Privacy and Regulatory Issues in Wearable Health Technology †

Abstract

This paper is based on a research literature review for identifying and evaluating the technical, ethical and regulatory challenges to adequately regulate the use of wearable health technology. The objective is to analyze how researchers address the use of smart wearables in healthcare under the scope of data privacy. The main challenges faced by states in regulating e-health wearables were identified, especially the different methods to ensure the privacy of personal health information (PHI) and the legal voids and complexities of regulating wearable health technology at both national and international levels. Finally, a few recommendations were made to more efficiently regulate wearable health technology at both national and international levels. AI could be used as a regulatory tool to monitor the use of e-wearables in healthcare. Also, European Union (EU) law—the upcoming EU Data Act and AI Act—can serve as models and guidance for the World Health Organization (WHO), which has a constitutional mandate to regulate the use of wearable health technology.