Unlocking Tomorrow's Health Care: Expanding the Clinical Scope of Wearables by Applying Artificial Intelligence.

As an integral aspect of health care, digital technology has enabled modelling of complex relationships to detect, screen, diagnose, and predict patient outcomes. With massive data sets, artificial intelligence (AI) can have marked effects on 3 levels: for patients, clinicians, and health systems. In this review, we discuss contemporary AI-enabled wearable devices undergoing research in the field of cardiovascular medicine. These include devices such as smart watches, electrocardiogram patches, and smart textiles such as smart socks and chest sensors for diagnosis, management, and prognostication of conditions such as atrial fibrillation, heart failure, and hypertension as well as monitoring for cardiac rehabilitation. We review the evolution of machine learning algorithms used in wearable devices from random forest models to the use of convolutional neural networks and transformers. We further discuss frameworks for wearable technologies such as the V3-stage process of verification, analytical validation, and clinical validation as well as challenges of AI integration in medicine such as data veracity, validity, and security and provide a reference framework to maintain fairness and equity. Last, clinician and patient perspectives are discussed to highlight the importance of considering end-user feedback in development and regulatory processes.