A Cardio-Passport for Europe: putting elderly heart patients in control of their own data across borders

Gnomon Informatics has been working in digital health for over thirty years. How did you come to UNITE and to CARDIO-HUB specifically?

We are always active in looking for European funding opportunities — through newsletters, networking, the usual channels. What made UNITE particularly interesting for us was that one of the seven participating regions is Central Macedonia, where Gnomon has its headquarters and where we have delivered projects and services for years. So when we saw there was a call coming, I followed it closely. I attended the webinars, understood what the programme was about, and when the call opened, we were ready.

The call itself had two possible directions: personalised remote care on one side, and the European Health Data Space on the other. We are active in both. But we made a deliberate choice to go deeper on the EHDS angle, because this is a regulation that has already been approved and that all of us — healthcare systems, technology companies, hospitals — are going to have to navigate. It felt like the right moment to be proactive about it rather than wait. We did not skip the remote care dimension either, because the two are deeply connected. But the EHDS, and specifically the secondary use of health data, was our strategic focus.

How did you build the consortium?

Well, when you have experience in European projects, your first instinct is to look at contacts you already trust and collaborations that worked well in the past.

The 3rd Cardiology Department at Aristotle University of Thessaloniki was a natural first choice. We had worked together before, including on InCareHeart, a previous project that was specifically focused on remote care for heart failure patients. That shared history meant we already had a working relationship and a common understanding of what these patients need.

For Italy, the University of Brescia was connected with us through Hanze University (Netherlands). They in turn brought in ASST Spedali Civili di Brescia — the hospital side.

Why heart failure? Why elderly patients specifically?

Several things converged. Our overall experience so far gave us real knowledge of what remote management of heart failure patients looks like in practice — what works, what is harder than expected. Our clinical partners have deep expertise in this area. And the disease itself is a particularly compelling case, because it does not exist in isolation.

When you work with elderly heart failure patients, you almost always have to think about comorbidities: diabetes, obesity etc. These are conditions that affect both Greece and Italy significantly, in ageing populations. So by tackling heart failure, we are not just solving one problem. We are creating an infrastructure and a care model that can address a whole cluster of interconnected challenges. That made it feel like the right anchor for this project.

Can you describe what CARDIO-HUB actually does — from the patient's point of view?

Let me try to keep it concrete. A patient enrolled in the project will receive a set of medical IoT monitoring devices. These devices connect to Gnomon’s eHealthPass platform, which is a certified medical software product. The patient has a mobile app. The supervising clinical team has a web application. Data flows continuously from the devices to the platform, and healthcare professionals can monitor patients remotely and receive alerts when something looks concerning.

On top of that — and this is where it becomes more than standard remote monitoring — we are building AI layers that analyse all of this data in context. The goal is risk prediction: can we detect, early enough, when a patient’s condition is deteriorating or improving? These are questions with real clinical and economic consequences. Avoiding one unnecessary hospitalisation makes a significant difference, both for the patient and the health system.

We are also working on a research infrastructure alongside the care platform. Data collected from patients (properly anonymised) feeds into a secondary use layer that researchers and data scientists can access under governed conditions. This is the EHDS dimension: making real-world health data available for research without compromising patient privacy.

You mention the EHDS quite centrally. For readers who are not familiar with it, how would you describe what it means for a project like this?

In simple terms, the European Health Data Space is about giving patients genuine control over their own data. It means that you, as a patient, should be able to access your health data from wherever you are, whenever you want. In a cross-border situation, you should be able to give a doctor in another country fast, secure, and easy access to your records.

Think about it practically: you are a Greek citizen, you travel for two months to another EU country, and you need medical attention. The doctor there knows nothing about you. With the EHDS, you should have the option to share your health summary instantly and securely with that doctor, so they can understand your condition and give you an accurate diagnosis. Today, that is not possible in any reliable way. CARDIO-HUB is building a demonstration of exactly that.

We call it the Cardio-Passport — a Travel Mode feature within the app that generates a standardised health summary compliant with international interoperability standards. The patient is in control at every step and can see an audit trail of who accessed their data.

When applying to the Open Call, you mentioned the use of synthetic data as part of the project. What is the role of that?

The challenge with training AI models for a specific patient population is always data availability. Heart failure in elderly patients is a specific enough category that you cannot simply assume existing generic datasets will be sufficient or representative. Our clinical partners have access to retrospective patient registries, consisting of historical cohorts of several thousand patients, and we are going to use those to generate synthetic data that mirrors the statistical characteristics of those populations without containing real patient information.

The innovative aspect here is not the technique itself, as synthetic data generation is not new, but the specificity: we are generating data tailored to the exact profile of patients we are going to work with, to the characteristics of the devices we are using, and to the research questions we are trying to answer.

How does CARDIO-HUB fit into what UNITE is trying to accomplish?

UNITE connects regions with different levels of digital health maturity — and that is genuinely useful. Central Macedonia and Lombardy are different healthcare environments. Northern Netherlands brings a research and health informatics tradition that differs from both. Having those three perspectives in the same project means the solution we build has to work across different healthcare systems, different levels of digital infrastructure, and different organisational cultures.

UNITE's logic of Regional Innovation Valleys: bridging strong-innovator and emerging-innovator regions, is exactly what happens in this consortium. You do not just export a solution from one region to another. You design something together that has to work for everyone. That is a harder design problem, but it produces something far more sustainable. If CARDIO-HUB works in Greece and Italy simultaneously, the replication roadmap for other regions becomes much more credible.

What keeps you up at night about this project?

Honestly? The delays. There are administrative processes that take longer than anyone would like, and the summer period is here, which adds its own complications with ethics committee timelines.

What reassures me is that we did not wait for everything to be in place before starting. We began working on the clinical protocol even before the project’s official start. We are already advancing on ethics committee preparation, on consent form design, on the technical setup. Our advantage is that we are building on existing, certified technology — eHealthPass has been tested in real clinical environments. We are not starting from scratch.

But I will not pretend the timeline is not tight. Eighteen months is short for a project of this scope. Every week matters.

What would success look like by September 2027?

Success has two faces. On the research side: a functioning EHDS-aligned data infrastructure that has actually processed real patient data from two countries, with documented governance procedures, interoperability specifications, and a validated synthetic dataset available for the research community. Something that other projects and health systems can learn from and replicate.

On the care side: patients in Greece and Italy who have been monitored remotely for a meaningful period, with clinical teams that found the system useful — that it actually helped them make better decisions, earlier. And at least some demonstration that the Cardio-Passport concept works in a real cross-border scenario.

And beyond that, I hope we are laying a foundation for something that continues. A dedicated product for heart failure care and a research platform for secondary use of health data .