‘Ambitious Platform’ Among EU Proposals For Increasing mHealth Data Use In Regulatory Decision-Making

mHealth data generated by smartphones and wearables show potential for enhancing the clinical evidence used in regulatory decision-making, but there are “notable challenges” that may hinder the use of such data, EU regulators say.

Data Synchronization Of Health Between Smartwatch And Smartphone
The role of digital, specifically mobile devices, in drug development and regulation is expected to grow (Shutterstock)

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