eHealth and Medical Care
Research and Development under Contract
Software Engineering and Data Intelligence
Artificial intelligence, machine learning, and decision support systems
FRAMEWORK
The growing adoption of Artificial Intelligence (AI) systems in healthcare, particularly Software as a Medical Device (SaMD), presents new challenges in terms of safety, transparency, privacy and regulatory compliance. AI Act and the Medical Devices Regulation (MDR) introduction reinforces the need for methodologies that ensure the reliability and compliance of these systems throughout their entire lifecycle.
In this context, the MedAIVeritas project aims to develop new processes and methodologies for the validation of AI solutions in healthcare, bringing together companies and organisations from Portugal's scientific and technological system.
The initiative seeks to address current gaps in the assessment of the safety, effectiveness, transparency, ethics and cybersecurity of these systems, promoting their safe adoption in compliance with European regulatory requirements.
PROPOSED SOLUTION
Integrated approach development for AI systems validation as medical devices, supported by innovative methodologies for transparency and explainability, safety and cybersecurity, data privacy and ethics, and clinical validation based on real-world data.
These methodologies are developed and validated through industrial research activities, culminating in new automated validation processes creation applicable to the development and certification healthcare AI solutions.
As a result, the project delivers processes capable of covering approximately 80% of the regulatory requirements applicable to AI as a medical device, providing the foundation for two new digital solutions designed to support medical device manufacturers and healthcare institutions in assessing the compliance, safety and performance of their AI systems.
This approach reduces the effort associated with validation and certification processes while increasing confidence in the adoption of AI technologies in clinical practice.
CCG/ZGDV CONTRIBUTION
CCG/ZGDV plays a key role in the research activities related to proposed methodologies development and validation, bringing advanced expertise in software engineering, data science, artificial intelligence and technology validation to consortium.
Its contribution focuses particularly on research activities related to AI model transparency and trustworthiness, validation pilots using clinical data, and project's scientific and technological results dissemination.
CCG/ZGDV also contributes to developed solutions technical validation, supporting results verification and ensuring knowledge transfer to industry.
Its expertise in AI-based solutions, MLOps, software engineering and advanced technologies integration strengthens the project's outcomes scientific and technological robustness, fostering their industrial adoption and enhancing the competitiveness of Portugal's digital health technology ecosystem.