The rapid advancement of AI in healthcare necessitates a robust framework to evaluate and regulate its innovations effectively. This chapter explores the pivotal role of regulatory sandboxes in testing AI healthcare technologies, offering a controlled environment for piloting and refining new solutions before widespread implementation. By balancing the drive for innovation with the need for stringent regulatory oversight, sandboxes provide a unique platform for assessing the efficacy, safety, and ethical considerations of AI systems. Key aspects discussed include the design and implementation of sandboxes, regulatory compliance, and the benefits and challenges associated with their use. The chapter underscores the importance of these controlled environments in fostering advancements while ensuring patient safety and regulatory adherence. This comprehensive examination highlights the transformative potential of regulatory sandboxes in the future of AI-driven healthcare.
The use of AI in healthcare was revolutionizing the field by improving patient outcomes, personalizing treatment plans, and improving diagnostic accuracy [1]. AI technologies are being used more and more to handle complicated medical data, forecast the course of disease, and assist in clinical decision-making [2]. These technologies include machine learning algorithms, data analytics, and natural language processing [3]. As these technologies develop further, have the potential to revolutionize the way healthcare was delivered by making interventions more successful and efficient [4]. But there are still a lot of obstacles to overcome before AI can be widely used in healthcare [5]. One major one was making sure these technologies are properly evaluated and controlled to protect patient welfare and adhere to legal requirements [6,7].
To address the challenges associated with the rapid advancement of AI technologies, regulatory sandboxes have emerged as a crucial tool in the healthcare sector [8]. Regulatory sandboxes provide a controlled environment where new technologies can be piloted under regulatory oversight, allowing for real-world testing and refinement before broader implementation [9]. This approach offers a unique opportunity to evaluate the safety, efficacy, and ethical considerations of AI healthcare innovations in a structured setting [10]. By facilitating iterative testing and feedback, regulatory sandboxes help to identify and mitigate potential issues early in the development process, ensuring that AI technologies are both innovative and compliant with regulatory requirements [11].
