Regulatory Responses to Medical Machine Learning

Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa002, https://doi.org/10.1093/jlb/lsaa002

Posted: 14 Aug 2020 Last revised: 7 Jul 2021

See all articles by Timo Minssen

Timo Minssen

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law

Sara Gerke

Pennsylvania State University, Dickinson Law

Mateo Aboy

LML, University of Cambridge

W. Nicholson Price II

University of Michigan Law School

I. Glenn Cohen

Harvard Law School

Date Written: April 11, 2020

Abstract

Companies 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.

Keywords: Medical Devices, Artificial Intelligence, Regulation

JEL Classification: I1, K

Suggested Citation

Minssen, Timo and Gerke, Sara and Aboy, Mateo and Price II, William Nicholson and Cohen, I. Glenn, Regulatory Responses to Medical Machine Learning (April 11, 2020). Journal of Law and the Biosciences, Volume 7, Issue 1, January-June 2020, lsaa002, https://doi.org/10.1093/jlb/lsaa002, Available at SSRN: https://ssrn.com/abstract=3651093

Timo Minssen (Contact Author)

University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law ( email )

Karen Blixens Plads 16
Copenhagen, 2300
Denmark
+46 708 607517 (Phone)

HOME PAGE: http://jura.ku.dk/cebil/staff/profile/?pure=en/persons/381631

Sara Gerke

Pennsylvania State University, Dickinson Law ( email )

150 S College St
Carlisle, PA 17013
United States

Mateo Aboy

LML, University of Cambridge ( email )

Trinity Ln
Cambridge, CB2 1TN
United Kingdom

HOME PAGE: http://www.lml.law.cam.ac.uk/people/Research-Scholars-Associates/Prof-mateo-aboy

William Nicholson Price II

University of Michigan Law School ( email )

625 South State Street
Ann Arbor, MI 48109-1215
United States

I. Glenn Cohen

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

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