Validation framework for the use of AI within healthcare – Specification

This British Standard specifies requirements for evaluation criteria, including:

a) clinical benefits;
b) standards of performance;
c) successful and safe integration into the clinical work environment;
d) ethical considerations; and
e) socially equitable outcomes from system use.

This British Standard is applicable to products, models, systems or technologies whose function uses elements of artificial intelligence (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:

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;
2) AI products that are user-facing (such as imaging software) or patient-facing (such as smartphone chatbots using AI); and
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 the procuring healthcare provider organization, clinicians and healthcare staff, the AI system supplier, product auditors, and patients and the public.