Key Ethical Challenges in the European Medical Information Framework

17 Pages Posted: 29 Apr 2021

See all articles by Luciano Floridi

Luciano Floridi

University of Oxford - Oxford Internet Institute

Ugo Pagallo

University of Turin, Department of Law

Burkhard Schafer

University of Edinburgh - School of Law

Christoph Luetge

Technische Universität München (TUM)

Peggy Valcke

affiliation not provided to SSRN

Effy Vayena

ETH Zurich

Janet Addison

affiliation not provided to SSRN

Nigel Hughes

affiliation not provided to SSRN

Nathan Lea

University College London - Institute for Health Informatics

Caroline Sage

affiliation not provided to SSRN

Bart Vannieuwenhuyse

Janssen Research & Development, LLC

Dipak Kalra

affiliation not provided to SSRN

Date Written: June 11, 2018

Abstract

The European Medical Information Framework (EMIF) project, funded through the IMI programme (Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115372), has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice (ECoP) to ensure the privacy protection of data subjects, protect the interests of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board (EAB), to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to defne, control and monitor the purposes (kinds of research) for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, ofering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources.

Keywords: Data ethics, Medical ethics, Ethics of algorithms, Health ethics, GDPR

Suggested Citation

Floridi, Luciano and Pagallo, Ugo and Schafer, Burkhard and Luetge, Christoph and Valcke, Peggy and Vayena, Effy and Addison, Janet and Hughes, Nigel and Lea, Nathan and Sage, Caroline and Vannieuwenhuyse, Bart and Kalra, Dipak, Key Ethical Challenges in the European Medical Information Framework (June 11, 2018). Edinburgh School of Law Research Paper No. 2021/12, Available at SSRN: https://ssrn.com/abstract=3831307 or http://dx.doi.org/10.2139/ssrn.3831307

Luciano Floridi (Contact Author)

University of Oxford - Oxford Internet Institute ( email )

1 St. Giles
University of Oxford
Oxford OX1 3PG Oxfordshire, Oxfordshire OX1 3JS
United Kingdom

Ugo Pagallo

University of Turin, Department of Law ( email )

Italy

Burkhard Schafer

University of Edinburgh - School of Law ( email )

Old College
South Bridge
Edinburgh, EH8 9YL
United Kingdom
0131-650-2035 (Phone)
0131-650-6317 (Fax)

Christoph Luetge

Technische Universität München (TUM)

Arcisstrasse 21
Munich, DE 80333
Germany

Peggy Valcke

affiliation not provided to SSRN

Effy Vayena

ETH Zurich ( email )

Zurich, 8001
Switzerland

Janet Addison

affiliation not provided to SSRN

Nigel Hughes

affiliation not provided to SSRN

Nathan Lea

University College London - Institute for Health Informatics ( email )

Gower Street
London, WC1E 6BT
United Kingdom

Caroline Sage

affiliation not provided to SSRN

Bart Vannieuwenhuyse

Janssen Research & Development, LLC

United States

Dipak Kalra

affiliation not provided to SSRN

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