The ethical and regulatory landscape of wearable, ingestible, and implantable technologies in the United States.

Abstract

Biosensing technologies, including wearables, ingestibles, and implantables, are transforming modern healthcare by enabling real-time monitoring and precise personalized treatment. As these technologies advance, ensuring their safety, efficacy, and ethical deployment remains paramount. This chapter explores the regulatory framework that governs biosensing devices in the United States, detailing premarket approval pathways, postmarket surveillance, and emerging regulatory incentives that balance innovation with patient protection. The discussion extends beyond compliance to address critical ethical considerations, including data privacy, informed consent, patient data ownership, and equitable access. By examining case studies of successful and failed biosensing devices, this chapter provides a comprehensive analysis of the evolving landscape, offering guidance for manufacturers, policymakers, and healthcare providers. A proactive approach to regulation and ethics will be essential to ensuring biosensing technologies enhance healthcare outcomes while maintaining public trust.