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Strategic Analysis
TRL 6 → 8
Based on programme defaults
Implement a scalable cloud-based AI/GenAI system running European trustworthy and safe AI/GenAI algorithms that were developed, trained and validated using very large sets of patient data.
Put in place a secure, privacy-preserving cloud environment required for the health data analysis tasks, with appropriate access and identification tools for authorised use only, and implement the whole system seamlessly integrated in regular clinical workflows of the care settings involved.
Address interoperability and the need to communicate with the health IT infrastructure (e.g. the electronic health record (EHR) of the patient, Picture archiving and communication systems (PACS), Radiological Information Systems (RIS), etc.).
Demonstrate the integration and large-scale validation of cloud-based AI/GenAI systems, following a thorough assessment and testing over a large number of patient test cases in real healthcare settings.
Choose the types of health data, the AI/GenAI algorithms that are trustworthy and secure, and the medical use cases, with the focus disease areas being cancer and cardiovascular.
Perform technical and clinical validation of the systems, generating evidence on AI systems’ performance and usability in different clinical settings.
Use the AI systems for screening in clinical settings, perform local performance evaluation and post-deployment monitoring of the solutions, including evidence generation on cost-efficiency in view of regulatory requirements and health technology assessment (HTA).
Whenever relevant, deploy AI/GenAI solutions already tested and validated within the TEF for Health.
One or more proofs-of-concept of replicable, scalable cloud-based AI/GenAI systems for analysis of medical imaging data in a healthcare setting, with demonstration of the role of the clinicians in validating AI/GenAI findings and reports showcasing seamless integration of the system into clinical workflows.
Evidence-based analysis of (cost-)efficiency of the piloted solutions for healthcare systems for regulatory and HTA purposes.
Two or more events or workshops organised per year and per project for the European network of AI-powered advanced screening centres. The agenda should include lessons learned from the project activities, as well as other items relevant to the network. Participant satisfaction rates should be measured for the events and workshops.
Medical centres in the consortium joined the European network of AI-powered advanced screening centres under the Apply AI Strategy.
A plan for obtaining regulatory approval for application of the AI/GenAI solutions in real life scenarios and clinical settings. This includes the required risk management and compliance activities, as well as clinical evaluation plans and post-market clinical follow-up.
Detailed data protection and cybersecurity plan, with measures to secure sensitive health data, mitigate cybersecurity risks, and comply with EU legal and ethical frameworks.
Sustainability plan for the uptake of the systems across the EU.
Stakeholder engagement and dissemination report with measurable actions (KPIs).
No expected impacts identified for this destination.
DEP Regulation 2021/964
highApply AI Strategy
highEU Financial Regulation 2024/2509
medium1. Admissibility conditions — Proposal page limit and layout described in section 5 of the call document . Proposal page limits and layout: described in Part B of the Application Form available in the Submission System.
2. Eligible Countries — described in section 6 of the call document .
3. Other Eligibility Conditions — described in section 6 of the call document .
4. Financial and operational capacity and exclusion — described in section 7 of the call document . 5a. Evaluation and award: Submission and evaluation processes described section 8 of the call document and the Online Manual . 5b. Evaluation and award: Award criteria, scoring and thresholds described in section 9 of the call document .
5c. Evaluation and award: Indicative timeline for evaluation and grant agreement — described in section 4 of the call document .
6. Legal and financial set-up of the grants — described in section 10 of the call document . Call document and annexes: Call document Application form templates Standard application form (DEP) — the application form specific to this call is available in the Submission System Ownership control declaration Model Grant Agreements (MGA) DEP MGA
DEP Work Programmes DEP Regulation 2021/964 EU Financial Regulation 2024/2509 Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment EU Grants AGA — Annotated Model Grant Agreement Funding & Tenders Portal Online Manual Funding & Tenders Portal Terms and Conditions Funding & Tenders Portal Privacy Statement
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| Requirement | Covered by | Carried | Status |
|---|---|---|---|
| Scope activities | |||
| SC1Implement a scalable cloud-based AI/GenAI system running European trustworthy and safe AI/GenAI algorithms that were developed, trained and validated using very large sets of patient data. | · | · | Sign up to track |
| SC2Put in place a secure, privacy-preserving cloud environment required for the health data analysis tasks, with appropriate access and identification tools for authorised use only, and implement the whole system seamlessly integrated in regular clinical workflows of the care settings involved. | · | · | Sign up to track |
| SC3Address interoperability and the need to communicate with the health IT infrastructure (e.g. the electronic health record (EHR) of the patient, Picture archiving and communication systems (PACS), Radiological Information Systems (RIS), etc.). | · | · | Sign up to track |
| SC4Demonstrate the integration and large-scale validation of cloud-based AI/GenAI systems, following a thorough assessment and testing over a large number of patient test cases in real healthcare settings. | · | · | Sign up to track |
| SC5Choose the types of health data, the AI/GenAI algorithms that are trustworthy and secure, and the medical use cases, with the focus disease areas being cancer and cardiovascular. | · | · | Sign up to track |
| SC6Perform technical and clinical validation of the systems, generating evidence on AI systems’ performance and usability in different clinical settings. | · | · | Sign up to track |
| SC7Use the AI systems for screening in clinical settings, perform local performance evaluation and post-deployment monitoring of the solutions, including evidence generation on cost-efficiency in view of regulatory requirements and health technology assessment (HTA). | · | · | Sign up to track |
| SC8Whenever relevant, deploy AI/GenAI solutions already tested and validated within the TEF for Health. | · | · | Sign up to track |
| Expected outcomes | |||
| EO1One or more proofs-of-concept of replicable, scalable cloud-based AI/GenAI systems for analysis of medical imaging data in a healthcare setting, with demonstration of the role of the clinicians in validating AI/GenAI findings and reports showcasing seamless integration of the system into clinical workflows. | · | · | Sign up to track |
| EO2Evidence-based analysis of (cost-)efficiency of the piloted solutions for healthcare systems for regulatory and HTA purposes. | · | · | Sign up to track |
| EO3Two or more events or workshops organised per year and per project for the European network of AI-powered advanced screening centres. The agenda should include lessons learned from the project activities, as well as other items relevant to the network. Participant satisfaction rates should be measured for the events and workshops. | · | · | Sign up to track |
| EO4Medical centres in the consortium joined the European network of AI-powered advanced screening centres under the Apply AI Strategy. | · | · | Sign up to track |
| EO5A plan for obtaining regulatory approval for application of the AI/GenAI solutions in real life scenarios and clinical settings. This includes the required risk management and compliance activities, as well as clinical evaluation plans and post-market clinical follow-up. | · | · | Sign up to track |
| EO6Detailed data protection and cybersecurity plan, with measures to secure sensitive health data, mitigate cybersecurity risks, and comply with EU legal and ethical frameworks. | · | · | Sign up to track |
| EO7Sustainability plan for the uptake of the systems across the EU. | · | · | Sign up to track |
| EO8Stakeholder engagement and dissemination report with measurable actions (KPIs). | · | · | Sign up to track |
| Other requirements | |||
| No other requirements in this call. | |||
| Expected impacts | |||
| No expected impacts in this call. | |||
| Underlying policies | |||
| POL1DEP Regulation 2021/964The Digital Europe Programme (DEP) Regulation underpins the call, emphasizing the deployment of AI in public sector services, including healthcare. It supports the development of secure, interoperable, and trustworthy digital solutions. | · | · | Sign up to track |
| POL2Apply AI StrategyThe Apply AI Strategy is central to this call, focusing on the deployment of AI in healthcare to improve screening, diagnosis, and patient outcomes. It emphasizes the creation of a European network of AI-powered screening centres. | · | · | Sign up to track |
The binding rules of this call. Items marked auto are verified by GrantForge from the call and the template. The others are yours to confirm.
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