Bridging ethical and governance gaps in digital health: insights from users and startups in Iran

Digital health adoption is accelerating in many low- and middle-income countries, yet governance, ethical safeguards, and data stewardship often lag behind technological uptake. This mismatch can undermine user trust, service quality, and the long-term sustainability of digital health innovations. This study aimed to identify and conceptualize key governance gaps influencing the development of Iran’s digital health ecosystem. A qualitative thematic analysis was conducted using 18 semi-structured interviews with policymakers, entrepreneurs, and healthcare professionals, alongside content analysis of 700 user comments extracted from major Iranian digital health platforms. Data were analyzed through the six-phase framework of Braun and Clarke, combining inductive (data-driven) and deductive (theory-informed) coding. Triangulation between interview and user datasets enhanced validity, and the COREQ checklist guided reporting. Six interrelated governance gaps were identified: (1) Regulatory and Oversight Gap – fragmented authorities and lack of unified licensing; (2) Ethical and Trust Gap – weak accountability and declining user confidence; (3) Data Governance Gap – unclear data ownership and poor privacy protection; (4) Quality and Standardization Gap – lack of evaluation indicators and accreditation systems; (5) Institutional Capacity Gap – limited expertise and low readiness for digital transformation; and (6) Economic and Sustainability Gap – insufficient financial incentives and policy support. Findings from user comments confirmed that governance weaknesses directly affect satisfaction, perceived fairness, and trust in digital health services. Digital health in emerging settings requires a multi-level governance approach that aligns national policy, institutional regulation, and operational accountability. We propose an integrated macro–meso–micro governance model with cross-cutting principles (transparency, responsibility and data integrity, participation, trust) to guide policymakers and platform operators. Strengthening a unified regulator, a national ethics charter for digital health, and a health data governance framework are priority actions.