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An XHTML Solution for a Secure EDC System for Traditional Chinese Medicine Clinics Based on ICD-11 MMS Database and E-Signature

机译:基于ICD-11 MMS数据库和电子签名的中医诊所安全EDC系统的XHTML解决方案

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Objective: To develop a secure data capture system in XHTML (eXtensible Hyper Text Markup Language) format, which can collect health records in Traditional Chinese Medicine (TCM) Clinics with capability of electronic signature at client, exchange data from internet to transmit or to receive EHRs for business and research usage, and retrieve ICD-11 MMS for traditional medicine (TM) that is stored with XML in SQL database server (DBS) within intranet. General Design: 1. To define two basic tables for ICD-11 table (tICD11) information and electronic medical record (EMR) table (EMRT). Fields of DEV (Data Element Value) for ICD codes and DEVM (Data Element Value Meaning) for ICD code meanings or terms are the essential fields of the tICD11; In EMRT, fields are defined, involving type of XML for EHRs built with Extensible Hypertext Markup Language (XHTML) and type of text for MD5 of EHRs. Besides, type of datetime for creating or updating record is affiliated in all tables. Microsoft Window's SQL server (WINSQLS) 2008, a kind of relation-type database management system for data of SQL or non-SQL, is selected as experiment environment within intranet. 2. To design views and storage procedures querying tICD11 or submitting EHRs. To create a series of Structure Query Language (SQL) such as views and SQL storage procedures (SPs) for managing the tICD11 data transaction (TRSs); and exchanging EHRs built with Extensible Hypertext Markup Language (XHTML) with SQL plus XPath, a non-SQL language, to express clinical or patient's demands, such as voice messages of patient reported outcomes (PROs) or electronic signatures (E-signature, ES). SPs may include parameters (PSPs) and end with a SQL term of FOR XMLAUTO, ROOT(`ROOTNAME'). 3. To deploy web service (WS) site with functional web-interface. According to a model with three-tier architecture and relative functions, we developed an interface of WS corresponding PSPs in the Window's server 2008 (64bits), a gateway web site accessing with heading of “https://” supported with the protocol of Secure Sockets Layer (SSL), and an account-administrative server ordinarily referred as Active Directory (AD). As one of keys, a function in WS solution is to get specified values of the attributes contained in the start tag of XHTML's data elements (XDE), which are parameters for DEV or DEVM required by SPs. Result: 1. More than 17,000 records of the codes and terms from the ICD-11 MMS were captured. Codes and terms in ICD-11 for symptoms, signs, clinical finding, diagnostic and treatment and even those for TM such as disorder, pattern and acupuncture, other than those in the ICD-10. These codes and terms can be retrieved from tICD11 to XDE involved DEV or/and DEVM via SPs and be bonded to list views of optional inputs, which will be selected as standardized inputs into EHRs. 2. Voice records of clinical visits and/or PROs post-clinical visits, and ES for XDE on EHRs can also be captured at local device, securely submitted to the remote servers to integrate into EDC system. 3. The system that runs at the intranet allows remote requests from internet clients to query with XHTML involving keywords and returns deidentified XHTML involving DEV and DEVM to the EHRs at client sites. The data-exchange-interface web site as the gateway (GW, URL: https://www.meacm.com/icd11ws) at a server (GWS) is marked with the SSL certificate so that these exchanges are commonly referred as secure and effective between different platforms and the inside of WINSQLS. Conclusion: The system offers a secure XHTML-structured web solution for high quality EHRs plus coding and terming input with the standard of ICD-11 MMS, legally binding input via electronic signature and sensitive masking input via encryption with public key and deidentified data exchanges for research. Such a system has the advantages of being flexible for application needs but rigorous in collection of real high qualitive data for scientific research and decision; and can be conveniently deployed in a distributed system. An integration of traditional medicine data into the entire EHRs system will collect broad and comprehensive healthcare data and generate real-world evidence for the role and effectiveness of TCM in patient care.
机译:目的:开发一种可扩展的XHTML(可扩展超文本标记语言)格式的数据采集系统,该系统可以在中医诊所收集具有电子签名功能的健康记录,并可以通过客户端交换来自互联网的数据以进行传输或接收用于业务和研究用途的EHR,以及检索传统医学(TM)的ICD-11 MMS,该XML与XML一起存储在Intranet内的SQL数据库服务器(DBS)中。总体设计:1.为ICD-11表(tICD11)信息和电子病历(EMR)表(EMRT)定义两个基本表。 tICD11的基本字段是ICD代码的DEV(数据元素值)字段和ICD代码的含义或术语的DEVM(数据元素值含义)字段。在EMRT中,定义了字段,涉及使用可扩展超文本标记语言(XHTML)构建的EHR的XML类型和EHR的MD5的文本类型。此外,用于创建或更新记录的日期时间类型与所有表相关。在内部网中,选择Microsoft Window的SQL Server(WINSQLS)2008作为一种用于SQL或非SQL数据的关系型数据库管理系统。 2.设计查询tICD11或提交EHR的视图和存储过程。创建一系列结构查询语言(SQL),例如视图和SQL存储过程(SP),以管理tICD11数据事务(TRS);并交换使用可扩展超文本标记语言(XHTML)和SQL加上非SQL语言XPath构建的EHR,以表达临床或患者的需求,例如患者报告结果(PRO)或电子签名的语音消息(E签名,ES )。 SP可以包括参数(PSP),并以SQL术语FOR XMLAUTO,ROOT(`ROOTNAME')结尾。 3.部署具有功能性Web界面的Web服务(WS)站点。根据具有三层体系结构和相关功能的模型,我们在Window的服务器2008(64位)中开发了WS对应的PSP的接口,该网关网站以安全协议支持标题为“ https://”的网关网站套接字层(SSL)和通常称为Active Directory(AD)的帐户管理服务器。作为关键之一,WS解决方案中的功能是获取XHTML数据元素(XDE)的开始标记中包含的属性的指定值,这些属性值是SP所需的DEV或DEVM的参数。结果:1.捕获了来自ICD-11 MMS的17,000多个代码和术语记录。 ICD-11中有关症状,体征,临床发现,诊断和治疗的代码和术语,除ICD-10中的代码和术语,甚至包括疾病,模式和针灸等TM的代码和术语。这些代码和术语可以通过SP从tICD11检索到涉及XDE的DEV或/和DEVM,并绑定到可选输入的列表视图,这些可选输入将被选作EHR的标准输入。 2.也可以在本地设备上捕获临床访问和/或PRO的临床访问的语音记录,以及EHR上XDE的ES,并将其安全地提交给远程服务器以集成到EDC系统中。 3.在Intranet上运行的系统允许来自Internet客户端的远程请求使用涉及关键字的XHTML进行查询,并将包含DEV和DEVM的已标识XHTML返回给客户端站点的EHR。服务器(GWS)上作为网关(GW,URL:https://www.meacm.com/icd11ws)的数据交换接口网站标记有SSL证书,因此这些交换通常称为安全和在不同平台和WINSQLS内部之间有效。结论:该系统为高质量EHR提供了一个安全的XHTML结构化Web解决方案,以及采用ICD-11 MMS标准的编码和术语输入,通过电子签名合法绑定的输入以及通过使用公钥加密和不明身份的数据交换的敏感屏蔽输入。研究。这样的系统的优点是可以灵活地满足应用程序的需求,但是严格收集用于科学研究和决策的真正高质量的数据;并可以方便地部署在分布式系统中。将传统医学数据整合到整个EHRs系统中,将收集广泛而全面的医疗保健数据,并为中医在患者护理中的作用和有效性提供现实的证据。

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