醫療院所同意書類型與電子簽署之探討

A Study on Categories of Medical Consent and Digital Signature in Hospital

衛福部自2007年起推動電子病歷計畫，電子病歷的實施除了病歷互通之外，最大的應用則是無紙化，然而醫療院所存在各項同意書，因涉及需要病人或家屬簽署，尚使用傳統紙本簽名的方法，故本研究針對中部某醫學中心進行的同意書電子簽署，在技術層面、作業層面及法規層面作出一系列研究，首先進行說明書、同意書及說明暨同意書之清查及盤點，共計清查1,302份各類同意書，並依各類同意書簽名的目的、同意書簽名的時機及簽名的流程及簽名人數多寡進行分類，再者進行同意書紙本流程簽名與電子簽署流程的比較探討，並依電子簽章法之要求實作住院同意書的電子簽署，實施半年後整體使用電子簽署的比率已達90%以上，最後進行民眾對於電子簽署的接受度調查，結果民眾接受度“大力推崇＂使用電子簽署為59.33%，“沒意見＂比率為39.44%。本研究最後提出在實作電子簽署同意書的各種解決方案與成本效益分析之建議供醫院做為參考之用。

The project of electronic medical record has been initiated since 2007 by Ministry of Health and Welfare in Taiwan. In addition to the interoperability of electronic medical record between hospitals, the extra benefit of adopting electronic medical records is eliminating paper and thereby creating paperless hospitals. However, there are still paper informed consent forms which have been used to get the prior written consent of patients because most patients do not have a digital certificate to create digital signatures of electronic informed consent forms. In this study, 1302 paper informed consent forms have been investigated and divided into 11 categories according to the signature processes and signers. The paperless signing system has been implemented to create the E-signatures of electronic informed consent forms. Conferences have been held to discuss the legality of E-signatures. Six months after the adoption of paperless signing system, the percentage of informed consent forms signed with E-signature have been increased to 90%. The results of satisfaction survey shows that 59.33% of patients express an excellent level of satisfaction with the E-signature and 39.44% of patients are neither satisfied nor dissatisfied.