Service for the Pseudonymization of Electronic Healthcare Records Based on ISO/EN 13606 for the Secondary Use of Information

Abstract

The availability of electronic health data favors scientific advance through the creation of repositories for secondary use. Data anonymization is a mandatory step to comply with current legislation. A service for the pseudonymization of electronic healthcare record (EHR) extracts aimed at facilitating the exchange of clinical information for secondary use in compliance with legislation on data protection is presented. According to ISO/TS 25237, pseudonymization is a particular type of anonymization. This tool performs the anonymizations by maintaining three quasi-identifiers (gender, date of birth, and place of residence) with a degree of specification selected by the user. The developed system is based on the ISO/EN 13606 norm using its characteristics specifically favorable for anonymization. The service is made up of two independent modules: the demographic server and the pseudonymizing module. The demographic server supports the permanent storage of the demographic entities and the management of the identifiers. The pseudonymizing module anonymizes the ISO/EN 13606 extracts. The pseudonymizing process consists of four phases: the storage of the demographic information included in the extract, the substitution of the identifiers, the elimination of the demographic information of the extract, and the elimination of key data in free-text fields. The described pseudonymizing system was used in three telemedicine research projects with satisfactory results. A problem was detected with the type of data in a demographic data field and a proposal for modification was prepared for the group in charge of the drawing up and revision of the ISO/EN 13606 norm.

An Interoperable System toward Cardiac Risk Stratification from ECG Monitoring

“…Putting in practice clinical standards to deal with interoperability at different levels of the e-health communication infrastructure for different e-health applications has become a promising line or research [ 15 , 39 ]. Clinical practice and knowledge discovery for clinical decision support was achieved in [ 40 ] by building a repository of anonymized information by using CEN/ISO 1360. Authors in [ 15 ] describe an open platform to improve the connectivity and reusability of context data to deliver different kinds of health.…”

“…In [ 47 ], an ontology was developed for yielding interoperability capabilities between clinical research and clinical care domains. A promising line of research that joins clinical practice with knowledge discovery for clinical decision support was achieved in [ 40 ] by building a repository of anonymized information using CEN/ISO EN13606. Apart from that, several standard information models based on archetypes for decision support have been proposed in the literature.…”

Using Secondary Health Data in Research

“…However, medical researchers may require a certain amount of personal or demographic information about patients such as age, gender, lifestyle and health-related issues, which is not possible through anonymisation . As a result, the concept of pseudonymisation has come into prominence as it replaces patients' identifiable information with codes called pseudonyms (Pommerening & Reng, 2004;Mourby et al, 2018) which retain enough personal data to serve the aims and objectives of the research Somolinos et al, 2014).…”

Big Data and Health Economics: Opportunities, Challenges and Risks

“…Data anonymization is a mandatory step to comply with the current legislation [35]. The available of open health data for secondary use is fundamental for advance in the medical knowledge.…”