Bridging ethical and governance gaps in digital health: insights from users and startups in Iran
Year: 2026
Type: article
Abstract: BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Source: BMC Health Services Research
Author: Nafiseh Salehnia
Institution: Tarbiat Modares University
Language: English
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,290
OpenAlex ID: W7155609349