OnRAMP for Regulating Artificial Intelligence in Medical Products

Medical artificial intelligence (AI) involves the application of machine learning (ML) algorithms to biomedical datasets to improve medical practices. Products incorporating medical AI require certification before deployment in most jurisdictions. To date, clear pathways for regulating medical AI ar...

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Autor principal:	David C. Higgins
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	artificial intelligence biostatistics medical applications methodologies regulatory guideline Computer engineering. Computer hardware TK7885-7895 Control engineering systems. Automatic machinery (General) TJ212-225
Acceso en línea:	https://doaj.org/article/ea7023db755c46c5a2849fadf82ab523
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spelling	oai:doaj.org-article:ea7023db755c46c5a2849fadf82ab5232021-11-23T07:58:48ZOnRAMP for Regulating Artificial Intelligence in Medical Products2640-456710.1002/aisy.202100042https://doaj.org/article/ea7023db755c46c5a2849fadf82ab5232021-11-01T00:00:00Zhttps://doi.org/10.1002/aisy.202100042https://doaj.org/toc/2640-4567Medical artificial intelligence (AI) involves the application of machine learning (ML) algorithms to biomedical datasets to improve medical practices. Products incorporating medical AI require certification before deployment in most jurisdictions. To date, clear pathways for regulating medical AI are still under development. Below the level of formal pathways lies the actual practice of developing a medical AI solution. This Perspective proposes best practice guidelines for development compatible with the production of a regulatory package which, regardless of the formal regulatory path, will form a core component of a certification process. The approach is predicated on a statistical risk perspective, typical of medical device regulators, and a deep understanding of ML methodologies. These guidelines will allow all parties to communicate more clearly in the development of a common good machine learning practice (GMLP), and thus lead to the enhanced development of both medical AI products and regulations.David C. HigginsWileyarticleartificial intelligencebiostatisticsmedical applicationsmethodologiesregulatory guidelineComputer engineering. Computer hardwareTK7885-7895Control engineering systems. Automatic machinery (General)TJ212-225ENAdvanced Intelligent Systems, Vol 3, Iss 11, Pp n/a-n/a (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	artificial intelligence biostatistics medical applications methodologies regulatory guideline Computer engineering. Computer hardware TK7885-7895 Control engineering systems. Automatic machinery (General) TJ212-225
spellingShingle	artificial intelligence biostatistics medical applications methodologies regulatory guideline Computer engineering. Computer hardware TK7885-7895 Control engineering systems. Automatic machinery (General) TJ212-225 David C. Higgins OnRAMP for Regulating Artificial Intelligence in Medical Products
description	Medical artificial intelligence (AI) involves the application of machine learning (ML) algorithms to biomedical datasets to improve medical practices. Products incorporating medical AI require certification before deployment in most jurisdictions. To date, clear pathways for regulating medical AI are still under development. Below the level of formal pathways lies the actual practice of developing a medical AI solution. This Perspective proposes best practice guidelines for development compatible with the production of a regulatory package which, regardless of the formal regulatory path, will form a core component of a certification process. The approach is predicated on a statistical risk perspective, typical of medical device regulators, and a deep understanding of ML methodologies. These guidelines will allow all parties to communicate more clearly in the development of a common good machine learning practice (GMLP), and thus lead to the enhanced development of both medical AI products and regulations.
format	article
author	David C. Higgins
author_facet	David C. Higgins
author_sort	David C. Higgins
title	OnRAMP for Regulating Artificial Intelligence in Medical Products
title_short	OnRAMP for Regulating Artificial Intelligence in Medical Products
title_full	OnRAMP for Regulating Artificial Intelligence in Medical Products
title_fullStr	OnRAMP for Regulating Artificial Intelligence in Medical Products
title_full_unstemmed	OnRAMP for Regulating Artificial Intelligence in Medical Products
title_sort	onramp for regulating artificial intelligence in medical products
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/ea7023db755c46c5a2849fadf82ab523
work_keys_str_mv	AT davidchiggins onrampforregulatingartificialintelligenceinmedicalproducts
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OnRAMP for Regulating Artificial Intelligence in Medical Products

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