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2024 | OriginalPaper | Buchkapitel

The Dynamic Context and Multiple Challenges of Data Sharing

verfasst von : Marcelo Corrales Compagnucci, Mark Fenwick, Timo Minssen, Mateo Aboy

Erschienen in: The Law and Ethics of Data Sharing in Health Sciences

Verlag: Springer Nature Singapore

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Abstract

This chapter outlines the dynamic context and multiple challenges of data sharing in the contemporary data ecosystem, specifically as it relates to healthcare. Here, we define “data sharing” as the practice of sharing health-related data between a number of data controllers and processors. Data collected in this manner can come from the provision of health, clinical trials, observational studies, public health surveillance programs, and other health data collection methods. Several justifications for such sharing are introduced. Our main contention is that the regulatory environment today is an increasingly complex and rapidly evolving combination of norms and principles. To navigate this environment successfully requires careful analysis and judgment from all stakeholders across diverse fields of technology and the law. The purpose of this volume, therefore, is to offer a series of case studies that integrate theoretical and practical perspectives and illustrate how to effectively navigate this complex and rapidly evolving space.

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Nächstes Kapitel The GA4GH Regulatory and Ethics Work Stream (REWS) at 10: An Interdisciplinary, Participative Approach to International Policy Development in Genomics

A ‘controller’ is the entity who ‘defines the means and purposes of the processing’ (Article 4(7) GDPR). A ‘processor’ is the entity who processes personal data on behalf of the controller, if the controller did not process personal data directly themselves but outsourced the task (Article 4(8) GDPR). For more information regarding the concepts of controllers and processors see: Dahi and Corrales Compagnucci (2022).

Tenopir et al. (2011).

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Yoong et al. (2022).

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Organisation for Economic Co-operation and Development (OECD), ‘Data governance: Enhancing access to and sharing of data’ available at: https://www.oecd.org/sti/ieconomy/enhanced-data-access.htm. Accessed 19 June 2023.

Bill and Melinda Gates Foundation, Information Sharing Approach, available at: https://www.gatesfoundation.org/about/policies-and-resources/information-sharing-approach. Accessed 19 June 2023.

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See, for example, Corrales Compagnucci et al. (2021), Jurcys et al. (2022), Minssen et al. (2020), Corrales Compagnucci et al. (2020).

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Corrales Compagnucci et al. (2022), pp. 1–15.

The Health Insurance Portability and Accountability Act of 1996 (HIPPA) is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1996. For a case study in the US, see, e.g., Celedonia et al. (2021), pp. 242–250.

Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC, OJ 2016 L 119, 1 (General Data Protection Regulation, GDPR).

Japan Act on the Protection of Personal Information, Act No. 57 of 2003 (APPI).

Corrales Compagnucci et al. (2019), pp. 144–145.

Corrales Compagnucci (2020) , pp. 159, 228, 229, 291.

See European Health Data Space, available at: https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en. Accessed 20 June 2023.

See Proposal for a Regulation of the European Parliament and of the Council laying down harmonized rules on artificial intelligence (Artificial Intelligence Act) and amending certain union legislative acts. COM/2021/206 final.

See, e.g., Cohen et al. (2022).

See Lucido (2022).

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Titel: The Dynamic Context and Multiple Challenges of Data Sharing
verfasst von: Marcelo Corrales Compagnucci
Mark Fenwick
Timo Minssen
Mateo Aboy
Verlag: Springer Nature Singapore
Buch: The Law and Ethics of Data Sharing in Health Sciences
Print ISBN: 978-981-9965-39-7

Electronic ISBN: 978-981-9965-40-3

Copyright-Jahr: 2024
DOI: https://doi.org/10.1007/978-981-99-6540-3_1