The EU has plenty of digitalised health data, which is not used to its full potential because of legal, interoperability and data quality obstacles. For this reason, the creation of a European Health Data Space has been one of the European Commission’s key priorities for 2019-2025. Such space would further advance digital transformation, optimise and expand the use of health data. Since May 2022 when European Commission published the proposal for a European Health Data Space (EHDS) legislation, the way was cleared for secure use of health data for secondary use - research, innovation, policy-making and regulatory activities. The “MyHealth@EU” infrastructure, already operational in 11 Member States, enables the exchange of e-prescriptions and patient summaries across MS within the EU, becoming the first concrete step into the implementation of the EU Health Data Space.
The above picture portrays the composition of the critical components of the EHDS, including MyHealth@EU and the new infrastructure HealthData@EU to support secondary use of health data.
The HealthData@EU infrastructure will be piloted by a 2-year project facilitating the cross-border use of health data for secondary purposes like research, policy making, regulatory activities and innovation. The HealthData@EU will take full advantage of the eDelivery Building Block services and reference implementations. The European Commission will provide the central services for the pilot project while the end users and health data access bodies' responsibilities will be supported by grants to national authorities. The pilot will design, develop, deploy and operate a network of nodes (representing different data brokers, holders and data consumers) supported by central services that will be provided jointly by the Member States and the European Commission.
How will eDelivery enable the creation of the EHDS? According to the blueprint for the HealthData@EU infrastructure, the HealthData@EU nodes (shown in yellow in the picture below) will use eDelivery AS4 Access Points to ensure interoperability for cross-border data sharing. The data space will also use the eDelivery PKI service to obtain the certificates that will be used by the HealthData@EU nodes to establish trust and ensure security. Information about the participants in the data space – data users and data holders – will be managed in a dynamic manner by publishing it in the (central) eDelivery SML service rather than encoding it on all HealthData@EU nodes. Given the large number of participants expected in the data space, a "dynamic discovery" model has been selected as more scalable. Publication of data about participants in the SML service will be done through an eDelivery SMP server that the European Commission will also operate as part of the planned central services. Once Member State administrators publish metadata about the participants in their Member State, all HealthData@EU nodes will be able to search and retrieve the metadata about the participant they need to contact (e.g., to find the HealthData@EU node through which they can send a request to that participant and the encryption key with which to secure it). As HealthData@EU is one of the first data spaces that will use eDelivery for data sharing, the eDelivery team will be closely involved to provide consultancy for how to best integrate eDelivery in this new context. For the duration of the pilot, the eDelivery team will assist DG SANTE by taking part in the HealthData@EU Advisory Board, formalising the technical assistance at the policy level.
Currently, the pilot covers the creation of infrastructure for secondary use of health data in eight EU Member States. It also assesses the scaling ability towards a Union-wide infrastructure as a core component of the European Health Data Space. Moreover, this pilot brings together key actors, such as existing health data authorities (i. e. national authorities empowered by national mandate and legal basis to enable access to health data) and other international or EU-level organisations (e.g., European research infrastructures, European health related agencies).
Once operational, the HealthData@EU pilot project will bring increased competitive advantage, greater international resilience, impact and visibility making large-scale collaborations possible in the European Union. The potential linkage between health and non-health data will promote timely and real-time assessment using new digital technologies. After the end of 2-year pilot, the EHDS is planned to be scaled up to cover all 27 Member States of the European Union.
The eDelivery Building Block
eDeliveryis a building block that provides technical specifications and standards, installable software and ancillary services to allow projects to create a network of nodes for secure digital data exchange.
Domibusis the sample software provided by the European Commission to implement an eDelivery AS4 Access Point for the interoperable, secure and reliable exchange of data. It is based on theeDelivery AS4 profile, an open technical specification for the secure, web-based, payload-agnostic exchange of data or documents.
DomiSMPis the sample software provided by the European Commission to implement an eDelivery Service Metadata Publisher for publishing and retrieving data necessary for an eDelivery party to dynamically configure its system for message exchange with counterparties using eDelivery. It is based on theeDelivery SMP profile, an open technical specification for publishing service metadata within a 4-corner network.
DomiSML is the sample software provided by the European Commission to implement an eDelivery Service Metadata Locator for an eDelivery party to discover the URLs of other counterparties using eDelivery Access Points and their corresponding metadata. It is based on theeDelivery BDXL profile, an open technical specification for locating Access Points within a network, and on thePEPPOL SML Specification, a technical specification defining a BDXL administration API.
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Photo by National Cancer Institute on Unsplash
