The European health data space: Too big to succeed?
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The European health data space : Too big to succeed? / Marelli, Luca; Stevens, Marthe; Sharon, Tamar; Van Hoyweghen, Ine; Boeckhout, Martin; Colussi, Ilaria; Degelsegger-márquez, Alexander; El-sayed, Seliem; Hoeyer, Klaus; Van Kessel, Robin; Zając, Dorota Krekora; Matei, Mihaela; Roda, Sara; Prainsack, Barbara; Schlünder, Irene; Shabani, Mahsa; Southerington, Tom.
In: Health Policy, Vol. 135, 104861, 2023.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - The European health data space
T2 - Too big to succeed?
AU - Marelli, Luca
AU - Stevens, Marthe
AU - Sharon, Tamar
AU - Van Hoyweghen, Ine
AU - Boeckhout, Martin
AU - Colussi, Ilaria
AU - Degelsegger-márquez, Alexander
AU - El-sayed, Seliem
AU - Hoeyer, Klaus
AU - Van Kessel, Robin
AU - Zając, Dorota Krekora
AU - Matei, Mihaela
AU - Roda, Sara
AU - Prainsack, Barbara
AU - Schlünder, Irene
AU - Shabani, Mahsa
AU - Southerington, Tom
PY - 2023
Y1 - 2023
N2 - In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European domain-specific “data spaces”, the EHDS is a high-stakes development that will transform health data governance in the EU region.As an international consortium of experts from health policy, law, ethics and the social sciences, we are concerned that the EHDS Proposal will detract from, rather than lead to the achievement of, its stated aims. We are in no doubt on the benefits of using health data for secondary purposes, and we appreciate attempts to facilitate such uses across borders in a carefully curated manner. Based on the current draft Regulation, however, the EHDS risks undermining rather than enhancing patient control over data; hindering rather than facilitating the work of health professionals and researchers; and eroding rather than increasing the public value generated through health data sharing. Therefore, significant adjustments are needed if the EHDS is to realize its promised benefits.Besides analyzing the implications for key groups and European societies at large who will be affected by the implementation of the EHDS, this contribution advances targeted policy recommendations to address the identified shortcomings of the EHDS Proposal.
AB - In May 2022, the European Commission issued the Proposal for a Regulation on the European Health Data Space (EHDS), with the aims of granting citizens increased access to and control of their (electronic) health data across the EU, and facilitating health data re-use for research, innovation, and policymaking. As the first in a series of European domain-specific “data spaces”, the EHDS is a high-stakes development that will transform health data governance in the EU region.As an international consortium of experts from health policy, law, ethics and the social sciences, we are concerned that the EHDS Proposal will detract from, rather than lead to the achievement of, its stated aims. We are in no doubt on the benefits of using health data for secondary purposes, and we appreciate attempts to facilitate such uses across borders in a carefully curated manner. Based on the current draft Regulation, however, the EHDS risks undermining rather than enhancing patient control over data; hindering rather than facilitating the work of health professionals and researchers; and eroding rather than increasing the public value generated through health data sharing. Therefore, significant adjustments are needed if the EHDS is to realize its promised benefits.Besides analyzing the implications for key groups and European societies at large who will be affected by the implementation of the EHDS, this contribution advances targeted policy recommendations to address the identified shortcomings of the EHDS Proposal.
U2 - 10.1016/j.healthpol.2023.104861
DO - 10.1016/j.healthpol.2023.104861
M3 - Journal article
C2 - 37399677
VL - 135
JO - Health Policy
JF - Health Policy
SN - 0168-8510
M1 - 104861
ER -
ID: 358436100