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Author: Giulia Schneider
Publisher: Springer Nature
ISBN: 3030954277
Category : Law
Languages : en
Pages : 388
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Book Description
This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.
Author: Giulia Schneider
Publisher: Springer Nature
ISBN: 3030954277
Category : Law
Languages : en
Pages : 388
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Book Description
This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.
Author: Rosa Maria Ballardini
Publisher: Kluwer Law International B.V.
ISBN: 9403503416
Category : Law
Languages : en
Pages : 517
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Book Description
The digitization of industrial processes has suddenly taken a great leap forward, with burgeoning applications in manufacturing, transportation and numerous other areas. Many stakeholders, however, are uncertain about the opportunities and risks associated with it and what it really means for businesses and national economies. Clarity of legal rules is now a pressing necessity. This book, the first to deal with legal questions related to Industrial Internet, follows a multidisciplinary approach that is instructed by law concerning intellectual property, data protection, competition, contracts and licensing, focusing on business, technology and policy-driven issues. Experts in various relevant fields of science and industry measure the legal tensions created by Industrial Internet in our global economy and propose solutions that are both theoretically valuable and concretely practical, identifying workable business models and practices based on both technical and legal knowledge. Perspectives include the following: regulating Industrial Internet via intellectual property rights (IPR); data ownership versus control over data; artificial intelligence and IPR infringement; patent owning in Industrial Internet; abuse of dominance in Industrial Internet platforms; data collaboration, pooling and hoarding; legal implications of granular versioning technologies; and misuse of information for anticompetitive purposes. The book represents a record of a major collaborative project, held between 2016 and 2019 in Finland, involving a number of universities, technology firms and law firms. As Industrial Internet technologies are already being used in several businesses, it is of paramount importance for the global economy that legal, business and policy-related challenges are promptly analyzed and discussed. This crucially important book not only reveals the legal and policy-related issues that we soon will have to deal with but also facilitates the creation of legislation and policies that promote Industrial-Internet-related technologies and new business opportunities. It will be warmly welcomed by practitioners, patent and other IPR attorneys, innovation economists and companies operating in the Industrial Internet ecosystem, as well as by competition authorities and other policymakers.
Author: Nilmini Wickramasinghe
Publisher: CRC Press
ISBN: 1003849709
Category : Medical
Languages : en
Pages : 449
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Book Description
This title demystifies artificial intelligence (AI) and analytics, upskilling individuals (healthcare professionals, hospital managers, consultants, researchers, students, and the population at large) around analytics and AI as it applies to healthcare. This book shows how the tools, techniques, technologies, and tactics around analytics and AI can be best leveraged and utilised to realise a healthcare value proposition of better quality, better access and high value for everyone every day, everywhere. The book presents a triumvirate approach including technical, business and medical aspects of data and analytics and by so doing takes a responsible approach to this key area. This work serves to introduce the critical issues in AI and analytics for healthcare to students, practitioners, and researchers.
Author: Kokkoris, Ioannis
Publisher: Edward Elgar Publishing
ISBN: 1789903793
Category : Law
Languages : en
Pages : 507
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Book Description
This incisive Research Handbook identifies and assesses the emerging trends in competition enforcement, investigating how such changes impact the enforcement approach of competition authorities and the behaviour of companies in an ever-evolving business and regulatory environment.
Author: Frank Hendrickx
Publisher: Kluwer Law International B.V.
ISBN: 9403541652
Category : Law
Languages : en
Pages : 334
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Book Description
The right to privacy is a fundamental right. Along with the related right to personal data protection, it has come to take a central place in contemporary employment relations and shows significant relevance for the future of work. This thoroughly researched volume, which offers insightful essays by leading European academics and policymakers in labour and employment law, is the first to present a thoroughly up-to-date Europe-wide survey and analysis of the intensive and growing interaction of workplace relations systems with developments in privacy law. With abundant reference to the EU’s General Data Protection Regulation, the case law of the European Court of Human Rights, and the work of the International Labour Organisation, the book proceeds as a series of country chapters, each by a recognised expert in a specific jurisdiction. Legal comparison is based on a questionnaire circulated to the contributors in advance. Each country chapter addresses the national legal weight of such issues and topics as the following: interaction of privacy and data protection law; legitimacy, purpose limitation, and data minimisation; transparency; role of consent; artificial intelligence and automated decision-making; health-related data, including biometrics and psychological testing; monitoring and surveillance; and use of social media. A detailed introductory overview begins the volume. The research for this book is based on a dynamic methodology, founded in scientific desk research and expert networking. Recognising that the need for further guidance for privacy at work has been demonstrated by various European and international bodies, this book delivers a signal contribution to the field for social partners, practitioners, policymakers, scholars, and all other stakeholders working at the crossroads of privacy, data protection, and labour law.
Author: Jan Krämer
Publisher: Centre on Regulation in Europe asbl (CERRE)
ISBN:
Category : Political Science
Languages : en
Pages : 103
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Book Description
This study provides recommendations on how to make personal data portability more effective. This will truly empower consumers to use the services they want and share their data with whoever they wish and stimulate innovation in Europe. With the entry into force of the GDPR, European citizens gained new rights, notably with data portability. But two years later, there is still little sign of people exercising this right, and of companies offering an easy and convenient service for data portability. While the European Commission is finalising its evaluation of the GDPR and closes its consultation on the European data strategy, the authors, professors Jan Krämer, Pierre Senellart and Alexandre de Streel*, warn that the current legal framework requires clarifications to better empower European citizens in a data-driven society. In this study, they identify barriers to data portability, including the lack of possibilities to import data as well as the lack of common standards and tools to access data as easy as the click of a button. The ability to provide users with a centralised dashboard for monitoring and controlling the flow of their data is also critically missing. “Today, consumers do not widely use data portability for reasons that can and should be overcome. Making data portability more effective is better for competition, for innovation and to empower users,” stress the authors. “There should be no second-guessing on whether to make data portability more effective, the time to act is now.” The current EU framework encourages data portability, but there are legal gaps that the EU should fill. The authors insist on the need for detailed guidance on how data portability can be facilitated and on which data is subject to data portability without violating privacy rights. They advocate that data provided by users when using a service, such as search history (i.e. “observed data”) should clearly be included under the scope of data portability. The authors consider it essential that the obligation to offer standardised Application Programming Interfaces (APIs) be much more widespread to enable consumers to continuously port their data. “We believe that standardised APIs that enable continuous data portability is a prerequisite for encouraging more organisations to import personal data, and for encouraging more consumers to initiate such transfers,” explain the authors. Projects, such as the Data Transfer Project have highlighted that continuous data portability is technically feasible. The authors argue that Personal Management Information Systems (PIMSs) facilitate the complex consent management and offer users a centralised dashboard for monitoring and controlling the flow of their data will have a crucial role to play for the wider adoption of data portability. “It must be as easy as clicking a button for consumers to continuously share data they created with one provider to another provider. This may also require educating and informing users on their rights through information campaigns alongside clear policy measures,” explain the authors. Nevertheless, they stress that PIMSs are not likely to find a sustainable business model, and thus, policy makers should support the emergence of open-source projects by setting common standards for data transfers, consent management, and identity management.
Author: Mario Mariniello
Publisher: Oxford University Press
ISBN: 0192567152
Category : Business & Economics
Languages : en
Pages : 497
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Book Description
The emergence of new technologies and business models such as data analytics, online platforms, and artificial intelligence has shaken the economy and society at their foundations. Recently, it has become apparent that public authorities must take a pro-active role to define the rules of the newly emerged markets before potential issues and concerns cement. How rules are currently written determines who will exert a stronger influence on the economy and society in the coming years. This is key reason why digital policymakers are currently exposed to tremendous pressure by stakeholders. This book takes a journey through all the main areas in the digital economy that beg for policy action. Readers may learn about the general features of a digital economy and the EU long term strategic plans to govern it. They may learn about telecom markets, the data economy, the digitization of the public sector, cybersecurity, the platform economy, liability for online content, e-commerce, the sharing economy, the impact of technology on labour markets, digital inequality, disinformation, and artificial intelligence. This book provides students with the background knowledge and analytical tools necessary to understand, analyse, and assess the impact of EU digital policies on the European economy and society. The approach is both theoretical and applied. The main goal is to prepare students to give informed and economically sound advice to an EU policymaker for digital affairs.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Björn Lundqvist
Publisher: Cambridge University Press
ISBN: 1009335170
Category : Law
Languages : en
Pages : 269
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Book Description
Data collected and distributed on the internet is generally free, non-exclusive, and non-rivalrous. Yet online data is often difficult to access. This book examines the infrastructure for collecting, storing, and distributing data to show how it is embedded behind intellectual property and technological barriers. It proposes that the EU introduce an access and transfer governance right to data that can work in tandem with data protection rules. Chapters explore the subject matter of this protection, potential rights holders and the scope of the protection, and exceptions and limitations under intellectual property law and competition law. Comprehensive and timely, Regulating Access and Transfer of Data sets the foundations for a new legal system for our data-driven generation.
Author: Richard Feasey
Publisher: Centre on Regulation in Europe asbl (CERRE)
ISBN:
Category : Technology & Engineering
Languages : en
Pages : 98
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Book Description
As the European Commission is preparing its Data Act, this new CERRE report provides concrete recommendations for effective data sharing governance, more specifically when a party has significant incentives not to share data. The forthcoming data act should provide better incentives to stimulate two forms of data sharing: individual users’ data sharing and bulk data sharing between firms. Data sharing is seen by many as an effective means to safeguard competition in digital markets, allowing smaller players to get access to precious data. The authors of the CERRE report, Richard Feasey and Alexandre de Streel, have analysed current EU rules imposing data sharing and conclude these do not provide the comprehensive governance framework needed for data sharing to effectively take place. “Given the incentives a gatekeeper platform may have not to share data, and the potential for this platform to leverage into other markets, we recommend imposing an obligation to share data”, explain Richard Feasey. “The most important and difficult task for regulators lies in determining the type and scope of data that is to be shared and which organisations should be obliged to share it. We conclude that better incentives and governance are needed to stimulate two forms of data sharing in the EU: data about individuals and bulk data between firms.” Regulating recipients as well as donors Regulation for data sharing should not be viewed as being limited to the oversight of a small number of large platforms that might be obliged to share data. It also requires strict oversight of potentially a very large number of smaller firms that might seek access to such data. Regulators will need to establish an effective and comprehensive system of regulation of both donors and recipients of data to guard against misuse and to ensure trust on all sides. Sharing individual users data Over time, the sharing or porting of data about individual users’ data could accumulate and be used for other purposes. For this reason, the authors recommend that obligations to share data about individual users should be quite extensive and apply to digital platforms which may be described as meeting the ‘gatekeeper minus’ threshold. The report encourages regulators to require the sharing of individual user data without any payment. If high transaction costs and uncertain users’ benefits prevent the effectiveness of this approach, policymakers should consider more radical approaches, such as allowing the use of an ‘opt-out’ option (rather than, the current ‘opt-in’) for the sharing of personal data in order to ensure fair competition in digital markets. The European Commission should consider provisions in the forthcoming Data Act to enable the use of ‘opt-out’ arrangements for the sharing of personal data to preserve market contestability under certain prescribed conditions. Although this may represent some loss of consumer sovereignty over their data, such a trade-off may need to be made if data sharing arrangements are to achieve their aim of ensuring contestability in digital markets. Bulk sharing of user data The competitive impact of the bulk transfer of aggregate user data could be significant since the volume of data to be shared is likely to be very substantial and may represent a significant proportion of the donor platform’s data assets. Since obtaining individual consent from every user would not be feasible in these circumstances, regulators and policymakers should consider other mechanisms to enable the bulk sharing of non-anonymised user data. Alternatively, regulators should consider requiring the platform that controls the data to allow third party access to the full data set so that third parties may train algorithms or otherwise derive the same sorts of insights from the data that are available to the incumbent. Recipients of aggregated data should be required to pay for the data, with the payment varying according to the volume and value of the data being shared (and not simply the costs of implementing the data sharing arrangements or storing the data). The primary concern here is to preserve incentives for both parties in the sharing arrangement to innovate and invest in existing or new digital services to acquire additional data for themselves. The Commission should undertake a study to consider how regulators would establish wholesale prices for data that was to be shared. The challenge ahead European policymakers should consider legislative changes with the Data Act to enable the sharing of personal data on an ‘opt-out’ basis under certain narrowly prescribed circumstances and to ensure contestability in digital markets. Finally, data sharing remedies that the report considers arise from the assumption that digital platforms will continue to derive significant market power from their centralised control of big data sets. Regulators and policymakers should also keep an eye on new technologies which might enable a much greater degree of decentralisation and wider distribution of data, thereby removing the very sources of market power which this report has sought to address. This report follows another CERRE research analysing the processes that turn data into economic value for online search, e-commerce and media platforms.
