Assessment and Implementation of Wearables in Health: Opportunities and Regulatory Challenges in Brazil

Abstract

Digital health is rapidly expanding and is associated with the use of digital technologies to promote health actions. Wearable electronic devices, also known as wearables, are part of the innovations in this area, with a personalized, patient-centered approach. These devices are used for monitoring, diagnosing and tracking chronic diseases, as well as for promoting health and well-being. This article aims to discuss the implementation of wearables in Brazil, highlighting the associated opportunities and regulatory challenges. This is an exploratory study, based on literature, with a narrative synthesis. The text discusses the registration of wearables in Brazil, the challenges for implementation in the country, and international experiences in evaluating digital health technologies. Finally, it points out some opportunities to promote the implementation of wearables in Brazil. It is important to emphasize that, to implement wearables on a large scale, technical, ethical, social and economic barriers need to be overcome. Several countries and institutions have adjusted traditional health technology assessment  methodologies to evaluate and promote the rational use of digital interventions. The successful implementation of wearables essentially depends on the consistency of the technology assessment process, including measuring benefits, risks, and costs, always based on the best evidence available.