This session continued to look forward in time. Once implemented, the European Health Data Space (EHDS) Regulation will interconnect the primary and secondary uses of health data. Through the regulation, individuals will have the right to access, download, and share their own health data. As a result, citizen-centric data ecosystems can be expected to complement a more traditional clinician-centric ecosystem. This session reflects on the implications of these paradigm shifts for three stakeholder types (industry, researchers, and public health organisations).
This session was held with the support of xShare, a large-scale project with a focus on electronic health record use in the EHDS. It was introduced by Henrique Martins of Instituto Universitario De Lisboa, Portugal. Formal presentations and informal discussions followed.
- “How to make the EHDS successful? An industry perspective” by János Vincze, GE HealthCare and Vendor Co-Chair of IHE-Europe.
- “Does research need to get data directly from people?” by Norman Sabbah, Telemedicine Technologies, France.
- “Leveraging the EHDS: Advancing public health and citizen impact” by Nienke Schutte, Sciensano, Belgium.
🗣️ Speakers
► Session introduction
Henrique Martins, Instituto Universitario De Lisboa, Portugal
► How to make the EHDS successful? An industry perspective
János Vincze, Vendor Co-Chair of IHE Europe
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Without the digital health industry, the EHDS will remain a dream. For industry to get fully engaged, two advances need to occur. Newly available data need to create value for individuals, patients and clinicians. New business models need to emerge as a result of the EHDS Regulation implementation. János therefore outlined the EHDS “in a nutshell”. He explored its 2025-2027 timeline, including the development and application of a set of implementing acts.
In János’s opinion, European success with the EHDS will come through medical innovation; hence, he explored Europe’s strengths and weaknesses as an innovation centre. A set of European projects have already provided a snowball of standards innovation for the European EHR eXchange Format (EEHRxF). Upscaling is certainly needed. However, “simply being standards-based is not enough,” János argued. For example, the steps involved in both the Integrating the Healthcare Enterprise (IHE) methodology and IHE profiles can be useful and were explained in detail. Three example cases were explored: on-demand generation of an EEHRxF-conformant patient summary; jurisdictional shared services; and the value of the “IHE family” on the road to eventual success of the EHDS. There are several key tasks. They include conformance testing; product compliance; and product integration. “If done well, the EHDS is a golden opportunity” to introduce products. Stakeholders and their collaboration are of the utmost importance. Several stakeholder types will benefit from the EHDS: European start-ups and small and medium-sized enterprises can scale up; healthcare providers can become more efficient; and patients can experience the highest standards of healthcare. A major next step on the journey is the June 2025 IHE-connectathon.
► Does research need to get data directly from people?
Norman Sabbah, Telemedicine Technologies, France
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The EHDS provides interesting links between the primary and secondary uses of health data. The right of individuals to have full control to their data will create a paradigm shift for researchers since they may obtain direct access to individuals and ask them for their data. One opportunity lies in assessing the feasibility of using specific research protocols.
Norman started his presentation by exploring six reasons why today the websites of clinical studies and clinical trials are “overwhelmed … hence, recruitment delays occur”. The “patients are out there … but only 0.2% of them are being referred to a study.” The current “solution landscape” involves using both historical databases and promotional efforts. There are downsides to both approaches: a lack of data accuracy, and increased workloads for healthcare professionals. Therefore, how can patient data be used – in a different way – to improve healthcare systems and services? The xShare project is working on at least three business use cases, particularly related to patient pre-screening. What happens when a patient wants to know if he or she has a condition that a possible clinical trial could find compatible? Norman’s example came from France, and was associated with hospitals in three cities: Lyon, Paris, and Rennes. He demonstrated a useful app. As a result of seeing the demo, a patient can learn where s/he could follow the progress of a specific clinical trial, and can sign up to the trial. See the Telemedicine Technologies website for more information.
► Leveraging the EHDS: advancing public health and citizen impact
Nienke Schutte, Sciensano, Belgium
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What is being done now to get more quality data to the health data agencies? What are the priority actions for Member States? Will EHDS deployment provide citizens with the opportunity to participate in adding to public health knowledge and tackling unsolved challenges? This presentation answered these key questions.
Nienke Schutte explored daily life in a public health institute/research organisation – Sciensano in Belgium. She described how a public health agency can mobilise data, when “quality is key”, and what is the "data journey". Article 78 of the EHDS Regulation will emphasise the importance of data quality, through the use of a data quality and utility label. For example, it is crucial to “translate” knowledge about health data so that the public can understand it, and to reach out to both the public and other kinds of stakeholders. In 2021-2022, TEHDAS, an initial joint action, conducted a citizen consultation on their attitudes towards secondary uses of data. Now, relevant rights are laid out in the text of the EHDS Regulation (see Articles 3-10 and 44-50). TEHDAS2, a second joint action, is working on these and future moves forward. Similarly, xShare and QUANTUM. The question remains, however: Are people and the public really ready for the EHDS? Nienke explored at least six ongoing challenges which face them. Ultimately, of course, there are many constructive possibilities. The EHDS can/will have positive impacts on: public health and citizens; the overall “landscape”; use of data; data quality; citizens’ control of their own health data; and the provision of data transparency and other attributes.
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This session’s presentations help to understand the EHDS and the ways it can be implemented from the perspectives of three stakeholder types. The importance of stakeholders and their collaboration was a point of real emphasis throughout. Still, both challenges and opportunities lie ahead, especially for health and care systems, services, and workforces.
