AI-driven medical devices are transforming the healthcare industry. These sophisticated tools are integral to enhancing diagnostic processes, such as interpreting X-rays and enabling remote monitoring of patient vital signs. Furthermore, AI algorithms are instrumental in synthesizing patient data and medical histories to formulate personalized treatment regimens. Surgical procedures, therapeutic strategies, and the production of medical devices are also benefiting from AI assistance, leading to advancements in clinical trials and pharmacovigilance studies.

However, these tools can have significant implications for an individual’s health and chances of recovery. Although healthcare is already a highly regulated sector, the use of AI can bring novel challenges that may not be adequately addressed by existing laws and regulations. As such, there is an increasing impetus to regulate AI systems used in healthcare through both specific and horizontal pieces of legislation.