Use Case Health

Secondary Use of Health Data

We are facing a major challenge in healthcare: Every day, huge amounts of health data are generated – for example, through hospital stays, diagnostic imaging, laboratory values, prescription data, digital health diaries, and applications such as fitness trackers or telemedicine solutions. This highly sensitive information is stored in a decentralized manner by a wide variety of actors (hospitals, private practices, laboratories, app operators, health insurance companies) and often remains unused, even though it could greatly advance research, innovation, and public health.

Used sensibly, combined data analyses could, for example, enable the development of new therapies, improve the early detection of diseases, or tailor healthcare services more precisely. However, the reality is often that, for data protection reasons, technical hurdles, and legal uncertainties, data from health apps or wearables in particular do not find their way into clinical and scientific contexts.

This is precisely where the HEALTH-X dataLOFT project comes in with its use case “secondary use of data.” It is embedded as a flagship project in the European Gaia-X initiative and was funded by the German Federal Ministry for Economic Affairs and Climate Protection from 2022 to 2025 as one of eleven funded projects. It pursues the vision of a federated health data space, an infrastructure for the exchange of health data and data-based services, to which various players from the health domain are connected (e.g., hospitals, registered doctors, laboratories, app operators, health insurance companies, etc.) and in which health data can be shared with a high degree of control and security: for research, innovative therapies, and new digital health services. The use of data is always voluntary, controlled, and subject to the highest data protection and security standards.

The solution enabled by HEALTH-X dataLOFT is therefore more than just a technical system—it is a social offering: users can use an app to “donate” their own health data for medical studies or innovation projects in a targeted and informed manner. Processes such as pseudonymization, secure management, and transparency are integrated as standard.

This makes the complex and time-consuming “secondary use” a clearly regulated process that is beneficial for all sides: Researchers and companies gain access to valuable data, while all parties involved can rely on reliable digital and organizational security mechanisms.

A strong network of research, healthcare, business, and technology

The HEALTH-X dataLOFT project brings together the expertise of over a dozen partners from various disciplines: Charité – Universitätsmedizin Berlin heads the consortium, which also includes research institutes such as the Fraunhofer Institute for Software and Systems Engineering ISST and the Fraunhofer Institute for Digital Medicine MEVIS, the Hasso Plattner Institute, OFFIS e.V., Freie Universität Berlin, and TMF – Technology and Method Platform for Networked Medical Research e.V. Companies such as Siemens Healthineers, Bundesdruckerei, and IONOS SE, as well as IT consultancies, eHealth start-ups, and International Data Spaces e.V. are also among the project partners.

The data space is being developed and operated in partnership. Tasks such as technical platform development, the design of user-friendly apps, and the negotiation of rules and governance are being implemented on a collaborative basis. One focus is on connecting to existing telematics infrastructures and European standards in order to ensure future readiness and interoperability.

What is the telematics infrastructure?

The telematics infrastructure is the digital networking platform for the German healthcare system. It connects doctors, hospitals, pharmacies, care facilities, health insurance companies, and other stakeholders via a secure network and enables the protected exchange of health data and documents. The telematics infrastructure is based on binding legal and technical requirements, is centrally coordinated, and ensures that data protection and information security are always guaranteed.

Focus on citizens

A key feature of this use case: it puts citizens first. They decide independently whether or not they want to release their data for research. Data trustees – often independent healthcare providers – guarantee the secure, data protection-compliant transfer of sensitive information.

Data space architecture and functionality for end users – step by step

In line with the principles from Course 2 of the Campus, this use case is also implemented in a modern, decentralized data space. The use of the HEALTH-X dataLOFT data space follows a clearly structured process, using the example of Jane Doe, who regularly collects health data such as heart rate, exercise, and sleep habits via wearables and apps:

1. Information phase:
   Jane Doe uses the dataLOFT app and learns that the “Heart Health in Central Europe” study is specifically looking for data on activity and heart rate. The app provides transparent information about the study’s objectives, procedure, and benefits.

2. Consent management and control:
   Jane Doe can use the app to consent to this specific data being transmitted to the study. She gives her consent knowingly – it can be revoked at any time, ensuring that Maxima retains full control over her data. 

3. Matching and transparency:
   Before any data is transferred, the platform automatically checks whether Jane’s data actually meets the study requirements, e.g., whether there are sufficient data points for heart rate. Only if she is eligible will Jane receive a notification and can then give her informed consent. 

4. Data protection, pseudonymization, and the trustee principle:
   Before data can be used for research or commercial purposes, it undergoes strict anonymization or pseudonymization. The data cannot be linked back to her later on. An independent data trustee is responsible for the administration and technical security of the data.

5. Secure data transfer to research and business:
   The researchers involved in the study project are granted clearly limited, documented access to the pseudonymized data of Jane Doe and other participants. Every “movement” of the data is documented in a traceable manner to ensure transparency.

Benefits for research, business, and society

• How does Jane Doe benefit?

Jane Doe can use the app to find out at any time what personal data of hers is currently being used and for what purpose. After the study is completed, she is informed about the results in a clear and accessible format – e.g., how everyday exercise affects heart health, or whether individual recommendations have been derived. In the best case scenario, Jane Doe and other participants will benefit in the future from prevention services tailored to their needs or advanced digital health services.

• How do researchers and companies benefit?

Researchers gain access to comprehensive, realistic health data. This makes it easier to plan meaningful, large-scale studies and develop new approaches to diagnostics or prevention. Companies, especially innovative start-ups, can develop and test new products, practical services, and analysis solutions on a secure and legally compliant basis.

• How does society benefit?

The secondary use of such data gives the healthcare system and society new impetus for making prevention and therapy more targeted and effective. The availability of high-quality data makes it possible to identify gaps in care more quickly, better assess individual risks, and accelerate medical progress overall.

Summary & Outlook

HEALTH-X dataLOFT finally turns the abstract promise of “secondary use of health data” into everyday reality: the platform enables citizens to make their data available for research and innovation in a secure and traceable manner – voluntarily and transparently. Researchers and companies benefit from easy access to valuable data, while data protection and digital sovereignty are maintained.

The platform itself is open and modular in design. It continuously integrates additional technical modules, partners, and new fields of application—such as prevention studies, AI development, and healthcare research. The results and technologies from HEALTH-X are specifically incorporated into larger initiatives such as the European Health Data Space (EHDA e.V.). In this way, Health-X contributes to promoting and establishing the sovereign, efficient, and secure handling of health data throughout Europe.

If you would like further information or to get involved:

• The official project website provides up-to-date information, use cases, and contact details: health-x.org
• The Gaia-X Hub Germany offers events, networking, and further publications.
• The results and approaches of Health-X dataLOFT flow directly into the European Health Data Space (EHDA e.V.), which also offers networks, working groups, and opportunities for participation for industry, researchers, and the interested public: https://ehda-ev.eu/

Conclusion

The Health-X dataLOFT use case combines digital sovereignty, efficient data protection, and economic innovation in healthcare in a decentralized data space. It creates a model that benefits citizens, research, and business alike – transparent, legally secure, and future-oriented.