同意書簽署數位化之安全可行性方案設計與評估研究－以醫院同意書簽署為例

Design and Evaluation of Secure and Practical Methods on Signing Digital Consent-A Case Study of Hospital Informed Consent

范仲玫(Chung -Mei Fan)；許建隆(Chien-Lung Hsu)；林子煒(Tzu-Wei Lin)

同意書 ； 電子簽章 ； 數位簽章 ； Consent ； Electronic Signature ； Digital Signature

資訊安全通訊

23卷2期（2017 / 04 / 01）

57 - 77

繁體中文

傳統病歷以紙本保存，倍數的成長使病歷面臨管理問題，近10年因法令鬆綁與外在環境因素各醫院積極推展電子病歷，至104年止衛生福利部公佈有363家醫院已宣告，以某醫學中心為例，醫院自99年起逐年推展至104年止已完成400多張，可以涵蓋紙本的87.8%，但涉及病人簽名之同意書仍採用書面簽名紙本保存，在醫療照護過程是重要記載須併同病歷保存，若簽署以自然人憑證執行，在民眾持卡不普及情況下無法全面實施。本研究參考國內外同意書簽署的相關理論與文獻，研析醫院紙本同意書流程並盤點各種同意書歸納七種簽署流程，由探討同意書相關法令與同意書數位簽署後之適法性，並參考衛生福利部104年度委託科技研究計畫－醫療院所同意書簽署數位化之可行研究之五個方案，設計一個符合法定文件安全可行保護手寫簽名數位特徵值之同意書數位簽署方案，本設計允許使用者透過手寫數位簽署方式來簽署同意書，而醫事人員則利用其醫事人員憑證來簽署同意書，以達到多元簽署整合方式，最後利用機構憑證方式來簽署同意書以作為歸檔及查證，本研究以醫院一般同意書為實驗設計簽署流程導入實作。

Managing paper-based medical record had become a heavy load to the hospital. Electronic Medical Record not only can help to improve the quality of health services but can also solve the storage problem. In this study case, making almost 90% of the paper document paperless, the hospital uses electronic signature technology to achieve electronic medical record although 8% of the consent forms still remain in paper. Paper consents have problems such as inconsistent version, illegible handwriting, and difficult to access. If patients use the national certificated cards, the availability of cardholders will limit the progress. In this study, we analysis hospital's paper consents and each workflow including signing process and applicable law, refer to research of ＂Science and technology research projects commissioned by the year 2015 - medical institutions signed consent feasibility study of the digital＂, we design a digital consent system identify all the consent forms, classify consent types and analysis workflows. This paper shows how to integrate pluralism signing, we propose the management model by programming users through handwritten digital signatures to sign the consent forms and pass to medical personnel using their medical certificated card signing the consent forms. Finally, using the medical institute certificated card to sign the consent forms as archiving and verification.

1. C. E. O'Leary, “Informed Consent - Principles and Practice,” American Society of Anesthesiologists Article, Available at: http://www.asahq.org/resources/publications/newsletter-articles/2010/february2010/informed-consent-principles-and-practice, 2010.
2. 經濟部，「電子簽章法」，http://law.moj.gov.tw/Law/LawSearchResult.aspx?p=A&k1=%E9%9B%BB%E5%AD%90%E7%B0%BD%E7%AB%A0%E6%B3%95&t=E1F1A1&TPage=1，2001
3. Adobe, “Adobe-Global-Guide-Electronic-Signatures,” Available at: https://acrobat.adobe.com/content/dam/doc-cloud/en/pdfs/adobe-global-guide-electronic-signatures.pdf, 2015.
4. ISO, “Information Technology - Biometric Data Interchange Formats - Part 7: Signature/Sign Time Series Data,” Available at: https://www.iso.org/obp/ui/#iso:std:iso-iec:19794:-7:ed-2:v1:en, 2014.
5. ROI, “White Paper 05-07_Healthcare's Most Expensive Piece of Paper,” Dialog Medical Review, Available at: http://www.dialogmedical.com/wp-content/uploads/2010/04/ROI%20White%20Paper%2005-07.pdf, 2007.
6. Centers for Medicare & Medicaid Services, “State Operations Manual Appendix A -Survey Protocol, Regulations and Interpretive Guidelines for Hospitals,” Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf
7. Appelbaum, P. S.,Grisso, T.(1995).The MacArthur Treatment Competence Study. I: Mental illness and Competence to Consent to Treatment.Law and Human Behavior,19(2),105-126.
8. Coiera, E.,Clarke, R.(2004).e-Consent: The Design and Implementation of Consumer Consent Mechanisms in An Electronic Environment.Journal of the American Medical Informatics Association,11(2),129-140.
9. Katz, J.(1977).Informed Consent-A Fairy Tale-Law's Vision.University Of Pittsburgh Law Review,39,137-174.
10. Yu, B.,Wijesekera, D.,Costa, P.(2014).Consent-Based Workflow Control in EMRs.Procedia Technology,16,1434-1445.
11. 李珮如(2015)。碩士論文(碩士論文)。龍華科技大學資訊管理系。
12. 許建隆(2016)。衛生福利部科技研究計畫衛生福利部科技研究計畫,衛生福利部。
13. 詹焯然(2006)。碩士論文(碩士論文)。東海大學資訊工程與科學研究所。

1. (2024)。導入同意書無紙化電子簽署經驗與效益分析－以中部某公立醫院為例。醫務管理期刊，25(1)，81-101。