European Health Data Space: ‘A path to effective and harmonious pan-European implementation’

With negotiations around the European Health Data Space legislation concluded, Europe’s healthcare sector is shifting focus from the ‘why’ to the ‘how’ of implementing the harmonised health data space. 

CEO of EIT Health, Jean-Marc Bourez, has over 20 years of experience across the pharmaceutical industry and broader health sector, previously of Aventis and Sanofi. 

As a critical element of a strong European Health Union, the European Health Data Space (EHDS) aims to give European citizens full control of and access to their own healthcare data, which will support more effective healthcare delivery, as well as open up datasets for research and public health uses.

However, this ambitious legislation will only meet its transformative aims through effective implementation involving multidisciplinary stakeholders exchanging and cooperating fully.

‘Health data follows people’

Shared European health data will significantly impact patient outcomes by allowing citizens access and control over their health data as they travel, live or work across the EU ensuring ‘health data follows people’. It is anticipated we should see better diagnosis and treatment for patients, informed policy and regulatory processes. The EHDS also opens the door for a wealth of medical and technological advancements such as more personalised medicine.

Easier access to holistic health data will optimise public health decision-making and accelerate innovation in healthcare. The COVID-19 pandemic highlighted the critical need for accurate, accessible healthcare data for decision-making purposes by diverse stakeholders. Data can save lives.

The potential benefits of the EHDS, both for direct patient outcomes and in the research and innovation space, are obvious and vast. As the legislation moves closer to formal adoption, it’s essential to fully understand the practical, logistical and political requirements for effective implementation to fully realise the transformative potential of the EHDS.

Engaging in dialogue with organisations across business, research, and education, as well as healthcare leaders and practitioners, the EIT Health Think Tank published a report, ‘Implementing the European Health Data Space across Europe’ identifying the main issues.  From within these themes, two striking factors broadly permeate. 

‘Health data remains disparate, disconnected, and ultimately inoperable’

Differing healthcare data collection practices across the EU result in variation across datasets. Nearly half of the 27 member states have proposed more centralised national health data systems, but there is no systematic link between them at a European level. Health data remains disparate, disconnected, and ultimately inoperable – the opposite of the EHDS’s aim. An implementation framework defined at the European level are necessary so all member states are appropriately integrated and aligned.

The digitalisation of national health systems also varies significantly, risking bias and exclusions of certain populations from EHDS datasets. To enable the EHDS to function effectively, interoperability is needed, requiring modernised data infrastructure and improved connectivity between health institutions and data access bodies.

Common standards, as well as a unified way of collecting metadata to improve the system, are all required. This should be conceived and implemented in consultation with relevant stakeholders, so those using the system can shape how it is built. Harmonised implementation across the EU will be vital to avoid increasing complexity for research and economic actors and potentially stifling innovation.

Building the EHDS will require synergies and collaborations

The second factor, effective collaboration, is also vital. Within the research findings, stakeholders were clear that they want to be involved and engaged in the implementation process. Collaboration should extend to raising awareness of the EHDS amongst all relevant stakeholder groups including patients and citizens and also recognising the need for continuing education which will place data at the forefront of healthcare delivery. 

Collaboration within the sector is crucial to optimise the use of data. We must draw on the experience of medical fields with strong data literacy, such as epidemiology, genetics and medical imaging, where large datasets are used regularly for decision-making purposes, to achieve the best outcomes in patient care and policy development. 

Building on EIT Health’s community of partners and key stakeholders, it is important to continue engaging with key stakeholders and experts who contributed to the EIT Health Think Tank report. Building the EHDS will require synergies and collaborations across all key EU initiatives including the TEHDAS 2 and  Xt-EHR  joint actions for the development of a harmonised system.

The scope of this legislation is vast and sector-altering, requiring funding from the EU, member states and the private and public sectors. Smaller states will depend on EU co-funding to share the financial burden. To manage costs, we must leverage lessons learned from previous EU legislation and work together with national governments so that this legislation truly represents a transformation that citizens of Europe will see and feel.

Only a harmonised and coordinated implementation of the new regulation will harness the full potential of health data for innovation in Europe.

[This article was shortened by Catherine Feore]