The Alignment of Real-World Evidence and Digital Health: Realising the Opportunity

Abstract

In the new era of healthcare digitalization, there is a golden opportunity in the overlap between digital health and Real-World Evidence (RWE). In this commentary, we define RWE and digital health and investigate their intersection. We describe the stages in the RWE value chain critical to the evidence generation process, how these stages change with new digital technologies and the opportunities and challenges that arise from how these stages evolve-including their application for stakeholders such as patients, physicians and regulators. We also discuss the current published guidelines and frameworks regarding digital health. We categorise these publications in terms of their clarity as "Extensive", "Intermediate" or "Basic" and according to whether they encompass all levels of digital health or are more focussed in their guidance. Finally, we provide recommendations to increase synergy between RWE and digital health.

Keywords: Digital health; Guidelines; Health data; Real-Word Data; Real-World Evidence; Wearables.

Figure 1.

Hierarchy definition of Digital Health. The constituent parts of Digital Health are the use of information and communication technology (eHealth) and of computing sciences in the areas of Artificial Intelligence, Big Data and genomics in support of health [3, 4].

Figure 2.

Stages in the RWE value chain. Areas that are critical in the evidence generation process are patient and caregiver consent, data collection, data storage transmission & aggregation, analysis and insight/evidence generation and use by stakeholders.