Regulations Governing Collection and Review of Vaccine Injury Compensation Fund Article 13
Conclusions of causality between vaccination and the alleged injury as assessed by the Working Group are classified as follows:1. Unassociated: The assessment result will be “unassociated” if any of the following situations applies:(1) Clinical examination or the laboratory test result substantiates that the injury was caused by something other than vaccination.(2) Medical evidence shows no causality or medical evidence does not support causality.(3) Medical evidence supports causality. However, the injury did not occur during a reasonable period of time following vaccination.(4) It is determined in consideration of medical principles and following a comprehensive review that there is no support for causality between the alleged injury and vaccination.2. Associated: The assessment result will be “associated” if the following situations all apply:(1) Medical evidence, clinical examination or the laboratory test result supports causality between vaccination and the alleged injury.(2) The alleged injury occurred within a reasonable period of time following vaccination.(3) After a comprehensive review, it is determined that a significant association exists.3. Indeterminate: The case is free of the situations described in the preceding two subparagraphs and causality cannot be determined following a comprehensive review.“Medical evidence” referred to in the preceding paragraph is defined as evidence from a population-based study or pathogenesis study that is published in a domestic or foreign journal.“Determined following comprehensive review” referred to in Paragraph 1 is defined as professional medical judgment made after giving considerations to the medical history of the alleged victim before and after vaccination, the alleged victim’s family history, adverse reactions experienced by the alleged victim in the past after receiving analogous vaccines, medications taken by victim, victim’s exposure to toxins, biologic coherence and other relevant factors.
中文原文 預防接種受害救濟基金徵收及審議辦法第13條
審議小組鑑定預防接種與受害情形關聯性之分類如下：
一、無關：有下列情形之一者，鑑定結果為無關：
（一）臨床檢查或實驗室檢驗結果，證實受害情形係由預防接種以外其他原因所致。
（二）醫學實證證實為無關聯性或醫學實證未支持其關聯性。
（三）醫學實證支持其關聯性，但受害情形非發生於預防接種後之合理期間內。
（四）衡酌醫學常理且經綜合研判不支持受害情形與預防接種之關聯性。
二、相關：符合下列情形者，鑑定結果為相關：
（一）醫學實證、臨床檢查或實驗室檢驗結果，支持預防接種與受害情形之關聯性。
（二）受害情形發生於預防接種後之合理期間內。
（三）經綜合研判具有相當關聯性。
三、無法確定：無前二款情形，經綜合研判後，仍無法確定其關聯性。
前項醫學實證，指以人口群體或致病機轉為研究基礎，發表於國內外期刊之實證文獻。
第一項綜合研判，指衡酌疑似受害人接種前後之病史、家族病史、過去接種類似疫苗後之反應、藥物使用、毒素暴露、生物學上之贊同性及其他相關因素所為之醫療專業判斷。
一、無關：有下列情形之一者，鑑定結果為無關：
（一）臨床檢查或實驗室檢驗結果，證實受害情形係由預防接種以外其他原因所致。
（二）醫學實證證實為無關聯性或醫學實證未支持其關聯性。
（三）醫學實證支持其關聯性，但受害情形非發生於預防接種後之合理期間內。
（四）衡酌醫學常理且經綜合研判不支持受害情形與預防接種之關聯性。
二、相關：符合下列情形者，鑑定結果為相關：
（一）醫學實證、臨床檢查或實驗室檢驗結果，支持預防接種與受害情形之關聯性。
（二）受害情形發生於預防接種後之合理期間內。
（三）經綜合研判具有相當關聯性。
三、無法確定：無前二款情形，經綜合研判後，仍無法確定其關聯性。
前項醫學實證，指以人口群體或致病機轉為研究基礎，發表於國內外期刊之實證文獻。
第一項綜合研判，指衡酌疑似受害人接種前後之病史、家族病史、過去接種類似疫苗後之反應、藥物使用、毒素暴露、生物學上之贊同性及其他相關因素所為之醫療專業判斷。