From innovation to integration: a bibliometric-systematic review of digital therapeutics and their impact on healthcare

Digital therapeutics (DTx) are an emerging class of evidence-based software interventions developed to prevent, manage, or treat medical conditions. Their increasing application across clinical settings reflects their potential to improve healthcare accessibility, enhance patient engagement, and support better treatment outcomes. When combined with artificial intelligence (AI), DTx can offer advanced capabilities such as real-time monitoring, personalised interventions, and predictive analytics, further strengthening its clinical impact. However, despite these technological advancements, widespread adoption remains limited due to persistent challenges in regulatory compliance, integration within clinical workflows, and the lack of standardised frameworks for evaluating effectiveness. This study presents a systematic literature review conducted according to PRISMA guidelines to explore the empirical landscape surrounding the implementation, ethical integration, and assessment of DTx within healthcare systems. From an initial pool of 1,951 records, 114 peer-reviewed studies met the inclusion criteria. The analysis identified three central research gaps: first, barriers to integration arising from limited acceptance by healthcare providers and patients; second, unresolved ethical and regulatory issues related to AI use, particularly concerning data privacy, algorithmic bias, and transparency; and third, the absence of consistent clinical benchmarks for evaluating DTx across different therapeutic areas. Bibliometric and thematic analyses reveal a rapidly expanding body of literature, with increasing attention to mental health and chronic disease management. AI integration stands out as a promising yet insufficiently validated DTx dimension. These findings highlight the need for unified regulatory approaches, robust ethical oversight, and interdisciplinary collaboration to support digital therapeutics' safe and effective integration into routine clinical care.