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It may seem counterintuitive to open a book on medical devices with chapters on software and data, but these are the frontiers of new medical device regulation and law. Physical devices are still crucial to medicine, but they – and medical practice as a whole – are embedded in and permeated by networks of software and caches of data. Those software systems are often mindbogglingly complex and largely inscrutable, involving artificial intelligence and machine learning. Ensuring that such software works effectively and safely remains a substantial challenge for regulators and policymakers. Each of the three chapters in this part examines different aspects of how best to meet this challenge, focusing on review by drug regulators and, crucially, what aspects of oversight fall outside that purview. Collectively, these chapters demonstrate the challenge of regulating and overseeing the AI- and data-powered software which increasingly shapes medical practice, both behind the scenes and within the examining room. These technologies bring immense potential along with real risk, but present new regulatory challenges due to their opacity, their plasticity, and the speed with which they are being incorporated into the health system. Ensuring the right sort of oversight so that medical devices centered on AI and big data are safe, effective, and deployed in such a way as to actually help the health system demands concerted action from stakeholders across the board.


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