What is it about?
Medical device regulations shape how new technologies reach patients, but these rules are written in complex legal language that is difficult to analyze at scale. In this study, we show how artificial intelligence can be used to transform medical regulations into structured, machine-readable data. We analyze a decade of medical device regulatory texts from the United States, the European Union, and China, and apply natural language processing techniques to capture how regulatory requirements evolve over time. By converting legal language into numerical representations, we reveal patterns of regulatory change, convergence, and divergence across regions. This approach makes it possible to study regulatory systems quantitatively, supporting researchers, regulators, and industry stakeholders who need to understand global regulatory trends, anticipate policy shifts, and design medical technologies that comply with multiple regulatory frameworks.
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Why is it important?
Regulatory complexity is a major barrier to medical innovation and global market access. This work introduces a data-driven way to analyze medical regulations at scale, moving regulatory research beyond manual review and qualitative comparison. By enabling quantitative analysis of regulatory texts across jurisdictions, our approach supports evidence-based regulatory science, helps policymakers identify long-term trends, and assists medical device developers in navigating cross-border compliance more efficiently.
Perspectives
I started this work after repeatedly encountering the same challenge in medical AI and device research: regulatory decisions are critical, but the regulatory texts themselves are difficult to analyze systematically. This paper reflects my interest in bridging artificial intelligence, regulatory science, and healthcare policy. I hope it encourages more interdisciplinary research that treats regulations not only as legal documents, but also as data that can be studied, compared, and improved.
Yu Han
University of Oxford
Read the Original
This page is a summary of: Transforming Medical Regulations into Numbers: Vectorizing a Decade of Medical Device Regulatory Shifts in the USA, EU, and China, ACM Transactions on Computing for Healthcare, January 2026, ACM (Association for Computing Machinery),
DOI: 10.1145/3793533.
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