18th May 2023
In the latest instalment of the Creating Impact series, we spotlight the research EIT Health is conducting on how feasible it is for Member States to achieve successful implementation of the European Health Data Space.
Today, 30% of the world’s data generated is attributable to the healthcare industry. Many activities patients and healthcare providers engage in get documented digitally via electronic health information systems and digital patient records. This has led to inconceivable volumes of data being generated from multiple sources such as genomics, diagnostic imaging, wearable devices, among others. The market value of Big Data in healthcare globally is expected to reach over €97 billion by 2030.
This vast amount of healthcare data provides profound insight into diseases, and – if shared securely and appropriately – has potential to advance scientific research and optimise healthcare delivery for patients through innovation. To achieve this, there is a growing need to provide a trustworthy setting for secure access to and processing of a wider range of health data.
At a European Union (EU) level, the European Commission published a legislative proposal on the “The European Health Data Space” on 3 May 2022. This new governance framework aims to connect European national health systems to ensure a secure and efficient health data transfer across Europe.
What is the European Health Data Space?
The European Health Data Space (EHDS) is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework. The proposed legislation aims to make it easier for individuals, clinicians, researchers, and regulators to access and use information about the health of millions of citizens across the EU. The EHDS will allow competent bodies to link health data sets, making them more accessible, and is a foundational part of Europe’s vision for the future of healthcare and the European Health Union.
What are the potential benefits of the European Health Data Space?
- Individuals will have better access to and control over their personal health data, including when traveling within the EU.
- Anonymised health data will be made available for research, innovation, and policymaking to help prevent, diagnose, and treat diseases; and improve healthcare delivery.
- Standardisation and harmonisation rules will help establish a genuinely single market for digital health products and services.
Initiating a national dialogue on the EHDS in Ireland
With the regulation potentially becoming operational in 25 Member States in 2025, the EIT Health Think Tank is engaging with key stakeholders nationally to understand the complexities of implementing the EHDS within existing infrastructure across Europe:
Implementation of European Health Data Space across Member States: Is it really feasible?
On 30 May 2023, EIT Health Ireland-UK, in partnership with the Irish Medtech Association at its Meeting of Minds event, brought together key opinion leaders and affected stakeholders to assess Ireland’s preparedness, and document recommendations for implementation during a 90-minute roundtable discussion.
- Dr. Andrzej Ryś, Principal Scientific Adviser, DG Sante European Commission (Keynote)
Vision and preparedness: What is the potential for the European Health Data Space and how prepared is Ireland to realise the benefits?
- Prof. Richard Greene, Chief Clinical Information Officer, Health Service Executive
- Dr. Joanne M. Hackett (PhD), Head of Genomics and Precision Medicine EMEA, IQVIA
- Dr. Barbara Foley (PhD), Health Information Quality Manager, HIQA
- Dr. Ronan Glynn, Partner Health Sector Lead, EY Ireland
Putting the regulation into practice: What measures could be taken to achieve successful implementation of the European Health Data Space in Ireland?
- Dr. Sinead Keogh (PhD), Head of Sectors & Director, Medtech & Engineering, Irish MedTech Association IBEC
- Dr. Derick Mitchell (PhD), Chief Executive Officer, Irish Platform for Patient Organisations, Science and Industry (IPPOSI), and Board Member of the European Patients’ Academy (EUPATI) Foundation
- Dr. Ricardo Simon Carbajo (PhD), Director of Innovation and Development, CeADAR
- Louise Corcoran, VP Quality and Regulatory Affairs, Fire1
Moderated by Sinead O’Connor, School of Medicine, Trinity College Dublin.
The discussion took place live on 30 May. Sign up to our newsletter to be the first to receive the whitepaper report that will summarise the findings.
Read EIT Health’s 2021 Think Tank Report ‘Learning from health data use cases’ which outlines the need to create the right environment across Member States to allow digital health technologies to reach their full potential.
Past issues of the Creating Impact series are available here.
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