Digitalization in healthcare is so much more than just the ePA

The ePA creates a very necessary basis for the healthcare system. Basic processes and data from care are uniformly structured and merged in the ePA. This is a great opportunity: sphin-X can be used to create the right digital foundation for the numerous processes and procedures in the healthcare sector, so that not only the data from the ePA can be used innovatively to improve patient care.

sphin-X is initially focusing on the creation of a health data space in Germany. Nevertheless, the overarching goal of sphin-X is to create a Europe-wide data space for data exchange in the healthcare sector that is compatible with the European Health Data Space (EHDS) and, with Gaia-X, is based on European standards.

However, the creation of a pan-European data space poses greater challenges than a national data space. In addition to the larger number of stakeholders, the different national data protection laws in particular represent an obstacle to the implementation of a Europe-wide health data space.

For this reason, sphin-X is initially aiming to create a health data space in Germany. In this way, it can be examined whether the implementation of a health data space with many players in the healthcare sector – from pharmaceutical companies to associations and MedTech companies – is possible without having to directly consider the additional legal challenges of other jurisdictions and legal interpretations in a first step.

At sphin-X there are various ways to participate:

1. Active design with financial resources, human resources and material support can be brought into the project as a driver. As part of this category, you are actively involved in the strategic management of sphin-X (note: this category is currently closed).
2. As a supporter, you are part of the inner circle of interested parties. You participate in sphin-X without being a member of the association, but still support the joint implementation of certain use cases
3. As an interested party, you will receive information about the next steps of sphin-X and have the opportunity to join the organization at a later date. We will keep you informed about our activities and look forward to welcoming your contributions and involvement in the future.

If you are interested in becoming part of sphin-X, you are welcome to contact Rabea Knorr, head of the BDI’s industrial health economy department, at r.knorr@bdi.eu or Richard Bildat, the BDI’s industrial health economy project officer, at R.Bildat@bdi.eu.

The IT architecture of sphin-X is built on the basis of those use cases that meet with broad interest among the partners and are ultimately implemented. The requirements for the IT architecture are determined accordingly by these use cases. As various use cases are being discussed and further use cases will be added over time, sphin-X is currently in talks with various partners who could implement the IT architecture. Depending on the use case, different partners may be responsible for setting up the IT architecture. However, sphin-X ensures that each architecture is compatible with the rest of the architecture. To this end, common IT standards are defined to ensure the interoperability of the various IT systems.

A new association is founded to transfer sphin-X as an initiative into a professional framework. This enables the coordination of the sphin-X partners through the clear distribution of roles and responsibilities. In addition, an association offers a defined legal structure to which the cooperation of all partners is oriented.

Data rooms are shared and trustworthy transaction spaces through which data is provided and shared by different groups of actors in a decentralized manner. In contrast to data platforms, no central operator is required for these transaction rooms; instead, the federated system enables every participant with an access point (e.g. IDS connector) to fulfill one or more roles in the data room. A data room can then be defined as the sum of all its participants.

No, the data that is available as part of sphin-X is provided in a decentralized manner by various stakeholder groups. A separate database is not to be set up at the moment.

The Data Connector, a software interface to the data room, is the central element for sharing data while protecting intellectual property rights. It guarantees control over the transmission and use of the data. The data is stored in secure containers that are protected by digital certificates. The Data Connector also enables encrypted communication between data room participants. Standardized interfaces allow different IT systems to be connected with each other. Authentication and authorization are used to control access to the data. Clear identification of data and the ability to manage access rights are also part of the technical implementation.

Gaia-X is a project to build a powerful, competitive, secure and trustworthy data infrastructure for Europe, which is supported by representatives from business, science and administration in Germany and France, together with other, predominantly European partners. The aim is to create data rooms in nine selected sectors (including health) in which large sectoral use cases can be implemented.

sphin-X follows the vision of Gaia-X with the intention of creating a data space in the healthcare sector in Germany in which joint applications can be developed and implemented collaboratively with all the necessary stakeholders.

The focus of sphin-X is on gathering experience in Germany and developing solutions that can serve as the basis for a future Europe-wide health data space. As the healthcare markets in Europe are different and have their own specific characteristics, we are starting with the setup in Germany. At a later date, it is therefore conceivable that sphin-X can and should be used beyond Germany as a European health data space.

Within the EU, there are projects that focus on the collection of (health) data and the creation of interoperability. These include initiatives such as Optimal Treatment for Patients with Solid Tumors in Europe Through Artificial Intelligence (OPTIMA) or the European Health Data Evidence Network (EHDEN). Other projects, such as OSCAR in Denmark, are attempting to make data available in a structured way by setting up a sustainable data platform.