About SMAILE

SMAILE - Stockholm Medical Artificial Intelligence and Learning Environments, is Karolinska Institutet's dedicated core facility for digital health and artificial intelligence in healthcare. Operating within the Department of Clinical Science, Intervention and Technology (CLINTEC), SMAILE serves as a hub for innovation, research, and education at the intersection of medical technology and artificial intelligence.

As a university core facility, SMAILE plays a pivotal role in the KI-Karolinska ecosystem, bridging academic research, clinical practice, and industry innovation. The facility provides specialized expertise, infrastructure, and training that enable researchers, clinicians, students, and industry partners to advance the field of AI-driven healthcare. Through its multidisciplinary approach, SMAILE facilitates collaboration across departments, research groups, and external stakeholders, creating an environment that fosters the development of cutting-edge medical AI research.

Our Vision

To be a pioneering university core facility that fosters innovation and supports cutting-edge research projects. By providing a multidisciplinary environment and integrating expertise in digital health and artificial intelligence, SMAILE aims to accelerate the development of transformative healthcare solutions, driving advancements in both academic research and clinical practice.

Our Mission

SMAILE's overarching goal is to support the adoption of medical technology, digital health solutions, and artificial intelligence across the KI-Karolinska ecosystem. We achieve this through three key objectives:

Supporting Research and Innovation Actions

We provide the technical expertise, infrastructure, and collaborative environment necessary to conduct world-class research in medical AI. Our team supports projects from conception to publication, offering specialized knowledge in machine learning, medical imaging analysis, data analytics, and regulatory compliance. We facilitate interdisciplinary collaborations that bring together clinicians, data scientists, and engineers to tackle complex healthcare challenges.

Facilitating Compliance with EU AI Regulations and Medical Device Standards

As AI systems increasingly enter clinical practice, regulatory compliance becomes paramount. SMAILE offers expert guidance on navigating the complex landscape of EU AI ACT regulations, medical device directives (MDR/IVDR), and quality management systems. We help researchers and industry partners understand regulatory requirements early in the development process, ensuring that innovations can successfully transition from research to clinical application while maintaining high standards of patient safety and data protection.

Providing Dedicated Training in AI and Digital Health

Education is at the heart of SMAILE's mission. We offer comprehensive training programs ranging from introductory AI literacy courses to advanced technical workshops. Our educational activities target diverse audiences, including healthcare professionals, researchers, students, and industry practitioners, ensuring that the next generation of healthcare innovators has the skills and knowledge needed to harness AI's potential responsibly and effectively.

Content reviewer:
11-11-2025