Frontiers in Digital Health | |
A Perspective on a Quality Management System for AI/ML-Based Clinical Decision Support in Hospital Care | |
Jeroen Dudink1  Saskia Haitjema2  Annemarie van ‘t Veen3  Richard Bartels5  Daniel Oberski5  | |
[1] Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands;Central Diagnostic Laboratory, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands;Department of Medical Microbiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands;Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands;Digital Health, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands; | |
关键词: AI; machine learning (ML); clinical decision support; implementation; quality management system; ISO15189; | |
DOI : 10.3389/fdgth.2022.942588 | |
来源: DOAJ |
【 摘 要 】
Although many artificial intelligence (AI) and machine learning (ML) based algorithms are being developed by researchers, only a small fraction has been implemented in clinical-decision support (CDS) systems for clinical care. Healthcare organizations experience significant barriers implementing AI/ML models for diagnostic, prognostic, and monitoring purposes. In this perspective, we delve into the numerous and diverse quality control measures and responsibilities that emerge when moving from AI/ML-model development in a research environment to deployment in clinical care. The Sleep-Well Baby project, a ML-based monitoring system, currently being tested at the neonatal intensive care unit of the University Medical Center Utrecht, serves as a use-case illustrating our personal learning journey in this field. We argue that, in addition to quality assurance measures taken by the manufacturer, user responsibilities should be embedded in a quality management system (QMS) that is focused on life-cycle management of AI/ML-CDS models in a medical routine care environment. Furthermore, we highlight the strong similarities between AI/ML-CDS models and in vitro diagnostic devices and propose to use ISO15189, the quality guideline for medical laboratories, as inspiration when building a QMS for AI/ML-CDS usage in the clinic. We finally envision a future in which healthcare institutions run or have access to a medical AI-lab that provides the necessary expertise and quality assurance for AI/ML-CDS implementation and applies a QMS that mimics the ISO15189 used in medical laboratories.
【 授权许可】
Unknown