article · BMJ
Deployment and uptake of artificial intelligence in clinical healthcare practice remain limited despite significant research advances. To address this gap, the FUTURE-AI framework delivers international guidance for building and implementing trustworthy healthcare tools. Developed over two years by an interdisciplinary consortium of 117 experts from 50 countries, the consensus framework is structured around six core principles: fairness, universality, traceability, usability, robustness, and explainability. These principles are operationalised through 30 best practices that address technical, clinical, legal, and socioethical considerations. The resulting recommendations cover the entire lifecycle of healthcare artificial intelligence, guiding projects from design, development, and validation through to regulatory assessment, clinical deployment, and long-term monitoring.
Although artificial intelligence offers immense potential for medicine, moving algorithms into real-world healthcare settings requires safety, trust, and accountability. By providing globally agreed standards across technical, ethical, and legal requirements, this framework offers a shared roadmap to help ensure that emerging medical software tools are safe, effective, and ethically sound for clinicians and patients.
The framework functions as an operational guideline directly applicable to technology developers, clinical teams, and regulatory bodies. Because it defines 30 concrete best practices spanning design, validation, regulation, deployment, and monitoring, it offers ready-to-use criteria for commercial entities seeking to navigate compliance and advance healthcare artificial intelligence tools from development into actual clinical deployment.
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Despite major advances in artificial intelligence (AI) research for healthcare, the deployment and adoption of AI technologies remain limited in clinical practice. 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.
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DOI: 10.1136/bmj-2024-081554
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