This spring, the European Parliament and the Council reached a political agreement regarding the Commission’s proposal on the European Health Data Space (EHDS).

What is the EHDS? The EHDS is a robust legal framework for the use of health data for research, innovation, public health, policy-making, and regulation purposes, providing access, under strict conditions, to large amounts of high-quality health data with a series of regulations and guidelines, along with a decentralized infrastructure (HealthData@EU) to support cross-border projects.

The implications this has for health data are significant; probably the most significant in recent years and also in the coming ones. In this way, it reaffirms what we already knew: the era of data standardization in healthcare has been a reality for some time, and it is time to start regulating by creating specific frameworks and expert guides and recommendations.

This new EHDS speaks to us about empowerment, control of health data for healthcare delivery, promoting a single market for electronic health record systems, reuse of data for research, and creating a reliable framework for secure access and processing of a wide range of health data.

But the question we ask ourselves is: do we really know what Europe is trying to tell us?

Let's see what this is all about.

To begin with, the fundamental requirement of the EHDS is that the patient can see all their information. However, from the outset, the focus has been on some old acquaintances: ePrescription, eDispensation, and International Patient Summary (IPS). And although the need to work in the future to expand it is recognized, this model will be nothing more than a utopia if European projects themselves are limited to sharing partial views of the data instead of addressing the sharing of a complete EHR model from the start.

The longitudinal view of the patient based on information models is fundamental. In this way, we can obtain all the available information with the desired granularity. If this is not achieved, we will continue to fall into the error of reducing all European health data communication to the simple sending of summaries or partial views of information.

Does this mean that things are being done wrong? No.

Does it mean they could be done better? Yes, a lot.

Even European projects based on HL7 FHIR suffer from “Profiliferation,”, where different profiles are created to talk about the same data element. For example, the profiles defined by the IPS project and those of the European Laboratory Report have been generated completely independently, even when they refer to the same data elements such as the patient or the laboratory result itself. This means that each project that uses any of these profiles will require mapping to the format required by the IPS, even though they are all talking about the same concepts. This happens often among different European projects based on FHIR. 

This problem can be alleviated if we use quality clinical models, agreed upon by multidisciplinary and international working groups, as a basis for the creation of systems. Moreover, dedicating efforts to creating general-scope information models would allow regions or countries to directly use them as a reference to build their information systems and EHRs. Thus, the modeling work done would have a double benefit: as a specification for sharing any clinical information and as a reference for building primary health data capture information systems.

On the other hand, although the EHDS is a regulatory framework and does not impose data formats, of the 25 features it aims to promote, openEHR is appropriate for 18 and potential for another 3. Each solution has its function, and various experts across Europe warn of the same thing we warn about: if we do not address a complete EHR model supported by information standards, its governance and massive, reliable exploitation will be almost impossible. 

So, do decision-makers have the proper training to know that these elements are necessary? If it is not mentioned and raised awareness of, we risk thinking that these are trivial or already resolved issues.

We are not alone in this opinion. It is shared by many other interoperability experts. For instance, we can see an excerpt from the dossier “Implementing the European Health Data Space in Sweden” promoted by EIT Health, where we are also warned about this:

Therefore, the IT industry will need to provide solutions that do not exist today [to build the EHDS], but the panelists advocate that these must be developed in cooperation with European healthcare systems, the government that controls them, and the future EHDS users.

Farrokhnia added that the process of building the EHDS infrastructure can and should be used as a means to unite healthcare institutions and medical professionals, who will play a key role in bringing the EHDS to life, early in the implementation process: “In terms of technical solutions, the EHDS’s goal of giving individuals control over their data and achieving data fluidity requires working with international standards such as OMOP, openEHR, and FHIR, rather than trying to reinvent the wheel at each level of local implementation.””.

From Sweden, they also mention the secondary use of data:

“But developing solutions based on concrete use cases that show data holders how data can be used for secondary purposes will be equally essential to help institutions see how to implement the EHDS […]”

And they end with two recommendations that we cannot agree more with:

“Encouraging international collaboration between the IT industry and key EHDS stakeholders to develop the technical infrastructure for the EHDS based on concrete use cases.”

“Promoting the development of scalable solutions based on international standards.”

At Veratech for Health, we are experts in interoperability standards and Electronic Health Records, and we have a very clear vision on this: it does not matter which format is ultimately chosen; quality data is needed inside to export quality data outside. And this is a reality we live day by day with all the projects we carry out and where we constantly try to raise awareness as an expert consultant in semantic interoperability.