This short course will focus on how digital health technologies are being developed and regulated in the pharmaceutical/combination products space. Although many digital health technologies follow a fairly straightforward regulatory path as devices, those that interact with drug products often encounter more regulatory uncertainty. FDA’s policy on how mobile medical apps, clinical decision support software, and wearables can be combined with pharmaceutical use is still in development, so it is often difficult to navigate the regulatory path to market for these products. This course will look at currently available FDA guidances and what they mean for digital health products that combine both a drug and device. Participants will explore how to work with FDA when developing digital health technologies that may veer outside of established regulatory pathways, and a series of case studies will examine how innovators have addressed development and regulatory hurdles.