The intersection of digital health and artificial intelligence: Clearing the cloud of uncertainty.

Digital health (DH) and artificial intelligence (AI) in healthcare are rapidly evolving but were addressed synonymously by many healthcare authorities and practitioners. A deep understanding and clarification of these concepts are fundamental and a prerequisite for developing robust frameworks and practical guidelines to ensure the safety, efficacy, and effectiveness of DH solutions and AI-embedded technologies. Categorizing DH into technologies (DHTs) and services (DHSs) enables regulatory, HTA, and reimbursement bodies to develop category-specific frameworks and guidelines for evaluating these solutions effectively. DH is the key in generating real-world data, which is increasingly important in decision-making processes. The potential benefits of DHTs in improving health outcomes and reducing health system costs can position them alongside traditional health technologies in certain medical conditions. AI, one of the potential tools for DH, can be embedded in technologies, such as medical devices or applications, to enhance functionality and performance. AI excels at handling numerical and perceptual data. In the context of numerical data, machine learning algorithms enable prediction, classification, and clustering. In managing perceptual data, AI recognizes image/video, voice, and text. In recent years, generative AI, a form of AI that generates new content by employing a combination of a wide range of learning approaches, has become prominent in research and influences the health sector. A thorough understanding of DH and AI, along with accurate terminology use, would facilitate the timely generation of regulatory and HTA-grade evidence that helps improve health outcomes and decision-making certainty.