SaudeAI.PT
National AI for Healthcare Initiative
Portugal: A Digital Nation in Healthcare.
A national initiative ensuring the responsible, ethical and transparent adoption of Artificial Intelligence across the Portuguese health system — aligned with the EU AI Act, the Medical Devices Regulations (MDR/IVDR) and the European Health Data Space.
A national response to AI transforming healthcare
Artificial Intelligence is no longer a future promise — it is already reshaping how medicine is practised, how decisions are made and how health systems operate.
Portugal cannot be passive during this revolution. SaudeAI ensures responsible, ethical adoption with the full participation of the clinical, regulatory and technological communities.
Portugal is committed to becoming a European reference in the responsible adoption of Artificial Intelligence in healthcare.
National Capacity and AI Literacy
Education and training for health professionals, researchers, regulators and policymakers.
Regulatory Framework for Innovation
Infrastructure aligned with the EU AI Act, the Medical Devices Regulations (MDR/IVDR) and the European Health Data Space (EHDS).
Responsible Innovation & Regulatory Science
National Regulatory Sandbox for testing and validation in real clinical environments.
European Digital Health Hub
Actively contribute to the European AI in health agenda and position Portugal as a reference.
Empowering those who decide, treat and regulate
A structured learning programme for health professionals, regulators and technologists — combining scientific rigour, clinical applicability and regulatory compliance.
AI Literacy Crash Course for Health Professionals
Practical introduction requiring no technical background. Covers what AI is, clinical applications and methods for critical evaluation.
Coming Soon
- AI regulation
- Clinical data governance
- Ethics in algorithmic decision-making
- AI implementation in hospital settings
REGULATORY SANDBOXPortugal AI in Health Sandbox
A controlled environment to test and validate high-impact AI systems in healthcare with legal certainty and regulatory oversight.
Strategic Focus Areas
High-risk, high social-value sectors:
Next-Generation Diagnostics
AI-powered medical devices for advanced diagnostics.
Care Optimisation
Predictive analytics for clinical workflows and patient outcomes.
Clinical Safety
Clinical Decision Support systems with mandatory human oversight.
An institutional network serving Portugal
SaudeAI brings together industrial stakeholders, clinical partners, regulators and professional associations — combining execution capacity, institutional legitimacy and real clinical ground.
Promotors
Regulatory Science Organization
Complear
Digital Health company leveraging regulation, compliance and automation to create value for patients and organisations.
Science and Technology Park
Biocant Park
Science and Technology Park focused on Biotechnology, founded in partnership with the University of Coimbra, providing R&D infrastructure and a collaborative ecosystem.
Hospital & Clinical Partners
Regulators & Government Entities · Professional Associations
These entities are independent and not formally part of the sandbox. They represent the key stakeholders and regulators in Portugal leading the work on AI in healthcare.
SUPPORTING PROJECTS
These projects built the infrastructure and continue to support the scientific work behind SaudeAI — from AI validation methodologies to operational regulatory test beds.
More projects joining
Let's collaborate
Submit requests for information, proposals for institutional collaboration or questions about the Regulatory Sandbox via the official channels.