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 (BPES) Framework

• Published in: Journal of medical Internet research Vol. 25; no. 1; p. e43386
• Main Authors: Khan, Waqas Ullah, Seto, Emily
• Format: Journal Article
• Language: English
• Published: Canada Gunther Eysenbach MD MPH, Associate Professor 05.04.2023; JMIR Publications
• Subjects: Algorithms; Artificial Intelligence; Biopsychosocial aspects; Cardiac arrhythmia; Checklist; Cost analysis; Decision making; Decision support systems; Deployment; Frame analysis; GDP; Government; Government Agencies; Gross Domestic Product; Health care access; Health care expenditures; Health care policy; Health status; Hippocratic oath; Humans; International organizations; Medical personnel; Medical technology; Mental health; Mobile Applications; Patients; Product testing; Professionals; Psychiatry; Public health; Regulatory agencies; Safety; Safety research; Smartwatches; Society; Stakeholders; Technology; Viewpoint; Wearable computers; Welfare; United States > US; AI medical hardware devices; economic factors; safety checklist; social factors; Do No Harm; AI; AI medical mobile apps; artificial intelligence; AI medical software programs; biological-psychological factors
• ISSN: 1438-8871; 1439-4456; 1438-8871
• DOI: 10.2196/43386

Given the impact artificial intelligence (AI)-based medical technologies (hardware devices, software programs, and mobile apps) 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 3-step framework to guide industry developers of AI-based medical tools as well as health care 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, health care 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 value of their AI tool before it is launched. We also introduce a novel cost-effective, time-sensitive, and safety-oriented mixed quantitative and qualitative clinical phased trial approach to help industry and government health care regulatory agencies test and deliberate on whether to launch these AI-based medical technologies. To our knowledge, our biological-psychological, economic, and social (BPES) framework and mixed method phased trial approach are the first to place the Hippocratic Oath of "Do No Harm" at the center of developers', implementers', regulators', and users' mindsets when determining whether an AI-based medical technology is safe to launch. Moreover, as the welfare of AI users and developers becomes a greater concern, our framework's novel safety feature will allow it to complement existing and future AI reporting guidelines.