Health data pools under European data protection and competition law : health as a digital business / / Giulia Schneider

• Autore: Schneider Giulia
• Pubblicazione: Cham, Switzerland : , : Springer, , [2022]; ©2022
• Descrizione fisica: 1 online resource (388 pages)
• Disciplina: 344.4041
• Soggetto topico: Medical informatics - Law and legislation
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: Intro -- Preface -- Contents -- Chapter 1: Introduction: Object, Methodology and Structure of the Research -- References -- Chapter 2: Digital Health Research and Health Data Pools -- 2.1 The Technological and Regulatory Context of Digital Health Research -- 2.1.1 The Object of Health Research: The Evolving Big Health Data Ecosystem -- 2.1.2 New Technological Capabilities and the Emerging Scientific Epistemiological Approach -- 2.1.3 Stakeholders Involved in Digital Health -- 2.1.4 The Newly Emerging Paradigm of Health Research -- 2.1.5 Regulatory Developments from the Perspective of the Data: The Case of Pharmaceutical Research -- 2.1.6 Regulatory Developments from the Perspective of the Technology: The Case of Medical Devices -- 2.2 The Organizational Patterns of Digital Health Research: The Rising Phenomenon of Health Data Pools -- 2.2.1 From Patent Thickets to Research Data Silos in Health-Related Markets -- 2.2.2 The Intellectual Property Tools over Digital Research Data Silos -- 2.2.3 Research Data Silos Contextualized within the Intellectual Property System -- 2.2.4 From the Privatization to the Trading of Research Data Silos: The Features of Health Data Pools -- 2.3 Conclusions: Health Data Pools as Private Ordering Tools of Digital Health Research -- References -- Chapter 3: Health Data Pools: Case-Studies and Involved Interests -- 3.1 Health Data Pools: Some Case-Studies -- 3.1.1 Health Data Pools Between Pharmaceutical Companies and Big Data Companies -- 3.1.1.1 The Case of Genomics Data: 23andMe´s Partnerships with Pharmaceutical Companies -- 3.1.1.2 The Joint Venture Between Google and Sanofi -- 3.1.2 Health Data Pools Between Public Institutions and Big Data Companies -- 3.1.2.1 The Sharing Agreement Between Google DeepMind and Royal Free Hospital -- 3.1.2.2 The Sharing Agreement Between IBM and Lombardia Region. ; 3.2 Health Data Pools as Innovation Networks -- 3.3 Mapping the Interests in Health Data Pools -- 3.3.1 Health Data and Innovation -- 3.3.2 Health Data Pools and Consumer Welfare -- 3.3.3 Health Data Pools and (the Right to) Digital Health -- 3.3.4 Health Data Pools and the Risks for Digital Health -- 3.3.5 Health Data Pools and Health Biases -- 3.3.6 Health Data Pools and Data Subjects -- 3.3.7 Health Data Pools and Commercial Interests -- 3.3.8 Health Data Pools and Competition -- 3.4 Findings: Connecting the Dots in Health Data Pools -- References -- Chapter 4: Health Data Pools Under the Digital Single Market Strategy -- 4.1 Health Data Pools Contextualized in European Policy -- 4.2 (Digital) Health in the European Union -- 4.3 Health Data Pools within the Digital Single Market Strategy -- 4.3.1 Digital Health Within the Digital Single Market Strategy -- 4.3.2 The Free Flow of Information within the Digital Single Market Strategy -- 4.3.2.1 The Free Flow of Information Initiative and Personal Data -- 4.4 The Free Movement of Research Data as an Emerging European Principle -- References -- Chapter 5: Health Data Pools Under European Data Protection Law -- 5.1 Health Data Pooling as Health Data Treatment Under Data Protection Law -- 5.2 European Data Protection Law´s Pillars -- 5.2.1 The Fundamental Rights´ Pillar -- 5.2.2 The Market-Oriented Pillar -- 5.3 The Regulation of Health Data Treatment Under the General Data Protection Regulation -- 5.3.1 The Object of Protection: The Notion of Health Data -- 5.3.1.1 The Notion of Personal Data -- 5.3.1.2 The Notion of Sensitive Personal Data -- 5.3.1.2.1 ``Genetic Data´´ -- 5.3.1.2.2 ``Biometric Data´´ -- 5.3.1.2.3 ``Data Concerning Health´´ -- 5.3.2 The Legal Bases for the Treatment of Health Data -- 5.3.2.1 Data Subject´s Consent and Related Legal Bases for Processing. ; 5.3.2.2 Public Interest-Related Legal Bases for Processing -- 5.3.2.3 Research and Statistical Purposes -- 5.3.2.3.1 The Notion of Research -- 5.3.2.3.2 The Special Data Protection Regime for Research-Oriented Processing Activities -- 5.4 The GDPR´s Research Exemption as a New Efficiency Defense for Health Data Pools -- References -- Chapter 6: Health Data Pools Under European Competition Law -- 6.1 Health Data Pools as Competitively Relevant Information Sharing Agreements -- 6.2 European Competition Law´s Goals Under Review: Some General Premises -- 6.2.1 The Protection of Non-Economic Efficiencies -- 6.2.2 The Protection of Economic (Dynamic) Efficiencies -- 6.3 Innovation as a ``Subversive´´ Parameter in the Competition Law Analysis of Digital Markets -- 6.3.1 Competition and Innovation: The Relevant Market Perspective -- 6.3.2 Competition and Innovation: The Theoretical Debate -- 6.3.3 Competition and Innovation: The Responses by European Law and Policy -- 6.4 Health Data Pools as Research and Development Agreements Under Art. 101 TFEU -- 6.4.1 The Relevant Market: Health Data Pools as Multi-Sided Data-Driven Innovation Markets -- 6.4.2 (Pro)Competitive Health Data Pools Under Art. 101(1) TFEU -- 6.4.3 Anticompetitive Health Data Pools Under Art. 101(1) TFEU -- 6.4.4 Health Data Pools under Art. 101(3) TFEU -- 6.4.4.1 Technological and Economic Progress Under Art. 101(3) TFEU -- 6.4.5 Health Data Pools under the Research and Development Block Exemption -- 6.4.6 Health Data Pools under the Technology Transfer Block Exemption -- 6.5 Health Data Pools as Information Exchanges Under Arts. 101(1) and 101(3) TFEU -- 6.6 Health Data Pools Under European Merger Policy -- References -- Chapter 7: Designing Health Data Pools: Data Protection Safeguards and Competition Remedies. ; 7.1 The Regulatory Design of Health Data Pools Under European Data Protection and Competition Law -- 7.2 The Ex Ante Design of Health Data Pools: Data Protection Safeguards -- 7.2.1 The GDPR´s Data Protection Principles for Health Research -- 7.2.2 The GDPR´s Data Protection Obligations for Health Research: An Overview -- 7.2.3 Data Protection Safeguards and the ``Scaled´´ Special Data Protection Regime for Research -- 7.3 The Ex Post Design of Health Data Pools: Competition Remedies -- 7.3.1 The Emerging Reality of Informational Abuses -- 7.3.1.1 Exploitative Health Information-Related Abuses -- 7.3.1.2 Exclusionary Health Information-Related Abuses -- 7.3.2 Information Sharing Remedies Under Art. 102 TFEU -- 7.3.2.1 The Evolution of the European Case Law -- 7.3.2.2 Sharing Remedies Over Digital Data: The Debate -- 7.3.2.2.1 The Arguments Against the Sharing Remedy Over Digital Data Under Art. 102 TFEU -- 7.3.2.2.2 The Arguments in Favour of the Sharing Remedy Over Digital Data Under Art. 102 TFEU -- 7.3.3 Information Sharing Remedies in Health Data Pools -- 7.3.3.1 Health Data as Essential Research Facilities -- 7.3.3.2 The Refusal to ``License´´ Health Data as Abuse under Art. 102 TFEU -- 7.3.3.3 The Sharing Remedy Over Health Data -- 7.3.4 Data Sharing Remedies in European Merger Policy -- 7.3.4.1 The Innovation Theory of Harm in Merger Policy -- 7.3.4.2 Data Sharing Remedies Through Commitments: The Divestment of Research Poles -- 7.3.5 The Regulatory Dimensions of Competition Sharing Remedies of Research Data -- 7.3.6 The Regulatory Design of Sharing Remedies Over Research Data -- 7.3.6.1 Open Questions Over the Administrability of Sharing Remedies of Research Data -- References -- Chapter 8: Research Results and Conclusions -- References.
• Titolo autorizzato: Health Data Pools under European Data Protection and Competition Law
• ISBN: 9783030954277; 9783030954260
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910561294703321
• Lo trovi qui: Univ. Federico II
• Serie: Munich Studies on Innovation and Competition Ser.