Abstract
Technologies based on artificial intelligence (AI) and machine learning (ML) are widely considered to have the potential to transform healthcare – by deriving new and important insights from the vast amount of data generated during the delivery of healthcare on a daily basis. These technologies are expected to significantly improve the quality of care that patients receive. An important factor for the further development and application of solutions based on AI and ML is the regulatory and legal framework. This chapter explains what AI is, how it works and what benefits it could bring in the life sciences and healthcare sectors. Several use cases of AI in healthcare are examined – from diagnostics to clinical trials and surgery robotics. The chapter also provides a thorough analysis of, and suggestions for overcoming, the main legal challenges surrounding the use of AI in healthcare, including the overarching regulatory framework, product liability issues, protection of intellectual property rights, as well as reimbursement issues.
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