6.G. Workshop: The European Health Data Space 2: is Europe ready to maximise the re-use of health data?

Abstract   The EU's Heads of State called in October 2020 to set up a European Health Data Space (EHDS): “The European Council welcomes the creation of common European data spaces in strategic sectors, and in particular invites the Commission to give priority to the health data space”. As a response, multiple initiatives were set-up to engage the views and expectations from EU member states in the development of the upcoming legislative proposal on the EHDS for primary (EHDS1) and secondary use of health data (EHDS2). One of these was the launch of the Joint Action (JA) Towards the European Health Data Space (TEHDAS) in February 2021. The aim of TEHDAS is to support the European Commission (EC) and Member States (MS), identifying the challenges and providing concepts and options for the EHDS2. It is built on the needs and expectations of national and international stakeholders, citizens’ engagement and existing infrastructure. The major expected outcome of this JA is a sustainable roadmap towards the EHDS2 implementation promoting the cross-border sharing of health data for secondary use. The EHDS2 will benefit population health by facilitating the timely exchange of and access to health data, improving not only the care of patients but also facilitating research, epidemiology, disease prevention and data-based policy decisions. This workshop aims to provide an overview of the preparedness of MS to join the EHDS for secondary use of health data, covering current state-of-play of health data management systems in the EU, barriers on the secondary use of health data, the ongoing work on the development and deployment of the EHDS2 infrastructure and finally, how population health research can benefit from the EHDS2. The workshop will begin with a short introduction on the TEHDAS JA, followed by a presentation on the outcomes of the TEHDAS country visits. In these country visits, the state-of-play of the health data management system and the preparedness to join the EHDS2 were mapped in 12 different EU MS. The next presentation will continue with the results from a study that collected more evidence on the barriers to cross-border sharing of health data for secondary use and options on how to overcome these. It will focus on the legal preparedness and barriers and will discuss how the options proposed by experts in the field align with the legislative proposal for the EHDS2. The audience will be able to give their opinion on the different options through an interactive voting poll during the session. Some of the options on how to overcome technical barriers will be taken further in the development of a pilot infrastructure for the EHDS2. Therefore, the last two presentations will focus on the development and deployment of this pilot infrastructure for the EHDS2 and the role and benefits that population health research will have in it. Throughout the workshop there will be discussion sessions between presentations to allow exchange of knowledge, experiences and opinions with the audience. Key messages • The main outputs will support EU countries to prepare their health data management system for the EHDS2 based on the best practices and actions presented. • The presentations will inform and align participants on the current work on the technical EHDS infrastructure that is being developed for secondary use of health data, the EHDS2.

Semantic interoperability allows machines to share, interpret and use data without ambiguity. Semantic Interoperability is a major concern in healthcare (c.f. the EU commission 2021 report on electronic record exchange formats). The lack of interoperability with regard to electronic health record (EHR) leads to fragmentation and a lower quality of cross-institution and cross-border healthcare. The simple choice of an interchange language (HL7, FIHR etc.)is not sufficient to ensure interoperability. Healthcare interoperability is associated with multi-level and multi-sectoral complexity, and this cannot be addressed without consideration of a range of people and needs, from application design to knowledge sharing. Each transaction needs to be defined in unambiguous details as part of a complete, consistent, coherent, and machine-readable set of specifications for interoperability between the machines to minimize any potential error. We propose a systematic process to achieve healthcare interoperability, working with healthcare professionals starting from design level to implementation level. In our seminar we will explain with examples how ontology can be used to achieve semantic interoperability in healthcare. Technical requirements, including the choice of tools (e.g. Protégé); data base (e.g. GraphDB); data model (i.e. Web Ontology Language 2 (OWL2); formal specification (i.e. Description logics (DL)); and the right syntax (RDF/XML). Will be introduced.
Abstract citation ID: ckac129.364 Terminologies matter -the case of ICNP and SNOMED-CT

Anthony Staines
A Staines 1 , P Hussey 1 , S Das 1 1 Centre for eIntegrated Care, Dublin City University, Dublin, Ireland Contact: anthony.staines@dcu.ie Terminologies can seem very abstract to end-users. While most health professionals will be familiar with some terminologies (for example MeSH (Medical Subject Headings), the controlled vocabulary thesaurus used for indexing articles for PubMed or ICD-10, WHO's terminology for disease coding), fewer will be aware of the depth and range of terminologies used in healthcare, nor of the central importance of multilingual standard terminologies in health care interoperability. Following a brief introduction to the use of terminologies, the integration of the International Classification for Nursing Practice (ICNP) the Systematized Nomenclature of Medicine -Clinical Terms (SNOMED CT) will be presented, as an example of the use of terminologies, and their ongoing curation, maintenance and development.
6.G. Workshop: The European Health Data Space 2: is Europe ready to maximise the re-use of health data?
Abstract citation ID: ckac129.365 The EU's Heads of State called in October 2020 to set up a European Health Data Space (EHDS): ''The European Council welcomes the creation of common European data spaces in strategic sectors, and in particular invites the Commission to give priority to the health data space''. As a response, multiple initiatives were set-up to engage the views and expectations from EU member states in the development of the upcoming legislative proposal on the EHDS for primary (EHDS1) and secondary use of health data (EHDS2). One of these was the launch of the Joint Action (JA) Towards the European Health Data Space (TEHDAS) in February 2021. The aim of TEHDAS is to support the European Commission (EC) and Member States (MS), identifying the challenges and providing concepts and options for the EHDS2. It is built on the needs and expectations of national and international stakeholders, citizens' engagement and existing infrastructure. The major expected outcome of this JA is a sustainable roadmap towards the EHDS2 implementation promoting the cross-border sharing of health data for secondary use. The EHDS2 will benefit population health by facilitating the timely exchange of and access to health data, improving not only the care of patients but also facilitating research, epidemiology, disease prevention and data-based policy decisions. This workshop aims to provide an overview of the preparedness of MS to join the EHDS for secondary use of health data, covering current state-of-play of health data management systems in the EU, barriers on the secondary use of health data, the ongoing work on the development and deployment of the EHDS2 infrastructure and finally, how population health research can benefit from the EHDS2. The workshop will begin with a short introduction on the TEHDAS JA, followed by a presentation on the outcomes of the TEHDAS country visits. In these country visits, the state-of-play of the health data management system and the preparedness to join the EHDS2 were mapped in 12 different EU MS. The next presentation will continue with the results from a study that collected more evidence on the barriers to cross-border sharing of health data for secondary use and options on how to overcome these. It will focus on the legal preparedness and barriers and will discuss how the options proposed by experts in the field align with the legislative proposal for the EHDS2. The audience will be able to give their opinion on the different options through an interactive voting poll during the session. Some of the options on how to overcome technical barriers will be taken further in the development of a pilot infrastructure for the EHDS2. Therefore, the last two presentations will focus on the development and deployment of this pilot infrastructure for the EHDS2 and the role and benefits that population health research will have in it. Throughout the workshop there will be discussion sessions between presentations to allow exchange of knowledge, experiences and opinions with the audience.

Key messages:
The main outputs will support EU countries to prepare their health data management system for the EHDS2 based on the best practices and actions presented. The presentations will inform and align participants on the current work on the technical EHDS infrastructure that is being developed for secondary use of health data, the EHDS2. Germany. The aim of the country visits is to map the stateof-play of health data management in different countries and explore their preparedness to join the EHDS. The topics explored include: the health data sources available, the health data infrastructure (storage, access and interoperability), data quality assurance mechanisms, data governance, as well as resource and training needs and opportunities. Another aim of the country visits is to explore needs and expectations at national level, and how the EHDS can respond to them. This presentation will include an overview of the health data management systems of the 12 countries mapped, providing a snapshot of the situation across Europe. It will then present the findings on their preparedness to join the EHDS. Preparedness takes into account a variety of factors, including political will, as well as legal and technical factors. The presentation will further share the lessons learnt and best practices highlighted from the country visits. Finally, based on these findings, the presentation will close with an overarching view on the preparedness across Europe to deploy the EHDS for the secondary use of health data, EHDS2, as well as planned actions that would facilitate the implementation of the EHDS2 in different member states.
Abstract citation ID: ckac129.367 Barriers on cross-border sharing of health data for secondary use and options to overcome these Rosie Richards Cross-border health data sharing is essential to facilitate vital health research into new treatments and to improve patient care and safety across Europe. The flagship European Health Data Space (EHDS) aims to promote better exchange and access to health data through the creation of a European-wide infrastructure. However, significant barriers to cross-border data sharing must first be resolved in order to fully ensure the successful functioning of the Data Space. To this end, the European Commission established a Joint Action (TEHDAS), as the policy development tool for the development of the EHDS. This presentation will be based around the findings of the recent TEHDAS report 'Barriers to cross-border sharing of health data for secondary use and options to overcome them.' The report draws on the results of a dedicated literature review, 133 case studies from across 23 countries and expert interviews to identify the primary barriers to cross-border data sharing and options to overcome these from the perspective of European data users (research and policymakers). The session will start with a concise presentation of the report methodology. The research team will then deliver an interactive presentation, in which they succinctly outline each barrier and policy option and ask participants to vote for their preferred policy option to overcome each barrier identified. EUPHA participants votes will inform the final TEHDAS recommendations on mitigations and solutions for barriers to cross-border data sharing which will be submitted to the European Commission for incorporation in the European Health Data Space legislative proposal. The EHDS2 Pilot consortium brings together 16 European partners (national platforms, research infrastructures, EU agencies and associations in the area of health) to respond to the EC's call for projects to set up a test version of the future European Health Data Space (EHDS) for the secondary use of health data (EHDS2). It aims to build this pilot version of EHDS2 by interconnecting data platforms in a network of nodes, implementing and testing a first user journey for creating, deploying and running health data research projects at EU level. The network will investigate the technical tools and set up the standards allowing researchers to query the metadata of all nodes, to request selected data via a single application form and to analyze data across national nodes. To build this network, the EHDS2 Pilot will propose legal and technical frameworks based on use cases selected by the EC. These will also serve to illustrate the powerful impact of exploiting health data from several countries and address topics from population health to healthcare pathways, cancer, rare diseases and genomics. This presentation will give an overview of the planned activities by the coordinating team.