Blazing the Trail for Digital Health Innovation: Resources and Examples Based on a Digital Health Application for Dementia Family Caregivers

PURPOSE: The rapid proliferation of digital health technologies and evolving US regulations to frame evidence requirements for approval have led to an urgent need for practical examples illustrating the research and development pathway for these innovations. This session will increase participants’ understanding of US government funding and regulation of digital health applications by presenting the latest developments on these topics from the National Institutes of Health (NIH) and Food and Drug Administration (FDA).

DESCRIPTION: Dr. Arnold will introduce the panelists and discuss the overall challenges and opportunities related to development of digital health apps in the US (10 minutes), Dr. Rousche will describe the number and types of digital health grants that have been funded by NIH and discuss unique NIH product development resources (10 minutes), Dr. Jutkowitz will present his real world experience in developing a digital solution that provides the caregivers of dementia beneficiaries with personalized care to address care challenges that would otherwise lead to costly healthcare utilization. The platform is powered by a database of more than 50 common care challenges, more than 1,000 strategies to address care challenges, assessments, and clinical algorithms that generate personalized care plans (15 minutes), and Ms. Saha will discuss the emerging US regulations for digital health (10 minutes). The presentation will be followed by audience Q&A (15 minutes).