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Institutional • 01 Apr 2025

Shared Health Data in a European System

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Shared Health Data in a European System

HENRIQUE MARTINS

Professor Iscte-Sintra

Integrated Researcher BRU-Iscte

Did you know you can fill a prescription in another country with a simple mobile phone? Or that you may efficiently access your medical tests and consult them in a hospital in another European city? With twenty-five partners, Iscte launched a project to create digital health solutions in a shareable format, allowing the cross-border exchange of this data.

The XpanDH project, which you coordinate, has proposed creating a standard format and set of rules that allow computer systems from different countries to exchange health data in a secure and clinically applicable way. How does a European project that wants to connect hospitals, health centres, laboratories and national registries become operational?

When we set up the consortium, we used an open consortium approach, i.e. we actively searched for new members. So, we looked for strategic partners. We involved the Shared Services of the Ministry of Health (SPMS) and the Ministry of Health of Spain, which wasn't in the initial project. This way, we expanded the number of partners from 26 to 33. At Iscte, three research units are involved: the Business Research Unit (BRU), the Centre for Research and Social Intervention (CIS) and the Centre for Research in Information Sciences, Technologies and Architecture (ISTAR).

Are there more people in the project with different kinds of know-how to make it possible to share health data transnationally?

These European projects have the so-called work packages - the work packages are subdivisions of the project. Iscte coordinates the project, which also has work package 1, which I lead with the invaluable help of the Project Manager, Anderson Carmo.
We have very experienced people who have coordinated many European projects. Giorgio Cangioli, an Italian, oversees work package 2 and has much experience in computer science and standards. In work package 3, we have a person from the digital industry, the French Sofia Franconi, who knows the industry that develops IT solutions and brings this know-how to the discussion. In work package 4, we have Maria Marques, from Uninova, who has training in computer control systems. In work package 5, we have a small German consultancy, Empiric, specialising in European health and strategy projects with Carola Schulz. Work package 6 is led by Dipak Karla, an English General and Family Medicine doctor who specialises in data analytics but has also led several projects to use data in scientific research. In 7, we have a Polish partner through the ECHAlliance (European Connected Health Alliance) network, where Karolina Mackiewicz, Director of Innovation, oversaw dissemination and networking. We, therefore, have technical know-how and knowledge from engineering to sociology.
An example is Professor Luisa Lima, from Iscte-Health, who organised the first meeting with Portuguese patient associations on this process of the European electronic record and will conduct the sessions in other countries. Marta Matos, a researcher at Iscte, is working on a co-creation area between computer engineering and patients.

In Portugal, we have a lot of connections in the public and private sectors, but we do not have a connection between the public and private sectors

What other important aspects do you highlight in this project?

The project covers all aspects of a university, whether teaching, research, or the relationship with the rest of society, for example, the transfer of technology and knowledge with the so-called ecosystem.
In this project, the ecosystem partners have several profiles, including those of non-governmental organisations (NGOs), public entities, and companies. We have a company in the IT area, the Lisbon Metropolitan Area, CP, and some NGOs such as Inovar Autismo, the Portuguese Confederation of Culture and Recreation Collectivises or the Portuguese Confederation of Volunteering. There are two Finnish organisations, others from Slovakia, and we also have, outside Europe, the University of Sherbrooke in Canada as an associate partner.

How does everything coordinate to move the project forward?

These European projects initially have a work plan approved by the European Commission. There is a set of tasks with deadlines, and in the middle of the journey or at the end, something concrete is supposed to be produced -- deliverables. We have a monthly meeting of the leading work packages, and each of them also has meetings with the partners who participate in their area and their teams. We also have the consortium meeting, in which all the partners participate, which takes place every two months. We also have webinars for information dissemination, usually involving several partners.
The website is essential, as it is a point of confluence of information. This project has little money: two million euros for two years, to be distributed among twenty-six partners! In December 2023, we held a meeting in Brussels at the request of the European Commission itself, which was an honor -- it was not foreseen in the project -- and we ended up having many people. In December 2024, we will have the closure of the project at Iscte, and it will be an opportunity to promote the Portuguese ecosystem.

The origin of the service MyHealth@EU

Was the fact that a prescription could already be readable in another country -- through the MyHealth@EU service -- and there is some interoperability in access to health data in the Member States a political decision by the European Commission, or was it motivated by the initiative of the Member States?

Henrique Martins Both. This fascinating story begins before Directive 2011/24/EU of 9 March 2011.
In 2007/2008, a complaint was lodged with the Court of Justice of the European Union by a German patient alleging that German insurers were refusing to pay for health expenses incurred outside Germany -- in his case, it was glasses. The case ended up in the EU courts. The assumption was simple: if the EU is an area of free movement of people and goods and a citizen is going to buy an optical device from another country with health insurance, there is no reason why he should not be reimbursed for the expense, at least with the equivalent he would have in his country of origin.
This made so much sense that the Court condemned it and called on the European Commission, with this jurisprudential decision, to create a legal instrument that would allow such cross-border recognition.
That is why it is called the Cross-Border Directive of Patients' Rights. At its core, it is a directive of rights. A project called epSOS - European Patient Smart Open Services - was already underway when this happened. It was the first project to share data between countries. It started in 2008, and the countries that were part of it contributed to the writing of the Directive: France, Germany, and Austria. On that occasion, it was decided to include an article on patient summaries and e-prescriptions.
In this way, the Directive now has a policy structure and the concept of cross-border data sharing, with the extraordinary argument that if patients circulate and we pay for their expenses, they may have little expense. And they should have access to their medications, no matter where they are.
In the health sector, European treaties entrust everything that is part of the functioning of health systems to the countries. The exceptions are the approval of medicines, blood products, tobacco policy issues, and cross-border infections such as COVID-19 - these are the only aspects of health that are the subject of European legislative policy.
Thus, the legal basis of the Directive is not health issues but the free market! -- Arguments remain regarding the digital free market.

The Portuguese ecosystem of health has significantly evolved.

Our ecosystem is perfect for this project. We have many connections in the public and private sectors, but we need to have connections between the public and the private.
The SPMS has been very much aligned with this project because the idea is to create European rules within the Portuguese system. This will allow us to resolve the connections between Hospital da Luz and Hospital de Santa Maria, for example, and between Santa Maria and the Charité University Hospital in Berlin. One of the partners that integrated the project in the middle was SIBS (Forward Payment Solutions, SA). Being in the business of healthcare transactions is the future. No health facility does not have an ATM. Instead of making the call through the Ministry of Health, we can use these ATM calls, for example, to print the prescriptions! The ATM is a potent communication mechanism.
Imagine - at the limit - what it would be like to be able to prick a finger at an ATM to take a test. It would turn ATMs into mini health points! It is essential to project these things beyond what is usual, creating new digital services and ways of looking at the circulation of information (object of work package 6).

Each work package, therefore, has its own specificity.

Work packages 2, 3 and 4 show how technology companies, hospitals and other areas of the health sector prepare and use the format as it has been defined, discussed and used.
Work packages 5, 6 and 7 are more about the ecosystem, that is, how we can motivate the ecosystem -- business associations, patient associations, civil society associations such as DECO, and academia -- from software academics to those who study issues of digital inclusion, literacy -- how the ecosystem can be dynamized.
In these interactions, we discover, for example, that it is relatively useless to hold a seminar for all patient organisations because there is no uniformity between them. It is something that needs to be done in the context of each country. In Portugal, if we talk about electronic prescriptions, most people know and have already used them; in Germany, there is no electronic prescription; it is a reality they are unaware of. Participation in clinical studies, for example, is higher in Germany than in Portugal. The clinical process for research purposes and standards is common ground for a Finn, as Finland has had a Health Data Act for several years.

In Portugal, the patient already sees some things online, but there is not even a portal or app for the National Health Service in other countries

Sharing the data carries risks to confidentiality. Can this project move forward?

It's a problem to reconcile protecting my data with allowing those who care for me access to relevant data.
There is a third dimension, which is "primary use." In Portugal, the patient sees some things online, but there needs to be a portal or app for the National Health Service in other countries. There is also the question of who takes care of my health to access my information. Still, there is also the plan for researchers -- or people in the public health system -- to access this data without identifying people by name. These administrative data are of interest for planning and of no interest from a clinical point of view.

Is there still a lot of reluctance to share data despite digitalisation's advances in several areas?

Usually, people are predisposed to share data contrary to what legal systems understand -- there are studies to prove this. We also know that patient associations almost always favour these projects, as they understand sharing will bring clinical value to the patient.
Fears about privacy vary across cultures. Germans are more nervous about sharing data than citizens of southern countries. The most laid-back are the Nordics, who don't worry about the government knowing their health problems.

Has the European Union already imposed many limits on data protection?

Yes. The GDPR regime's limits are excessive and need to be clarified. Two countries can interpret the same European law differently, which has caused many problems. The only way to resolve the situation was to design the Multilateral Agreement, a legal agreement between countries that clarifies what was unclarified in the GDPR.

When this XpanDH project ends at the end of 2024, what results can we expect?

We will deliver two projects with a set of evidence.
In one case, we will deliver proposals for the future regulation of electronic health records. Once the regulation has been approved, a fundamental piece of legislation for each area -- the medical prescription, the hospital discharge note, the images of exams, etc. is an Implementing Act. This text will receive substantial contributions that have been asked of us, both in terms of structure and the content of the document.
The other deliverable is more intangible: the X-nets, that is, networks of partners we have been approaching and want to remain active when the project ends. For example, we have fifteen Portuguese patient associations. If we get ten more sessions like the one with Professor Luísa Lima, we could discuss a network of 150 patient associations spread across Europe.
As I mentioned, we will hand over this asset to the xShare Project, which is led by Catherine Chronaki, who also participates in XpanDH. She will continue these efforts in the xShare project for another two years. Therefore, we will hand over documents that help hospitals, IT companies, and others adapt to the so-called 'networks of people'.