Artificial intelligence in medicine: mitigating risks and maximizing benefits via quality assurance, quality control, and acceptance testing.

The adoption of artificial intelligence (AI) tools in medicine poses challenges to existing clinical workflows. This commentary discusses the necessity of context-specific quality assurance (QA), emphasizing the need for robust QA measures with quality control (QC) procedures that encompass (1) acceptance testing (AT) before clinical use, (2) continuous QC monitoring, and (3) adequate user training. The discussion also covers essential components of AT and QA, illustrated with real-world examples. We also highlight what we see as the shared responsibility of manufacturers or vendors, regulators, healthcare systems, medical physicists, and clinicians to enact appropriate testing and oversight to ensure a safe and equitable transformation of medicine through AI.
Competing Interests: U.M., A.S.-D., H.-P.C., R.K.S., D.V., H.G., N.P., B.S., Z.H., K.C., G.T., T.M.D., D.R., R.M., and L.H. have nothing to disclose. K.D. receives royalties from Hologic. Q.C. has received compensations from Carina Medical LLC, not related to this work, provides consulting services for Reflexion Medical, not related to this work. R.M.S. received royalties for patents or software licenses from iCAD, Philips, ScanMed, Translation Holdings, PingAn, and MGB, and received research support from PingAn through a Cooperative Research and Development Agreement, not related to this work. J.J.N. has received royalties from Hologic and from MEDIAN Technologies, through the University of Chicago licensing, not related to this work. H.Y. has received royalties from licensing fees to Hologic and Medians Technologies through the University of Chicago licensing, not related to this work. K.S. provides consulting services for Canon Medical, not related to this work. L.M. has received funding from HealthTriagesrl, not related to this work. H.H. has received funding from Siemens Healthineers for a scientific research project, not related to this work. SG.A. III has received royalties and licensing fees for computer-aided diagnosis through the University of Chicago Consultant, Novartis, not related to this work.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the British Institute of Radiology.)