Artificial Intelligence (AI) technology is rapidly advancing and being incorporated into the health care field, bringing about changes to the development and commercialization of new medicines and medical devices.

For example, AI applications in drug discovery opened a new horizon in new drug development by almost perfectly predicting protein fold structures and potential targets, and diagnostic software which analyzes medical images and bio-signals with AI technology has been commercialized. Now, medical devices to predict prognosis and diagnose diseases more accurately and rapidly are under development.

Recently, AI technologies such as Generative AI, Multimodal AI, and Digital Twin have been widely applied to various areas for addressing medical challenges and providing health care services.

However, there are also challenges to overcome in the use of AI technology. New threats are posed such as hallucination, where fake information is presented as real; biased information provided by biased machine learning; and cybersecurity issues such as hacking.

Additionally regulatory considerations may be needed to actively accommodate the new AI technology innovation in the use environment where learning and dissemination of information is made through GPU/NPU-based large-scale computing technology and data centers.

Given the recognition of such changes, Korea MFDS and U.S. FDA signed a Memorandum of Cooperation (MOC) on April 27, 2023 (local time) to hold a FDA-MFDS joint symposium. In this symposium, experiences on the use of AI in medical product development and how regulators can help advance the use of these innovative technologies to deliver safe and effective medical products will be shared.

▲ To share experiences, global trend and examples of the use of AI in medical product ▲ To share information with each other among regulators, industry and academia with different perspectives ▲ To discuss regulatory considerations for the use of AI technologies in how to regulate medical products developed by using AI technologies.

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• AIRIS is an acronym for AI Regulatory & International Symposium, and it means an international symposium related to regulation on the use of AI technology. Its subtitle is Use of AI in Medical Product Development.

  AIRIS 2024 aims to carry out discussions on the direction to be taken for regulation together with stakeholders from various countries to vitalize the development of medical products using AI.

  B.I. gave shape to an integration of AI, the shape of a face that symbolizes humanity, network, cooperation and so forth, and it aims to vitalize the development of medical products and enhance safety using AI to contribute to the improvement of the health of humanity through an active cooperation among various regulatory institutions.