Endorsed by the Lombardy Region Life Sciences Cluster, this discussion paper consolidates our research group’s recent submission to the TEHDAS2 second public consultation on the European Health Data Space Regulation.
The document addresses core aspects of the secondary use framework, including fee structures, permitted and prohibited uses of health data, metadata cataloguing, data access application and request procedures, enforcement and sanctions, and individual opt-out mechanisms.
We identify an important and largely unacknowledged issue related to expectations of value that inform key decisions throughout development and implementation of the EHDS.
We are pleased that in the revised documents, the vast majority of our recommendations were either partially or fully taken up.
Image Credit: Benedetta Muda