FUTURE-AI: international consensus guideline for trustworthy and deployable artificial intelligence in healthcare

This paper describes the FUTURE-AI framework, which provides guidance for the development and deployment of trustworthy AI tools in healthcare. The FUTURE-AI Consortium was founded in 2021 and comprises 117 interdisciplinary experts from 50 countries representing all continents, including AI scientists, clinical researchers, biomedical ethicists, and social scientists. Over a two year period, the FUTURE-AI guideline was established through consensus based on six guiding principles-fairness, universality, traceability, usability, robustness, and explainability. To operationalise trustworthy AI in healthcare, a set of 30 best practices were defined, addressing technical, clinical, socioethical, and legal dimensions. The recommendations cover the entire lifecycle of healthcare AI, from design, development, and validation to regulation, deployment, and monitoring. data interactions have been increasingly used to develop computer aided models, for example, disease diagnosis, prognosis, prediction of therapy response or survival, and patient stratification. 1 Despite major advances, the deployment and adoption of AI technologies remain limited in real world clinical practice. In recent years, concerns have been raised about the technical, clinical, ethical, and societal risks associated with healthcare AI. 2 3 In particular, existing research has shown that AI tools in healthcare can be prone to errors and patient harm, biases and increased health inequalities, lack of transparency and accountability, as well as data privacy and security breaches. 4-8 To increase adoption in the real world, it is essential that AI tools are trusted and accepted by patients, clinicians, health organisations, and authorities. However, there is an absence of clear, widely accepted guidelines on how healthcare AI tools should be designed, developed, evaluated, and deployed to be trustworthy-that is, technically robust, clinically safe,

The FUTURE-AI Consortium unites 117 experts from 50 countries to define international guidelines for trustworthy healthcare AI The FUTURE-AI framework is structured around six guiding principles: fairness, universality, traceability, usability, robustness, and explainability

The guideline addresses the entire AI lifecycle, from design and development to validation and deployment, ensuring alignment with real world needs and ethical requirements

The framework includes 30 detailed recommendations for building trustworthy and deployable AI systems, emphasising multistakeholder collaboration Continuous risk assessment and mitigation are fundamental, addressing biases, data variations, and evolving challenges during the AI lifecycle FUTURE-AI is designed as a dynamic framework, which will evolve with technological advancements and stakeholder feedback