Health Data Pools Under European Data Protection and Competition Law: Health as a Digital Business (Munich Studies on Innovation and Competition, 17)

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