There are privacy[1] concerns with using smart wearables for health monitoring. One of the primary ethical concerns with wearable digital health technology is data collection[2] and storage. As these devices track and monitor personal health data, such as heart rate, activity levels, and sleep patterns, they collect a significant amount of personal data. This data is often stored in the cloud, and third-party access is granted to companies and researchers who may use this data for various purposes. This can lead to concerns regarding data privacy and security.[3] There are ongoing efforts[4] to address these concerns, including the development of industry self-regulation and voluntary codes of conduct.[5] However, there is still a need for stronger regulations and harmonization between states to ensure the proper use and protection of personal health data.[6] Regulations for smart wearables vary depending on the region. In Europe, there is no separate regulation for smart wearables, but it is mandatory to adhere to the applicable EU directive or EU Regulation such as the General Data Protection Regulation (GDPR). In the US, the FDA views wearable devices as ‘general wellness’ products that promote wellness and present very low risk to the user’s safety, thus they refrain from regulating wearable devices. Wearable OEMs are either self-regulating their offerings or fitting into medical device compliance guidelines. Most wearable devices fall outside federal regulatory frameworks, but they could still be subject to state consumer protection laws and other state-level regulatory frameworks, which vary per jurisdiction.
[1] Kapoor, Vidhi, et al. "Privacy issues in wearable technology: An intrinsic review." Proceedings of the International Conference on Innovative Computing & Communications (ICICC). 2020.
[2] Huarng, Kun-Huang, Tiffany Hui-Kuang Yu, and Cheng fang Lee. "Adoption model of healthcare wearable devices." Technological Forecasting and Social Change 174 (2022): 121286.
[3] Barua, Arup, et al. "Security and privacy threats for Bluetooth low energy in IoT and wearable devices: A comprehensive survey." IEEE Open Journal of the Communications Society 3 (2022): 251-281.
[4] Chikwetu, Lucy, et al. "Does deidentification of data from wearable devices give us a false sense of security? A systematic review." The Lancet Digital Health (2023).
[5] Paul, Metty, et al. "Digitization of healthcare sector: A study on privacy and security concerns." ICT Express (2023).
[6] Boumpa, E., Tsoukas, V., Gkogkidis, A., Spathoulas, G., Kakarountas, A. (2022). Security and Privacy Concerns for Healthcare Wearable Devices and Emerging Alternative Approaches. In: Gao, X., Jamalipour, A., Guo, L. (eds) Wireless Mobile Communication and Healthcare. MobiHealth 2021. Lecture Notes of the Institute for Computer Sciences, Social Informatics and Telecommunications Engineering, vol 440. Springer, Cham. https://doi.org/10.1007/978-3-031-06368-8_2.
