Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China

Daolu Tang, Xuezhi Xi, Yong Li and Meiling Hu

Health Policy, 2025, vol. 153, issue C

Abstract: The swift progression of AI within the realm of medical devices has precipitated an imperative for stringent regulatory oversight. The United States, the European Union, and China stand as vanguard entities in the regulatory landscape for AI-enhanced medical devices, each delineating unique regulatory frameworks. The European Union is renowned for its avant-garde approach to AI legislation, placing a significant onus on data security. Conversely, the regulatory paradigm in the United States is characterized by its market adaptability and flexibility. Meanwhile, China adopts a comprehensive and process-oriented approach towards the regulation of AI in medical devices. A comparative analysis of regulatory mechanisms across the United States, the European Union, and China reveals that the articulation of coherent technical review standards, the critical points of AI regulation including the emphasis on data consistency evaluations, the integration of clinical trial data to an appropriate degree, and the implementation of forward-looking strategies for software modification control, etc.. Jurisdictions beyond these leading entities are advised to assimilate the regulatory insights from these frontrunners for a more balanced regulatory framework, tailor them to the unique exigencies of their respective locales, institute a definitive ethical framework, and astutely establish core evaluative benchmarks on algorithm interpretability, consistency, and clinical validity.

Keywords: AI medical devices; Regulatory framework; Risk assessment focusing on algorithmic characteristics (search for similar items in EconPapers)
Date: 2025
References: Add references at CitEc
Citations:

Downloads: (external link)
http://www.sciencedirect.com/science/article/pii/S0168851025000168
Full text for ScienceDirect subscribers only

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:eee:hepoli:v:153:y:2025:i:c:s0168851025000168

DOI: 10.1016/j.healthpol.2025.105260

Access Statistics for this article

Health Policy is currently edited by Katrien Kesteloot, Mia Defever and Irina Cleemput

More articles in Health Policy from Elsevier
Bibliographic data for series maintained by Catherine Liu () and ().