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 - Zajac, Dorota Krekora
AU - Matei, Mihaela
AU - Roda, Sara
AU - Prainsack, Barbara
AU - Schlünder, Irene
AU - Shabani, Mahsa
AU - Southerington, Tom
N1 - Funding Information:
European Research Council (ERC) , grant agreement number 101096999 (K.H.)
Funding Information:
This work originates from a workshop convened by LM, IVH, MSt, and TSh at KU Leuven, 25 October 2022, with funding from the Belgian Science, Technology & Society network (B.STS) and the ERC-funded project "Digital Good”. We would like to thank Elisa Leila Elhadj (KU Leuven), Steven Kraaijeveld (Radboud University) and Vittoria Porta (European Institute of Oncology IRCCS & University of Oxford) who provided invaluable help with the organization of the event.
Funding Information:
European Union's Horizon 2020 research and innovation Programme, grant agreement 945263 (IMMERSE) (L.M., I.V.H.).The Research Foundation – Flanders (FWO) WOG Grant 3H190080 (I.V.H., L.M.)European Research Council (ERC), Grant Number 804985 (T.Sh., M.St.)Cariplo Foundation (Social Science Research Grant), grant 2020-1314 (L.M.).European Union's Horizon 2020 research and innovation Programme, grant agreement 874662 (HEAP) (M.B.).European Research Council (ERC), grant agreement number 101096999 (K.H.)National Science Center, Poland Grant No. 2016/23/D/HS5/00411 (D.K.Z.).
Funding Information:
European Union's Horizon 2020 research and innovation Programme , grant agreement 874662 (HEAP) (M.B.).
Funding Information:
Privasa project funded by Business Finland (TSo)
Funding Information:
Cariplo Foundation (Social Science Research Grant) , grant 2020-1314 (L.M.).
Funding Information:
National Science Center, Poland Grant No. 2016/23/D/HS5/00411 (D.K.Z.).
Funding Information:
European Union's Horizon 2020 research and innovation Programme , grant agreement 945263 (IMMERSE) (L.M., I.V.H.).
Funding Information:
European Research Council (ERC) , Grant Number 804985 (T.Sh., M.St.)
Publisher Copyright:
© 2023
PY - 2023/9/1
Y1 - 2023/9/1
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.
KW - Data governance
KW - Data sharing
KW - EHDS
KW - European health data space
KW - Public value
U2 - 10.1016/j.healthpol.2023.104861
DO - 10.1016/j.healthpol.2023.104861
M3 - Article
C2 - 37399677
SN - 0168-8510
VL - 135
JO - Health Policy
JF - Health Policy
IS - 1
M1 - 104861
ER -