1 Scope
This British Standard specifies requirements for evaluating the development of safe,
effective and ethical healthcare AI products, including:
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a) healthcare benefits;
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b) standards of performance;
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c) successful and safe integration into the healthcare working environment;
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d) ethical needs; and
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e) socially equitable outcomes from system use.
This British Standard is applicable to products, models, systems or technologies whose function uses elements of AI, including machine learning
(ML), and whose key function is to enable or provide treatment or diagnoses, or enable
the management of health conditions, for the purposes of healthcare, including:
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1) both regulated medical devices (such as software as a medical device) and those healthcare AI products that are not within remit for such regulation;
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2) AI products that are clinician facing (such as imaging software) or service user facing (such as smartphone chatbots using AI); and
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3) AI products that are used in the home (such as monitoring products) or in community, primary, secondary or tertiary care settings.
This British Standard is relevant to healthcare AI productsuppliers, procuring healthcare provider organizations, clinicians and healthcare staff, product auditors, users, patients and others affected by healthcare AI products.