Ethical and legal implications of health monitoring wearable devices: A scoping review

Background: health monitoring wearable devices (HMWDs) are increasingly implemented for personalized and preventive care. This review aims to summarize the existing literature on the ethical and legal implications of HMWDs in healthcare. Methods: the study design is a scoping review and narrative synthesis of scientific literature. The literature search was conducted in May 2023, and updated on March 15th, 2024, from the following databases: PubMed, EBSCO (including CINAHL, PsycInfo, Index to Legal Periodicals & Books, Philosopher's Index), HeinOnline, Engineering Village, Nexis Uni and Cochrane Library. Pairs of blinded authors independently screened articles using Rayyan software, and manually checked reference lists of included articles. Peer-reviewed articles in English discussing ethical and/or legal implications of HMWDs in healthcare were included. A thematic synthesis approach was used to identify and summarize ethical and legal issues and recommendations. Protocol registration: https://osf. io/kfuh4/. Findings: overall, out of 7767 records retrieved, 405 full texts were assessed, and 12 articles, published between 2017 and 2024, were included. We identified 6 main themes: the use of HMWDs may adversely affect and reshape care relationships and the healthcare system; the use of HMWDs raises a variety of justice-related concerns; there are ethical issues related to personal data; HMWDs present several risks but the benefits are still uncertain; there are ethical issues regarding clinical research on HMWDs; and the current regulatory framework is inadequate. Interpretation: the use of HMWDs in clinical and research settings raises several ethical and legal concerns, ranging from patient safety to autonomy, justice, and data protection. Implementing HMWDs without addressing these concerns may lead to dehumanization and datafication of care relationships and further marginalization of vulnerable populations.