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Regulating the safety of health-related Artificial Intelligence

Regulating the safety of health-related Artificial Intelligence
Regulating the safety of health-related Artificial Intelligence
This article analyzes whether Canada’s present approach to regulating health-related artificial intelligence (AI) can address relevant safety-related challenges. Focusing primarily on Health Canada’s regulation of medical devices with AI, it examines whether the existing regulatory approach can adequately address general safety concerns as well as those related to algorithmic bias and challenges posed by the intersections of these concerns with privacy and security interests. It identifies several issues and proposes reforms that aim to ensure Canadians can access beneficial AI while keeping unsafe products off Canadian markets and motivating safe, effective use of AI products for appropriate purposes and populations.
Artificial Intelligence, Medical Devices, Safety, Algorithmic Bias, Data Protection, Software as a Medical Device, AI
1715-6572
63-77
Da Silva, Michael
05ad649f-8409-4012-8edc-88709b1a3182
Flood, Colleen
a3853c9e-6bd3-400e-b908-140559d871a0
Goldenberg, Anna
98c9d6c5-65fd-4b4c-aee9-4a6fcffb498b
Singh, Devin
01386f99-c49a-4119-ac1a-783145c66c87
Da Silva, Michael
05ad649f-8409-4012-8edc-88709b1a3182
Flood, Colleen
a3853c9e-6bd3-400e-b908-140559d871a0
Goldenberg, Anna
98c9d6c5-65fd-4b4c-aee9-4a6fcffb498b
Singh, Devin
01386f99-c49a-4119-ac1a-783145c66c87

Da Silva, Michael, Flood, Colleen, Goldenberg, Anna and Singh, Devin (2022) Regulating the safety of health-related Artificial Intelligence. Healthcare Policy, 17 (4), 63-77.

Record type: Article

Abstract

This article analyzes whether Canada’s present approach to regulating health-related artificial intelligence (AI) can address relevant safety-related challenges. Focusing primarily on Health Canada’s regulation of medical devices with AI, it examines whether the existing regulatory approach can adequately address general safety concerns as well as those related to algorithmic bias and challenges posed by the intersections of these concerns with privacy and security interests. It identifies several issues and proposes reforms that aim to ensure Canadians can access beneficial AI while keeping unsafe products off Canadian markets and motivating safe, effective use of AI products for appropriate purposes and populations.

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More information

Accepted/In Press date: 18 February 2022
Published date: 25 May 2022
Keywords: Artificial Intelligence, Medical Devices, Safety, Algorithmic Bias, Data Protection, Software as a Medical Device, AI

Identifiers

Local EPrints ID: 457282
URI: http://eprints.soton.ac.uk/id/eprint/457282
ISSN: 1715-6572
PURE UUID: a95c56be-f1bc-4821-869d-f1d64eadb1ad

Catalogue record

Date deposited: 30 May 2022 17:03
Last modified: 30 May 2022 17:04

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Contributors

Author: Michael Da Silva
Author: Colleen Flood
Author: Anna Goldenberg
Author: Devin Singh

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