Real-world-data Enabled Assessment for heaLth regulatory decision-Making
The overall aim of the REALM project is to create a collaborative framework for regulatory authorities, application developers, healthcare professionals and policy officers to co-create and evaluate software for medical and healthcare use. We propose to create an inclusive platform leading to a transparent ecosystem for the evaluation and certification of software in healthcare where both the developers and the regulatory (and Health Technology Assessment) bodies have access to a standardized set of technology stacks and data. Building on the proposed project architecture, five real Medical Device Software (MDSW) projects are going to be implemented across three countries (the Netherlands, Belgium and Greece).
- Professor Michel DumontierUniversiteit MaastrichtEmail