Digital Health Technologies for Medical Devices – Real World Evidence Collection – Challenges and Solutions Towards Clinical Evidence

Abstract

The need for sufficient clinical evidence and the collection of real-world evidence (RWE) is at the forefront of medical device and drug regulations, however, the collection of clinical data can be a time consuming and costly process. The advancement of Digital Health Technologies (DHTs) is transforming the way health data can be collected, analysed, and shared, presenting an opportunity for the implementation of DHTs in clinical research to aid with obtaining clinical evidence, particularly RWE. DHTs can provide a more efficient and timely way of collecting numerous types of clinical data (e.g., physiological, and behavioural data) and can be beneficial with regards to participant recruitment, data management and cost reduction. Recent guidelines and regulations on the use of RWE within regulatory decision-making processes opens the door for the wider implementation of DHTs. However, challenges and concerns remain regarding the use of DHT (such as data security and privacy). Nevertheless, the implementation of DHT in clinical research presents a promising opportunity for providing meaningful and patient-centred data to aid with regulatory decisions.