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TEF-Health Workshop: "European Gateway for Trusted AI in Digital Health: Orchestrating Innovation from Data to Deployment" @ ADRA Forum

Porto, Portugal

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How can Europe turn its AI, robotics and health-data investments into certified, trusted healthcare products that actually reach patients?

This workshop will demonstrate how coordinated national ecosystems, fully embedded in European initiatives, can act as trusted gateways for researchers and SMEs, connecting them with the right expertise, infrastructures and cross-border partnerships according to their technological maturity, validation needs and regulatory objectives.

Using the Portuguese ecosystem as an example of this orchestration model, using the Portuguese innovation ecosystem as a case study, this workshop will demonstrate how coordinated support mechanisms—including EDIH (DigiHealthPT), Testing and Experimentation Facilities (TEF-Health), AI Factories, Regulatory Sandbox, research centres (INESC TEC, IPN) and innovation agencies—can accelerate the journey from research prototype to validated, regulatory-compliant medical technology.

The session will focus on three friction points where the "lab-to-deployment" journey most often breaks: (i) access to high-quality, legally usable health data and privacy-preserving methods to work with it; (ii) validation and benchmarking of AI-enabled medical devices under MDR and the AI Act; and (iii) cross-border clinical validation through European networks. Moreover, it will also highlight how the European Health Data Space (EHDS) and AI Act create new opportunities while simultaneously requiring better data governance, validation methodologies and regulatory readiness from the earliest stages of development. Through practical case studies, participants will explore how data quality, regulatory planning and validation strategies should be integrated from the beginning of innovation projects to accelerate deployment while ensuring safety, trust and compliance.

Agenda

Setting the scene: Why Europe needs integrated innovation pathways
Why Europe invested in AI Factories, EDIHs, TEFs, Regulatory Sandboxes and EHDS—and why SMEs still need integrated guidance to navigate them.
Trusted health data pipelines: from privacy-preserving research to EHDS-ready deployment
  • The bottleneck: 80% of the effort in health AI projects is data readiness, governance and legal usability, not modelling.
  • Privacy-preserving analytics, federated learning, synthetic data, and secure processing environments as building blocks for EHDS-compliant AI
  • What an SME should ask for from day one when partnering with an RTO
Validation and regulatory pathways for AI Medical Devices: TEFs, AI Act and MDR

-How the Portuguese ecosystem co-designs tailored innovation pathways, connecting SMEs with the right infrastructures, expertise and European networks according to their maturity and objectives.

-Validation strategies for AI Medical Devices, regulatory planning from day one, AI Act, MDR, TEF-Health services and access to European clinical validation infrastructures.
Interactive roundtable: Opportunities and remaining barriers
Moderated discussion with panel + audience: what still blocks deployment?
Key takeaways and recommendations
Recommendations for strengthening European innovation ecosystems and improving SME access to integrated support.