South Korea’s Ministry of Food and Drug Safety (MFDS) announced on January 24th that it has released the first-ever guidelines for the approval and assessment of generative artificial intelligence (AI)-based medical devices. The document, titled “Guidance on Licensing and Review of Generative AI Medical Devices,” sets forth regulatory expectations for manufacturers looking to gain approval for these technologies in South Korea.
These new guidelines are designed to assist in evaluating the safety and effectiveness of AI-driven medical devices while also streamlining their commercialisation.
The guidelines outline a comprehensive framework for the development, validation, and deployment of generative AI systems in medical devices. Generative AI, which includes technologies like large language models (LLMs) and image-generation tools, has shown immense potential in areas such as medical imaging, drug discovery, and personalised treatment planning. However, its use in healthcare also raises concerns about accuracy, bias, and patient safety. The MFDS guidelines address these challenges by emphasizing rigorous safety and efficacy assessments.
The MFDS established a collaborative committee in March of last year. This committee has researched the latest advancements and regulatory developments in generative AI, creating guidelines that will inform regulatory decisions throughout the approval process.v
Key Highlights of the Guidance
- Manufacturers must mitigate risks specific to generative AI, including hallucinations, data drift, and inconsistencies while adhering to international standards like ISO 14971:2019.
- The guidance emphasizes the importance of real-world testing that is specifically tailored to generative AI applications, focusing on user expertise and various scenarios.
- There is a strong focus on mitigating vulnerabilities such as data breaches and API risks, with explicit requirements for protecting sensitive medical data.
- Recommendations are provided for more efficient approval processes, all while maintaining safety and effectiveness in healthcare settings.
Additionally, the MFDS has released new guidelines regarding “usability documentation” for standalone digital medical device software. This type of software functions independently from hardware devices like electronic or mechanical instruments, typically running on general-purpose computers, and is recognized as a medical device in its own right.
The release of these guidelines reflects South Korea’s proactive approach to fostering innovation while safeguarding public health. By establishing a clear regulatory pathway, the MFDS aims to accelerate the adoption of generative AI in healthcare, enabling the development of cutting-edge medical devices that can improve patient outcomes. This initiative is expected to set a precedent for other countries grappling with the challenges of regulating AI in medicine.v
