Digital Health Trends

Abstract

Innovation in digital health tools, including mobile health apps and wearable sensors, bring new approaches to the management of health conditions. Digital therapeutics to treat human disease are being approved by regulatory agencies around the world and routes to reimbursement are being established as developers generate and submit high-quality data on effectiveness to payers and employers. Further, new digital biomarkers are being created using consumer wearables, with the intent to track elements of patient health remotely. As these digital tools begin to have a fundamental impact on patient care and influence clinical trial design, it is important to assess the innovation and evidence they contribute as well as the barriers to and facilitators of their adoption. This study of digital health covers trends in four areas-innovation, evidence, regulation, and adoption-to assess how these new tools are becoming an entirely new therapeutic modality alongside traditional medicines and medical devices. We analyze health-related mobile applications that are available to consumers on top app stores, along with shifts in the types of apps available. We further examine trends in the overall body of clinical evidence on app effectiveness, including the types of studies published over time, and use cases where high-quality evidence exists and select apps can be considered for inclusion into guidelines. A pipeline of digital therapeutic products has also emerged, and we review aspects of their development, evidence generation and commercialization. Shifts in policy intended to encourage innovation and make these accessible to populations, including the new routes to approval and reimbursement being created around the world, are also explored. Wearables that enable patient self-care and remote monitoring of patient health in real time as digital biomarkers are discussed, along with connected sensors used in clinical trials that are enabling decentralized trial designs. Finally, we examine the roles of life sciences companies, payers, employers, and app developers in the commercialization of these products, as well as barriers to reimbursement and adoption.