Digital Health Technologies (DHTs)
Project Description |
This Working Group project aims to explore the current use of digital health technologies (DHTs) in clinical trials and regulatory submissions, providing a structured overview of key concepts and applications. Areas of focus include telemedicine, mobile health, wearable and implantable devices, software as a medical device, and the generation of continuous data streams, as well as the clinical and analytical validation of these technologies. The project will also examine the role of digital biomarkers, digital interventions and digital medicine within the broader DHT ecosystem, recognising that these cannot be considered in isolation. In addition, it will establish a platform for discussion of evolving regulatory guidance and expectations. With the rapid growth of DHTs – accelerated by increased adoption of remote healthcare – this initiative seeks to support organisations in navigating regulatory complexity and improving understanding of how these technologies can be effectively integrated into clinical development. |
Project Leads | |
|---|---|
Vijay Pasapula, Cerus | |
Unnat Patel, AnalysisMate | |
Nicola Newton, PHUSE Project Coordinator | nicky@phuse.global |
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