ECO Publishes Proposed Amendments to European Health Data Space Legislation

November 2022

Since its inception in 2020, the Digital Health Network of the European Cancer Organisation has been a forum through which a wide range of stakeholders in the cancer community have been able to meet, discuss, exchange and share information and views about fast emerging developments in digital technology and its prospective application in cancer care.

It has followed therefore that the emergence of a major initiative by the European Commission, to create a European Health Data Space, has occupied some particular attention of the Network and ECO has been pleased to convene Network participants towards some consensus positioning which is not translating into very tangible recommendations to policy makers for how the proposed legislation creating the European Health Data Space might be improved and made more fit for purpose.

Aided by shared responses to Commission consultations, an expert roundtable on the European Health Data Space earlier this year (see Report here), the October meeting of the Digital Health Network, and virtual consultation with Network participants, the European Cancer Organisation has published 6 priority areas for amendment to the European Commission’s published legal proposal. They can be summarised as below:

  1. Ensuring that the legislation mandates that the EHDS Board includes stakeholder representation, including for patients and healthcare professionals.  
  2. Requiring the European Commission to conduct a study on the impact of the General Data Protection Regulation upon cancer research in Europe, including the divergence of implementation approaches, and with provision of remedial recommendations.  
  3. Requiring explicit time-based targets for implementation and progress on cross-border health data interoperability, including for cancer registry interoperability.  
  4. Including in the legislation understanding that EU funding support, from a range of sources, will be made available to assist all health data systems in the EU prepare and be in a state of readiness for the introduction of the European Health Data Space.  
  5. Making clear in the legislation that the EHDS Board has mandate to explore connections with health systems outside of the EU for the purposes of creating and maintaining a highly effective health data space with maximised benefits for patients.  
  6. Ensuring that lessons are learned from implementation difficulties associated with other legislative initiatives, such as GDPR. This includes ensuring that terms and definitions within the legislation are appropriately and tightly described.  

See the proposed amendments and their justification in full here.

The suggested amendments have been shared with both Members of the European Parliament as well as representatives of national governments, both of whom are presently conducting active scrutiny of the legislation. A series of follow up meetings are now taking place with cautious optimism that at least some of the amendments will receive parliamentary support.

ECO thanks all who have provided time to assist the development of the positioning and hopes that in 2023 concrete results from the advocacy actions can be achieved.