Abstract

Background: Digital health is a widely discussed topic in both the lay and professional press. Innovators in this space continue to raise significant funds to develop applications and devices that will change how healthcare is managed in the United States. Wearable devices and mobile health applications are used by up to one third of all American consumers, presenting a key opportunity to give put healthcare into consumers’ hands. However, who will have the biggest role in this space remains to be seen.

Discussion: Technology giants, biopharma firms, and startups all have a chance to take advantage of a new frontier and change the way healthcare interacts with patients. While the entrepreneur tech industry is leading the way, they lack the expertise that big pharma companies have with regulation and healthcare. However, the pharma industry will not be able to continue to tread lightly as startups and large technology companies continue to push innovation in this space. Companies who decide to take stock in this market will have to decide how to interact with the healthcare space in one of three ways: operating within the current system, providing new technology to hospitals and patients via devices, or developing new platforms through which healthcare can be provided via software and applications.

Conclusion: This article will provide introduction to the digital health market, progress in the regulatory landscape and current state of clinical trials in the digital health space, and discuss the new FDA pre-certification program established in 2017. We conclude with some insights on considerations for entrepreneurs who may be interested in this space.

Keywords: Digital health, healthcare, FDA regulation, clinical trials, pre-market approvals, FDA precertification program.