EHDS: an opportunity to unleash the power of data?

The creation of a European Data Space (EHDS) is one of the key priorities of the Commission for the coming years. Through EHDS1 (for primary use) and EHDS2 (for secondary use) it has the potential to facilitate health data sharing with numerous benefits for health research, policy making and healthcare. The upcoming legislation has the unique opportunity to provide an aligned legal framework for secondary use of data for health research at European level.

The BioMed Alliance Taskforce on Health Data Sharing, in close cooperation with the European Association of Urology (EAU) and the European Organisation for Research and Treatment of Cancer (EORTC), has collected views and experiences of healthcare professionals and researchers on the foundations that the European Health Data Space must be built on to ensure health data becomes a powerful tool advancing European health research.

To ensure that the EHDS will unleash the power of data, the BioMed Alliance proposes key recommendations on data governance, the implementation of EHDS2 and the necessary skills and knowledge needed to facilitate participation.

Summary of the main recommendations

  • We should use the EHDS legislation as an opportunity to align different legislative
    approaches with a clear and enabling EU legal framework which defines secondary use for
    all EU member states, enables research, and gives legal clarity on the framework which
  • Researchers, healthcare professionals, medical societies and patients are important
    stakeholders which should be included as trusted partners to bring the EHDS to full success.
  • The eHealth network and eHealth stakeholder network should act as a catalyst for
    engagement and communication, but it needs increased resourcing, a clear strategy,
    broader membership and a more effective structure.
  • A multi-stakeholder health data advisory and ethics committee for the European health
    data space at EU level can play a key role in ensuring a European approach.
  • Sector based guidance must be developed for and with health researchers to provide legal
    clarity on how to process health data for research purposes without adding unnecessary
    layers of complexity.
  • The possibility of a European Health data protection seal or certification should be
    explored, and additional standards/certification for secondary use of health data need to be
    developed with different stakeholders, and these standards should be freely available.
  • Targets and benchmarks for data interoperability should be established.
  • We need to incentivise adoption to the EHDS and build skills and capacity, by funding
    digital health and digital literacy programs, creating training methodologies for continuous
    professional development and funding joint initiatives on standardisation and certification of
    healthcare professionals on data governance.

More information here

Back to news list

Related News

  • EORTC Quality of Life Group celebrating 40 years

  • Results of two EORTC studies have been published in NEJM and the Lancet Oncology

  • Interview with Winette van der Graaf: enhanced patient participation in trials may help make cancer research more heterogeneous

  • New results, updates, and forthcoming EORTC trials in melanoma, soft tissue sarcoma, head and neck, testicular and lung cancer presented at ESMO 2022

  • Important new data from EORTC trials to be presented at ESMO 2022

  • EORTC Item Library provides considerable coverage of CTCAE side effects, new study finds

  • EORTC Completes Patient Recruitment to Study of Treatment for unresectable or metastatic melanoma

  • In Memoriam: Dr Martin Charles Mihm

  • The 1500th patient has been enrolled in the E²-RADIatE cohort OLIGOCARE (RP-1822)

  • PRESS RELEASE: Better treatment for better health: lifting the veil on treatment optimisation