Abstract
In this chapter, we explore the regulatory challenges of data protection laws in the United States (U.S.) and EU and how these challenges create disproportionate issues for individuals reliant on medical devices. We map the realities of data generated by compulsory medical wearables, attending especially to implications for the patient, their agency, and their options for education about the algorithmically generated data that these devices produce. We focus on smart hearing aids as our primary example, given that they are a compulsory medical wearable that is distributed globally and generates rich streams of data that are frequently inaccessible to the patient. The introduction of AI-enabled medical devices, complete with big data infrastructures, have complicated patient understanding and complicated many contemporary data protection laws’ communication models, central to informed decision-making.
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