Key Technologies Study On International Clinical Data Exchange And System Implementation

Health information exchange (HIE) becomes more and more important in medical services within the exchange of information among heterogeneous systems in medical institutions and regions. The sharing of clinical information could not only facilitate clinic visit, lower medical costs, and maximize the use of limited resources, but also assure the consistency and accessibility of clinical data to make a patient centered service, by which doctors could fast read the important clinical information such as medical and allergic history, to assure the safety and continuity of treatment, reduce human errors, and enhance the entire service qualities of medical industries.Since the2004Presidential Union Message proposed a strategic target that every US citizen would have an EUR within a decade, the HIE researches and practices proceed rapidly, the technologies in communication, standards, interoperability, and information safety techniques are being mature. However, due to the development stage of HIE, most clinical data exchange at present occurs between organizations within a regional system, with some occurrences at a national level. Other than communication, standardization, and interoperability, international clinical data exchange has to adapt to different healthcare work flows, privacy rules, legal environment, insurance system and translate documents from the source language to the destination language. To explore the key technologies and feasibility of HIE between different countries, we studied HIE standards and information security technologies, designed and developed an international clinical data exchange system, and tested the functionalities. The main work and innovative points are as follows:1) Study on international clinical data exchange and system implementation between China and Japan for the first timeAccording to the need of medical consistency cross countries, we designed the whole frame of the international clinical data exchange system. A global directory service, a data transformation module, a language translation system, and a medical image interoperating service were utilized to implement a cross-border medical information exchange, and a user interface based on B/S architecture was established, technically solved the problems of different healthcare work flows, privacy rules, and language translation in international clinical data exchange.2) Clinical information exchange standard adaptability reformation between China and JapanWe analyzed the HIE standards and localized the Medical Markup Language (MML) standard. The MML data definition tables were translated and modified according to the specifications published by the Ministry of Health of China; the constraints of MML were upgraded from DTD to Schema. Meanwhile, a data mapping set was designed to transform the data definition tables and medical terminologies between China and Japan.to maintain the meaning of the information being exchanged.3) Research of clinical information security technologies and data authenticity assurance process improvementWe designed and developed a information security system within the processes of HIE. A public key infrastructure (PKI) was set up and several workflows were designed to secure the identification authentication and data transportation; a role-based access control (RBAC) method was applied to manage the privileges of different kinds of users:through the two infrastructures, we built a basic security architecture. The data authenticity workflow was studied and improved using a creative rolling digest method, achieving a greatly improvement in efficient of MML verification, and a pattern matching method was designed and developed to de-identify PHIs in free-text paragraphs, assuring the consistency of clinical data and preventing the disclosure of patients’ private information.4) Experiments and evaluation of international clinical data exchange systemA case study was carried out among the three linked regional data centers, implementing several functionality experiments. We have exchanged the clinical data of57test patients for study, and a total of1153documents were exchanged, including1327MML files and187images, involving all the10MML content modules; as well as data authenticity experiment and PHI de-identification experiment. A10000-file comparison experiment shows that the verify time drops form6.71s as the mean time in hash list method to0.21s in rolling digest method, greatly improved the efficiency of verification:the relevance ratio of PHIs in free-text is92.37%. higher than the mean relevance ratio of one-man’s work which is81%, achieving the practical level.This research is a trial of cross-border clinical data exchange. Currently, the system is linked with the three regional information centers in Miyazaki, Kyoto, and Zhejiang University, and is technically ready for the exchange of clinical data between the two countries. As the development and experiments of international clinical data exchange continue. we would hope to find more issues and to improve the clinical data exchange between different countries and languages, facilitating the patient-centered medical information access in a safety, timely, and effective manner.