[Edaily Reporter Kim Seung-kwon ] The Presidential Committee on National AI Strategy, which reports directly to the President, is moving to unify the digital healthcare bills that have been pursued separately by the Ministry of Health and Welfare and the Ministry of Trade, Industry and Energy.

The Legal Task Force (TF) within the AI Strategy Committee determined that the Ministry of Health and Welfare’s “Draft Act on Support for Digital Healthcare and the Utilization of Health and Medical Information” and the Ministry of Trade, Industry and Energy’s “Draft Act on the Promotion and Support of the AI Biohealth Industry” overlap significantly in key provisions—such as support for research and development, training of specialized personnel, and the establishment of committees—and has decided to recommend that both ministries streamline their respective provisions.

Although the two bills focus on different areas—the protection and utilization of health information (Ministry of Health and Welfare) and support for the industrialization of the AI biohealth sector (Ministry of Trade, Industry and Energy)—there have been ongoing concerns that confusion in the field would be inevitable if the frameworks for data utilization and industrial promotion were designed separately.

The negative impact on companies is already becoming apparent. Lunit Inc.(328130), which received U.S. FDA approval for its AI-based chest X-ray interpretation solution, reportedly faced difficulties determining whether to proceed with commercialization through the Ministry of Health and Welfare or the Ministry of Trade, Industry and Energy while seeking coverage under the national health insurance system in South Korea. VUNO, Inc.(338220), which also possesses various medical AI products such as ECG and bone age analysis, struggled to sign data collaboration agreements with hospitals due to the lack of legal grounds for data utilization. Kakao Healthcare has been calling for the introduction of a right to request the transfer of medical MyData to expand its PHR (Personal Health Record) platform “Pasta,” but has been unable to accelerate its business due to delays in legislation.

The Ministry of Health and Welfare has concluded public hearings and is currently working to refine the bill, aiming for its passage during the regular session of the National Assembly in the second half of this year. An official from the Ministry of Trade, Industry and Energy took a cautious stance, stating, “Since this is a bill proposed by lawmakers, it is not easy for the ministry to take direct action,” but coordination between the two ministries is expected to begin in earnest once the task force’s recommendations are officially conveyed.