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Healthcare is quickly moving from a generic, reactive, care model to a personalized, proactive, care model. This tectonic change is being driven by a combination of BigData, Artificial Intelligence, and an explosion of IoT – technologies that complement each other and provide a positive feedback loop, further accelerating improvements to healthcare. These bring a plethora of challenges that I will discuss in this talk, including making data analytics timely and relevant; creating safer medical devices; implementing IoT effectively and safely in clinical settings; and making regulatory systems and risk management fit-for-purpose to deliver health technologies that are innovative, empowering… and also safe.