디지털헬스케어법 발의안 분석

Comparative Analysis of Digital Healthcare Act: Focusing on the Healthcare Data Regulatory Environments of South Korea and Finland

BACKGROUNDS The efficacy of digital healthcare, which harnesses ICT for personalized medical services, hinges on the balanced regulatory design for utilizing real-world data. South Korea aims to enhance healthcare data utilization through the Digital Healthcare Act, amidst legal constraints. METHODS Qualitative research methods were employed to analyze South Korea’s Data 3 Laws and Finland’s healthcare data legislation. RESULTS The pre-proposal legal environment faced challenges, lacking clarity on healthcare data definition, consent, and third-party rights. The Digital Healthcare Act addressed some issues but didn’t alter the consent system. By benchmarking Finland’s practices, it suggests improvements for Korea’s legislation, emphasizing clear data ownership and a comprehensive consent system. CONCLUSIONS This study benchmarks Finland to recommend policy changes for Korea’s Digital Healthcare Act, aiming to address legal issues and improve healthcare data utilization, acknowledging differences between the two countries’ healthcare environments.