Brandner R, van der Haak M, Hartmann M, Haux R, Schmücker P
Institute for Medical Biometry and Informatics, Department of Medical Informatics, University of Heidelberg, Im Neuenheimer Feld 400, Germany.
Methods Inf Med. 2002;41(4):321-30.
Our objectives were to determine the user-oriented and legal requirements for a Public Key Infrastructure (PKI) for electronic signatures for medical documents, and to translate these requirements into a general model for a signature system. A prototype of this model was then implemented and evaluated in clinical routine use.
Analyses of documents, processes, interviews, observations, and of the available literature supplied the foundations for the development of the signature system model. Eight participants of the Department of Dermatology of the Heidelberg University Medical Center evaluated the implemented prototype from December 2000 to January 2001, during the course of an intervention study. By means of questionnaires, interviews, observations and database analyses, the usefulness and user acceptance of the electronic signature and its integration into electronic discharge letters were established.
Since the major part of medical documents generated in a hospital are signature-relevant, they will require electronic signatures in the future. A PKI must meet the multitude of responsibilities and security needs required in a hospital. Also, the signature functionality must be integrated directly into the workflow surrounding document creation. A developed signature model, fulfilling user-oriented and legal requirements, was implemented using hard and software components that conform to the German Signature Law. It was integrated into the existing hospital information system of the Heidelberg University Medical Center. At the end of the intervention study, the average acceptance scores achieved were mean = 3.90; SD = 0.42 on a scale of 1 (very negative attitude) to 5 (very positive attitude) for the electronic signature procedure. Acceptance of the integration into computer-supported discharge letter writing reached mean = 3.91; SD = 0.47. On average, the discharge letters were completed 7.18 days earlier.
The electronic signature is indispensable for the further development of electronic patient records. Application-independent hard and software components, in accordance with the signature law, must be integrated into electronic patient records, and provided to certification services using standardized interfaces. Signature-oriented workflow and document management components are essential for user acceptance in routine clinical use.
我们的目标是确定用于医疗文档电子签名的公钥基础设施（PKI）的面向用户和法律要求，并将这些要求转化为签名系统的通用模型。然后，在临床常规使用中对该模型的原型进行了实施和评估。
对文档、流程、访谈、观察以及现有文献的分析为签名系统模型的开发提供了基础。海德堡大学医学中心皮肤科的八名参与者在2000年12月至2001年1月的一项干预研究过程中对实施的原型进行了评估。通过问卷调查、访谈、观察和数据库分析，确定了电子签名的实用性和用户接受度及其在电子出院小结中的整合情况。
由于医院生成的医疗文档大部分与签名相关，未来它们将需要电子签名。PKI必须满足医院所需的众多职责和安全需求。此外，签名功能必须直接集成到围绕文档创建的工作流程中。使用符合德国签名法的硬件和软件组件实现了一个满足面向用户和法律要求的已开发签名模型。它被集成到海德堡大学医学中心现有的医院信息系统中。在干预研究结束时，对于电子签名程序，在从1（非常消极态度）到5（非常积极态度）的量表上，平均接受得分为均值 = 3.90；标准差 = 0.42。对整合到计算机辅助出院小结书写中的接受度均值 = 3.91；标准差 = 0.47。出院小结平均提前7.18天完成。
电子签名对于电子病历的进一步发展不可或缺。必须将符合签名法的与应用无关的硬件和软件组件集成到电子病历中，并使用标准化接口提供给认证服务。面向签名的工作流程和文档管理组件对于在常规临床使用中的用户接受度至关重要。
