NSAFEDARE Training Platform Receives Accreditation from EFMI

A significant milestone for the INSAFEDARE project, reinforcing its commitment to high-quality education in digital health, medical device regulation, and health data innovation.

The INSAFEDARE project is pleased to announce that its Training Programme, “Regulatory Decision-Making in Digital Health and Medical Devices,” has received accreditation from the European Federation for Medical Informatics (EFMI).

This recognition marks an important achievement for the project, highlighting its contribution to professional education and capacity building in the rapidly evolving fields of digital health, artificial intelligence, and medical device regulation.

Advancing Education in Digital Health and Regulatory Decision-Making

Developed within the framework of the EU-funded Horizon Europe INSAFEDARE project, the INSAFEDARE Training Platform provides accessible educational resources designed to strengthen knowledge and practical competencies in the responsible use of real-world and synthetic health data.

The training programme addresses key topics, including:

• Digital health and medical device regulation

• Real-world and synthetic health data

• Artificial intelligence in healthcare

• Data quality, FAIR principles, and interoperability

• Regulatory decision support and validation frameworks

The programme includes a foundational module followed by four specialised learning pathways tailored to medical device manufacturers, notified bodies and regulators, independent technical assessors, and data analysts and healthcare professionals.

Recognition from a Leading European Scientific Federation

The European Federation for Medical Informatics (EFMI) promotes excellence in biomedical and health informatics across Europe. Through its Accreditation and Certification initiative, coordinated by the EFMI Accreditation and Certification Committee (AC2), the federation supports quality in education and professional development.

The accreditation represents an important recognition of the INSAFEDARE training initiative and its contribution to strengthening competencies at the intersection of healthcare innovation, data science, and regulatory practice.

Supporting the Long-Term Impact of INSAFEDARE

As the INSAFEDARE project approaches its completion, this achievement further strengthens its educational legacy, supporting the continued dissemination of knowledge and the practical application of its research outcomes.

By making specialised training resources available to a broad professional audience, the platform contributes to more informed, transparent, and evidence-based regulatory decision-making in digital health.

Explore the INSAFEDARE Training Platform:https://training.insafedare.org/

Learn more about EFMI Accreditation and Certification:https://efmi.org/accreditation-and-certification/