Within the healthcare sector, there is increasing talk of the ‘European Health Data Space’, or the EHDS. But what does the EHDS entail and how will it benefit healthcare?
What is the EHDS?
The European Health Data Space is the European Commission's proposal for a regulation aimed at improving data availability and data exchange at European level. Harmonisation of how we handle data is already being examined in different kinds of European legislation - the EHDS specifies how to handle healthcare data for primary and secondary use and what this means for the healthcare IT market.
Why does the EHDS matter?
European citizens gain control over access to their medical data and healthcare providers within Europe need to have access to data for the purpose of the care they provide - including across national borders. This is the aforementioned primary use. Additionally, anonymised or pseudonymised data is needed for secondary use, in the form of scientific research and policy-making.
Ultimately, through better data availability, the goal is to:
-
give citizens more control over access to their data,
-
facilitate better diagnostics,
-
improve prevention,
-
work more efficiently,
-
better insure continuity of care,
-
accelerate innovation.
And all of this within the European Union, across national borders where necessary.
The Netherlands and the EHDS
The Dutch cabinet is positive about the approach of the EHDS. In March this year, Minister Helder of the Ministry of Health informed the House of Representatives about the preliminary political agreement on the EHDS. This does include several caveats, especially in the area of data protection and regulating consent from citizens.
The EHDS also requires every member state to set up one or more Health Data Access Bodies (HDABs), that will facilitate data availability for scientific research, innovation and policy. As of 1 December 2023, the Netherlands has started the HDAB-NL programme for this purpose.
Dutch organisations like Nictiz are also closely involved in various European collaborations related to the EHDS, such as TEHDAS (Towards European Health Data Space) and TEHDAS-2.
How does the EHDS relate to other legislation?
The EHDS builds on other legislation, such as the Data Governance Act (DGA), the General Data Protection Regulation (GDPR), the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Ultimately, each regulation is drafted with a specific interest and purpose - that is mostly where the differences lie, although there is often some overlap.
These other regulations, for instance, are already looking at harmonising European legislation. For example, the DGA aims to facilitate data availability in the EU at a broad level - the EHDS is the specification of the DGA in healthcare.
Regarding the GDPR, the Dutch Ministry of Health says the following: "The GDPR already gives citizens the right to access their healthcare data, but does not prescribe in what form, nor does it give citizens rights to simple, effective data portability. EHDS does." Additionally, the aforementioned secondary use requires a legal basis, for which the EHDS also builds on the GDPR.
Within the Netherlands, we also have the Wegiz: the Electronic Data Exchange Act. This act obliges healthcare providers to exchange medical data electronically and provides a fairly solid foundation for further implementation of the EHDS, precisely because it already includes issues such as interoperability, infrastructures and standardisation.
What is interesting is that in many of these discussions and proposals, the terms data availability and data exchange are often used interchangeably. See our article ‘Data availability or data exchange?’ for our perspective on the distinction between these two concepts.
Should healthcare organisations get ready for the EHDS?
The EHDS is coming - the only question is how. Until it is completely clear what IT and policy adjustments are required, there are not many steps one can take. Fortunately, discussions on data availability are increasingly taking place and the use of standards such as HL7 FHIR, openEHR and OMOP is being actively explored in various living labs.
Ultimately, the boards of healthcare organisations will mainly have to ask themselves how they can future-proof their IT landscape. Here, the use of open standards will only become more important - as will the possibility of extracting data from more traditional, closed systems.
And software vendors?
All vendors will need to be able to handle the aforementioned permissions. Structured and standardised data is also an important factor here - standardisation of data in a modular format also helps with to apply permissions.
Additionally, vendors of closed systems will have to take steps towards more openness to meet the requirements around interoperability. Data extraction and data conversion will also play an important role here, especially in the transition phase towards more open architectures.
Is your organisation optimising your IT landscape in view of these developments? We would be happy to discuss what open standards and structured data can offer healthcare organisations, regions and suppliers.