환자안전법상 환자안전사고의 범위에 관한 고찰

To ensure patient safety and improve quality of medical services in Korea the Patient Safety Act has been enacted as a special law on January 28, 2015 and with its implementing ordinances the law became effective from July 29, 2016. The concept and the scope of the ‘Patient Safety Accident’ as introduced in the Patent Safety Act is to be materialized through the Act and the implementing ordinances. However, if the definition of the ‘Patient Safety Accident’ in the statute is abstract and unclear, the scope of the ‘Patient Safety Accident’ may expand without limits to include unnecessary accidents in the patient safety system that have not been intended by legislators. On the other hand, if the scope of the ‘Patient Safety Accident’ is too narrow, accidents which necessitate collection for patient protection may be excluded. Therefore, this study intends to prevent conflict in the interpretation of the statute after analyzing whether the concept and the scope of the ‘Patient Safety Accident’ as introduced by the Act and the implementing ordinances embody significances in reaching the legislative intent. This study also analyzes the cases of the U.S. and Japan, and compares with the Korean Act and investigates on possible amendments. Patient Safety Law is enforced under the subordinate statute and it is welcomed that the purpose of the law is to protect the life, body and health rights of the people. However, there are still unclear aspects of the concept and category of patient safety accident in the Patient Safety Act of Korea in light of the purpose pursued by the Patient Safety Act and the precedent of other countries in relation to patient safety accident. Therefore, there is a need for inventory in the future revision of the Patient Safety Act as to what areas should be included in the category of patient safety accident.