A recent report by the EU joint action Towards the European Health Data Space (TEHDAS) presents recommendations for policymakers at the EU and national level, and data altruism organisations on how to involve individuals in data sharing – data altruism – in the European health data space (EHDS).

Data altruism refers to people and organisations who voluntarily make data available in the public interest, thereby enabling new sources of data for secondary purposes such as research and innovation, without seeking reward. An example is health data gathered by an individual’s smartwatch or other smart devices. Data altruism organisations make data available on a large scale in accordance with the principles of data altruism.

The report argues that there is a need to encourage individual involvement in the EHDS and especially in data altruism. Transparency, trust and citizen empowerment are crucial elements for public acceptance. Without voluntary data sharing by individuals, there will not be enough rich data available for research, innovation and decision-making.

The report makes recommendations on how to adopt and harmonise the identified good practices for building national or European health data spaces. The recommendations include:

• Supporting digital literacy in the society. The shift towards digital tools such as smart devices or health applications for gathering and analysing health data demands attention to digital skills. Neglecting this could damage public trust.
  
  
• Data altruism organisations should provide incentives to encourage individuals and groups to participate in making health data available for public interest, such as scientific research. These incentives could include informing individuals about how their data has been used and the results of that use, and recognising their contributions.
  
  
• Data altruism organisations should ensure that high-quality and unbiased data is accessible and available. The report also recommends that they cooperate with academic institutions, non-profits and charities to share best practices.
  
  
• The public and private sectors should increase collaboration to provide richer datasets for research.
  
  
• Guidelines for data altruism should be prepared in cooperation with a wide range of stakeholders, such as data altruism organisations, data holders and private sector organisations. The Data Governance Act defines that common rules need to be developed for data altruism organisations, such as a common consent form.
  
  
• Trust on health data altruism organisations depends on their accountability. An essential element for building trust is citizens’ and patients’ control over their data, as well as transparency about how and with whom health data is shared, and what the benefits and risks of data sharing are.

The recommendations are based on applicable legal instruments, especially the General Data Protection Regulation (GDPR), the Data Governance Act (DGA) and the EHDS, and they are in line with the views of stakeholders.

This concludes the work of TEHDAS on data altruism.

The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.

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The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.

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The project steering group has approved the report. The European Commission gives final approval to all joint action’s deliverables.

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A recent report by the joint action Towards the European Health Data Space (TEHDAS) calls for clarification of the provisions in the EHDS concerning the secondary use of health data across the EU borders. The report argues that in its current form the EHDS is not precise enough to enable harmonised implementation across the member states.

The report contains several recommendations to address ambiguous points in the EHDS proposal given by the European Commission in May 2022 before the regulation is agreed upon in the legislative procedure. These include:

• Providing guidelines to member states for establishing the health data access bodies (HDAB) and dedicating significant human, technical and financial resources, given the multitude of tasks assigned to the bodies. Each member state will create one or more health data access bodies to enable access to health data for secondary purposes.
  
  
• Clarifying the role and responsibilities of the national coordinator of the health data access bodies in member states in cases where there are several bodies involved.
  
  
• Refining the concept of mutual recognition. The EHDS proposal includes the intention that the health data access bodies will collaborate but doesn’t specify how. Mutual recognition means that a data permit issued by one health data access body in one country would be recognised by a health data access body in another country.
  
  
• Providing a clear answer to whether pooling data from multiple countries to one secure processing environment, meaning transferring data cross-borders, is possible. The use of secure processing environment takes place after a data permit has been granted.
  
  
• Addressing the language regime. For instance, metadata catalogues (information about data) are often only available in the local language.
  
  
• Designing fee policy to consider the different phases of using data, such as preparing data and making it available for research.
  
  
• The European Commission could provide a model for data use agreements between HDABs and data users, such as researchers, that would include conditions of use. This would avoid the need for each member state to develop its agreements.

Currently, researchers who need data from several European countries for their research are faced with diverging national authorisation processes, which are often untransparent and lengthy. Furthermore, their work is complicated by the fact that the procedures often cannot be conducted in English and that the data available may not be interoperable.

This concludes the work of TEHDAS on data governance.

The project steering group has approved the report. The European Commission gives final approval to all joint action’s deliverables.

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The capacity of different EU countries to facilitate the use of health data for research and innovation varies widely, according to the results of the joint action Towards the European Health Data Space (TEHDAS). For the EU-wide use of health data to be successful and sustainable, EU and national legislation need to be clarified.

Currently, European researchers, policy-makers and businesses face many obstacles to accessing health data nationally and across borders. At present, data cannot be fully used, to the detriment of health policy and innovation such as the development of more effective medicines and treatments.

The main obstacle is different interpretations of the General Data Protection Regulation (GDPR). In addition, practices for collecting and processing health data vary from one EU country to another because of differences in their national legislation.

Although the EHDS plans to harmonise the secondary use of health data by creating a common legal framework, the results clearly indicate that all member states need to take steps to meet the requirements of the EHDS.

Enabling secure access to quality data

In the future, decisions on using health data will be taken by a specialised authority in each country, a health data access body. Access to data would only be allowed for specific purposes.

The TEHDAS project developed a data quality framework which aims to ensure that health data collected across Europe and reused for policymaking, regulation and research is reliable enough and fit for purpose.

The project also produced recommendations on secure data processing environments and related practices across national borders. The European Commission’s proposal for a regulation on the EHDS in 2022 includes these recommendations. Protecting people’s privacy will be enhanced by defining common practices for data sharing and use across Europe.

Stakeholder engagement at the heart of the project

TEHDAS fostered dialogue with policymakers and other key stakeholders at national and EU level to raise awareness of the profound changes that are expected once the EHDS regulation enters into force. This has increased the readiness of the member states and the Commission to establish the EHDS.

Public engagement showed that people are interested in sharing their health data but with clear safeguards for privacy and security.

Throughout the project, TEHDAS prioritised stakeholder engagement by hosting forums and other events and participating in almost 300 speaking engagements across Europe. The main TEHDAS events attracted about 2000 European stakeholders to discuss the use of health data in Europe.

A lasting contribution to EU regulation

In TEHDAS, 25 European countries have developed policy options and recommendations needed to make people’s health data more seamlessly and securely accessible. The aim has been to improve the secondary use of health data in the EU to enable better health for all.

The project has been led by Sitra and is part of a wider EHDS initiative, where health data would be available on request for both research and for patient care, wherever patients are in Europe.

In May 2022, the European Commission issued a proposal for a regulation on the EHDS. The TEHDAS results laid the groundwork for the proposal and the implementation of the regulation.

“I would like to thank all TEHDAS partners for their hard work and express my gratitude to the member states, the European Commission, stakeholders and external advisors for their valuable input. The impact of the TEHDAS project can be seen in the EHDS proposal, which will benefit Europe for decades to come,” explains Markus Kalliola, Project Director at Sitra, who led the European collaborative project.

Towards EHDS in collaboration

The legislative process is in full swing. Negotiations are ongoing in the European Parliament and in the Council of the European Union. The final legal text is expected in 2024 and, once adopted, will enter into force after a transitional period.

The work towards better health and care is not yet complete, but thanks to the TEHDAS project, the secondary use of health data in the EU has taken a major step forward. This work will continue, focusing on the successful implementation of the EHDS, which will require broad collaboration throughout Europe.

The TEHDAS joint action, funded by the EU and 25 countries, ended this July. A follow-up joint action is planned to begin in mid-2024.

This TEHDAS report summarises the main findings of the project in a single document to serve European health data stakeholders and the public.

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The EHDS is expected to bring about many positive changes to the cross-border use of health data for secondary purposes such as research, innovation and policymaking. These include effective governance – the legal framework and rules – set to protect health data and quicker procedures for granting access to data and making it available.

The workshop identified the following needs for recommendations:

• Provide guidelines to member states for establishing the health data access bodies and dedicating significant human, technical and financial resources, given the multitude of tasks assigned to the bodies. Under the Commission’s EHDS proposal, each member state will create one or more health data access bodies to enable access to health data for secondary purposes.
  
  
• The role of the national coordinator of the health data access bodies in member states needs to be more clearly defined in cases where there are several bodies involved. This could be done by specifying the tasks of the coordinator in the legislation (or in a recital) or in Commission guidelines.
  
  
• Refine the concept of mutual recognition. The EHDS proposal includes the intention that the bodies for access to health data will collaborate but doesn’t specify how. The article of the legal proposal concerning mutual recognition will need to be defined in order for it to work in practice.
  

Currently, the diversity of health data management in EU member states hinders cross-border data use. TEHDAS has already surveyed a range of data holders to understand the processes for accessing health data in Europe.

TEHDAS will issue final recommendations on cross-border data access procedures in late summer 2023.

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The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.

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Involving European ministries with EHDS

Health is both impacted by and has a strong impact on a variety of policies and government ministries. By hosting policy forums for European ministries of health, finance and research TEHDAS provided an arena for cross-sectoral and cross-border discussion, to ensure national perspectives were reflected in the Commission’s proposal on the EHDS, allow ministry representatives to learn from other countries’ experiences, and to help the member states to prepare for regulation.

The discussions included what countries need to create the EHDS for the secondary use of health data, the financial sustainability of EHDS and the services expected from the EHDS. Countries are willing to join the EHDS, but more investments are needed for implementation.

A recent TEHDAS report found that member states’ readiness to benefit from the EHDS regulation varies widely. The inputs from the policy forum participants echoed the findings of the country visits. Whilst some countries already have well-developed systems for the secondary use of health data, there may be issues in adapting existing arrangements to match the requirements of the EHDS.

As EU member states are preparing to implement the European health data space and are considering what measures will be needed and how to finance them, TEHDAS will deliver recommendations on EHDS sustainability in June 2023.

The policy forum participants reported that the forums have helped the member states to understand the EHDS proposal and TEHDAS’ work in support of it and enabled discussion between and within countries on the regulation. They stressed that they found these informal settings for discussions especially useful.

Connecting European health data projects

By hosting project forums, TEHDAS has aimed to build dialogue and collaboration between different EU projects working on health data sharing and the secondary use of health data, to ensure TEHDAS builds on existing work and receives valuable feedback to its results. The discussions included a deep dive into the EHDS proposal, how the projects’ work might adapt in light of it and what challenges they envisage with the EHDS.

In the project forums, EU-funded projects reported that they have struggled with different regulations on health data use and different interpretations of the EU’s personal data regulations (GDPR). The projects expect that the EHDS regulation will overcome these challenges. They also noted that novel technical solutions can be used to solve complex problems, for example safe spaces that allow data to be analysed without moving it from its source.

Stakeholder engagement to be continued

Throughout the project TEHDAS prioritised stakeholder engagement by hosting forums and other events as well as attending numerous speaking engagements across Europe.

“Based on the positive feedback from participants, we clearly see that collaboration needs to continue after TEHDAS. Building networks, increasing awareness and facilitating dialogue between various stakeholders are key to building a sustainable EHDS”, says Petronille Bogaert from Sciensano, the TEHDAS partner leading the work on outreach and engagement.

The forums are likely to be continued by a joint action starting in 2024. In the meantime, discussions are ongoing between European health projects to organise a policy forum at the end of 2023.

The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.

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Maturity to implement EHDS is multi-dimensional

The report highlights the diversity of the member states’ health data management procedures. In most countries data management is organised among various stakeholders while only a few countries have centralised organisation. Although the EHDS plans to harmonise the secondary use of health data by creating a common legal framework, the visits clearly indicate that all member states have steps to take to meet the EHDS requirements.

Each country will need its own roadmap to achieve the steps. Many countries expressed a need for additional human and financial resources. TEHDAS will deliver recommendations on EHDS sustainability in spring 2023.

Legal barriers hinder the use of data repositories

Many countries also reported legal barriers as the main obstacles to the secondary use of health data. Currently, countries and even organisations in the same country interpret the General Data Protection Regulation (GDPR) differently. Most do not have specific national legislation for the secondary use of health data. TEHDAS has previously identified options to overcome data barriers.

Most of the countries visited have rich data repositories. However, the countries reported that researchers and policymakers experience challenges in accessing data from different repositories due to diverse, lengthy and sometimes nontransparent access procedures.

TEHDAS visited the countries in 2021–2022. The visits included interviews with national health data stakeholders, using a tool developed to map the countries’ health data management systems and preparedness for the EHDS. This TEHDAS mapping tool can be used in the future for similar mapping exercises and is found in the report. A factsheet on each country visited was also created.

The report has been approved by the project steering group. The European Commission gives final approval to all joint action’s deliverables.

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Secure processing environments

The Commission’s EHDS legislative proposal underlines the importance of ensuring a secure processing environment (SPE), where data processing takes place after a data permit has been granted, as a key element of the EHDS architecture. The stakeholders emphasised that when creating SPEs one size does not fit all data users’ needs. Security requirements, such as the authentication of data users and default tools for data analysis, should be standard. Any organisation, including private companies, should be allowed to create SPEs and provide additional features and services, but they need to be audited against commonly agreed standards.

Stakeholders were of the opinion that several SPE’s per country should be available, including cloud based SPEs. They also highlighted that data users need different options for data analysis: transferring data from different data sources to create larger datasets for analysis (centralised approach) and analysis where data is not transferred (federated approach). Data holders should be able to provide their data using common data models and SPEs should have application programming interfaces (APIs) to support federated analysis.

Dataset catalogue systems

The EHDS proposal entails requirements for data holders and data access bodies to keep catalogues of available health data sets to inform data users about what kind of data is available in a given country for secondary use. Stakeholders stressed that existing metadata standards, catalogues and data discovery solutions form a good basis for fulfilling EHDS requirements.

The technical infrastructure and services have been addressed by the TEHDAS advisory board workshops involving about 40 experts from across Europe.

“We are grateful to all advisory group participants for their valuable insights and guidance to our work”, says Juan González-García of the Institute for Health Sciences in Aragon, a TEHDAS partner leading the work.

The report summarises the results of two latest workshops organised between November 2022 and February 2023.

TEHDAS will issue final recommendations on the EHDS technical infrastructure in spring 2023.

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