Artificial intelligence (AI) systems for healthcare settings need to be rigorously evaluated to make sure they meet sufficient quality, safety, and ethical standards.
BS 30440:2023 is a new British Standard that synthesizes a wide body of literature on assessing AI in healthcare into an actionable and informative framework. This can guide suppliers as they develop AI systems for healthcare, and – because the standard presents a set of auditable clauses – can be used to conduct conformity audits that lead to certification. Healthcare organizations can then mandate BS 30440 certification as a requirement in their procurement processes, thus ensuring these systems have met a known standard.
Suppliers of AI systems in healthcare, who will use the standard to guide their development process and produce evidence for conformity with each clause
Auditors and notified bodies
Procuring healthcare organizations
Clinicians and healthcare staff
Patient advocacy groups and civil society organizations
Healthcare insurers, payers, and regulators
Direct to consumer technology organisations
BS 30440 gives a comprehensive set of requirements for key evaluation criteria such as clinical benefits, standards of performance, successful and safe integration into the clinical work environment, ethical considerations, and socially equitable outcomes from system use.
The contents of BS 30440 have been shaped in response to the needs of a range of stakeholders who’ll use it in practice.
BS 30440 is both a guide for the development of AI systems for use in healthcare, and a means to assess them for conformity and certification. It will help suppliers develop products that demonstrate efficacy and reach sufficient standards of technical performance. Meanwhile healthcare providers, clinicians and patients can gain assurance that AI systems will integrate safely into the clinical working environment, are clinically effective and ethical.
In addition, using BS 30440 can:
Enable the validation of AI in healthcare
Accelerate innovation in AI healthcare systems
Facilitate trade in AI healthcare solutions
Improve the efficiency with which beneficial solutions are developed and deployed
Increase the confidence in adoption of AI in healthcare
Strengthen the risk management of both suppliers and purchasers of AI systems used in healthcare settings