Abstract
BACKGROUND: Clinicians' scope of responsibilities is being steadily transformed by digital health solutions that operate with or without artificial intelligence (DAI solutions). Most tools developed to foster ethical practices lack rigor and do not concurrently capture the health, social, economic, and environmental issues that such solutions raise. OBJECTIVE: To support clinical leadership in this field, we aimed to develop a comprehensive, valid, and reliable tool that measures the responsibility of DAI solutions by adapting the multidimensional and already validated Responsible Innovation in Health Tool. METHODS: We conducted a 3-phase mixed methods study. Relying on a scoping review of available tools, phase 1 (concept mapping) led to a preliminary version of the Responsible DAI solutions Assessment Tool. In phase 2, an international 2-round e-Delphi expert panel rated on a 5-level scale the importance, clarity, and appropriateness of the tool's components. In phase 3, a total of 2 raters independently applied the revised tool to a sample of DAI solutions (n=25), interrater reliability was measured, and final minor changes were made to the tool. RESULTS: The mapping process identified a comprehensive set of responsibility premises, screening criteria, and assessment attributes specific to DAI solutions. e-Delphi experts critically assessed these new components and provided comments to increase content validity (n=293), and after round 2, consensus was reached on 85% (22/26) of the items surveyed. Interrater agreement was substantial for a subcriterion and almost perfect for all other criteria and assessment attributes. CONCLUSIONS: The Responsible DAI solutions Assessment Tool offers a comprehensive, valid, and reliable means of assessing the degree of responsibility of DAI solutions in health. As regulation remains limited, this forward-looking tool has the potential to change practice toward more equitable as well as economically and environmentally sustainable digital health care.