Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Oct 10, 2022
Open Peer Review Period: Oct 10, 2022 - Dec 5, 2022
Date Accepted: Mar 10, 2023
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
A “Do No Harm” Novel Safety Checklist and Research Approach to Determine Whether to Launch an Artificial Intelligence Based Medical Technology – Introducing the Biological-Psychological, Economic, and Social Framework
ABSTRACT
In light of the impact artificial intelligence (AI) based medical technologies can have on society, debates regarding the principles behind their development and deployment are emerging. Using the Biopsychosocial model applied in Psychiatry and other fields of medicine as our foundation, we propose a novel three step framework to guide technology industry developers of AI-based medical tools as well as healthcare regulatory agencies on how to decide if a product should be launched; a “Go or No-Go” approach. More specifically, our novel framework places stakeholders (patients, healthcare professionals, industry, and government institutions) safety at its core by asking developers to demonstrate the biological-psychological (impact on physical and mental health), economic, and social (BPES) value of their AI tool before it is launched. We also introduce a novel cost-effective, time-sensitive, and stakeholder safety oriented quantitative and qualitative clinical phased trial approach to help industry and government healthcare regulatory agencies test and deliberate on whether to launch these AI based medical technologies. To our knowledge, our BPES framework and mixed method phased trial approach are the first to place the Hippocratic Oath of “Do No Harm” at the centre of developers, implementers, regulators, and users mindsets when determining whether an AI-based medical technology is safe to launch.
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Copyright
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