  Despite major advances in artificial intelligence (AI) for medicine and
healthcare, 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 legal risks associated with medical AI. To
increase real world adoption, it is essential that medical AI tools are trusted
and accepted by patients, clinicians, health organisations and authorities.
This work describes the FUTURE-AI guideline as the first international
consensus framework for guiding the development and deployment of trustworthy
AI tools in healthcare. The FUTURE-AI consortium was founded in 2021 and
currently comprises 118 inter-disciplinary experts from 51 countries
representing all continents, including AI scientists, clinicians, ethicists,
and social scientists. Over a two-year period, the consortium defined guiding
principles and best practices for trustworthy AI through an iterative process
comprising an in-depth literature review, a modified Delphi survey, and online
consensus meetings. The FUTURE-AI framework was established based on 6 guiding
principles for trustworthy AI in healthcare, i.e. Fairness, Universality,
Traceability, Usability, Robustness and Explainability. Through consensus, a
set of 28 best practices were defined, addressing technical, clinical, legal
and socio-ethical dimensions. The recommendations cover the entire lifecycle of
medical AI, from design, development and validation to regulation, deployment,
and monitoring. FUTURE-AI is a risk-informed, assumption-free guideline which
provides a structured approach for constructing medical AI tools that will be
trusted, deployed and adopted in real-world practice. Researchers are
encouraged to take the recommendations into account in proof-of-concept stages
to facilitate future translation towards clinical practice of medical AI.
