BackgroundArtificial intelligence (AI) and digital health technological innovations from startup companies used in clinical practice can yield better health outcomes, reduce health care costs, and improve patients' experience. However, the integration, translation, and adoption of these technologies into clinical practice are plagued with many challenges and are lagging. Furthermore, explanations of the impediments to clinical translation are largely unknown and have not been systematically studied from the perspective of AI and digital health care startup founders and executives.ObjectiveThe aim of this paper is to describe the barriers to integrating early-stage technologies in clinical practice and health care systems from the perspectives of digital health and health care AI founders and executives.MethodsA stakeholder focus group workshop was conducted with a sample of 10 early-stage digital health and health care AI founders and executives. Digital health, health care AI, digital health–focused venture capitalists, and physician executives were represented. Using an inductive thematic analysis approach, transcripts were organized, queried, and analyzed for thematic convergence.ResultsWe identified the following four categories of barriers in the integration of early-stage digital health innovations into clinical practice and health care systems: (1) lack of knowledge of health system technology procurement protocols and best practices, (2) demanding regulatory and validation requirements, (3) challenges within the health system technology procurement process, and (4) disadvantages of early-stage digital health companies compared to large technology conglomerates. Recommendations from the study participants were also synthesized to create a road map to mitigate the barriers to integrating early-stage or novel digital health technologies in clinical practice.ConclusionsEarly-stage digital health and health care AI entrepreneurs identified numerous barriers to integrating digital health solutions into clinical practice. Mitigation initiatives should create opportunities for early-stage digital health technology companies and health care providers to interact, develop relationships, and use evidence-based research and best practices during health care technology procurement and evaluation processes.