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Session 7 | Creating interoperability at source: Interoperability governance in a multi-centre data-sharing context

Various levels of interoperability are involved in creating a lively and productive data ecosystem, there. Of all the different interoperability layers, semantic interoperability is probably the most challenging. Complexity occurs particularly when data comes from a variety of sources. This session explored what happens when background data comes from, and is shared among, a variety of sources. First, it looked at data – involved with medicinal products – which is fundamental to the emergence of a truly open European Health Data Space Second, it looked at patient summaries. It examined what kind of global collaboration is needed in these – and other – circumstances. Although roles and responsibilities differ, both of these two use case examples rely on having a highly integrated and cooperative ecosystem.

The session started with a presentation by Robert Vander Stichele of the UNICOM project. Dr Vander Stichele’s focus was on medical product identification and international classifications. Prescribing is a very important part of medical activity. Hence, information about medicinal products represents a very significant part of all healthcare transactions. This information is also critical for patient safety. As soon as this information crosses borders (when travellers become patients, or patients become travellers) problems arise with interoperability. Creating interoperability at the source for medicinal products, and establishing a global governance process, is a difficult but necessary task. A solution will bring immediate functional results, such as cross-border prescribing, but also far-reaching changes in the global health ecosystem. It holds the promise to create bridges between all health care actors and make a major contribution to patient safety, efficient research, personalised medicine, decision support, and administrative simplification. In the end, ePrescribing will be a cornerstone of the European Health Data Space. Sadly however, a global identifier for medical products has yet to come into being!


Robert Stegwee from CEN/TC251 was the second speaker in this session. CEN/TC251 is a decision-making CEN working group that focuses on the standardisation of eHealth/digital health in the European Union. With the European Health Data Space, the patient summary is the most important item for the travelling (cross-border) patient. Typically, a  Patient Summary is a health record extract. It is made up of fragments of a patient’s electronic health record  – these fragments are often scattered across multiple healthcare providers or systems. Making sense of these fragments at a regional, national, or global level(s) requires a number of approaches. They include the combination, de-duplication, and sometimes location of equivalent coding systems that suit the needs of the clinicians who want to look at the summary in order to provide safe and effective care. Having reliably coded source data is therefore a prerequisite for creating a meaningful and useful patient summary. Developing and implementing global standards  needs global collaboration to make the data work to people’s advantage. A variety of examples of patient summaries were shown from e.g., Canada and the Netherlands. The example of the International Patient Summary shows how international collaboration is developing in many different venues and with multiple layers.

This session was moderated by Catherine Chronaki, HL7, Belgium. It took place with the support of the UNICOM project.

🗣️ Discussion: The three invited panellists hinted that international developments are currently considerably to the fore. Work is still needed, however, said Malin Fladvad from the WHO Uppsala office in Sweden, on activities such as: a common terminology, translation, and language(s). Zoltan Lantos from Hungary announced that a  new coordination and support action project, called PATHed, is due to start in January 2023. It is anticipated that this new project will particularly help with terminology mapping (see this session’s ePoll)  Charlie McKay of ISO/CEN emphasised the need for trustworthiness in both software and apps. He argued the need to work on, and grasp, low-hanging use cases – he suggested the example of diabetes. To sum up, Catherine Chronaki stressed the need to work on do-able, manageable activities with patients still at the centre.

✅ ePoll: An ePoll undertaken with the Symposium attendees showed that their biggest perceived challenge in this field is terminology mapping. Roughly one-third of the people present at the Symposium who answered a second online poll believed that global governance of medicinal products will materialise within the next 3-5 years’ time.



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