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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. This work was supported inpart by Project PI08/1148, Project PI08/90330, Project PI12/01476, and ProjectPI12/01305 (coord. PI12/00508) from Fondo de Investigaci ́on Sanitaria (FIS)Plan Nacional de I+D+i and by Project CEN-20091043 Sí

This paper presents a service for the anonymisation of electronic health care record (EHR) extracts for secondary use based on the ISO/EN 13606 norm. The sending of clinical data for secondary use, in accordance with current legislation, must be carried out using anonymised data. The ISO/EN 13606 standard has characteristics which favour the development of an anonymisation service, thanks to a design that separates clinical information from demographic information and allows a semantic interoperability to be achieved in the exchange of information. The developed system, based on ISO/EN 13606, consists of two modules: demographic server and an anonymising module. El demographic server is able to work independently, while the anonymising module must always work with an associated demographic server. The anonymisation is the process through which it is no longer possible to establish the link between the data and the subject to whom it refers. The demographic server is responsible for the permanent storage of the demographic entities. The anonymising module is responsible for eliminating everything linked to the demographic data of a given extract. The anonymisation process consists of four phases: storage of the demographic information included in the extract, substitution of identifiers, elimination of the demographic information of the extract and final validation. The anonymising system has been integrated into Telemedicine projects with favourable results. The sending of anonymised data for a secondary use allows the generation of large clinical databases from which knowledge can be deduced using data-mining techniques.

Objective: The objective of this paper is to introduce a new language called ccML, designed to provide convenient pragmatic information to applications using the ISO/EN13606 reference model (RM), such as electronic health record (EHR) extracts editors. EHR extracts are presently built using the syntactic and semantic information provided in the RM and constrained by archetypes. The ccML extra information enables the automation of the medico-legal context information edition, which is over 70% of the total in an extract, without modifying the RM information. Materials and methods: ccML is defined using a W3C XML schema file. Valid ccML files complement the RM with additional pragmatics information. The ccML language grammar is defined using formal language theory as a single-type tree grammar. The new language is tested using an EHR extracts editor application as proof-of-concept system. Results: Seven ccML PVCodes (predefined value codes) are introduced in this grammar to cope with different realistic EHR edition situations. These seven PVCodes have different interpretation strategies, from direct look up in the ccML file itself, to more complex searches in archetypes or system precomputation. Discussion: The possibility to declare generic types in ccML gives rise to ambiguity during interpretation. The criterion used to overcome ambiguity is that specificity should prevail over generality. The opposite would make the individual specific element declarations useless. Conclusion: A new mark-up language ccML is introduced that opens up the possibility of providing applications using the ISO/EN13606 RM with the necessary pragmatics information to be practical and realistic. This research has been partially supported by projects PI09/90110 ‘Plataforma de innovación en nuevos servicios de telemedicina y eSalud para pacientes crónicos y dependientes (Innovation platform for new telemedicine and e-health services for chronic and dependent patients)—PITES’ and PI08/1148 ‘Representación de información clínica en cáncer de mama mediante arquetipos (Modeling clinical information in breast cancer through archetypes)—CAMAMA’ from Fondo de Investigación Sanitaria (FIS) Plan Nacional de I+D+i, and by project CEN-20091043 ‘Tecnologías disruptivas para la rehabilitación del futuro (Disruptive technologies for Rehabilitation in the Future)—REHABILITA’ from Plan Nacional de Investigación Científica Desarrollo e Innovación Tecnológica—CENIT-E. Sí

■ PURPOSE: Efficient ways are needed to implement the secondary prevention (SP) of coronary heart disease. Because few studies have investigated Web-based SP programs, our aim was to determine the usefulness of a new Web-based telemonitoring system, connecting patients provided with self-measurement devices and care managers via mobile phone text messages, as a tool for SP. ■ METHODS: A single-blind, randomized controlled, clinical trial of 203 acute coronary syndrome (ACS) survivors, was conducted at a hospital in Madrid, Spain. All patients received lifestyle counseling and usual-care treatment. Patients in the telemonitoring group (TMG) sent, through mobile phones, weight, heart rate, and blood pressure (BP) weekly, and capillary plasma lipid profile and glucose monthly. A cardiologist accessed these data through a Web interface and sent recommendations via short message service. Main outcome measures were BP, body mass index (BMI), smoking status, low-density lipoprotein-cholesterol (LDL-c), and glycated hemoglobin A 1c (HbA 1c ). ■ RESULTS: At 12-month followup, TMG patients were more likely (RR � 1.4; 95% CI � 1.1-1.7) to experience improvement in cardiovascular risk factors profile than control patients (69.6% vs 50.5%, P � .010). More TMG patients achieved treatment goals for BP (62.1% vs 42.9%, P � .012) and HbA1c (86.4% vs 54.2%, P � .018), with no differences in smoking cessation or LDL-c. Body mass index was significantly lower in TMG (� 0.77 kg/m 2 vs � 0.29 kg/m 2 , P � .005). ■ CONCLUSIONS: A telemonitoring program, via mobile phone messages, appears to be useful for improving the risk profile in ACS survivors and can be an effective tool for secondary prevention, especially for overweight patients.