What is the future of the European Health Data Space? What has the joint action Towards European Health Data Space (TEHDAS) achieved? This blog post summarizes the discussions from the TEHDAS stakeholder forum that took place in Helsinki in June 2023, before the release of the final result documents and the end of the joint action.
Towards European Health Data Space (TEHDAS) stakeholder forum took place in Helsinki on the 14th of June 2023. The event was attended by a couple hundred people in person and another 600 people online. The event was organized to present the results of the TEHDAS joint action to relevant stakeholders and to discuss the topics showcased.
The high level goal of TEHDAS has been to produce information for the new Health Data Space legislation and to develop a basis for business models that lead to better health services and enable new innovation related to health data.
TEHDAS joint action was coming to its end and according to the people who were involved in the project, it was a successful effort between several national organizations from 25 countries in the EU. The success metrics of the project were sticking within the budget and the timeline.
It was seen that timing has been an important success factor in the TEHDAS project. COVID-19 pandemic put health policy and health data in the spotlight and increased the urgency for improved legislation and practices. Due to these circumstances, the new regulation is expected to become effective relatively soon.
TEHDAS stakeholder forum presented early results and recommendations from the different streams of the joint action. Final reports will be published at the end of June 2023. Currently there are already several result documents for the work packages published on the TEHDAS website.
Parties involved in Health Data Space
It could be said that the topic of health data touches us all.
In the TEHDAS stakeholder forum it was communicated that from the policy makers’ perspective there are two main groups involved in the development of the European Health Data Space:
- Researchers and innovators
- Policy makers and regulators
Researchers and innovators who are the customers, the parties to want the data for their research and development, need to be understood to build a service or a product that suits their needs.
Policy makers and regulators are not the product owners, but they oversee the future product owners and define the framework for the product.
Quickly thinking there are then at least third, fourth and fifth group that should be taken into consideration:
- Product owners
- Countries outside of the EU
It was highlighted during the TEHDAS stakeholder forum that Citizens had been consulted on several different topics. People of the European Union were represented either directly through surveys or indirectly through patient organizations.
The product owners are a mixed group of national organizations that will have the challenging task of building processes and tools to enable data sharing according to the new regulation. This group has also been represented at least on a high level in the TEHDAS joint action.
Third countries are a more mixed group, and a group that is not immediately obvious. Because diseases and health issues know no borders, the development and use of healthcare services, medical devices, and of course medicinal products, is often a global task if the health product becomes truly important. This means that if there is a treatment, device or drug developed by a smaller national organization, it is soon adapted globally if the results show promise. To prepare for this situation there are parties who wish to access health data within the EU. They might want to know the number of patients for specific disease groups or they wish to know how a specific patient group is treated in different countries. There might be a commercial need to understand the existing products on the market and their market shares.
Data quality framework
One of the key topics that was discussed at TEHDAS stakeholder forum was the data quality framework. The data quality framework work package prepared to be released now at the end of June, should contain recommendations to the data holders for data preparation and to the HDAB and Secure Processing Environment (SPE) providers for the interaction with the users.
The recommendations touch upon topics, such as:
- Data management procedures
- Data quality assurance
- Mapping to semantic standards
- Dataset linkage
- Metadata cataloging
- Publishing metadata on datasets
- Datasets and procedures enrichment
- Minimization and purpose limitation
- Secure Processing Environment processing
- Research results return
- Users’ feedback fitting-for-purpose
Infrastructure of EHDS
What is the infrastructure of the upcoming European Health Data Space?
At the TEHDAS stakeholder forum, there was some discussion about the topic, but not very directly. This could indicate that right now, nobody can really tell what the infrastructure of EHDS should be.
It was mentioned that a suggested process model for data lifecycle should be applied to structure the technical work that will be required, that recommended options should be adopted for the further development of the services and that the guidelines generated by TEHDAS should be used to develop the blueprints of the infrastructure. All this sounds very fancy, but let’s say that in practice, there is no infrastructure at the moment and there is no plan for the infrastructure. There might be a plan to develop a plan, but even that is a bit unclear.
Right now, the best option seems to be to take existing models from the national level and implement one of them across the EU and link the systems together. The architecture options that were mentioned in the TEHDAS stakeholder forum are based on two best practice models in use in a handful of the EU countries:
- Centralized (for example, Finland and France)
- Decentralized (for example Spain and the Netherlands)
Services related to EHDS
Some of the services included in the European Health Data Space would hopefully include the following:
- Metadata publications and search
- Data permits request
- Data integration or harmonization and analysis
- Results communication
In order for these services to be developed and deployed nationally (or in Europe), the following guidelines need to be developed and adopted:
- Catalog publication and management
- Data access applications and data requests systems
- Secure processing environment (SPE)
- Examples and best practices
Challenges related to EHDS
Obviously there are many challenges related to the development of the European Health Data Space.
An agreement needs to be reached between the EU countries on the interaction between technical infrastructures. In general, there is currently a need for clarity on services to be provided by the Health Data Access Body (HDAB).
Some of the topics that were picked up by the moderator from the discussion were compensation for work on data acquisition and cleaning, governance – lack of clarity related to governance and and resources, legislation clarification and harmonization, legislation as a barrier or rather the interpretation of the legislation and clarity to those who should follow it – in other words; people are afraid to do things because they think it’s illegal.
At the TEHDAS stakeholder forum, the question of a new agency in relation to the governance issues was spoken aloud. The possibility of a virtual agency for EHDS was mentioned, to avoid similar issues that were seen when EMA had to relocate from London.
The stakeholder forum discussed a few of them and asked the audience, which consisted of people interested in the topic, to list what they think will be the biggest challenges.
Top 3 difficulties expected by the attendees:
- Data management procedures
- Data quality assurance
- Dataset linkage
Most critical element in the infrastructure was thought to be the secure processing environment to process the data with a high security level.
All of these challenges and difficulties can be said to be caused by one thing: the people. Currently, there is lack of capacity, lack of data professionals, and lack of relevant education of the workforce.
Sustainability of EHDS
Sustainability is one of those buzzwords that, like AI, gets brought into any discussion no matter what the topic or content with or without a good reason. Sustainability for the European Health Data Space should be thought of from one main point: sustainability of the data.
How can the data be acquired and shared? How is it ensured that the data can be used for different purposes and reused? How is it ensured that the data will remain usable for a longer period of time? How can all this be done in a way that is not too costly? What is a sustainable economic model for EHDS? What will be the role of fees?
Fees of EHDS
Especially the fees are already a large challenge in the health data space. Either the fees are so high that they hinder the initiatives to acquire data from the registries or the fees are too low, and the registry holder’s economic model does not support large scale data distribution to the interested parties.
The fees are paid either directly to the registries or to the Health Data Access Bodies (Denmark, Finland, and France).
EHDS and the People Outside the EU
Most patients and data related to the patients and diseases resides outside of the EU and US. There are huge biases in the health data space related to age, race and gender. In some areas of the world this is understandable, the primary objective is to get access to basic health and only then start thinking about getting data. However, basic healthcare and health data are closely linked.
The general perceived status of the market does not guarantee that there are good systems for health data. For example, one of the largest individual markets in healthcare, the United States, has no national register for Parkinson’s disease.
When talking about health data, countries could be roughly divided into data rich and data poor. Data rich countries have quality data and easy access to data, and the data poor countries do not.
For example in Japan, there is a basic data layer but things are still moving slowly because there are certain processes where the country is stuck in the past century.
In China things move fast and there’s a lot of data but there’s a lack of transparency related to the data collection and data usage processes.
The future of EHDS
As mentioned for China, the EHDS, AI and generally all modern systems produce great amounts of data. And with the current systems, the challenge is how to produce knowledge from the data?
On the day of the TEHDAS Stakeholder Forum, the European Commission voted to move forward with the proposed AI act, which will hopefully act as an example of how legislation provides protection of data while still supporting innovation.
It was mentioned during the discussion that the upcoming EU election can have a large impact on activities related to EHDS due to time delay and political decisions following the new commission.
Few of the ideas that were mentioned to push the initiative forward were:
- Designing a user journey for the researcher who wants to use European health data
- Starting a pilot for crossborder use
- Provide a grant for the Member States for setting up a HDAP
- Do a next joint action program (EHDS2), hopefully starting in 2024
In a slightly corny last point, it has to be mentioned that it all boils down to the people: decision makers who understand the issues enough to make the right decisions, local officials who are able to implement the system as required, healthcare professionals and administrators who understand the value of the data that they are recording during their actual work of taking care of patients, and data analysts and data management specialists who are motivated to build efficient and sustainable data structures that can be shared securely with the researchers who know where to acquire the data.