A European Health Data Space – a small step or a giant leap?
Voltaire once supposedly said of the Holy Roman Empire that it was neither especially Holy or Roman, nor an Empire. This quote comes to mind when reading the mission letter to Stella Kyriakides to set up a European Health Data Space. Probably the most ambitious of all her tasks, because what we have today when it comes to health data is certainly neither European or a Space. And some people would argue that also the data is of the wrong type or of insufficient quality.
In fact, most Member States don’t even have a national health data space – instead the data is stored in a number of separate and often incompatible silos - so how on earth to construct a European one?
What is a data space anyway? The word space (or indeed “cloud” or “lake” which are other common buzzwords in this area) brings to mind a vast empty void where the data is just floating around freely like atoms in a gas canister for anyone to catch. But that’s probably not how most people would want health data to be handled. Specifically, when it comes to personal health data, there is an expectation from citizens and patients that this will be governed in an appropriate, safe and accountable way.
The future is federated…?
However, it is not always necessary to pool vast quantities of data in one place to be able to perform high-quality analysis at scale. A much more pragmatic way forward can be to build a federated network, where a big number of data sets can be analysed at the same time without moving the data from its source location. The European Health Data and Evidence Network (EHDEN, 2018-2024), a project under the Innovative Medicines Initiative (IMI2), is a primary example of a large-scale federated data network being developed as we speak. EFPIA companies together with public partners (led by Erasmus Medical Centre) are leading the way to standardize the data structure of different data sources all over Europe, corresponding to at least 100 million health records. This is done through implementing the OMOP model, an open source “common data model” which basically ensures that all databases have the same way of labelling and structuring their data. When this is done, researchers can send the same research question to all these data sources at once – for example “how many patients with type 2 diabetes over the age of 55 on a certain medication has experienced a certain type of cardiovascular complication during the last 12 months”. The analysis is done behind the fire-wall of each data set - after the approval of the data partner (for example a hospital) - after which only the answer is sent back to the researcher, not the underlying patient data.
This is an effective way of analysing large quantities of data in a way which is fully compliant with the EU’s data protection rules, and also at great speed. EHDEN will not only make millions of anonymized data records available for research, but also greatly reduce the time it takes to get from a question to an answer.
… and patient-centred
However, figuring out how to connect data across silos and borders in only one part of the equation. The other question is, are we having the right types of data to answer the questions we want answered? As underlined by the OECD health ministers in 2017, health systems are awash with data on activities (How many patients were referred to hospital in a given year?) but not so much on what the outcomes were (Did these patients get better? Are they back to their normal lives?).
In order to improve the situation, another IMI project starting in 2020 will aim to set up “Outcomes Observatories”, independent third-party structures working closely with patient organisations, which will be able to collect Patient Reported Outcomes in different disease areas directly from patients using state of the art digital tools. This outcomes data, which will be reported in a standardised format (for example an ICHOM standard, also used in EHDEN), can then be integrated into registries and Electronic Health Records.
However, the Observatories would not only be a technical project, they would more importantly work on the issue of governance of patient-reported data. Better data on patient-relevant outcomes is key to establishing more patient-centred healthcare, but patients have to be able to feel a high level of trust in the systems to which they are entrusting their data, both in terms of data protection standards and in terms of clarity and accountability regarding how the data is handled. This is also why EFPIA together with MedTech Europe and EiT Health is supporting the #DataSavesLives initiative led by the European Patients Forum and the European Institute for Innovation through Health Data, which aims to increase awareness and understanding on why and how health data is used and create a community for multi-stakeholder dialogue.
The future is European?
Most policy makers and stakeholders agree about the huge potential that health data has for improving healthcare quality and outcomes, guiding personalised care, empowering citizens and patients through access to their own data and records, identify inefficient spending and driving research and innovation. Given all the data which is already produced by European health systems, there is a huge potential for Europe in this area if we can only figure out how to do it in the right way, which is why the mission to create a European Health Data Space is so important. This is also about the competitiveness of Europe in a world where other regions are developing fast in this area, sometimes under less stringent data protection regimes than that of Europe.
However, the question should not be if we in Europe should lower our data protection standards to compete in a race to the bottom with other regions of the world, but how we can achieve an effective and innovative use of health data in a way which is compatible with Europe’s societal values. A health data space that is European not only in a geographical sense but also in terms of values. Strong data protection and accountability should in this sense be seen as strengths, not weaknesses, of the system, as it increases trust in sharing the data in the first place. We strongly believe that several of the key solutions for achieving this balance and building the European Health Data Space are already being developed, through the Innovative Medicines Initiative and other public-private partnerships underway in different parts of our continent. Let’s put them together and start building on what we have, and the vision of a joined-up framework for sharing health data in Europe will seem less distant, not requiring a giant leap into the unknown but rather several measured steps into a landscape we can already see before us.