| Modern information technology and internet has been widely applied into all fields of our society. Digitalization in healthcare has become more important in supporting the development of healthcare. Electronic Healthcare Record (EHR) and electronic Medical Record (EMR) are new subjects in digitalizing healthcare information. In order to share health information across different institutes, an unified form and content of records are necessary. That means patients'EMR must have semantic and syntactic interoperability. Interoperability is a critical factor for information sharing. At present, standards of EMR in hospital lacks information model to refer to, and in the situation of information sharing it is urgent to solve this problem. Research on health information standards has been well-developed for many years in foreign countries, and rich result has been generated. Because of the significant difference in medical systems and culture backgrounds between china and developed countries, existing standards do not directly apply to china's medical system. To assure consistency and unity, our researches on healthcare information standards are based on developed international standards and at the same time combine the practices of china medical system and social system. The combination will set a good foundation to bring china's health standards up to the consistence with international practice.Founded in 1987, Health Level Seven is the largest international organization dedicated to the development of healthcare information standards that presented today's world. Its standards series include concept standard, such as HL7 Reference Model; document standard, such as HL7 Clinical Document Architecture; application standard, such as HL7 Clinical Context Object Workgroup; language for representing and sharing medical knowledge, such as HL7 Arden Syntax; XML document structure standard, such as CDA Schema; and vocabulary and terminology standard. Among the series of standards, HL7 CDA R2 is clinic document standard used to markup document and constrain the structure and semantics of exchanged information. CDA adopt a markup language called XML-- eXtensible Markup Language, and is constrained by RIM concept model and HL7 V3 data types. HL7 CDA protocol has three levels: document, segment, and entry. At present, HL7 CDA has been widely used as document standard for EMR.Considering the lack of unified EMR content standard for China hospitals at present, the aim of this research is to build an EMR content information model that is suitable for China hospitals and is consistent with national EHR standard. The result model will set a reference guideline for building EMRs in Chinese hospitals, and will set a good foundation for sharing information among different hospitals. Methods used in this research include collecting clinical sheets in hospitals, combining theory of diagnostics with HL7 CDA R2 RMIM model based on related national health information standards and protocols, combining top-down and bottom-up design modeling method, and building EMR content information model with data group as minimal information unit.Results in this research include:(1) We collected all kinds of clinical sheets used in 17 digital hospitals, After comparing, combining, and eliminating redundant items, a set of 145 sheets were obtained. This set of sheets and items included were to regular EMR content as information foundation.(2) Adopted CDA R2 RMIM model, referred to national related health protocols and theory of diagnostics, built the first level of EMR content model structure. Categorized items of sheet set into information class and match the with EMR model. After matching, subclasses of information were created and sublevel of EMR model was built.(3) Standardized data items of sheet set according to national data elements standard and EHR data elements specification. After substituting data elements of EHR for data items in sheet set, information classes in the EMR model were valued by standard elements, basic data groups of EMR model were created and information model of data group was built. After comprehensively considered the two levels of EMR model and data group model, EMR information architecture figure and information model figure were built.(4) Data groups that valued by standardized data elements were used to rebuild clinical sheet'consent records for operation'and described the way that EMR templates were built. To verify practicability and applicability of the obtained model, an actual medical summary clinic sheet was sampled from XiJing hospital and was rebuilt by the template that composed of data groups. The rebuilt sheet was implemented in XMLSpy.(5) A discussion on the feasibility of combining top-down and bottom-up modeling method was conducted to develop health information standards that are suitable to medical and social system of China. Provided a new test and means for localizing international developed standards.Main conclusions are as following:(1) By abstracting information from clinical sheets used in routing work of hospitals, the general range of clinical information used in hospital was defined, and general information structure of clinical document was illustrated.(2) Regulations/law documents about health informatics and related standards in China, such as specification of writing medical record, health information data element standard, EHR data element standard, etc, are bases of health information standard research nationally and research must keep record of those regulations/law documents to implement information share. (3) This research made data group as minimum information unit for modeling, and those data groups were concreted by standardized data elements defined in national EHR standards. The accordance to national standards make this model operable and data groups have the advantages of maneuverability. The outcome data groups of this research could be used to rebuild clinic sheet and create EMR templates.(4) The model of this research has the characters of stability and extensibility. The domains of special medical are not described in this research and new data elements of those domain could be appended into data groups through register. The appending of new data elements will not change the structure of the model and assure the stability of the model.Clinical records of healthcare institute are very complex and diversified. More research are needed in this field to implement information sharing among different institutes. This research focused on general medical domain and medical descriptions in china, and has not reached special medical yet. The modeling of the clinical document content did not take the form of message and specific EMRs into consideration. In terms of its contribution to methodology, this research proposed new ideas of modeling besides referring to modeling method of HL7. As an innovative suggestion, data groups are proposed as minimum modeling unit in this research. The outcome of this research can become component of national EMR standards.
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