This expert review report supports the delivery of the BDSG workplan 2023 to 2025 (HMA/EMA joint Big Data Steering Group, 2023). To further progress and strengthen the work already done to enable the use and establish the value of different types of RWD to support regulatory decision-making, the BDSG aims at looking further into how mHealth data generated in real life or in routine care could be
useful in regulatory decision-making, and what could be possible points for consideration for future actions for their optimal use in the EU regulatory network moving forward.
EMA EUROPEAN MEDICINE AGENCY mHealth Data for Real World Evidence in Regulatory Decision Making
An expert review report for the HMA/EMA Big Data Steering Group – 2024