All Times EDT
Keywords: Mobile Apps, study design, statistical performance measure
Mobile medical applications (commonly called mobile medical apps), lend to new types of challenges with data, design and statistical methods to evaluate performance for regulatory decision. The apps can span the gamut from measuring motion, sleep related disorders to atrial fibrillation to list a few among many. These medical apps can and are able to provide output of clinical interest on a continuous basis leading to large data from a single patient. This presentation will focus on some examples and statistical challenges faced from design to analysis, in evaluating these devices from a regulatory perspective.