Civil Liability in the Use of Digital Therapeutics and AI-Based Software: A Comparative and Narrative Review

Document Type : Original Article

Authors

1 Department of Private Law, Faculty of Law and Political Sciences, Allameh Tabatabai University, Tehran, Iran.

2 Department of Health Information Technology, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran

10.30476/jhmi.2026.111121.1365

Abstract

Introduction: The rapid advancement of digital health technologies, particularly artificial intelligence (AI) and digital therapeutics (DTx), has created challenges for existing regulatory and civil liability frameworks. This study compared regulatory approaches and civil liability models across the European Union (EU), the United States (US), and the Asia–Pacific region to identify governance strategies that balance patient safety and innovation.
Methods: A comparative narrative review was conducted. Literature was searched in PubMed, Google Scholar, and Google without time restrictions using terms related to DTx, AI, software as a medical device (SaMD), civil liability, and legal responsibility. English-language publications addressing regulatory frameworks or liability issues for DTx and AI-based medical software were included. Duplicates, non-English publications, conference abstracts without full text, and studies lacking regulatory or legal relevance were excluded. Official reports and websites from regulatory authorities and international organizations were also reviewed.
Results: The search identified 640 records, with 58 duplicates removed. After screening and full-text review, 13 peer-reviewed articles and 7 authoritative websites were included. The EU follows a comprehensive risk-based framework based on the MDR, AI Act, and strict product liability. The US combines flexible FDA pathways with a hybrid tort-based liability model, whereas the Asia–Pacific region demonstrates diverse approaches involving product liability, negligence, and data protection frameworks.
Conclusion: Regulatory systems are increasingly adopting risk-based governance; however, civil liability frameworks remain fragmented and insufficiently adapted to AI-enabled medical software. A lifecycle-based liability model integrating oversight, transparency, post-market monitoring, and adaptive accountability may strengthen future digital health governance.

Highlights

Zahra Bagheri: Google Scholar

 Sohrab Almasi: Google Scholar

Keywords

Main Subjects

References

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Health Management & Information Science
Volume 13, Issue 3
July 2026
Pages 245-258

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