Validation, verification, and reliability

Abstract Wearable devices are widely used within healthcare paradigms to both collect various data related to the health and well-being of the user and to deliver therapeutic treatment to users. The popularity and range of use of wearable devices continue to grow dramatically worldwide, with devices available for a range of treatments, from managing diabetes to Parkinson’s disease. These devices could be classed as medical devices, depending on their intended use and the medical claims they make, and hence whether they require regulatory approval. In this chapter, we review the general processes involved in validating wearable devices for real-world use, such that sufficient evidence can be provided to regulatory bodies of their effectiveness and safety. We also review several specific devices and describe their use case, their path to regulatory approval, and the testing activities which were carried out to collect validation evidence. We also review the use of wearables as endpoints in clinical trials and how researchers can make the right decisions when it comes to choosing validated wearable devices. Finally, we review the trends which are emerging in the field of wearable devices and describe the opportunities and challenges for manufacturers, regulatory bodies, and users.