同意書電子簽署探討——以區域及地區醫院為例

A Study on Electronic Signature of Consent in Hospital–Taking the Regional and Area Hospitals as an Example

近年來各層級醫院在電子病歷發展趨勢及成果上，已符合衛福部自2007年起推動電子病歷計畫之發展，除了電子病歷的實施已走向無紙化之外，醫療院所日常使用到的各種同意書，自2015年衛福部也以研究案方式委託相關醫學中心進行可行性的研究。然而當時都以醫學中心為研究對象，其研究成果在技術層面、作業層面能否直接適用於區域及地區層級的醫院是本研究要進一步瞭解的目的。本研究首先對區域及地區醫院使用的各類同意書及說明書進行盤點，發現區域及地區醫院分別有462份及213份，與醫學中心的1,302份進行是否可直接套用的比對，發現可直接套用醫學中心同意書的比率分別為91%及95%，並提出無法套用的同意書的解決方案。本研究又將前述醫學中心的同意書簽名技術實際應用至區域及地區醫院上，並驗證技術、臨床應用的可行性，最後本研究藉由問卷的方式，進行其他醫療院所多項與同意書電子簽名有關因素調查。發現問卷中現在同意書有納入標準化管理的比率約為73%，採取紙本簽署還是佔91%，同意書以電子保存的比率僅有6.3%。因此同意書電子簽署尚有很大的努力空間，最後我們提出對於各層級醫院要實行同意書電子簽署議題上的建議以供各醫療院所做為參考之用。 Initiated since 2007, the development of electronic medical records at different hospital accreditation level has met the expectation of the Ministry of Health and Welfare. Paperless hospitals are the challenges and trends in the implementation of electronic medical record system. Since 2015, the Ministry of Health and Welfare commissioned some medical centers to research if various kinds of consent forms, which are used in medical institutions, could be signed electronically. However, the objects of research are medical centers, so that we don't know if research findings of the technical feasibility and operation feasibility fit other hospitals at different accreditation level. Thus, a wide variety of informed consent forms are inventoried in this study; totally 462 informed consent forms in regional hospitals and 213 informed consent forms in district hospitals are surveyed. After comparing them with those 1302 informed consent forms in medical center, we found that 91% in regional hospitals and 95% in district hospitals respectively can be applied directly. We also propose alternative solutions to those informed consent forms which cannot be applied directly. The electronic signature technology has been transfer smoothly to regional hospitals and the district hospitals and the technical feasibility is well verified. The survey of other factors related to informed consent forms shows that 73% of hospitals have standardized management and 91% still use paper-based informed. Suggestions are also summarized in this study for the reference of other medical institutes to implement electronic informed consent forms.

Initiated since 2007, the development of electronic medical records at different hospital accreditation level has met the expectation of the Ministry of Health and Welfare. Paperless hospitals are the challenges and trends in the implementation of electronic medical record system. Since 2015, the Ministry of Health and Welfare commissioned some medical centers to research if various kinds of consent forms, which are used in medical institutions, could be signed electronically. However, the objects of research are medical centers, so that we don't know if research findings of the technical feasibility and operation feasibility fit other hospitals at different accreditation level. Thus, a wide variety of informed consent forms are inventoried in this study; totally 462 informed consent forms in regional hospitals and 213 informed consent forms in district hospitals are surveyed. After comparing them with those 1302 informed consent forms in medical center, we found that 91% in regional hospitals and 95% in district hospitals respectively can be applied directly. We also propose alternative solutions to those informed consent forms which cannot be applied directly. The electronic signature technology has been transfer smoothly to regional hospitals and the district hospitals and the technical feasibility is well verified. The survey of other factors related to informed consent forms shows that 73% of hospitals have standardized management and 91% still use paper-based informed. Suggestions are also summarized in this study for the reference of other medical institutes to implement electronic informed consent forms.