Analysis and evaluation of the Electronic Health Record standard in China: A comparison with the American national standard ASTM E 1384

摘要

Objective: To analyze and evaluate the newly issued Electronic Health Record (EHR) Architecture and Data Standard of China (Chinese EHR Standard) and identify areas of improvement for future revisions. Design: We compared the Chinese EHR Standard with the standard of the American Society for Testing and Materials Standard Practice for Content and Structure of Electronic Health Records in the United States (ASTM E 1384 Standard). Methods: The comparison comprised two steps: (1) comparing the conformance of the two standards to the international standard: Health Informatics-Requirements for an Electronic Health Record Architecture (ISO/TS18308), and showing how the architectures of the two standards satisfy or deviate from the ISO requirements and (2) comparing the detailed data structures between the two standards. Results: Of the 124 requirement items in ISO/TS 18308, the Chinese EHR Standard and the ASTM E 1384 Standard conformed to 77 (62.1%) and 111 (89.5%), respectively. The Chinese EHR Standard conformed to 34 of 50 Structure requirements (68.0%), 22 of 24 Process requirements (91.7%), and 21 of 50 Other requirements (42.0%). The ASTM E 1384 Standard conformed to 49 of 50 Structure requirements (98.0%), 23 of 24 Process requirements (95.8%), and 39 of 40 Other requirements (78.0%). Conclusions: Further development of the Chinese EHR Standard should focus on supporting privacy and security mechanism, diverse data types, more generic and extensible lower level data structures, and relational attributes for data elements.