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

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.