ArticleJournal of Korean medical science2026
The Enactment and Implementation of Korea's Digital Medical Products Act: A Comparative Study Exploring Policy Implications.
Article in Journal of Korean medical science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Progress in the research of artificial intelligence in andrology: a narrative review.Translational andrology and urology · 2026Review
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Authors and funding
5 authors.
Funding
Abstract
backgroundWith the rapid expansion of the digital healthcare industry, advanced medical technologies, including artificial intelligence-based diagnostic software and digital therapeutics, are being introduced at an unprecedented pace. However, existing regulatory frameworks have encountered substantial challenges in adequately addressing the unique characteristics of these products. In response, Republic of Korea (South Korea) has enacted the world's first "Digital Medical Products Act" and established an integrated regulatory system tailored to this emerging domain.
methodsThis study undertook a comparative analysis across three regulatory dimensions-scope of application, approval procedures, and reimbursement policies-by examining corresponding legal frameworks in the United States, Germany, the United Kingdom, and Japan. In addition, qualitative interviews were conducted with three experts, each possessing more than 10 years of experience in digital healthcare regulation, to capture early field-level perspectives and identify areas that require refinement.
resultsThe findings demonstrated a generally positive assessment of the institutional significance of the new system, while also highlighting several limitations, including the absence of detailed evaluation criteria and the potential for confusion among stakeholders in practical implementation.
conclusionBased on these results, this study provides policy implications to guide the future advancement and refinement of regulatory frameworks for digital medical products.
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