Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives

Introduction. Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed. Areas covered. AI systems may qualify as standalone medical dev...

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Autores: Fraser, Alan G., Biasin, Elisabetta, Bijnens, Bart, Bruining, Nico, Caiani, Enrico G., Cobbaert, Koen, Davies, Rhodri H., Gilbert, Stephen H., Hovestadt, Leo, Kamenjasevic, Erik, Kwade, Zuzanna, McGauran, Gearóid, O’Connor, Gearóid, Vasey, Baptiste, Rademakers, Frank E.
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2023
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositório:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:10230/70215
Acesso em linha:http://hdl.handle.net/10230/70215
http://dx.doi.org/10.1080/17434440.2023.2184685
Access Level:Acceso aberto
Palavra-chave:Medical devices
Professional consensus recommendations
Standards regulations
EU medical device regulation
Artificial intelligence
Evidence-based medicine
Machine learning
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spelling Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiativesFraser, Alan G.Biasin, ElisabettaBijnens, BartBruining, NicoCaiani, Enrico G.Cobbaert, KoenDavies, Rhodri H.Gilbert, Stephen H.Hovestadt, LeoKamenjasevic, ErikKwade, ZuzannaMcGauran, GearóidO’Connor, GearóidVasey, BaptisteRademakers, Frank E.Medical devicesProfessional consensus recommendationsStandards regulationsEU medical device regulationArtificial intelligenceEvidence-based medicineMachine learningIntroduction. Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed. Areas covered. AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device. The draft EU Regulation on AI proposes rules that will apply across industry sectors, while for devices the Medical Device Regulation also applies. In the CORE-MD project (Coordinating Research and Evidence for Medical Devices), we have surveyed definitions and summarize initiatives made by professional consensus groups, regulators, and standardization bodies. Expert opinion. The level of clinical evidence required should be determined according to each application and to legal and methodological factors that contribute to risk, including accountability, transparency, and interpretability. EU guidance for MDSW based on international recommendations does not yet describe the clinical evidence needed for medical AI software. Regulators, notified bodies, manufacturers, clinicians and patients would all benefit from common standards for the clinical evaluation of high-risk AI applications and transparency of their evidence and performance.This work was supported by grant 965246 from the European Union Horizon 2020 Research and Innovation Programme, for the CORE–MD project (Coordinating Research and Evidence for Medical Devices).Taylor & Francis (Routledge)202520252023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/70215http://dx.doi.org/10.1080/17434440.2023.2184685http://hdl.handle.net/10230/70215reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésExpert Review of Medical Devices. 2023 Jun 3;20(6):467-91info:eu-repo/grantAgreement/EC/H2020/8965246© 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/702152026-05-29T05:05:01Z
dc.title.none.fl_str_mv Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
title Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
spellingShingle Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
Fraser, Alan G.
Medical devices
Professional consensus recommendations
Standards regulations
EU medical device regulation
Artificial intelligence
Evidence-based medicine
Machine learning
title_short Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
title_full Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
title_fullStr Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
title_full_unstemmed Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
title_sort Artificial intelligence in medical device software and high-risk medical devices: a review of definitions, expert recommendations and regulatory initiatives
dc.creator.none.fl_str_mv Fraser, Alan G.
Biasin, Elisabetta
Bijnens, Bart
Bruining, Nico
Caiani, Enrico G.
Cobbaert, Koen
Davies, Rhodri H.
Gilbert, Stephen H.
Hovestadt, Leo
Kamenjasevic, Erik
Kwade, Zuzanna
McGauran, Gearóid
O’Connor, Gearóid
Vasey, Baptiste
Rademakers, Frank E.
author Fraser, Alan G.
author_facet Fraser, Alan G.
Biasin, Elisabetta
Bijnens, Bart
Bruining, Nico
Caiani, Enrico G.
Cobbaert, Koen
Davies, Rhodri H.
Gilbert, Stephen H.
Hovestadt, Leo
Kamenjasevic, Erik
Kwade, Zuzanna
McGauran, Gearóid
O’Connor, Gearóid
Vasey, Baptiste
Rademakers, Frank E.
author_role author
author2 Biasin, Elisabetta
Bijnens, Bart
Bruining, Nico
Caiani, Enrico G.
Cobbaert, Koen
Davies, Rhodri H.
Gilbert, Stephen H.
Hovestadt, Leo
Kamenjasevic, Erik
Kwade, Zuzanna
McGauran, Gearóid
O’Connor, Gearóid
Vasey, Baptiste
Rademakers, Frank E.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Medical devices
Professional consensus recommendations
Standards regulations
EU medical device regulation
Artificial intelligence
Evidence-based medicine
Machine learning
topic Medical devices
Professional consensus recommendations
Standards regulations
EU medical device regulation
Artificial intelligence
Evidence-based medicine
Machine learning
description Introduction. Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed. Areas covered. AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device. The draft EU Regulation on AI proposes rules that will apply across industry sectors, while for devices the Medical Device Regulation also applies. In the CORE-MD project (Coordinating Research and Evidence for Medical Devices), we have surveyed definitions and summarize initiatives made by professional consensus groups, regulators, and standardization bodies. Expert opinion. The level of clinical evidence required should be determined according to each application and to legal and methodological factors that contribute to risk, including accountability, transparency, and interpretability. EU guidance for MDSW based on international recommendations does not yet describe the clinical evidence needed for medical AI software. Regulators, notified bodies, manufacturers, clinicians and patients would all benefit from common standards for the clinical evaluation of high-risk AI applications and transparency of their evidence and performance.
publishDate 2023
dc.date.none.fl_str_mv 2023
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/70215
http://dx.doi.org/10.1080/17434440.2023.2184685
http://hdl.handle.net/10230/70215
url http://hdl.handle.net/10230/70215
http://dx.doi.org/10.1080/17434440.2023.2184685
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Expert Review of Medical Devices. 2023 Jun 3;20(6):467-91
info:eu-repo/grantAgreement/EC/H2020/8965246
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Taylor & Francis (Routledge)
publisher.none.fl_str_mv Taylor & Francis (Routledge)
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
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