High-level guidance, designed to build greater digital trust in artificial intelligence (AI) products used to diagnose or treat patients, ranging from medical devices to smartphone chatbots or in-home monitoring tools, has been published by the British Standards Institution (BSI).
With the onset of more innovative AI tools, clinicians and health providers will have the opportunity to make informed diagnostic decisions to intervene, prevent and treat diseases, ultimately improving patients’ quality of life, and benefiting society. As debate continues globally regarding the appropriate use of AI, Validation framework for the use of AI within healthcare – Specification (BS 30440) is being published to help increase confidence among clinicians, healthcare professionals and clinical providers that the tools they are using have been developed in a safe, effective and ethical way. The auditable standard, which can be used globally, is specifically targeted at products whose key function is to enable or provide treatment or diagnosis, or support the management of health conditions.
It covers healthcare AI products used in a range of settings, from regulated medical devices (such as software as a medical device) but also user-facing products (such as imaging software) or patient-facing (such as smartphone chatbots using AI). It also encompasses AI products that are used in the home (such as monitoring products) or in community, primary, secondary or tertiary care settings. The specification applies to products, models, systems or technologies that use elements of AI, including machine learning, and is also relevant to the AI system supplier and product auditors.
It has been developed by a panel of experts partnering to identify best practice, including clinicians, software engineers, AI experts, ethicists and healthcare leaders, and draws together existing guidance literature and good practice, then translates the assessment of complex functionality into an auditable framework against which an AI system can be assessed for conformity. Healthcare organisations can mandate BS 30440 certification as a requirement in their procurement processes, thus ensuring these systems meet known standard.