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

 
• By Neena Brizmohun

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)

EU drug regulators have proposed measures to increase the use of mobile health (mHealth) data from tools such as smartphones in their regulatory decision-making for drugs, including the creation of a large health database where patients across Europe can choose to share their data directly on a common platform.

Key Takeaways
  • A newly published EU report reviews relevant literature related to the use of mHealth data in the context of medicine regulation and aims to discuss their utility for regulatory uses.

The role of digital, specifically mobile devices, in drug development and regulation is expected to grow, according to the joint...

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