Abstract
Smartphone applications ("apps") with artificial intelligence (AI) algorithms are increasingly used in healthcare. Widespread adoption of these apps must be supported by a robust evidence-base and app manufacturers' claims appropriately regulated. Current CE marking assessment processes inadequately protect the public against the risks created by using smartphone diagnostic apps.
Publication types
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Algorithms
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Artificial Intelligence* / legislation & jurisprudence
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Artificial Intelligence* / standards
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Diagnostic Test Approval* / legislation & jurisprudence
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Diagnostic Test Approval* / standards
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Early Detection of Cancer / instrumentation
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Early Detection of Cancer / methods
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Early Detection of Cancer / standards
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Europe
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European Union
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Evidence-Based Medicine
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Humans
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Mobile Applications* / legislation & jurisprudence
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Mobile Applications* / standards
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Precancerous Conditions / diagnosis
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Risk Assessment
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Sensitivity and Specificity
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Skin Neoplasms / diagnosis*
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Skin Neoplasms / etiology
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Skin Neoplasms / pathology
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Smartphone / legislation & jurisprudence
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Smartphone / standards
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United States
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United States Food and Drug Administration