ISO outlines healthcare-specific safeguards for AI

The International Organization for Standardization (ISO) has published “Healthcare-Specific Considerations for AI”, examining how established principles should apply to healthcare development, evaluation and deployment. Fairness, safety, transparency, human oversight, accountability and data governance must account for the consequences of clinical decisions, sensitive patient information, complex workflows and regulatory requirements.

In personalised medicine, AI supports analysis of complex and multimodal health data, biomarker identification, disease prediction and clinical decision support. Fairness requires distinguishing clinically justified differences in patient care from bias arising from unrepresentative training data, inappropriate proxy variables or existing healthcare inequalities. Strong technical performance alone does not establish clinical suitability. Systems need evaluation against their intended purpose, patient populations and clinical settings, alongside ongoing monitoring because performance can change across healthcare environments.

Meaningful human oversight and patient participation are also central to responsible use. AI recommendations should support clinical judgement, while patients should be able to understand how AI contributes to care decisions, including relevant uncertainties and available alternatives. Data governance, interoperability and clear accountability are particularly important when personalised medicine combines clinical, genomic and other health information across organisations and healthcare systems.