Reports of side effects related to the use of new medical technologies have been increasing annually, yet there have been no reported incidents involving artificial intelligence (AI)-based medical devices, according to a report by Yonhap News on October 12. Lawmakers are urging a reassessment of the reporting system for AI medical device incidents.
On October 12, Rep. Heo Jong-sik of the Democratic Party, a member of the National Assembly's Health and Welfare Committee, revealed data received from the Ministry of Food and Drug Safety indicating that the number of approvals and certifications for AI-based software medical devices has been rising each year.
Specifically, the number of approvals increased from 62 in 2023 to 108 in 2024, and then to 157 last year, marking a 2.5-fold increase over two years. In the first quarter of this year alone, an additional 55 approvals were granted, bringing the total to 382 AI medical devices introduced since 2023.
In stark contrast, there have been zero reported incidents during the same period. In comparison, 27 incidents have been reported for other new medical technologies excluding AI. Reports of side effects from new medical technologies have risen from one in 2023 to eight in 2024, and 16 last year, with two incidents reported by June of this year.
New medical technologies include not only AI but also robotic surgical systems, patient-specific 3D printing medical devices, and digital therapeutics.
Rep. Heo stated, "The lack of any reports for AI medical devices over the past three years, despite reporting being a legal obligation, may indicate that the reporting system for identifying software errors is not functioning properly."
AI medical devices are used for tasks such as assisting in the interpretation of imaging scans like CT and MRI, as well as aiding in disease diagnosis. Errors in algorithms or missed interpretations could potentially delay diagnoses and impact patient safety.
Heo emphasized the need to establish criteria for reporting the inherent risks of software and to ensure that medical institutions and manufacturers are actually reporting incidents.
* This article has been translated by AI.
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