Global Mapping of Telemedicine Regulation and Ethical Safeguards: Mixed Methods Exploratory Document Analysis.

内容摘要

Telemedicine has become central to digital health strategies, yet the regulatory environment that shapes ethical safeguards and equitable access remains uneven and incompletely assessed across countries. Legal and normative instruments matter because they define requirements for privacy, consent, accountability, professional readiness, and barrier reduction. This study aimed to map the current global landscape of normative instruments related to telemedicine and identify which ethical and social safeguards are explicitly addressed, with particular attention to equity. We conducted a document analysis guided by the READ (ready the materials, extract data, analyze data, and distill findings) framework. From February 2024 to February 2026, we conducted a structured web-based search across all World Health Organization (WHO) member states with no language restrictions, using official government sources, statutory professional regulators, and institutional publication channels. Retrieval combined internal site searches, direct navigation, external search engine queries, and targeted snowball sampling to identify currently in-force instruments. Two researchers independently extracted and coded data using a predefined codebook. We operationalized 10 binary items covering regulatory presence and scope (questions 1 and 2), safeguards for data protection (question 3), consent and disclosure (questions 4 and 5), prior in-person prerequisites (question 6), monitoring (question 7), training requirements (question 8), and equity (questions 9 and 10). We summarized frequencies overall and stratified by WHO region and World Bank income group and conducted a qualitative thematic analysis of included normative instruments. Of the 194 WHO member states, 81 (41.8%) had at least one current normative instrument related to telemedicine in force. Among these, 72.8% (59/81) defined telemedicine or telehealth. Data protection provisions were most common (73/81, 90.1%), followed by mandatory informed consent (n=71, 87.7%) and monitoring mechanisms (n=65, 80.2%). Fewer countries required disclosure of telemedicine limitations (n=36, 44.4%) or mandated telemedicine-specific training (n=26, 32.1%). Prior in-person consultation requirements were uncommon (n=8, 9.9%). Equity-related safeguards were uneven: 51.9% (n=42) referenced justice, equity, or nondiscrimination, whereas 30.9% (n=25) included concrete barrier reduction provisions (eg, digital inclusion or accommodations for people with disabilities and minors). Telemedicine regulation is becoming more common, but both coverage and safeguarding content remain uneven. While privacy, consent, and monitoring are frequently addressed where regulation exists, disclosure, physician competency, and operational equity measures are less consistently specified. Strengthening telemedicine governance will require translating ethical commitments into enforceable standards that address digital determinants of access and protect groups at risk of exclusion.