Wearable sensors for cardiological monitoring in the SUS: regulatory challenges and impacts on Brazilian Public Health

Cardiovascular diseases are the leading cause of death in Brazil, with approximately 400,000 deaths annually, which corresponds to almost 30% of all deaths in the country. In addition to the impact on mortality, these conditions generate an enormous economic burden for the health system, with costs associated with the treatment of diseases such as heart attack and heart failure exceeding R$50 billion per year. In this context, the use of wearable devices for continuous monitoring of cardiovascular parameters emerges as an opportunity to improve the management and prevention of these diseases. This study conducts a scoping review of the regulatory challenges involved in the incorporation of wearables into the Unified Health System (SUS), with a focus on cardiological monitoring. Articles published between 2019 and 2024 were analyzed, discussing issues such as data accuracy, interoperability between systems, protection of sensitive data, and training of health professionals. In addition, the study examines the economic and social implications of the adoption of these technologies in a context of profound socioeconomic inequalities. The results indicate that, although wearables have the potential to transform cardiovascular care in Brazil, regulatory and technical barriers still limit their large-scale adoption in the SUS. Adequate regulation, aligned with the General Data Protection Law (LGPD), and investments in infrastructure and training are essential for the safe and effective integration of these technologies into public health.