The Ministry of Food and Drug Safety announced it will establish and publish the world's first "Guideline for Approval and Review of Medical Devices Using Generative Artificial Intelligence (AI)" on the 24th to assist in evaluating the safety and efficacy of medical devices using generative AI and to support commercialization.
Generative AI is a technology where AI, which learns from big data and patterns, produces new results like text, images, video, music, and coding. OpenAI's "ChatGPT," released at the end of 2022, is a representative example, and there have been increasing attempts to use generative AI in various areas of medicine, including medical image interpretation, diagnostic assistance, and treatment planning. However, concerns about data bias, lack of accuracy, and ethical issues have raised the need to evaluate safety and efficacy.
In response, the Ministry of Food and Drug Safety has formed a consultative body with experts from academia, the medical community, and industry since March of last year to investigate and discuss the latest technologies and regulatory trends related to generative artificial intelligence and establish considerations for the approval review process.
The Ministry of Food and Drug Safety presented examples of medical devices corresponding to generative AI in the guidelines and provided guidance on how to write approval application forms and submission materials. The main contents of the guidelines are broadly divided into: △Scope of application (clarification of the management scope of generative AI medical devices) △Examples of applicable medical devices △Risk management (examples of major risk factors) △Application materials △Submission materials.
Additionally, the Ministry of Food and Drug Safety also established and published guidelines detailing the "Usability Documentation" for standalone digital medical device software.
Standalone digital medical device software operates independently without being integrated with electronic or machinery and equipment hardware in an environment equivalent to that of a general computer and is considered an independent form of software that constitutes a digital medical device.
Usability has been introduced as a concept in the management of medical device safety due to an increase in medical accidents caused by user errors in medical settings, meaning the characteristics of a user interface (UI) that are effective, efficient, and satisfactory for the user.
The usability approval and review guidelines for standalone digital medical device software demonstrated writing standards and methods for the approval (certification) application form and usability summary by utilizing examples and presented the targets for change approval (certification) and methods for collecting usability-related hazard information.
Oh Yu-kyung, the head of the Ministry of Food and Drug Safety, emphasized, "The Ministry will continue to prepare a proactive and transparent regulatory framework while actively promoting regulatory diplomacy for international regulatory harmonization so that domestic corporations can secure competitiveness in the global market."