The British Standards Institution (BSI) has released a comprehensive guidance document titled “Validation framework for the use of AI within healthcare – Specification (BS 30440)” in an effort to promote greater digital trust in AI products used for medical diagnoses and treatment. The main objective of this standard is to enhance confidence among healthcare professionals and providers regarding the safe, effective, and ethical development of AI tools in the medical field.
The guidance specifically targets AI products designed for healthcare interventions, diagnoses, and health condition management. It aims to address the growing global debate on the appropriate use of AI in healthcare, especially as the healthcare AI market is projected to exceed $187.95 billion by 2030.
Jeanne Greathouse, the Global Healthcare Director at BSI, emphasizes the transformative potential of AI in healthcare, enabling clinicians and healthcare providers to make informed diagnostic decisions and ultimately improve patients’ quality of life.
The BS 30440 specification provides a set of criteria for evaluating healthcare AI products, encompassing aspects such as clinical benefit, performance standards, safe integration into clinical environments, ethical considerations, and equitable social outcomes. This framework covers various AI-driven healthcare products, including regulated medical devices, imaging software, patient-facing AI-powered chatbots, and home monitoring devices.
A panel of experts, including clinicians, software engineers, AI specialists, ethicists, and healthcare leaders, collaborated in the development of this specification. By drawing from existing literature and best practices, they translated complex functionality assessments into an auditable framework for AI system conformity.
Healthcare organizations can mandate BS 30440 certification in their procurement processes to ensure adherence to these recognized standards. Scott Steedman, the Director General for Standards at BSI, highlights that the new guidance can foster digital trust in cutting-edge AI tools, benefiting both patients and healthcare professionals. The specification addresses the need for an agreed validation framework for AI development and clinical evaluation in healthcare and has undergone piloting and revision in collaboration with stakeholders in the AI and machine learning fields.
With the publication of this guidance, BSI aims to instill confidence in AI products used in healthcare, enabling doctors, healthcare leaders, and patients to make informed and ethical choices for improved patient care and societal benefit.
