Insights on Regulatory Trends in Medical AI

With over seven years of experience in the medical AI industry and a career spanning two decades in regulatory affairs, I am pleased to share insights based on my recent interview with the economic journal.
"In a rapidly evolving technological landscape, regulations ensure that medical solutions are used safely. Countries worldwide are tightening their regulations, and companies must develop strategies to adapt to these changes."

Medical AI is an industry gaining recognition for reducing physicians’ workloads and improving diagnostic accuracy. According to global market research firm Statista, the medical AI market is expected to grow from $11 billion in 2021 to $188 billion by 2030. However, issues surrounding safety and reliability persist, prompting regulatory shifts across various countries. South Korea leads the way, having published the world's first regulatory guidance for AI-based medical devices. Moreover, on October 26, South Korea's "AI Framework Act" passed the National Assembly's Science, ICT, and Broadcasting Committee, with only a few steps remaining before it becomes law. Similarly, the U.S. FDA has moved beyond traditional approaches to establish specific guidelines for AI-based medical devices.
Medical AI is particularly sensitive in terms of patient safety and data privacy. Errors stemming from faulty AI algorithms or device malfunctions can lead to unforeseen risks, necessitating stringent management of device safety and data handling practices. Comprehensive and in-depth regulations are required for medical devices, including AI-based ones, reflecting the global trend toward stricter regulatory frameworks.
In the European Union, the European Commission (EC) implemented the AI Act in August 2023, the first comprehensive AI regulation globally. This law provides unified rules for products entering the EU market, including medical devices, which will be subject to the regulation starting in 2026. Previously, the EC transitioned from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in 2017, introducing more rigorous requirements.
The shift from MDD to MDR aimed to strengthen the safety and efficacy of medical devices and expand manufacturers’ responsibilities. This includes preparing extensive clinical data, undergoing robust verification processes, and enhancing post-market surveillance.

Adapting to Evolving Regulations in the Medical AI Industry

As the medical AI industry advances, regulatory frameworks must also evolve to keep pace. Flexibility in applying these regulations is crucial to fostering innovation while ensuring safety. In particular, data-related regulations are expected to develop rapidly, with a focus on enhancing the reliability and transparency of AI models. However, these shifts pose challenges; some companies in the industry have even abandoned plans for global expansion due to an inability to adapt to the changing regulatory landscape.

The medical AI industry is at a pivotal moment where collaboration between businesses and regulatory bodies is essential. By fostering a proactive approach to regulations and securing government support, South Korea can strengthen its position as a leader in this rapidly evolving field.