Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions

The integration of Quality Management System (QMS) principles into the life cycle of development, deployment, and utilization of machine learning (ML) and artificial intelligence (AI) technologies within healthcare settings holds the potential to close the AI translation gap by establishing a robust...

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Main Authors: Shauna M. Overgaard, Megan G. Graham, Tracey Brereton, Michael J. Pencina, John D. Halamka, David E. Vidal, Nicoleta J. Economou-Zavlanos
Format: Article
Language:English
Published: Nature Portfolio 2023-11-01
Series:npj Digital Medicine
Online Access:https://doi.org/10.1038/s41746-023-00968-8
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author Shauna M. Overgaard
Megan G. Graham
Tracey Brereton
Michael J. Pencina
John D. Halamka
David E. Vidal
Nicoleta J. Economou-Zavlanos
author_facet Shauna M. Overgaard
Megan G. Graham
Tracey Brereton
Michael J. Pencina
John D. Halamka
David E. Vidal
Nicoleta J. Economou-Zavlanos
author_sort Shauna M. Overgaard
collection DOAJ
description The integration of Quality Management System (QMS) principles into the life cycle of development, deployment, and utilization of machine learning (ML) and artificial intelligence (AI) technologies within healthcare settings holds the potential to close the AI translation gap by establishing a robust framework that accelerates the safe, ethical, and effective delivery of AI/ML in day-to-day patient care. Healthcare organizations (HCOs) can implement these principles effectively by embracing an enterprise QMS analogous to those in regulated industries. By establishing a QMS explicitly tailored to health AI technologies, HCOs can comply with evolving regulations and minimize redundancy and rework while aligning their internal governance practices with their steadfast commitment to scientific rigor and medical excellence.
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spelling doaj.art-12978f36937843baad12e4f776b42da22023-11-26T14:19:32ZengNature Portfolionpj Digital Medicine2398-63522023-11-01611510.1038/s41746-023-00968-8Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutionsShauna M. Overgaard0Megan G. Graham1Tracey Brereton2Michael J. Pencina3John D. Halamka4David E. Vidal5Nicoleta J. Economou-Zavlanos6Mayo ClinicMayo ClinicMayo ClinicDuke UniversityMayo ClinicMayo ClinicDuke UniversityThe integration of Quality Management System (QMS) principles into the life cycle of development, deployment, and utilization of machine learning (ML) and artificial intelligence (AI) technologies within healthcare settings holds the potential to close the AI translation gap by establishing a robust framework that accelerates the safe, ethical, and effective delivery of AI/ML in day-to-day patient care. Healthcare organizations (HCOs) can implement these principles effectively by embracing an enterprise QMS analogous to those in regulated industries. By establishing a QMS explicitly tailored to health AI technologies, HCOs can comply with evolving regulations and minimize redundancy and rework while aligning their internal governance practices with their steadfast commitment to scientific rigor and medical excellence.https://doi.org/10.1038/s41746-023-00968-8
spellingShingle Shauna M. Overgaard
Megan G. Graham
Tracey Brereton
Michael J. Pencina
John D. Halamka
David E. Vidal
Nicoleta J. Economou-Zavlanos
Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions
npj Digital Medicine
title Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions
title_full Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions
title_fullStr Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions
title_full_unstemmed Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions
title_short Implementing quality management systems to close the AI translation gap and facilitate safe, ethical, and effective health AI solutions
title_sort implementing quality management systems to close the ai translation gap and facilitate safe ethical and effective health ai solutions
url https://doi.org/10.1038/s41746-023-00968-8
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