Ethical and Legal Challenges of AI-Powered Biomedical Devices and Wearable Health Monitors

Artificial intelligence (AI) has become an inseparable part of modern healthcare,
powering biomedical devices and wearable health monitors that promise early diagnosis, personalized treatment, and continuous patient support.This chapter explores
the delicate balance between innovation and responsibility in the AI-driven healthcare
ecosystem. It highlights critical issues such as patient privacy, data protection, and
informed consent in the face of opaque “black box” algorithms. Concerns around
algorithmic bias, fairness, and transparency are discussed, underscoring how representative datasets can deepen health inequities if left unchecked. Real-world
case studies illustrate both the promise and pitfalls of AI integration, while failures
emphasize the urgent need for safeguards. The discussion concludes with strategies
for responsible innovation, including privacy-by-design principles, continuous auditing, and the training of healthcare professionals to work effectively with AI tools.