New Toolbox Launched to Support Trustworthy AI in Diagnostics

The Clinical AI Pathway Toolbox is now available as a free, open-access resource designed to support both healthcare professionals and companies working on AI-based diagnostic tools.  

Developed by the CAIDX project and co-financed by the European Regional Development Fund through the Interreg Baltic Sea Region Programme, the toolbox guides users from early-stage innovation to real-world clinical implementation. 

Figure 1: The Clinical AI Pathway Toolbox is available at clinicalai.eu.

Why This Toolbox Matters

AI in diagnostics holds great promise — but many solutions fall short when it comes to real-world clinical use. Industry players don’t always understand the specific needs and workflows of hospitals or users. Meanwhile, healthcare providers often lack the expertise or capacity to evaluate, procure, and implement complex AI tools.

The Clinical AI Pathway Toolbox helps bridge this gap by guiding hospitals and companies through joint development, ensuring that solutions are not only technically sound but also clinically relevant, compatible with existing IT systems, and usable by staff. It supports decision-makers in navigating legal and regulatory approvals, clinical validation, healthcare system integration — all major hurdles in AI deployment.

Tested Through Real-World Pilots

To ensure its relevance, the toolbox was piloted with those who matter most: professionals developing or working with AI in healthcare. CAIDX conducted three pilot programmes using a total of 16 real-world use-cases from across all six partner countries: Denmark, Estonia, Finland, Germany, Poland, and Sweden.

These pilots covered the full lifecycle — from initiation and development to implementation — and included both certified and non-certified AI products in clinical and imaging contexts. Solutions were developed by hospitals, companies, or in public-private partnerships. The feedback gathered ensures that the toolbox responds to real challenges and real workflows.

Mads Lause Mogensen, Chief Executive Officer at Treat Systems, who piloted the Clinical AI Pathway Guide, commented:

“AI presents immense opportunities in a clinical setting, but it also comes with complex requirements. The (Clinical AI Pathway) guide helps us navigate both technical and regulatory aspects, enabling us to develop solutions that are innovative, secure, and compliant with current legislation. It creates a shared understanding across disciplines and ensures a structured approach from idea to implementation within the public-private innovation collaboration.”

Support For Healthcare Professionals, Companies and Developers

Built with and for healthcare professionals, the toolbox offers clinicians and researchers a structured, practical framework to develop trustworthy diagnostic AI. For AI startups, MedTech firms, and other digital health companies, the toolbox helps bridge innovation with the realities of clinical practice, regulation, and deployment. The toolbox includes:

• Clinical AI Pathway Guide: a practical and structured guide designed to support healthcare professionals, researchers, and companies in the development and implementation of AI solutions. It offers a clear, stage-based framework to help healthcare teams move from early ideas to real-world clinical use.
• Secure Data: a supportive text document for raising awareness on cyber and data security, minimizing the risk of data breaches and reducing the risk of harm for patients and healthcare systems.
• Project Initiation Tools: three tools that support early innovation by identifying clinical needs, choosing project paths, and setting up agreements for public-private collaborations. The tools provide guidance for need analysis, project strategies, and agreement considerations, offering structured steps for AI development and co-development projects.
• Implementation and Change Management Guide: the guide supports healthcare leaders and project teams in navigating the human and organisational challenges of AI adoption in healthcare to ensure successful, sustainable outcomes.
• Additional resources: documents produced by the CAIDX project as well as a curated list of external resources that has been assembled during the development phase of the CAIDX project, complementing the Clinical AI Pathway Guide.

“AI in healthcare requires that legal considerations are integrated from the beginning. The (Clinical AI Pathway) guide makes it easy to identify relevant requirements and creates a common language between developers, clinicians, and legal professionals.”

Nicklas Krag Halvorsen, Lawyer. Contracts Unit, Aalborg University Hospital 

The toolbox is free to use, requires no registration, and the site collects no personal data. It’s part of CAIDX’s mission to foster responsible, secure, and relevant AI innovation in healthcare.

Bringing the Toolbox to You: Roadshow Events Across the Baltic Sea Region

To ensure broad awareness and real-world adoption, the Clinical AI Pathway Toolbox is being promoted through a series of Roadshow events across the CAIDX partner countries. These events — including conferences, workshops, seminars, and exhibitions — provide hands-on introductions to the toolbox and foster dialogue between healthcare professionals, researchers, developers, and innovation enablers. Organised by the CAIDX partners in Denmark, Estonia, Finland, Germany, Poland, and Sweden, the Roadshow aims to support local implementation and strengthen regional cooperation around responsible, clinically meaningful AI.

Figure 2: Showcasing the Clinical AI Pathway Toolbox at Vitalis 2025.

Follow us on LinkedIn and visit the CAIDX project website to find a roadshow event near you.

👉 Explore the toolbox at clinicalai.eu

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The Clinical AI Pathway Toolbox was developed by the CAIDX project and co-financed by the European Regional Development Fund through the Interreg Baltic Sea Region Programme. The CAIDX project partners include hospitals and medical centres: Aalborg University Hospital, The Innovation Clinic, The North Denmark Region, (lead partner, Denmark), Aarhus University Hospital, AUH Innovation and International Affairs, Central Denmark Region (Denmark), Rostock University Medical Centre (Germany), The Wellbeing Services County of Southwest Finland, Turku University Hospital (Finland), Lower Silesian Centre of Oncology, Pulmonology and Hematology, Research and Innovation Department (Poland), Region Skåne, Skane University Care (Sweden), business support organisations: Danish Life Science Cluster (Denmark), BioCon Valley® GmbH (Germany), Tartu BT Park OÜ (Estonia), Business Turku (Finland), Wroclaw Technology Park, Quality and Research Projects (Poland), Innovation Skåne, Health (Sweden), and a university: Faculty of Computer Science and Electrical Engineering – Business Information Systems, University of Rostock (Germany).

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Video: Introduction to the Clinical AI Pathway Toolbox

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