Regulatory Aspects on AI and Pharmacovigilance for COVID-19

This chapter looks at current and perspective legislative and regulatory scenario, identifying rules governing the use of Artificial Intelligence in the health sector at European Union level with a focus on the impact of AI on pharmacovigilance activities. After some preliminary considerations on definitory issues, attention will be paid to the challenges posed by AI to pharmaceutical industry in developing medicinal products and monitoring their quality, safety and efficacy. The European strategy addressing the use of AI in pursuing a better health policy will then be outlined, followed by some caveat concerning ethical implications and protection of personal data. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

A survey of automatic contact tracing approaches using bluetooth low energy

To combat the ongoing Covid-19 pandemic, many new ways have been proposed on how to automate the process of finding infected people, also called contact tracing. A special focus was put on preserving the privacy of users. Bluetooth Low Energy as base technology has the most promising properties, so this survey focuses on automated contact tracing techniques using Bluetooth Low Energy. We define multiple classes of methods and identify two major groups: systems that rely on a server for finding new infections and systems that distribute this process. Existing approaches are systematically classified regarding security and privacy criteria.Copyright © 2021 ACM.

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.

Blockchain-based Health Data Sharing for Continuous Disease Surveillance in Smart Environments

The Covid-19 pandemic ushered in multiple paradigms of personal health data sharing with particular emphasis on Person-to-Institution sharing and Institution-to-Institution sharing. While the data aggregated by technology companies and health authorities was instrumental in the development of vaccines and ultimately flattening the curve of infection rates, egregious abuses of privacy occurred. In many instances acceptable guarantees of appropriate utility for the data were not made available. Personal health data sharing for the containment of infections with privacy limitations present a classic case of collaboration among mutually distrustful entities. In this regard the blockchain network and attendant protocols for data integrity, transaction transmission and provenance can prove useful. Thus, in this paper we present a blockchain-based method for disease surveillance in a smart environment where smart contracts are deployed to monitor public locations instead of individuals. The data aggregated is analysed and tagged with a lifetime commensurate with the time for infection. Once the data utility period has elapsed the monitored data are removed from the active surveillance pool and the entities involved can be notified. Such a method of continual surveillance protects privacy by shifting the emphasis from individuals to locations. Experimental data suggests this method is efficient and can be implemented on top of existing disease surveillance strategies for later pandemics.

Improving on and assessing ethical guidelines for digital tracking and tracing systems for pandemics.

So-called digital tracking and tracing systems (DTTSs) have been proposed as a means to prevent the spread of SARS-CoV-2. There are ethical guidelines and evaluations of such systems available. As part of a research project, I will build on and critically evaluate the foundations of such guidelines. The goal is to provide both incremental improvements of the specific requirements for DTTSs and to present and discuss more fundamental challenge, the risk for indirect effects and slippery slopes. The nature of slippery slopes makes ethical guidelines more difficult since it requires a more complex analysis than, for example, using a checklist allows for.

The ethical, legal and social issues of pandemics: An analysis from the EU perspective

This book proposes an ethical and legal framework to improve the responses to social issues related not only to the current SARS-CoV-2 pandemic, but also to future pandemics. Its contents cover the issues that are likely to be most controversial in any public health crisis. It starts by discussing non-pharmacological measures, such as the appropriateness of confinement, how to control compliance with public health measures and the ethical, legal and social acceptability of health certificates. Then it turns to issues related to the production, distribution and administration of vaccines, with a particular focus on the design and implementation of vaccination policies. Finally, it analyses the most appropriate criteria to develop a triage, when the situation brings us to this terrible scenario. The analyses presented in this book are based on the ethical and legal frameworks, as well as the social context, of the European Union, and aims to address the main dilemmas faced by any liberal democracy dealing with a pandemic: how to reconcile the defense against a public health crisis together with a respect for fundamental rights and freedoms. The European legal systems have developed a number of conceptual tools designed to ensure that there is no room for arbitrariness in the restrictions introduced by the political power in emergency situations, and this book builds upon these tools. The Ethical, Legal and Social Issues of Pandemics: An Analysis from the EU Perspective is a predominantly practice-oriented book, which will help policy makers to adopt policies that effectively combine public health needs with individual rights and freedoms. It will also help health care givers to understand better the ethical and legal issues involved in their work and citizens, in general, to participate in public decision making in an informed manner. Finally, it will help to design tools that faithfully comply with existing fundamental rights standards. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Blockchain-Based Patient-to-Patient Health Data Sharing

The Covid-19 pandemic catalyzed many exciting forms of health data sharing. Aside from the institution-to-institution health data sharing among cooperating institutions for research and discovery of insights in healthcare, individual-to-many and individual-to-individual health data sharing also came to the fore. However, the security risks involved here are substantial since health data disclosures can lead to privacy and security breaches or complications. In this research, we present a scheme to enable individuals to share details of medical experiences with other individuals or interested groups. Our system provides the sharing entities with anonymity and thus, facilitates rapid dissemination of empirical insights during public health emergencies like Covid-19.

The Legal Aspects of Telehealth

Telehealth seems to be the new normal in this fast-changing environment. According to the European Commission eHealth was among the highest priorities before the COVID -19 pandemic. Transformation of health and care in the digital single market is among the EU's six political priorities of the Commission 2019-2024 (2018 Communication on Digital Health and Care). The pandemic caused by COVID-19 just accelerates the necessity of the inclusion of digital health into the traditional healthcare systems. Telehealth services are among the biggest eHealth trends in EU. Therefore, one of the challenges is the national, regional and regulatory priorities regarding telehealth. There is lack of telehealth special legislative and governmental policies that needs to stimulate the developing and innovative solutions in medicine through technology and to envisage the upcoming innovation technology. Therefore, the government support and adequate policy making is important to support the development of the telehealth services. One of the main challenges is the electronic transactions of patient data among the telehealth providers and services and the cross-border patient data share. Another issue is the exchange of information among the national health institutions and providers and their interoperability. The Macedonian legislation does not have special legislation (policies, or laws) about telehealth. Telehealth is regulated as a term in the Law on health protection. Additionally, there is a lack of national acts, literature, and research in this subject matter. Thus, this paper will explore the telehealth from two main perspectives: scientific theories and legal practice and the users' practice. Hence, this paper will analyze the legislation about the telehealth on the EU level and the EU Member States and the Macedonian legislation and the impact on the e-health that was made during COVID-19 pandemic. Furthermore, it will make comparative analyses among different countries into the EU zone compared with the EU aspirant country- the Republic of North Macedonia. A survey conducted among doctors in private and public healthcare institutions in the primary, secondary, and tertiary healthcare levels in the city of Stip and in the city of Skopje will provide data about the challenges, risks, and trends in telehealth before and during COVID -19.

Blockchain-based Health Data Sharing for Continuous Disease Surveillance in Smart Environments

The Covid-19 pandemic ushered in multiple paradigms of personal health data sharing with particular emphasis on Person-to-Institution sharing and Institution-toInstitution sharing. While the data aggregated by technology companies and health authorities was instrumental in the development of vaccines and ultimately flattening the curve of infection rates, egregious abuses of privacy occurred. In many instances acceptable guarantees of appropriate utility for the data were not made available. Personal health data sharing for the containment of infections with privacy limitations present a classic case of collaboration among mutually distrustful entities. In this regard the blockchain network and attendant protocols for data integrity, transaction transmission and provenance can prove useful. Thus, in this paper we present a blockchain-based method for disease surveillance in a smart environment where smart contracts are deployed to monitor public locations instead of individuals. The data aggregated is analysed and tagged with a lifetime commensurate with the time for infection. Once the data utility period has elapsed the monitored data are removed from the active surveillance pool and the entities involved can be notified. Such a method of continual surveillance protects privacy by shifting the emphasis from individuals to locations. Experimental data suggests this method is efficient and can be implemented on top of existing disease surveillance strategies for later pandemics. © 2023 IEEE.

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.

[The limits of internal medicine]. / Die Grenzen der Inneren Medizin.

"The limits of internal medicine" was the congress motto of the 128th Congress of the German Society of Internal Medicine in Wiesbaden in 2022. In his presidential address Prof. Lerch focused on four aspects of this motto: physician-assisted suicide, lessons from the corona pandemic, deficits in the digitalization of the German healthcare system and the German Sonderweg in applying EU regulations for patient data protection. Using data from Canada, Switzerland and the Netherlands, where different forms of physician-assisted suicide are practiced, Prof. Lerch appealed to internists, specifically in family practices, to confront this issue in view of a German Supreme Court ruling. With respect to the development of the corona pandemic he discussed the root causes of the opposition to vaccination in parts of society as well as the question why non-clinically active and only few clinical disciplines have shaped the discussion about corona protection measures in Germany. Another focus of his speech was the insufficient digital maturity of the German healthcare system, which clearly lags behind other countries with respect to digital transformation. Physicians need to become more involved in the digital transformation in order to reorganize the healthcare system for the benefit of the patients. The German Sonderweg in the application of the General Data Protection Regulation (GDPR) requires a new legal framework to enable a pragmatic and progressive use of patient data for medical research and patient safety.

Tell me who your contacts are, or what can we learn from standard setting in the context of COVID-19 tracing apps

At the beginning of the pandemic, digital contact tracing was a much-hoped-for initiative that spurred a myriad of apps. Despite a great theoretical promise, however, the tool fell short of significant impact and, essentially, came to nothing. The technological development effort has attracted much scholarly and media attention and coverage. This article seeks to contribute to this growing body of knowledge by approaching the topic from a largely unexplored perspective. It examines the emergence of digital contact tracing as a standard setting exercise, focusing on key actors, processes of technical specification development and data protection assessment of technological choices. It also explores the governance attributes of standard settings from the perspective of data protection law. Given a potential of a technical standard to act as a regulatory means, it is proposed that the governance and legitimacy issues should receive much more consideration. It is believed that for a technical solution to stand the competition for a regulatory share and succeed in the future, the values of inclusiveness, transparency, accountability and openness should be meaningfully internalised in the very process of its development. © 2023

Remote work during the COVID-19 pandemic: identification of working life impacts, employees' data protection abilities and trust outcomes

Purpose: This study examined employees' experiences of remote work and the impact of remote work on working life. Design/methodology/approach: This was a mixed-methods study undertaken in three Finnish nonprofit firms. In total, 1,154 respondents took part during the first and second COVID-19 waves in Finland. Findings: COVID-19 remote working saved employees' and businesses' financial resources;increased job satisfaction, firms' performances and employee employment opportunities;and positively affected organizations' trust outcomes. This study found that female team leaders were significantly more likely than male team leaders to trust team members' data protection abilities. In addition, remote work can reduce climate pollution. Remote work during the COVID-19 pandemic also affected the social lives of the employees and work relationships and led to a reduction in physical activity levels and work overload. Research theoretical implications: The main theoretical contributions of this study are the identification of remote working characteristics during the COVID-19 pandemic, positive/negative outcomes of remote working, and further forms measurable propositions. This study contributes to the change management literature and opens up new avenues for future research. Practical implications: This study can help managers to better understand and lead employees at a time when significant numbers continue to work remotely. Continued work in this field is important because organizations are required to be agile in a changing operating work environment. Given that home-based work has become the new normal, organizations may need to update their data protection rules and address organizational trust issues. Social implications: Social effects can be seen as an increased understanding of the effects of remote work in the colleague network. Although remote work suits many employees, they also wish to see their colleagues occasionally. Thus, a mix of remote work with some in-office time may be a more attractive option than remote work only. Originality/value: The integrated multidimensional framework applied in this study is based on research findings. The framework is dynamic and can be further expanded with new findings, serving as a theoretical basis to guide future research. © 2023, Emerald Publishing Limited.

COVID-19 Contact-Tracing Technology, Users' Privacy and Security

Nowadays, the entire world is struggling to adapt and survive the SARS-CoV-2/COVID-19 pandemic, the new mutations in the Coronavirus disease is causing damage and disruption across the world. Taking preventive measures to control the spreading of the virus, including lockdowns, curfews, social distancing, masks, vaccination are not enough to stop the virus. Many countries have sought to support their contact tracers with the use of digital contact tracing apps to manage and control the spread of the virus. Using the new technologies to adapt the prevention measures furthermore enhancing the existing ones, will definitely be more efficient. There are many contact tracing apps that have already been launched and used since 2020. There has been a lot of speculations about the confidentiality and security aspects of these apps and their possible violation of data protection principles. In this paper we propose a system of contact tracing, we explain how this system treats sensible information to preserve the user's identity and protect their personal information. © 2023, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Next generation EU and the future of economic governance: towards a paradigm change or just a big one-off?

Next Generation EU (NGEU), the new temporary program (2021-2026) decided by the European Union (EU) to deal with the economic consequences of the COVID-19 pandemic, represents a substantial break with respect to previous EU responses to economic crises. After identifying the discontinuity introduced by the NGEU compared to the governance response to the sovereign debt crisis of the early 2010s, the paper investigates the conditions under which a new paradigm of economic governance would emerge and not remain simply a major one-off, when the EU should deal with an exogenous shock. Those conditions are conceptualised in terms of three trilemmas. The possibility of the NGEU becoming the harbinger of a new paradigm of economic governance will depend on the solutions of those trilemmas – favouring the EU supranational institutions, promoting a new policy mix in fiscal policy, and implementing national reforms coherent with the EU's aims notwithstanding national electoral cycles. The solutions are then evaluated according to the 'Monnet Compatibility Test' (MCT) which implies coherence between the institutional, economic and political features of the new economic governance arrangements. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

EU health policy in the aftermath of COVID-19: neofunctionalism and crisis-driven integration

In March 2020, the COVID-19 pandemic shook the European Union (EU). The EU responded to the multifaceted challenge with an integrative leap forward. Member States substantially increased their investment in existing health policy tools such as civil protection and financing for health initiatives. There was innovation in EU law, where a process of redefining public health began, and in strategies for vaccines and pharmaceuticals, where the EU took on a direct and significant role in medicines procurement for the first time. We use the framework of neofunctionalism to analyse developments in health policy during the pandemic to further understand the dynamics of integration and, in particular, to understand why EU Member States opted for further integration in response to the pandemic. As neofunctionalism might predict, Member States solved problems born of integration with more integration: preserving the internal market, insuring against disasters, preventing border closures and enhancing EU power in vaccine development and procurement. Reflecting decades of entrepreneurs who had created various mechanisms, they primarily built on pre-existing, if often weak, structures and enhanced EU governance more than competences. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Crisis management performance and the European Union: the case of COVID-19

A seemingly continuous stream of crises in Europe has turned scholarly agendas towards assessment of the EU's management of crises. Those assessments vary widely, depending on the analytical focus and criteria used. This paper introduces three assessment criteria drawn from crisis research that pertain to the detection of a crisis, the mobilization of necessary resources, and the nature of the public debate about critical choices made in times of crisis. We relate these crisis management insights to long-standing debates in European integration theory to help link traditional crisis management assessments with EU-focused theorizing. The article offers a framework for assessment of the EU's performance as a crisis manager. We illustrate the utility of the framework with a brief application to the EU's response to Covid-19. We assess the EU's performance in positive terms: the Union acted quickly after a somewhat slow start and was very effective in mobilizing a variety of resources. At the same time, we note that major policy choices were made without a significant public debate about potential effects on the future character of the Union. [ FROM AUTHOR] Copyright of Journal of European Public Policy is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Exploring Personal Data Processing in Video Conferencing Apps

The use of video conferencing applications has increased tremendously in recent years, particularly due to the COVID-19 pandemic and the associated restrictions on movements. As a result, the corresponding smart apps have also seen increased usage, leading to a surge in downloads of video conferencing apps. However, this trend has generated several data protection and privacy challenges inherent in the smart mobile ecosystem. This paper aims to study data protection issues in video conferencing apps by statistically and dynamically analyzing the most common such issues in real-time operation on Android platforms. The goal is to determine what these applications do in real time and verify whether they provide users with sufficient information regarding the underlying personal data processes. Our results illustrate that there is still room for improvement in several aspects, mainly because the relevant privacy policies do not always provide users with sufficient information about the underlying personal data processes (especially with respect to data leaks to third parties), which, in turn, raises concerns about compliance with data protection by design and default principles. Specifically, users are often not informed about which personal data are being processed, for what purposes, and whether these processes are necessary (and, if yes, why) or based on their consent. Furthermore, the permissions required by the apps during runtime are not always justified. © 2023 by the authors.

Implementation of data protection laws in the European Union and in California is associated with a move of clinical trials to countries with fewer data protections.

The European Union implemented data privacy laws in mid-2018 and the state of California enacted a similar law several weeks later. These regulations affect medical data collection and analysis. It is unclear if they achieve this goal in the realm of clinical trials. Here we investigate the effect of these laws on clinical trials through analysis of clinical trials recorded on the US's ClinicalTrials.gov, the World Health Organization's International Clinical Trials Registry Platform and scientific papers describing clinical trials. Our findings show that the number of phase 1 and 2 trials in countries not adhering to these data privacy laws rose significantly after implementation of these laws. The largest rise occurred in countries which are less free, as indicated by the negative correlation (-0.48, p = 0.008) between the civil liberties freedom score of countries and the increase in the number of trials. This trend was not observed in countries adhering to data privacy laws nor in the paper publication record. The rise was larger (and statistically significant) among industry funded trials and interventional trials. Thus, the implementation of data privacy laws is associated a change in the location of clinical trials, which are currently executed more often in countries where people have fewer protections for their data.