Background: The uptake of artificial intelligence (AI) in health care is at an early stage. Recent studies have shown a lack of AI-specific implementation theories, models, or frameworks that could provide guidance for how to translate the potential of AI into daily health care practices. This protocol provides an outline for the first 5 years of a research program seeking to address this knowledge-practice gap through collaboration and co-design between researchers, health care professionals, patients, and industry stakeholders.

Objective: The first part of the program focuses on two specific objectives. The first objective is to develop a theoretically informed framework for AI implementation in health care that can be applied to facilitate such implementation in routine health care practice. The second objective is to carry out empirical AI implementation studies, guided by the framework for AI implementation, and to generate learning for enhanced knowledge and operational insights to guide further refinement of the framework. The second part of the program addresses a third objective, which is to apply the developed framework in clinical practice in order to develop regional capacity to provide the practical resources, competencies, and organizational structure required for AI implementation; however, this objective is beyond the scope of this protocol.

Methods: This research program will use a logic model to structure the development of a methodological framework for planning and evaluating implementation of AI systems in health care and to support capacity building for its use in practice. The logic model is divided into time-separated stages, with a focus on theory-driven and coproduced framework development. The activities are based on both knowledge development, using existing theory and literature reviews, and method development by means of co-design and empirical investigations. The activities will involve researchers, health care professionals, and other stakeholders to create a multi-perspective understanding.

Results: The project started on July 1, 2021, with the Stage 1 activities, including model overview, literature reviews, stakeholder mapping, and impact cases; we will then proceed with Stage 2 activities. Stage 1 and 2 activities will continue until June 30, 2026.

Conclusions: There is a need to advance theory and empirical evidence on the implementation requirements of AI systems in health care, as well as an opportunity to bring together insights from research on the development, introduction, and evaluation of AI systems and existing knowledge from implementation research literature. Therefore, with this research program, we intend to build an understanding, using both theoretical and empirical approaches, of how the implementation of AI systems should be approached in order to increase the likelihood of successful and widespread application in clinical practice. © Petra Svedberg, Julie Reed, Per Nilsen, James Barlow, Carl Macrae, Jens Nygren.