Abstract

Artificial Intelligence (AI) describes systems capable of making decisions of high cognitive complexity; Autonomous AI systems in healthcare are AI systems that make clinical decisions without human oversight. Ensuring that autonomous AI provides these benefits requires evaluation of the Autonomous AI's effect on patient outcome, design, validation, data usage and accountability, from a bioethics and accountability perspective.Case study with literature review and bioethical analysis.Online library search for articles with AI and ethics as subject. Definition of terminology. Review of bioethical principles, and derivation of evaluation rules for Autonomous AI. Case study with an FDA de novo authorized Autonomous AI system.Preliminary evaluation rules derived from bioethical principles include patient outcome, validation, reference standard, design, data usage, and accountability for medical liability. Application of the rules explains successful FDA de novo authorization.Physicians need to become competent in understanding the limitations and risks as well as the potential benefits of autonomous AI, and understand its design, safety, efficacy and equity, validation, liability, and how its data was obtained. The Autonomous AI evaluation rules introduced here can support this process.

View details for DOI 10.1016/j.ajo.2020.02.022

View details for PubMedID 32171769