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The European Health Data Space Proposal (Ehds) Explained

On the 3rd of May, the European Commission presented the EHDS proposal. What’s inside, and why is EHDS such critical legislation for the EU? A conversation with Ioana-Maria Gligor (Head of Unit in DG SANTE, responsible for European Reference Networks and Digital Health) and Andrzej Rys (Director Health Systems, Medical Products & Innovation at DG Santé) from the European Commission.

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Can you describe what the European Health Data Space is?

Andrzej Rys (AR): In a nutshell, the European Health Data Space is a health-specific data sharing framework establishing clear rules, common standards and practices, infrastructures and a governance framework for the use of electronic health data by patients and for research, innovation, policy-making, patient safety, statistics or regulatory purposes.

What are the critical elements of the Regulation on the European Health Data Space, and what makes it such an important project?

Ioana-Maria Gligor (IG): We believe the European Health Data Space brings us closer to making health data work for people, patients and innovation. And it is a crucial part of Europe’s digital transition and the European Health Union.

It has three main objectives. The first is to empower individuals across the EU to control their personal health data by, for instance, enabling them to access and share health data like their medical history, test results or prescriptions with hospitals and medical practitioners in and across the Member States.

The second objective is to ensure a consistent framework for the use of individuals’ health data for research, innovation, policy-making and regulatory activities.

The third is to unleash the data economy by fostering a genuine single market for digital health services and products (EHR systems).

The President of the European Commission, Ursula von der Leyen, has often stated that European Data Spaces are the key to a stronger European position in the global competition in innovation and AI. Why?

AR: The European Health Data Space aims to revolutionise how we use health data for research, innovation and policy-making.

It will create a legal framework that allows public institutions, researchers and industry to combine and re-use health data. For example, to develop new, revolutionary life-saving treatments, medicines or medical devices, or next-generation antibiotics; to make progress on personalised medicine; to train innovative artificial intelligence health tools with high-quality data; or to inform government decisions during a pandemic.

Subject to strong privacy and security safeguards, researchers will spend less time and money on gaining consent for various research projects. Therefore, they will be able to spend more time and money on the research itself.

They will have access to large amounts of health data, in particular healthcare and real-world evidence data, with the higher quality that medical breakthroughs require.

Among many assumptions on the EHDS, individuals should have the right to access a minimum set of ‘primary’ health data using a free-of-charge access service. How will cross-border interoperability be ensured?

IG: The European Health Data Space will empower individuals across the EU to fully exercise their rights over their health data. People will be able to easily access and share these data while retaining greater control, fully in line with our overall EU approach to data protection.

Regarding the primary use of health data, the use of health data for health service provision, as illustrated in different studies, is quite fragmented. Some Member States have achieved high levels of digitalisation and interoperability within their borders, while others are in the process of taking the necessary steps. Patient summaries and e-prescription services exist in two-thirds of all Member States and are most frequently accessed via an online portal. However, only in a few countries can they be sent or received across borders and 11 countries are still using paper printouts for prescriptions.

Today, ten Member States support the sharing of patient summaries and ePrescriptions via [email protected], a cross-border digital infrastructure for the exchange of health data. However, there are plans for all Member States to join [email protected] by 2025 and expand services  to include Medical images, Laboratory results, Discharge letters, Rare diseases data, and other health information categories.

Finally, a Pilot project will explore Patient Access to their health data in [email protected] as soon as 2023.

Another pillar of the EHDS is the secondary use of data for better research and better policy-making. Can you please give here some examples of how and what kind of data will be used?

IG: The European Health Data Space aims to boost the use of health data for research, innovation and policy-making.

One example is an innovative health tech company developing a new AI-based medical decision support tool to assist doctors in diagnostic and treatment decisions. Through the EHDS, the company is able to have efficient and secure access to a large number of medical images to train the AI algorithm and optimise its accuracy and effectiveness before seeking market approval.

Likewise, easier access to clinical, research or administrative data for regulators and policy-makers will benefit public health and healthcare systems. Indeed, the COVID-19 pandemic has shown that sharing up-to-date, reliable health data is key to countering health threats and preventing future ones. The introduction of EHDS should result in better access to healthcare, lower costs, higher efficiency, more resilient health systems, and better policy-making.

This is made possible by creating consistent rules and mechanisms for the use of individuals’ health data for research, innovation, policy-making and regulatory activities and through the establishment of [email protected], a new decentralised EU infrastructure for secondary use of health data. This federated infrastructure will operate in all EU Member States and integrate other relevant actors such as European Research Infrastructures, the European Medicines Agency (EMA) or the European Centre for Disease Control (ECDC).

Work is already taking place to make this infrastructure a reality. A pilot project exploring the technical and governance specifications to scale towards a Union-wide infrastructure is expected to start in a few months from now.

It all requires new data governance. How will it be organised?

IG: The EHDS will reinforce governance at the national and EU level and it builds upon the current cooperation for the primary use of data (the use of data by the patients themselves) within the eHealth Network – a voluntary network of EU countries that give direction to eHealth developments in Europe and help shape policy on eHealth. EHDS will set up digital health authorities that will implement the rights of individuals and contribute to digitalisation.

The EHDS extends the scope also to regulate secondary uses of health data (the use of health data by health care professionals, policy-makers, industries, etc.). It will also set up health data access bodies that will provide access to

The EHDS is expected to save around EUR 11 billion over ten years for the EU.health data

A new European Health Data Space Board will be created, composed of the representatives of digital health authorities and new health data access bodies from all the Member States, the Commission and observers. It will contribute to a consistent application of the rules throughout the EU, including advising the European Commission while cooperating with other EU bodies. Member States will also cooperate at the EU level for two cross-border digital infrastructures (one for primary uses of health data and another for secondary uses of health data).

Since the announcement of the EHDS, there have been many discussions around transparency and data as a private asset. Will citizens gain more control over their data?

IG: Yes. The European Health Data Space will empower individuals across the EU to fully exercise their rights over their health data. The Health Data Space, together with GDPR rights, will give them greater control over their health data. In particular, they will:

  • have access to your health data in electronic form immediately and without any cost
  • be able to share your data with health professionals within the EU and cross-border
  • have your health data issued and accepted in a common European format, supporting interoperability and data sharing
  • be able to add information, rectify errors, restrict access and obtain information on what health professional accessed your data
  • have certain categories of health data, such as patient summaries, ePrescriptions, images and image reports, laboratory results and discharge reports be issued and accepted in a European electronic health record exchange format

Shouldn’t EC first develop a kind of ethical codex of data processing in Europe to avoid discussions on data privacy every time the Member States are working on new digital-related legislation?

AR: Data privacy and trust are important elements of the EHDS. The EHDS builds on the General Data Protection Regulation (GDPR) and other legislations such as the proposed Data Governance Act, draft Data Act and NIS Directive on Cybersecurity. So we do have a strong EU-wide framework for the safe processing of data in Europe being created. The EHDS complements these initiatives and provides more tailor-made rules for the health sector where needed.

This is because we believe strict measures are paramount given the sensitive nature of health data. For instance, EHDS introduces security criteria for electronic health record systems and requires manufacturers to certify them. Similarly, processing electronic health data for secondary use of data is only possible for strict purposes foreseen in the Regulation, based on a permit issued by a data access body. Some purposes will be strictly forbidden, such as using the data to make decisions detrimental to individuals. For example, to increase insurance premiums or to market health products towards health professionals or patients.

Data processing can only take place in secure processing environments, which need to comply with very high standards of privacy and (cyber)-security. No personal data can be downloaded from such environments. Moreover, the researcher, company or public institution can only access pseudonymised data and it is forbidden for the user to re-identify the data subjects.

When do you expect the new Regulation on the EHDS to be passed?

AR: The EHDS proposal was put forward by the European Commission on the 3rd of May. It will now be discussed by the European Council and the European Parliament.

In parallel to these discussions, we will pursue a series of activities to make it possible to implement the EHDS framework as soon as an agreement is reached.

What other benefits do you foresee from the introduction of EHDS?

AR: Sharing up-to-date, reliable health data is not only key to the use of electronic health data by patients and for research, innovation, policy-making, patient safety, statistics or regulatory purposes.

It can also save money. For instance, estimates show that hospitals could make important savings (of up to 15%) with better use of existing health information. This would free up billions of euros for other vital healthcare needs.

And sharing health data across hospitals and between medical practitioners could cut spending on medical images across our Union – currently at 14 billion euros a year – by up to 10%.

Overall, the EHDS is expected to save around EUR 11 billion over ten years for the EU from better access and exchange of health data in healthcare (EUR 5.5 million) and from better use of health data for research, innovation and policy making (EUR 5.4 million).

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