Health experts from across the European Union make recommendations on implementation of European Health Data Space

• The data-sharing framework has the potential to revolutionise European healthcare, but without adequate funding, this potential may remain unrealised
• Experts call for enhanced commitment, awareness and collaboration to realise the full potential of the European Health Data Space
• Experts also recommend concerted public awareness-raising efforts on the contents and rationale of the regulation

Enhanced commitment, awareness, and collaboration are needed to realise the full potential of the European Health Data Space (EHDS), concludes a new EHDS Think Tank report conducted by a pan-European group of experts on the initiative of EIT Health, and launched on 18^th April in Rotterdam.

The EHDS is designed to deliver an EU-wide system for citizens’ health data, to improve care across borders. The European Commission hopes it will also boost opportunities for research by supplying academics and industry with reams of health data to study.

The report “Implementing the European Health Data Space across Europe“ was published following a series of 10 roundtable discussions in 11 countries países, involving around 100 leaders in public health, healthcare, innovation and health data economics from across the EU. The initiative was coordinated by a Steering Committee of 11 international members, including a Spanish representation, chaired by Dr Andrzej Rys, Chief Scientific Advisor Chief Scientific Advisor to the Directorate-General for Health of the European Commission.

The insights were consolidated in late 2023 before the provisional agreement on the EHDS Regulation was reached by the Council and European Parliament last month. The experts found that the EHDS has the potential to revolutionise European healthcare, but without adequate funding, this potential may remain unrealised.

“We all want the healthcare system to improve, but managing change is not easy and this is an issue of concern in all EU countries. There are barriers, but we have a clear vision of where to go in the transformation and, while it is not easy, it is not impossible,” summarises Ana Miquel, head of innovation and international projects within the directorate general for research and teaching of the Madrid Ministry of Health and member of the Steering Committee of the EIT Health Think Tank, which produced the report.

As Europe strives to strengthen its position as a global leader in healthcare innovation, it is imperative that adequate resources are allocated to initiatives such as EHDS to drive progress and improve the health and well-being of European citizens. The successful implementation of EHDS has the potential to transform both care delivery and health research. It has the potential to improve patient care by facilitating and improving their access and control of primary health data. It would also facilitate the use of secondary data in research to drive health innovation.

The report assesses the feasibility of implementing the EEDS legislation in all countries by analysing potential hurdles and solutions in six dimensions of implementation: governance, capacity and skills, resources and funding, data quality, the relation between primary and secondary data use, and the change towards a data culture in Health (awareness, education and communication).

Experts believe that current funding is currently misaligned with the ambition outlined by the Commission and the financial commitment from some member countries falls short of the necessary level to support healthcare and infrastructure developments.

Amongst other recommendations, the report advises member states to increase their commitment to funding EHDS initiatives to ensure its success and maximise its impact on healthcare outcomes across Europe.

The experts also found that the scale and timeline of the EHDS “will require the buy-in and cooperation of stakeholders across politics, healthcare, research, industry and civil society”.

Analysis across countries reveals that understanding of the challenge amongst key stakeholders and its public acceptance was generally low, particularly on the relationship between primary (access to patient health information records) and secondary (research, innovation, policy and regulatory activities) data use.

In this regard, the report recommends concerted public awareness-raising efforts on the contents and rationale of the regulation, particularly surrounding the use of data to drive critical innovation in the sector.

Similarly, in response to concerns in some areas about the introduction of data-driven culture and innovation in clinical practice, and the challenge of using primary and secondary data, the report recommends health data access bodies should “facilitate data traceability to foster trust in the new outputs and technologies to be fed back into healthcare”.

The EIT Health Think Tank report provides practical recommendations for the actors leading the transformation at local, national and EU levels to ensure a harmonised and inclusive European approach.

It suggests EU policymakers should “ensure meaningful patient and civil society representation on EU-level data governance bodies” and “foster collaborative initiatives between member states for sharing best practices and lessons learnt for designing governance frameworks.”

To enhance the technical and human capacities and skills needed for data management, extraction and transfer, the report suggests health institutions should: “build the right capacity for data gathering in healthcare workflows, automating primary data collection and improvement processes as much as possible with technology solutions” and “upskill current staff and develop career pathways promoting skill acquisition and development for data management and data science”.

Ensuring the quality of the data to be integrated in particular from electronic health records and other healthcare sources involves great complexity, effort and recurring cost. The report recommends healthcare providers should: “contribute to developing standard approaches to improving primary data quality that are compatible with routine work processes.”

European patients and citizens deserve clarity on the benefits they can expect from granting access to their data and answers about the safeguards that will be in place for its secondary use. To that end, the report highlights the role of patient associations in mobilising them “as advocates for data-sharing towards the general public.”

A great opportunity for Spain

The EHDS is seen as a great opportunity for Spain to move forward in innovation and digital health, as well as towards value-based care for patients, the report points out. Spain is uniquely positioned to lead the process of implementing the European Health Data Space regulation across Europe.  “It is ranked among the top five countries in Europe in data digitalisation and is also a world leader in clinical research, with different strategies and programmes at the public level, as well as funding to advance the digital transformation of the healthcare system,” summarises Izabel Alfany, managing director of EIT Health Spain.

However, its implementation must face numerous challenges in a short time, such as developing agile regulation, defining strategic resource allocation, distributing roles and responsibilities for governance, developing efficient services and technical solutions, standardising and making all data interoperable, and ensuring data protection. Both patients and healthcare professionals can be the driving forces behind this change, which will unleash the power of health data to help develop safer and more effective treatments and healthcare solutions and design more sustainable and patient-centred public health services.

Ana Miquel stresses, in this sense, the potential of the secondary use of health data: “We could be facing a revolution that will make scientific knowledge and innovation advance enormously and will open up the possibility of new personalised treatments“. This will require profound cultural changes in healthcare and in Spanish society as a whole to move from privacy-centred approaches to the sharing of health data in the public interest and also changes from a legal, ethical and security point of view. “In Spain, our data protection legislation offers a very high level of security,” says Miquel. Spain can make the EHDS a reality in the not-too-distant future, but “to ensure that it is successfully implemented requires the collaboration and commitment of all players in the public and private sector, as well as the provision of resources in infrastructure and capacity building,” adds Alfany.

EIT Health reaffirms its commitment to EHDS’s objectives and stands ready to contribute its expertise, resources, and networks to facilitate its implementation. Through collective efforts and strategic investments, EHDS has the potential to transform healthcare delivery and drive positive health outcomes for all European citizens.

Download the report here.