When the proposal to create a European Health Data System was first announced ECHAlliance and i~HD created in 2020 a virtual multi-stakeholder Round Table Programme on Calls to Action on Health Data Ecosystems. The purpose was to help the European Union design the EHDS and the enabling regulation.
Now that the regulation is almost final and will imminently be formally adopted, an ambitious program is underway to develop the implementing acts (secondary legislation) that provides the legal details necessary for putting the measures of the regulation into practice including conformance details and enforcement measures. These implementing acts will involve legislation from both the European Commission and Member States. This is an important window of opportunity to influence that secondary legislation so that it drives the best possible implemented European Health Data Space for the benefit of all stakeholders. Whether you are a patient, healthcare professional, citizen, healthcare provider or researcher or work in medtech, pharma or technology it is in the interests of all stakeholders for EHDS to be as successful as possible.
In order to inform our stakeholders about the possible areas to promote to the attention of the legislators, ECHA and i~HD have revisited all seven reports to map these sets of recommendations to the EHDS Regulation, in particular which recommendations have been incorporated, and which recommendations should be re-emphasised to the legislators. We were pleased to see that 28 and 16 of our recommendations were respectively fully and partially incorporated into the EHDS regulation and only two not included.
All the participants to our previous round tables, and some additional stakeholders, were invited to a webinar on 5th December 2024, to review and discuss these recommendations. The webinar discussed the enabling measures that could scale up data availability and access for secondary use including interoperability and quality, measures that can strengthen public trust and transparency, and from a primary use perspective enabler to accelerating the adoption of interoperability standards focusing on the European EHR exchange format. The webinar attracted one hundred participants. A document with these outstanding recommendations is being circulated to all webinar invitees for feedback and additional points to be put to the legislators, which will be consolidated and published as a new call to action for EHDS legislators in February 2025.
Dipak Kalra
President, The European Institute for Innovation through Health Data
Professor of Health Informatics, UCL
Visiting Professor, University of Gent
R Bleddyn V Rees
Deputy Chair, ECHAlliance, The Global Health Connector
