Integrated Analytical Framework for the Development of Artificial Intelligence-Based Medical Devices

A persistent fundamental problem in applying artificial intelligence (AI) to medical devices is achieving high performance while guaranteeing the safety and reliability of AI solutions. However, the regulation of medical devices and that of AI implementations both differ among countries, resulting in "double-layered" differences in the regulations for medical devices employing AI.

To overcome these differences and examine the universal requirements for AI-based medical devices, we clarify legal and ethical issues, regulatory requirements, and terms in representative guidances related to AI-based medical devices from different countries. Then, we propose an integrated framework for analyzing the requirements of AI-based medical devices for a comprehensive comparison.

We demonstrate that no guidance completely covers all the evaluation requirements, and the differences in coverage per country may direct the international harmonization of these requirements.

Consequently, we show two development strategies available to manufacturers, namely adherence to local regulations with tedious efforts or compliance with universal requirements using our integrated framework even under the low level of international harmonization; the latter is recommended for efficiency and convergence.