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
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.