An electronic management and digital signature system for surgical consent

Objective: To develop a system for creating and managing electronic surgical consent forms including the incorporation of digital signatures. Design: Developmental study. Setting: The system has been developed for use in hospitals in Taiwan but can be adapted for use in other countries. Methods: A database of generic consent forms encompassing several operations and invasive procedures performed in a variety of specialities was created. Healthcare professionals can select an appropriate consent form from the database through a user friendly interface. The form is then customised for an individual patient using automatic data entry to create an XML document. The contents of the document and its output format are separately managed using XML (eXtensible Markup Language) and XSLT (eXtensible Stylesheet Language: Transformation). The XML file is sent (together with an XSLT document) to a transformation engine to create a PDF (Portable Document Format) file. This is then digitally signed using the appropriate Acrobat tool by a patient whose credentials have been digitally verified. Results: We were able to create a database, access it to obtain a consent form, customise the form for an individual patient and then process the form so that it could be digitally signed. Conclusion: We have demonstrated the feasibility of our system and it may play a role in moving Taiwan further towards total Electronic Medical Records. However further work is first necessary to establish its suitability and practicality for everyday use.