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KMID : 1142220200150020093
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Regulatory Research on Food, Drug & Cosmetic
2020 Volume.15 No. 2 p.93 ~ p.104
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Consideration from the Regulatory Perspective for the Future of the Use of Medical Big Data
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Jo In-San
Woo Hyun-Ki
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Abstract
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This study analyzes regulatory recommendations for the present and future of medical big data. The healthcare data industry is developing based on the HIPAA established in 1996 in the United States and the GDPR established in 2016 in Europe. In particular, the United States is designing the future of precision medicine through the 21st Century Cures Act, which was passed in 2016. Also they acknowledge the importance of medical data and prepare to realize the future of precision medicine through the medical data. In order to accelerate the approval of medical devices and medicines, FDA has adapting and using the medical data, which is often referred to as real world data. For the purpose of regulatory decision, regulatory agencies are rapidly changing through seamless collaboration with private data analysis companies. Along with the rapidly aging population, the total costs of healthcare are subsequently increasing all around the world, especially the cost of developing new drugs is astronomical. It is essential to use data to secure the competitiveness of new drug development in a global environment for Korea’ Bio&pharmaceutical industry which has emerged as a future flagship in Korea. In January 2020, the amendment to the Personal Information Protection Act passed the National Assembly as a social consensus to grow the data industry while keeping personal information safe. The core of the amendment is to open the way of data use through pseudonymization. Through the analysis of medical data accumulated well in Korea, the future of healthcare such as precision medicine should be realized.
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KEYWORD
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medical big data, regulation, privacy, precision medicion, real world data
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