AI-Driven Wearables in Healthcare: Rethinking the Legal Framework for Smartwatches
AI-Driven Wearables in Healthcare: Rethinking the Legal Framework for Smartwatches

Summary/Abstract: The increasing use of wearable technologies like smartwatches has revolutionised personal health tracking, offering features such as heart rate monitoring and atrial fibrillation detection. Despite their advanced health-monitoring capabilities, these devices are still classified as consumer electronics rather than medical devices within the legal frameworks of the European Union and Slovakia. This legal distinction poses significant challenges related to user safety, device reliability, and regulatory oversight. Current regulations, including the European Union’s Medical Devices Regulation, impose strict standards on medical devices that smartwatches, as wellness products, are not required to meet. This paper examines the legal rationale behind the non-classification of smartwatches as medical devices and highlights the gaps in regulatory frameworks. Through a comparative analysis of Slovak and European laws, the study reveals the challenges in regulating AI-driven wearables and suggests the need for legal reforms to better integrate these technologies into healthcare, ensuring a balance between innovation, safety, and accountability.

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