DANSK DSF/ISO/DTS 9321 PDF

This document specifies the general requirements for conducting a multi-center medical data collaborative analysis in aspects of system architecture, data storage, data standardization, data analysis, system features, functions requirements and security while the original medical data should be stored inside and cannot leave the local medical centers in any unencrypted formats. Data in this document mainly refers to electronic health records data for observational clinical cohort studies, including structured data, medical text data and image report data, etc. Purpose of using anonymization data is classified according to ISO/TS 14265:2011 for data consistency management. This document applies to researchers, developers, maintenance staffs and management personnel of multi-center medical data collaborative analysis systems, as well as decision makers of multi-center system design and planning, clinical researchers and third-party clinical data demander. The potential uses for this document are to: - support developers of new medical data analysis platforms establishing distributed systems with compliant and secured framework. - support technicians in medical centers rapidly and safely linking their local medical resources into a collaborative analysis platform. - support supervisors in medical centers to manage the research processes. - support physicians and medical researchers conducting the collaborative analysis of multi-center medical data when the original medical data cannot leave the local medical centers in any unencrypted formats. - provide a core set of functional requirements to ensure the major functionality and security while the functions of collaborative analysis platforms are gradually enriched.