주요국 보건의료분야 인공지능 관련 규제 동향과 입법적 함의

Regulatory trends and legislative implications related to artificial intelligence in healthcare

This study focused on the healthcare sector and reviewed the legislative background and main contents centered on the AI laws of the US and EU. Through this, the implications of the legislative direction and contents for the use of AI in the healthcare sector in Korea were derived. The research results showed that the US classified the healthcare sector as a specific area in the executive order and stipulated differentiated prohibitions, responsibilities, management, and supervision systems. On the other hand, the EU regulated the healthcare sector in a single system like general industries, but classified healthcare as a high-risk sector in categories based on risk level and comprehensively regulated it. The Korean Basic Artificial Intelligence Act also adopted a method similar to the EU to regulate AI in the healthcare sector as high-impact AI. However, it is necessary to consider a plan to include AI in individual laws on the use of AI in the healthcare sector or in legislation related to digital healthcare, taking into full consideration the special nature of the healthcare sector. The results of the analysis of the contents of AI-related regulations in the healthcare sector showed that the US classified healthcare as a special area and imposed more responsibilities and obligations, while the EU established a more comprehensive regulatory system by including the healthcare sector in high-risk sectors. However, in the case of our country's Basic Artificial Intelligence Act, the regulations are somewhat loose. Therefore, more detailed responsibilities and obligations for each stage of application of artificial intelligence technology and each subject are needed in lower-level laws and separate legislative processes, and additional regulations on systems for evaluating the safety of artificial intelligence technology and management and supervision are needed.