Theoretical models and frameworks clarify stakeholder perspectives during the commercial digital health innovation life cycleNew framework helps teams navigate complex digital health technology

Health digitalization entails a complex array of actors and roles, including healthcare stakeholders and commercial digital-health innovators. The implementation of digital health innovations (DHIs) is notoriously prone to failure. Consequently, many theories, models, and frameworks (TMFs) have been developed to explain or guide the process of health digitalization. Depending on their scholarly origins, these TMFs differ in their perspective, origin, and terminology, leading to knowledge fragmentation and confusion. The aim of this review was to create an overview of the available TMFs, bringing together and clarifying different perspectives of healthcare stakeholders and innovators during the DHI life cycle. This study focused on TMFs describing, explaining, predicting, or prescribing parts of the innovation pathway considering influential factors and actors. Three databases (PubMed, EMBASE, and Web of Science) were searched using the aid of an information specialist in February 2025. We identified relevant keywords for the search by extensively reviewing eHealth and health digitalization literature. Studies were eligible for inclusion if they were published after 2000, written in English, and presented a new or significantly adapted TMF empirically tested in healthcare settings involving a commercial DHI. Studies applying only a known TMF without contextual adaptation or a DHI in the prototype phase were excluded. From the 4628 potentially relevant articles, 12 fulfilled the inclusion criteria. The included TMFs came from diverse scholarly disciplines, pointing to the multidisciplinary knowledge needed for health digitalization. Four TMFs focused on behavior change of end users, two TMFs explored organizational adoption of the DHI, and six TMFs dealt with factors that shape innovation design and development. Several constructs were found in two or all of the TMF groups. The actors involved came from diverse backgrounds and differed according to the type of DHI and scope of implementation. The included TMFs synthesized foundational theories and constructs from specific problem areas in health digitalization. Analyzing the reasons for adding certain constructs indicated how actors and researchers in the different groups perceive the landscape of health digitalization and the realities that shape the digitalization process, helping to create a holistic view aiding continuity and outward growth of the digitalization team. https://www.crd.york.ac.uk/PROSPERO/view/CRD420251027510, PROSPERO CRD420251027510.