A plethora of digital ECG formats have been proposed and implemented. This heterogeneity hinders the design and development of interoperable systems and entails critical integration issues for the healthcare information systems. This paper aims at performing a comprehensive overview on the current state of affairs of the interoperable exchange of digital ECG signals. This includes 1) a review on existing digital ECG formats, 2) a collection of applications and cardiology settings using such formats, 3) a compilation of the relationships between such formats, and 4) a reflection on the current situation and foreseeable future of the interoperable exchange of digital ECG signals. The objectives have been approached by completing and updating previous reviews on the topic through appropriate database mining. 39 digital ECG formats, 56 applications, tools or implantation experiences, 47 mappings/converters, and 6 relationships between such formats have been found in the literature. The creation and generalization of a single standardized ECG format is a desirable goal. However, this unification requires political commitment and international cooperation among different standardization bodies. Ongoing ontology-based approaches covering ECG domain have recently emerged as a promising alternative for reaching fully fledged ECG interoperability in the near future.

The ISO/IEEE 11073 standard for Personal Health Devices (X73PHD) aims to ensure interoperability between Personal Health Devices and aggregators-e.g. health appliances, routers-in ambulatory setups. The Integrating the Healthcare Enterprise (IHE) initiative promotes the coordinated use of different standards in healthcare systems (e.g. Personal/Electronic Health Records, alert managers, Clinical Decision Support Systems) by defining profiles intended for medical use cases. X73PHD provides a robust syntactic model and a comprehensive terminology, but it places limited emphasis on security and on interoperability with IHE-compliant systems and frameworks. However, the implementation of eHealth/mHealth applications in environments such as health and fitness monitoring, independent living and disease management (i.e. the X73PHD domains) increasingly requires features such as secure connections to mobile aggregators-e.g. smartphones, tablets-, the sharing of devices among different users with privacy, and interoperability with certain IHE-compliant healthcare systems. This work proposes a comprehensive IHE-based X73PHD extension consisting of additive layers adapted to different eHealth/mHealth applications, after having analyzed the features of X73PHD (especially its built-in security), IHE profiles related with these applications and other research works. Both the new features proposed for each layer and the procedures to support them have been carefully chosen to minimize the impact on X73PHD, on its architecture (in terms of delays and overhead) and on its framework. Such implications are thoroughly analyzed in this paper. As a result, an extended model of X73PHD is proposed, preserving its essential features while extending them with added value.

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The standardization of Electronic Health Records (EHR) is a crucial factor for ensuring interoperable sharing of health data. During recent decades, a plethora of initiatives-driven by international organizations-has emerged to define the required models describing the exchange of information between EHRs. These models cover different essential characteristics for building interoperable EHRs, such as architecture, methodology, communication, safety or terminology, among others. In this context, the European reference frame for the standardized exchange of EHR is the recently approved ISO/EN 13606 standard. This multi-part standard provides the syntactic and semantic capabilities (through a dual model approach) as well as terminology, security and interface considerations for the standardized exchange of EHR. This paper provides (a) an introduction to the different standardization efforts related to the interoperable exchange of EHR around the world, and (b) a description of how the ISO/EN 13606 standard provides interoperable sharing of clinical information.

Ambient assisted living and integrated care in an aging society is based on the vision of the lifelong Electronic Health Record calling for HealthCare Information Systems and medical device interoperability. For medical devices this aim can be achieved by the consistent implementation of harmonized international interoperability standards. The ISO/IEEE 11073 (x73) family of standards is a reference standard for medical device interoperability. In its Personal Health Device (PHD) version several devices have been included, but an ECG device specialization is not yet available. On the other hand, the SCP-ECG standard for short-term diagnostic ECGs (EN1064) has been recently approved as an international standard ISO/IEEE 11073-91064:2009. In this paper, the relationships between a proposed x73-PHD model for an ECG device and the fields of the SCP-ECG standard are investigated. A proof-of-concept implementation of the proposed x73-PHD ECG model is also presented, identifying open issues to be addressed by standards development for the wider interoperability adoption of x73-PHD standards.