Lessons learned from the implementation of remote control for the interoperability standard ISO/IEEE11073-20601 in a standard weighing scale.

The Point of Care (PoC) version of the interoperability standard ISO/IEEE11073 (X73) provided a mechanism to control remotely agents through documents X73-10201 and X73-20301. The newer version of X73 oriented to Personal Health Devices (PHD) has no mechanisms to do such a thing. The authors are working toward a common proposal with the PHD Working Group (PHD-WG) in order to adapt the remote control capabilities from X73PoC to X73PHD. However, this theoretical adaptation has to be implemented and tested to evaluate whether or not its inclusion entails an acceptable overhead and extra cost. Such proof-of-concept assessment is the main objective of this paper. For the sake of simplicity, a weighing scale with a configurable operation was chosen as use case. First, in a previous stage of the research - the model was defined. Second, the implementation methodology - both in terms of hardware and software - was defined and executed. Third, an evaluation methodology to test the remote control features was defined. Then, a thorough comparison between a weighing scale with and without remote control was performed. The results obtained indicate that, when implementing remote control in a weighing scale, the relative weight of such feature represents an overhead of as much as 53%, whereas the number of Implementation Conformance Statements (ICSs) to be satisfied by the manufacturer represent as much as 34% regarding the implementation without remote control. The new feature facilitates remote control of PHDs but, at the same time, increases overhead and costs, and, therefore, manufacturers need to weigh this trade-off. As a conclusion, this proof-of-concept helps in fostering the evolution of the remote control proposal to extend X73PHD and promotes its inclusion as part of the standard, as well as it illustrates the methodological steps for its extrapolation to other specializations.

Formalize clinical processes into electronic health information systems: Modelling a screening service for diabetic retinopathy.

Most healthcare services use information and communication technologies to reduce and redistribute the workload associated with follow-up of chronic conditions. However, the lack of normalization of the information handled in and exchanged between such services hinders the scalability and extendibility. The use of medical standards for modelling and exchanging information, especially dual-model based approaches, can enhance the features of screening services. Hence, the approach of this paper is twofold. First, this article presents a generic methodology to model patient-centered clinical processes. Second, a proof of concept of the proposed methodology was conducted within the diabetic retinopathy (DR) screening service of the Health Service of Navarre (Spain) in compliance with a specific dual-model norm (openEHR). As a result, a set of elements required for deploying a model-driven DR screening service has been established, namely: clinical concepts, archetypes, termsets, templates, guideline definition rules, and user interface definitions. This model fosters reusability, because those elements are available to be downloaded and integrated in any healthcare service, and interoperability, since from then on such services can share information seamlessly.

Event-driven, pattern-based methodology for cost-effective development of standardized personal health devices.

Experiences applying standards in personal health devices (PHDs) show an inherent trade-off between interoperability and costs (in terms of processing load and development time). Therefore, reducing hardware and software costs as well as time-to-market is crucial for standards adoption. The ISO/IEEE11073 PHD family of standards (also referred to as X73PHD) provides interoperable communication between PHDs and aggregators. Nevertheless, the responsibility of achieving inexpensive implementations of X73PHD in limited resource microcontrollers falls directly on the developer. Hence, the authors previously presented a methodology based on patterns to implement X73-compliant PHDs into devices with low-voltage low-power constraints. That version was based on multitasking, which required additional features and resources. This paper therefore presents an event-driven evolution of the patterns-based methodology for cost-effective development of standardized PHDs. The results of comparing between the two versions showed that the mean values of decrease in memory consumption and cycles of latency are 11.59% and 45.95%, respectively. In addition, several enhancements in terms of cost-effectiveness and development time can be derived from the new version of the methodology. Therefore, the new approach could help in producing cost-effective X73-compliant PHDs, which in turn could foster the adoption of standards.

On the seamless, harmonized use of ISO/IEEE11073 and openEHR.

Standardized exchange of clinical information is a key factor in the provision of high quality health care systems. In this context, the openEHR specification facilitates the management of health data in electronic health records (EHRs), while the ISO/IEEE11073 (also referred to as X73PHD) family of standards provides a reference framework for medical device interoperability. Hospitals and health care providers using openEHR require flawless integration of data coming from external sources, such as X73PHD. Hence, a harmonization process is crucial for achieving a seamless, coherent use of those specifications in real scenarios. Such harmonization is the aim of this paper. Thus, the classes and attributes of a representative number of X73PHD specializations for medical devices--weight, temperature, blood pressure, pulse and heart rate, oximetry, and electrocardiograph--along with the X73PHD core document--ISO/IEEE11073-20601--have been analyzed and mapped to openEHR archetypes. The proposed methodology reuses the existing archetypes when possible and suggests new ones--or appropriate modifications--otherwise. As a result, this paper analyzes the inconsistencies found and the implications thereof in the coordinated use of these two standards. The procedure has also shown how existing standards are able to influence the archetype development process, enhancing the existing archetype corpus.

Implementation methodology for interoperable personal health devices with low-voltage low-power constraints.

Traditionally, e-Health solutions were located at the point of care (PoC), while the new ubiquitous user-centered paradigm draws on standard-based personal health devices (PHDs). Such devices place strict constraints on computation and battery efficiency that encouraged the International Organization for Standardization/IEEE11073 (X73) standard for medical devices to evolve from X73PoC to X73PHD. In this context, low-voltage low-power (LV-LP) technologies meet the restrictions of X73PHD-compliant devices. Since X73PHD does not approach the software architecture, the accomplishment of an efficient design falls directly on the software developer. Therefore, computational and battery performance of such LV-LP-constrained devices can even be outperformed through an efficient X73PHD implementation design. In this context, this paper proposes a new methodology to implement X73PHD into microcontroller-based platforms with LV-LP constraints. Such implementation methodology has been developed through a patterns-based approach and applied to a number of X73PHD-compliant agents (including weighing scale, blood pressure monitor, and thermometer specializations) and microprocessor architectures (8, 16, and 32 bits) as a proof of concept. As a reference, the results obtained in the weighing scale guarantee all features of X73PHD running over a microcontroller architecture based on ARM7TDMI requiring only 168 B of RAM and 2546 B of flash memory.

Seamless integration of ISO/IEEE11073 personal health devices and ISO/EN13606 electronic health records into an end-to-end interoperable solution.

The new paradigm of personal health demands open standards and middleware components that permit transparent integration and end-to-end interoperability from new personal health devices to healthcare information system. The use of standards seems to be the internationally accepted way to face this challenge. In this article, the implementation of an end-to-end standard-based personal health solution is presented. It integrates the ISO/IEEE11073 standard for the interoperability of personal health devices in the patient environment and the ISO/EN13606 standard for the interoperable exchange of electronic healthcare records and proposes a new approach for the end-to-end ISO/IEEE11073-ISO/EN13606 communication. The design strictly fulfills all the technical requirements of the most recent versions of both standards. An entire prototype has been designed, developed, and tested as a proof-of-concept of a personal health solution.

Interoperability in digital electrocardiography: harmonization of ISO/IEEE x73-PHD and SCP-ECG.

The ISO/IEEE 11073 (x73) family of standards is a reference frame for medical device interoperability. A draft for an ECG device specialization (ISO/IEEE 11073-10406-d02) has already been presented to the Personal Health Device (PHD) Working Group, and the Standard Communications Protocol for Computer-Assisted ElectroCardioGraphy (SCP-ECG) Standard for short-term diagnostic ECGs (EN1064:2005+A1:2007) has recently been approved as part of the x73 family (ISO 11073-91064:2009). These factors suggest the coordinated use of these two standards in foreseeable telecardiology environments, and hence the need to harmonize them. Such harmonization is the subject of this paper. Thus, a mapping of the mandatory attributes defined in the second draft of the ISO/IEEE 11073-10406-d02 and the minimum SCP-ECG fields is presented, and various other capabilities of the SCP-ECG Standard (such as the messaging part) are also analyzed from an x73-PHD point of view. As a result, this paper addresses and analyzes the implications of some inconsistencies in the coordinated use of these two standards. Finally, a proof-of-concept implementation of the draft x73-PHD ECG device specialization is presented, along with the conversion from x73-PHD to SCP-ECG. This paper, therefore, provides recommendations for future implementations of telecardiology systems that are compliant with both x73-PHD and SCP-ECG.

Standard-compliant real-time transmission of ECGs: harmonization of ISO/IEEE 11073-PHD and SCP-ECG.

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.