How Does Apple Change Clinical Trials?  
[Thursday, September 12, 2019]

This week Apple created another big news with its announcement for the start of three clinical trials for three different indications using iWatch creating big anticipation for its forays into healthcare. The three studies use three different applications of iWatch for health-related uses. All studies are designed as open-label observational studies conducted in collaboration with large academic centers. The details of the study designs are not available but based on Apple’s announcement they use simple iWatch applications such as calendar-like app for tracking menstruation to predict gynecological conditions, listening app to monitor the loud sounds around a user to infer potential impact on hearing loss, and linking cardiovascular health to mobility coupled with heart rate measurements. These functionalities are already built into iWatch so these trials represent practical applications of an already in-use wearable device. The claims, however, represent new intended uses which may require FDA approval. Knowing Apple’s history with FDA and its unlimited resources, one can assume that FDA will be involved both with the review of the study designs and analysis of the results. These three new studies will add on to Apple’s ongoing clinical research efforts to add medical claims to iWatch. Clinicaltrials.gov lists 3 completed and 3 ongoing clinical trials with iWatch, not including the newly announced studies; the new studies expand on that experience. It would be interesting to see how Apple changes the overall landscape of mobile health applications. Does this indicate a new trend where all medical apps would need large clinical trials to support claims? These trials test the FDAs guidance on general heath awareness devices for new applications of mobile technology that do not require formal approval. Apple may try to stifle competition to its products by designing claims that tread above general health claims that may require formal FDA approval and more expensive to develop. Or these studies may open doors to other app developers for healthcare applications hosted on wearable devices. We will need to wait and see.