors in conducting remote audits, ensuring audit data integrity, and detecting fraudulent financial reporting in various ways. Furthermore, various factors influence blockchain utilization, such as human resources aspects, the effectiveness of the IT control environment, and the CPA size firm. Lastly, auditors should face several challenges in the present and future. © 2022 ACM.

Making better IS security investment decisions: discovering the cost of data breach announcements during the COVID-19 pandemic

PurposeStock price reactions have often been used to evaluate the cost of data breaches in the current information systems (IS) security literature. To further this line of research, this study examines the impact of data breaches on stock returns, information asymmetry and unsystematic firm risk in the context of COVID-19.Design/methodology/approachThis paper employs an event study methodology and examines data breach events released in public databases, spanning pre- and post-COVID settings. This study investigated 283 data breaches of the US publicly traded firms, and the economic cost was measured by cumulative abnormal returns (CARs), trading volume, bid-ask spread and unsystematic risk.FindingsThe authors observe that data breaches during the COVID pandemic make investors react more negatively to data breach announcements, as reflected in the significantly negative difference in CARs between breached firms before COVID and those after COVID. The findings also indicate that, after the disclosure of data breach incidents, information asymmetry is reduced to a lesser extent compared with that in the pre-COVID setting. The authors also find that data breach events lead to an increase in the unsystematic risk of breached companies in the pre-COVID era but no change in the post-COVID era.Originality/valueThis study is the first effort to examine the economic consequences of data breaches by investigating the effects in the form of trading activities and risk measurement in the COVID setting.

A Study of Cryptographic Primitives in the context of Blockchain's Data Integrity and Privacy

In Today's World, Blockchain is a promising Technology in all areas;things have also been drastically changed after COVID-19;challenges surfaced for implementing blockchain technology in the context of its computational complexity and security. After invention of it in 2008, cryptocurrency applications, i.e., Bitcoin it also getting introduced in Different applications. One of the Major Building blocks of Blockchain is Cryptography techniques. This paper discusses Cryptographic primitives used in different phases of Blockchain implementation and the challenges of implementing these cryptographic primitives. Bitcoin uses Cryptographic primitives to generate public-private key pairs and mining, while Ethereum uses Elliptic curve cryptography to create public-private keys and digital signatures. This paper divided uses of cryptographic primitives into three categories used in Blockchains, i.e., key generation Hashes, signature generation hashes, and proof hashes. © 2022 IEEE.