BackgroundThe idea of using serious games to effectuate better outcomes in health care has gained significant traction among a growing community of researchers, developers, and health care professionals. Many now recognize the importance of creating evidence-based games that are purposefully designed to address physical and mental health challenges faced by end users. To date, no regulatory resources have been established to guide the development of serious games for health (SGH). Developers must therefore look elsewhere for guidance. Although a more robust level of evidence exists in the research literature, it is neither structured nor is there any clear consensus. Developers currently use a variety of approaches and methodologies. The establishment of a well-defined framework that represents the consensus views of the SGH research community would help developers improve the efficiency of internal development processes, as well as chances of success. A consensus framework would also enhance the credibility of SGH and help provide quality evidence of their effectiveness.ObjectiveThis research aimed to (1) identify and evaluate the requirements, recommendations, and guidelines proposed by the SGH community in the research literature, and; (2) develop a consensus framework to guide developers, designers, researchers, and health care professionals in the development of evidence-based SGH.MethodsA critical review of the literature was performed in October to November 2018. A 3-step search strategy and a predefined set of inclusion criteria were used to identify relevant articles in PubMed, ScienceDirect, Institute of Electrical and Electronics Engineers Xplore, CiteSeerX, and Google Scholar. A supplemental search of publications from regulatory authorities was conducted to capture their specific requirements. Three researchers independently evaluated the identified articles. The evidence was coded and categorized for analysis.ResultsThis review identified 5 categories of high-level requirements and 20 low-level requirements suggested by the SGH community. These advocate a methodological approach that is multidisciplinary, iterative, and participatory. On the basis of the requirements identified, we propose a framework for developing theory-driven, evidence-based SGH. It comprises 5 stages that are informed by various stakeholders. It focuses on building strong scientific and design foundations that guide the creative and technical development. It includes quantitative trials to evaluate whether the SGH achieve the intended outcomes, as well as efforts to disseminate trial findings and follow-up monitoring after the SGH are rolled out for use.ConclusionsThis review resulted in the formulation of a framework for developing theory-driven, evidence-based SGH that represents many of the requirements set out by SGH stakeholders in the literature. It covers all aspects of the development process (scientific, technological, and design) and is transparently described in sufficient detail to allow SGH stakeholders to implement it in a wide variety of projects, irrespective of discipline, health care segments, or focus.