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KMID : 0986720160240010051
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Korean Journal of Medicine and Law
2016 Volume.24 No. 1 p.51 ~ p.73
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Study on Damage relief system against side effects of medicine, medical supplies and devices
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Choi Chol-Ho
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Abstract
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Damage relief system against side effects of medicine, medical supplies and devices is a system to relieve victims by paying compensation in addition to medical expenses in the event health damage by side effects occur notwithstanding appropriate use of medicine, medical supplies and devices. Compensation system against side effects of medicine, medical supplies and devices is divided into various systems such as no-fault compensation system that compensates without asking a fault, a system that facilitates mediation of medical accidents and disputes maintaining the principle of fault liability without taking no-fault compensation system obstinately and a system that enables victims of medical accidents to receive relief easily by repairing consultation system specialized for medical malpractice suits.
In Japan, a damage relief system against side effects of medicine and medical supplies was established in 1980 based on the Act on Adverse Drug Reaction Compensation Fund, and it has been operated in accordance with the Comprehensive Law on Medicine and Medical Supplies, an independent administrative law after 2002. Damage relief system against side effects of medicine, medical supplies and devices is one of no-fault compensation systems.
This thesis gives a general description of the background that damage relief system against side effects of medicine, medical supplies and devices in Japan first, and considers merits and demerits of general compensation system for medical accidents by introducing system and method of judgment on the side effects of medicine, medical supplies and devices. Among the contents are compensation system for damage by the side effects of medicine, medical supplies and devices through general overview of Japan’s systems related to compensation for medical accidents and description of the relation to medical safety that has been discussed so far in Japan.
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KEYWORD
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adverse events, incident monitoring, prevention, malpractice, no fault, patient Safety
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