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Session 3 | Using and re-using real-world data: Options for interoperability

The Electronic Health Records (EHR) market is far from being ready to allow the re-use of patients’ data for purposes other than care (i.e. the “only once” strategy). Chapter 3 of the European Commission proposal for the European Health Data Space lays out the legal foundations for electronic health records to comply with the future European Electronic Health Record Exchange Format (EEHRxF) standards.

This session reported on the state-of-play with national and regional electronic health records systems, and explored what it takes for various digital health building blocks to comply with legal provisions. It reflected on the governance to be put in place to enforce the implementation of standards as well as expand them to additional use cases. Some aspects of the session looked at the market side of things.

In the session, there were three speakers from the Netherlands, Estonia, and international organisation, IHE Europe.

The first speaker was Gaby Wildenbos, NICTIZ, Netherlands. She indicated the next steps in implementing the EEHRxF. She drew on the perspective, experience, and current policies and regulations of the Netherlands, including future opportunities relating to the exchange format in the Dutch situation. Key challenges, such as a decentralised infrastructures, formed the focus of her presentation.

Terje Peetso, North-Estonia Medical Center, Estonia described how her medical centre is preparing for the procurement of a new, up-to-date electronic health record. She shared what can be learned from the hospital’s own experience, what can be learned from others’ experiences, how to work together to bring health data management into 21st century, and how to overcome the main obstacles. One of the centre’s main challenges is budgetary. Ms Peetso also related the centre’s strategy to Estonia’s exploration of the use of genomic data (see e.g., the 2021 insights from Lili Milani of Estonia’s Genome Centre on progress made in Estonia on genomic data).

The third speaker, Alexander Berler, IHE Europe presented several aspects of testing and certification. He discussed the current existing testing governance and tools for MyHealth@EU, and proposed some ideas on how to move forward from testing to certification. He emphasised the need for an open testing strategy and ecosystem. This approach is considered to facilitate the adoption of the EEHRxF specification into existing products and solutions. It will also enable the necessary ISO 17025 process to allow certification of EHRs across Europe in the context of the upcoming regulation on the European Health Data Space. Mr Berler presented a range of examples and best practices.


The session was moderated by Janne Rasmussen, MedCom, Denmark, and took place both with the support of MedCom, Denmark and the X-eHealth project.

🗣️ Discussion: With regard to the differences between European Member States, audience members were keen to discuss a number of approaches. First, they assessed which countries have actual experience with the compulsory certification of electronic health records (example countries include Belgium, Finland, France, Germany,  the Netherlands, and Spain). Second, they explored what types of good advice could be suggested to countries on how to shift from one stage of electronic health records implementation to another. Third, they were also interested in how countries go about obtaining health data from a diversity of sources e.g., from fields as varied as health, welfare, and sport. Fourth, the so-called “ownership” of healthcare data was also of interest to the audience.



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