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.
‘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.
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