BSI Releases Guidance on BS 30440: Building Trust in ai for Medical Diagnostics and Treatments
In response to the growing debate on the appropriate use of ai in healthcare, the (BSI) has issued a new high-level guidance document titled BS 30440: Healthcare ai Products – Evaluation Criteria.
Boosting Confidence in Safe, Effective, and Ethical ai Tools
This auditable standard aims to help healthcare professionals, clinicians, and providers make informed decisions regarding the development of ai tools for interventions, diagnoses, and health condition management.
Navigating the Global Healthcare ai Market
With the global healthcare ai market projected to exceed $187.95 billion by 2030, the need for a standardized evaluation process becomes increasingly important as healthcare providers and clinicians face challenges in assessing ai products due to time, budget constraints or lack of in-house capabilities.
Comprehensive Evaluation Criteria for Healthcare ai Products
The BS 30440 specification covers a wide range of healthcare ai products, including regulated medical devices, imaging software, patient-facing products like ai chatbots, and home monitoring devices. It is applicable to both ai system suppliers and product auditors.
Collaborative Development Process
The development of this standard involved a panel of experts, including clinicians, software engineers, ai specialists, ethicists, and healthcare leaders. The guidance draws from existing literature and best practices to create an auditable framework for evaluating the conformity of ai systems.
Empowering Informed Choices in Healthcare
Healthcare organizations can require BS 30440 certification during procurement processes to ensure adherence to these recognized standards. This guidance from BSI is designed to instill confidence in ai products used for medical purposes and empower doctors, healthcare leaders, and patients to make informed decisions.
Setting the Stage for Safe and Ethical ai Integration
The publication of this guidance marks a significant step in ensuring the safe and effective integration of ai technologies in medical practice as they continue to shape the future of healthcare.
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