Regulation of Health-Related Websites in the United States, European Union, United Kingdom, and United Arab Emirates: A Comparative Legal Analysis
Year: 2026
Type: preprint
Abstract: One of the most acute problems in global healthcare remains the highly unequal access to primary health care: according to WHO data, about half of the world's population lack access to basic medical services. A potential solution to this problem could be the widespread introduction of telemedicine, AI-based diagnostic systems, and online health platforms. However, the realisation of this potential directly depends on overcoming regulatory and infrastructural barriers at the interstate level, since the effectiveness of such tools remains limited without the possibility of their cross-border application. Today, a single website selling supplements, collecting symptom data, and offering an AI assistant may simultaneously violate the laws of four jurisdictions while operating from a single legal entity. It reflects a structural mismatch between transboundary digital health activity and territorially fragmented legal regimes. Such conflicts are not unprecedented: the international community has already developed mechanisms for their resolution in related areas — information security, global infectious disease monitoring, aviation safety, and tobacco market regulation — which provides a basis for seeking similar instruments in digital healthcare.Existing scholarship has examined digital health governance, health-data privacy, telemedicine regulation, online tracking on health-related websites, and general digital platform regulation, but it does not appear to connect these strands into a single functional comparison of website-level compliance triggers across the four regimes examined here. This paper surveys the United States (FDA, FTC, HIPAA, CLIA), the European Union (GDPR, AI Act, MDR/IVDR), the United Kingdom (UK GDPR, CQC, MHRA), and the United Arab Emirates (PDPL, DHA, MOHAP) — comparing their rules on health claims, health data, telehealth, AI disclosure, and penalties. Drawing on a functional comparative analysis of primary legal sources, the paper argues that the current fragmentation fits a recurring institutional pathway: from soft law toward a possible framework convention, with progressive hardening through protocols. The analysis suggests that a framework instrument for health-related websites should be considered as a plausible institutional pathway for reducing regulatory barriers to cross-border digital health services. The paper identifies existing convergences and divergences across the four regimes as a necessary first step toward defining the core elements such a treaty would need to address.
Source: OSF Preprints (OSF Preprints)
Authors: Maxim Osovsky, Natalia Salomahina
Language: English
Subfield: Law
Field: Social Sciences
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W7204221046