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KMID : 0986720170250010049
Korean Journal of Medicine and Law
2017 Volume.25 No. 1 p.49 ~ p.69
Legal liability of medical professional standards in data-based medicine
Kim Ki-Young

Abstract
The study presents new legal challenges for creating a clear concept of standardization of data-based medicine. On one hand, not only enormous data storage and management solution but also advanced technical support are required to record and store health data in digital form and to process. On the other hand, the stored medical data may provide critical medical infornation for treating individuals who look forpersonalized medicine for them. It is clear that the way of processing and using medical data would shape the structures of the health care market.
In the future, the collection of data with the smartphone or wearables devices will be very common. Information and technology (IT) advances will create new phenomenon and then will bring great changes in the medical sector. Future changes would presents new challenges to patients as well as healthcare professionals. To prepare changes and challenges of a new personalized health care system, certain legal prerequisites must be fulfilled.
Then the study discusses technical developments in medicine brought by the degitalization (II). The legal and practical problems regarding conceptualization of medical standards in data-based medicine are examined in detail. Next, the legal implications of liability for data-based medicine are explored (III). Lastly, the study assesses a political outlook on the new challenges and the assessment of opportunities and risks in system medicine (IV).
KEYWORD
Medical device, Standard, system medicine, big data, liability, health data, precision medicine
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