BS 30440:2023

What is BS 30440 - Validation framework for the use of AI about?

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.

Who is BS 30440 - Validation framework for the use of AI for?

• 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

What does BS 30440 - Validation framework for the use of AI do?

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.

Why should you use BS 30440 - Validation framework for the use of AI?

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

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