Evaluating the Impact of Regulatory Guidelines on Market Adoption and Implementation of Telehealth for COPD Patients: A Systematic Literature Review.

Abstract

<b>Purpose:</b> Telehealth (TH) offers promising solutions for enhancing the management of chronic obstructive pulmonary disease (COPD), particularly in resource-limited or remote settings. However, regulatory uncertainty remains a significant barrier to adopting and integrating TH technologies into routine care. This systematic review aims to evaluate the role of regulatory guidelines in implementing and adopting TH solutions for COPD care and to identify key barriers and facilitators shaping these regulatory efforts. <b>Methods:</b> Following PRISMA guidelines, a comprehensive search of five databases up to 18 October 2025 (PubMed, Web of Science, Scopus, CINAHL, and JSTOR) and grey literature was conducted. Studies and governmental reports were included if they examined regulatory frameworks, stakeholder perspectives, or implementation challenges related to TH in COPD care. Study quality was assessed using the Critical Appraisal Skills Programme (CASP) tool. Narrative and data synthesis were employed. <b>Results:</b> From 343 identified records, 33 sources (18 peer-reviewed studies and 15 governmental/organizational reports) met the inclusion criteria. Findings revealed wide disparities in the existence, specificity, and enforcement of TH regulatory guidelines across countries. Developed nations often had more structured yet nonspecific frameworks, while emerging health systems, such as Saudi Arabia, exhibited fragmented but evolving regulatory landscapes. Common barriers included unclear stakeholder roles, inadequate funding, technological limitations, and resistance to organizational change. <b>Conclusions:</b> Clear, inclusive, and context-sensitive regulatory guidelines are essential to support the successful integration of TH in COPD care. Enhanced regulatory clarity can improve patient trust, engagement, and adherence by addressing safety, accountability, and accessibility concerns. Future research should focus on stakeholder-informed policies that reflect the practical realities of healthcare delivery in both developed and emerging systems.