Key Exploitable Results (KER)

• Multimodal Standard Data Quality Framework (SDQF) for Medical Device Software evaluation
• OMOP (The Observational Medical Outcomes Partnership) mapped, REALM Data Catalogue consisting of real-world data, synthetic data and digital twins
• Federated cloud-based, DARWIN-enabled REALM infrastructure interoperable across EU countries
• Transparent and standardised software certification process using Blockchain Smart-Contracts
• REALM powered improved Medical Device Software guidelines
• REALM education materials for competent authorities, Notified Bodies, Health Technology Assessment agencies and manufacturers

Outcomes

For different stakeholders

• Deployment of REALM in DARWIN Coordination Centre as the hub
• Requirement of Standard Data Quality Framework in all regulatory requests for Medical Device Software across EU members states
• Inclusion of REALM's improved Medical Device Software guidelines across health regulatory authorities
• REALM Academy has achieved in reaching most health regulatory authorities, such as National Ministries of Health, Notified Bodies and Health Technology Assessment agencies, for being trained in data-driven decision-making using REALM components
• Notified Bodies and Health Technology Assessment agencies benefiting from standardised certification and monitoring per Medical Device Software via Blockchain Smart-Contracts allowing seamless evidence development
• Pre-to-Post marketing surveillance integrated in REALM dashboard will allow timely policy making

Scientific Impacts

REALM Contributes to Key Strategic Orientation Promoting an open strategic autonomy by leading the development of key digital, enabling and emerging technologies, sectors and value chains in Cluster 1 Health

Improved evaluation leads to functioning and precise medical/healthcare software

Economical Impacts

REALM Contributes to Open strategic autonomy in digital technologies, contributing to job creation and economic growth, in particular Small and Medium-sized Enterprises (SMEs).

Improved and transparent Medical Device Software certification process leads to efficient and responsible deployment of software and creation of jobs around it

Societal Impacts

REALM Contributes to Key Strategic Orientation Creating a more resilient, inclusive, and democratic European society by addressing inequalities across EU regulatory bodies in Medical Device Software.

Reduced inequalities across regulatory bodies across EU member states leads to fair adoption of key health technologies