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Over the past few months, there has been a wave of digital health guidelines and whitepapers issued by regulators, institutes, and organisations worldwide. In the field of artificial intelligence (AI), EU guidelines, published in April, promote the development of trustworthy AI across all disciplines, while a US Food and Drug Administration (FDA) whitepaper proposes a regulatory framework for constantly developing software in health care. Guidelines from the National Institution of Health and Care Excellence (NICE) tackle the level of evidence required for a new digital health intervention, and NHSX and Public Health England have both reported their intention to produce their own AI guidelines.
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The Lancet Digital Health (2019) studied this question.
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