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All Times EDT

Wednesday, September 23
Wed, Sep 23, 1:30 PM - 2:45 PM
Virtual
Regulatory Challenges with Mobile Medical Apps and Big Data

Challenges in Validating Mobile Medical Applications (301174)

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*Arkendra De, FDA/CDRH 
Saryet Kucukemiroglu, FDA / CDRH 

Keywords: digital health, mobile medical apps

Mobile Medical Applications (Apps) are a burgeoning class of software growing in importance, both for clinically managing care of individuals and in clinical trials. This group of software is diverse in terms of input, functionality, output, and the specific context of use. Regardless of these differences, validating the performance of mobile medical apps is an important and crucial step before the software is widely used for making clinical decisions. This presentation will discuss challenges associated with the clinical validation of mobile medical apps in terms of study design and statistical analyses.