Access Health Data Hub (HDH) services for designing and conducting validation studies at €0 — granted in compliance with the EU de-minimis state aid Regulation (EU) 2023/2831.
About the sponsor
The Health Data Hub, created on 30 November 2019, is part of the French node of TEF-Health. It takes over the missions of the French Health Data Institute while expanding them. Its range of services for those seeking access to health data covers:
- A single gateway facilitating access to the necessary health data for projects contributing to public interest, while respecting patients' rights and ensuring transparency towards civil society.
- A documented data catalog, built up progressively to make priority data available to the community (historical SNDS, cohorts, registers, hospital data, etc.).
- A secure, state-of-the-art platform offering data storage, calculation, matching and analysis capabilities, enabling innovative projects sometimes considered impossible today.
- A range of tools to help bring together key actors within the ecosystem.
Context
Under the Digital Europe Programme, the European Commission, in collaboration with several Member States, is co-financing a 5-year project that started in January 2023 under the name Testing and Experimentation Facility for Health AI and Robotics (TEF-Health; Project: 101100700 — TEF-Health — DIGITAL-2022-CLOUD-AI-02).
TEF-Health is coordinated by Charité Universitätsmedizin Berlin, Germany and comprises 52 partners from 9 European Union countries — each forming a so-called Node. The project is co-financed by national funding provided by Belgium, France, Germany, Portugal, Slovakia and Sweden.
TEF-Health establishes a network of testing facilities offering access to physical and digital infrastructure, consulting, data and computational resources, living labs, laboratory testing facilities and real-world testing environments — supporting healthcare innovators in making their solutions compliant with the EU AI Act and other regulations.
Objectives
The objective of this call is to provide access to testing facilities that enable healthcare innovators to validate and scale up their Artificial Intelligence (AI) and robotics solutions in realistic large-scale environments. These facilities aim to bridge the gap between innovation and market deployment by offering a safe, sustainable, and ethically supervised environment for testing new technologies.
Core HDH services available to selected SMEs:
- Simple use case support — including secure processing environment use (without access and/or linkage to the French National Healthcare Data System).
- Complex use case support — including secure processing environment use (with access and/or linkage to the French National Healthcare Data System).
These services include:
- Project launch — assistance in framing the project, particularly in identifying and implementing regulatory procedures; establishment of contacts with relevant stakeholders; support in collaborating with bodies in charge of health data, particularly with regards to contracting and meeting technical prerequisites.
- Institutional actor support — particularly when several data sources are involved and need to be combined or synchronized.
- Data handling — support for data custodians in extracting, structuring, qualifying, documenting, standardizing and/or transferring data involved as part of the project.
- Support to research implementation — provision of technological capabilities (dedicated project spaces with computing resources for 3 years, state-of-the-art data management, analysis and visualization tools, alongside user onboarding and ongoing technical support); expert support (legal, data scientist, engineer, etc.); training and networking.
- Results and project valorization — communication events, networking within the ecosystem, etc.
Additional optional services (also at €0 under de-minimis):
- Protocol review — rigorous evaluation of experimental design, statistical power, reagent specificity and controls to ensure methodological integrity and data reliability, identifying potential biases or flaws before study commencement.
- Protocol writing — comprehensive scientific protocol authorship: experimental design, statistical considerations, methodological steps, robust control measures.
- Analysis — in-depth data analysis expertise, specifically focused on the exploitation of the French National Health Data System (SNDS) and, where applicable, its linkage with other datasets. Deliverables include commented R or Python programs for data processing and a detailed report with descriptive and analytical results, visualizations, conclusions and recommendations — completed within 60 days.
Who can apply
SMEs from European Union (EU) and European Economic Area (EEA) member states may receive discounted services, if the applicable conditions are met (see Eligibility & Evaluation Process).
Timeline
The call stays open until 30 May 2026.
Contact
For questions related to the application process, please use the chatter function in the TEF-Health Platform after registration. For all other questions, contact info@tefhealth.eu.
Eligibility criteria
- SME is legally incorporated and established in one of the EU or EEA member states. The ownership or shares of the SME must not be held by individuals or entities outside the EU/EEA. The fulfilment shall be confirmed through an official declaration issued by the legal representative of the SME.
- Company is an SME according to the EU definition (Commission Recommendation 2003/361/EC). The fulfilment shall be confirmed by an official declaration issued by the legal representative of the SME.
- According to EU Regulation 2023/2831 (de-minimis) of the European Commission, the company must present evidence — in the form of a formal declaration by the legal representative of the SME — that it has not received over €300,000 in state aid support during the previous 3 fiscal years.
- AI and robotics solutions must be at a minimum Technology Readiness Level (TRL) of 5 (self-declared by the SME).
Budget requirements
No financial contribution is required from applicants, as access to Health Data Hub services is provided at a price reduced to €0, granted in compliance with the EU de-minimis state aid Regulation (EU) 2023/2831. Applicants will not receive any direct funding or financial support for the development of their solution.
The budget consists solely of the services selected from the TEF-Health platform. However, applicants must ensure that they have sufficient internal resources and organisational capacity (e.g., staff availability, time allocation, technical readiness). These internal costs remain the responsibility of the applicant.
Application & evaluation process
To apply, fill in the application webform on the TEF-Health Platform https://tef.charite.de. Detailed instructions are available at https://tef.charite.de/docs/call/applicant/.
The application process is divided into three phases:
- Phase 1 — Application to TEF-Health through the current call coordinated by the HDH.
- Phase 2 — Eligibility Assessment (see Eligibility).
- Phase 3 — Selection of eligible projects. Upon closure of the application period, each submitted research proposal is reviewed for eligibility, then by a jury per the Evaluation schema. Members of the jury convene a selection committee to rank eligible projects; the list is submitted to HDH management for final decision.
Evaluation schema
Expert evaluators assess each application using the criteria below:
| Criteria | Weight |
|---|---|
| Expertise of project teams and project maturity | 25 / 100 |
| (1) Clear and feasible timeline for the solution. | |
| (2) Prior experience with health data reuse projects. | |
| (3) Alignment between project team composition and project vision. | |
| Solution | 30 / 100 |
| (4) Novel solution that is innovative and promotes clear advancement beyond the state of the art. | |
| (5) The solution addresses a significant unmet medical need. | |
| (6) Soundness and consistency of the AI or robotics system and core technology used. | |
| Fit to TEF-Health | 20 / 100 |
| (7) The applicant's needs may be supported by the HDH service offerings in the current TEF-Health Service Catalogue. | |
| (8) The solution can increase TRL after implementation of TEF-Health services. | |
| User centricity | 15 / 100 |
| (9) The applicant involves Medical Practitioners and/or Patients in co-design, testing, or feedback activities. | |
| (10) The applicant ensures the solution is accessible and inclusive — age, disability, digital literacy, language. | |
| (11) The applicant demonstrates a plan to measure the impact of the solution on Medical Practitioners and/or Patients' experience or satisfaction using relevant indicators. | |
| (12) Transparency and adherence to AI ethics, in compliance with the AI Act and/or MDR. | |
| Commitment & Resources | 10 / 100 |
| (13) The applicant demonstrates the necessary internal commitment, staffing and resources to fully benefit from Health Data Hub services. |
Each criterion is scored from 1 to 7 (1 — Very Poor, 2 — Poor, 3 — Below expectations, 5 — Above expectations, 6 — Good, 7 — Very Good). Level 4 is not used.
Final score:
Evaluation = Weight(1)·Score(1) + … + Weight(13)·Score(13)
Click any service to view its details on the TEF-Health portal.
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Support for simple use case including secure processing environment use (without access and/or linkage to French National Healthcare Data System) Health Data Hub (Plateforme des Données de Santé)0€
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Support for complex use case including secure processing environment use (with access and/or linkage to French National Healthcare Data System) Health Data Hub (Plateforme des Données de Santé)0€
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[extra] Analysis Health Data Hub (Plateforme des Données de Santé)0€
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[extra] Protocol review Health Data Hub (Plateforme des Données de Santé)0€
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[extra] Protocol writing Health Data Hub (Plateforme des Données de Santé)0€
What is a solution in TEF-Health?
Solutions are digital products or services developed using AI and/or robotic technologies, subject to testing, experimentation and consulting services provided by TEF-Health.
Can SMEs apply for multiple solutions in the same call?
Yes. SMEs may benefit from TEF-Health services for one or multiple solutions. Each solution requires an individual application.
If I am not an EU/EEA-based SME, can I still apply?
No — only SMEs legally incorporated and established in EU/EEA member states are eligible to apply and receive discounts under EU state aid regulations.
Does IP remain with the SME?
The contract between the HDH and the SME is governed by private law and reflects the terms decided between the parties, in compliance with applicable laws and regulations.
How do EU state aid rules apply across member states?
Uniformly. If the SME is registered in a different EU member state from the service provider, the rules still apply.
Where can I find the complete list of HDH services?
All HDH services are discoverable at tefhealth.eu.
What is the required Technology Readiness Level (TRL)?
Your solution must have a minimum entry TRL of 5.