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Real-world-data enabled assessment
for health regulatory decision-making


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Short Term results during the projectMedium Term3–5 years after the projectLong Term>5 years after the projectKey Exploitable Results (KER)Expected Outcomesfor different stakeholdersScientific ImpactsImproved evaluation leads to functioning and precise medical/healthcare softwareEconomical ImpactsImproved and transparent Medical Device Software certification process leads to efficient and responsible deployment of software and creation of jobs around itSocietal ImpactsReduced inequalities across regulatory bodies across EU member states leads to fair adoption of key health technologies