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dc.contributor.authorMinssen, Timoen
dc.contributor.authorGerke, Saraen
dc.contributor.authorAboy, Mateoen
dc.contributor.authorPrice, Nicholsonen
dc.contributor.authorCohen, Glennen
dc.date.accessioned2020-12-08T00:30:36Z
dc.date.available2020-12-08T00:30:36Z
dc.identifier.issn2053-9711
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/314835
dc.description.abstractCompanies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML). MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and Europe. We then examine international perspectives and broader implications, discussing considerations such as data privacy, exportation, explanation, training set bias, contextual bias, and trade secrecy.
dc.languageenen
dc.publisherOxford University Press (OUP)
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttps://creativecommons.org/licenses/by-nc-nd/4.0/
dc.titleRegulatory responses to medical machine learningen
dc.typeArticle
prism.publicationNameJournal of Law and the Biosciencesen
dc.identifier.doi10.17863/CAM.61941
dcterms.dateAccepted2020-03-16en
rioxxterms.versionofrecord10.1093/jlb/lsaa002en
rioxxterms.versionVoR
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2020-03-16en
dc.identifier.eissn2053-9711
rioxxterms.typeJournal Article/Reviewen
cam.issuedOnline2020-04-11en


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Attribution-NonCommercial-NoDerivatives 4.0 International
Except where otherwise noted, this item's licence is described as Attribution-NonCommercial-NoDerivatives 4.0 International