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Background: Health care has evolved to support the involvement of individuals in decision making by, for example, using mobile apps and wearables that may help empower people to actively participate in their treatment and health monitoring. While the term "participatory health informatics" (PHI) has emerged in literature to describe these activities, along with the use of social media for health purposes, the scope of the research field of PHI is not yet well defined., Objective: This article proposes a preliminary definition of PHI and defines the scope of the field., Methods: We used an adapted Delphi study design to gain consensus from participants on a definition developed from a previous review of literature. From the literature we derived a set of attributes describing PHI as comprising 18 characteristics, 14 aims, and 4 relations. We invited researchers, health professionals, and health informaticians to score these characteristics and aims of PHI and their relations to other fields over three survey rounds. In the first round participants were able to offer additional attributes for voting., Results: The first round had 44 participants, with 28 participants participating in all three rounds. These 28 participants were gender-balanced and comprised participants from industry, academia, and health sectors from all continents. Consensus was reached on 16 characteristics, 9 aims, and 6 related fields., Discussion: The consensus reached on attributes of PHI describe PHI as a multidisciplinary field that uses information technology and delivers tools with a focus on individual-centered care. It studies various effects of the use of such tools and technology. Its aims address the individuals in the role of patients, but also the health of a society as a whole. There are relationships to the fields of health informatics, digital health, medical informatics, and consumer health informatics., Conclusion: We have proposed a preliminary definition, aims, and relationships of PHI based on literature and expert consensus. These can begin to be used to support development of research priorities and outcomes measurements., Competing Interests: None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Medullated fibres, due to their higher resistance to bending and pressure, constitute a problem for the textile industry. Thus, having practical instruments to identify them is essential. Therefore, the aim of this research was to develop and validate a novel, swift, automatic system (referred to as S-FiberMed) for medullation and diameter assessment of animal fibres based on artificial intelligence. The medullation of 88 samples of alpaca, llama and mohair fibres (41, 43 and 4, respectively) was evaluated. Additionally, 269 samples of alpacas were considered for average fibre diameter (AFD) and the results were compared with the Portable Fiber Tester (PFT) and Optical Fibre Diameter Analyser (OFDA) methods (72 and 197 samples, respectively). The preparation of each sample to be analysed followed the procedure described in IWTO-8-2011. Version 5 of "You Only Look Once" and DenseNet models were used to recognise the type of medullation and diameter of the fibres, respectively. Within each image (n = 661 for alpaca), all fibres were labelled (as Non-Medullated, Fragmented Medulla, Uncontinuous Medulla, Continuous Medulla and Strongly Medullated) using the LabelImg tool. Data augmentation technique was applied to obtain 3 966 images. Such data set was divided into 3 576 and 390 images for training and test data, respectively. For mohair samples (n = 321), a similar process was carried out. The data to train the model used to infer the diameter contained 16 446 fibres labelled with his respective AFD. A complementary hardware composed of three subsystems (mechanical, electronic, and optical) was developed for evaluation purposes. T-test, Pearson and Concordance correlation, Bland-Altman plot and linear regression analyses were used to validate and compare the S-Fiber Med with other methods. Results indicate that there was no significant difference between medullation percentage obtained with the projection microscope and the S-Fiber Med. The Pearson and Concordance correlation analysis shows a strong, high and significant relationship (P-value < 0.001). The AFDs of alpaca and llama fibre samples obtained with the two methods are very similar, because no significant difference was found at the t-test (P-value > 0.172), and they have a strong, high and significant relationship between them, given the high Pearson correlation value (r ≥ 0.96 with P-value < 0.001), high Concordance coefficient and bias correction factor. Similar results were found when PFT and OFDA100 were compared with S-Fiber Med. As a conclusion, this new system provides precise, accurate measurements of medullation and AFD in an expeditious fashion (40 seconds/sample)., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

In the context of hospital management and operation, Intensive Care Units (ICU) are one of the most challenging in terms of time responsiveness and criticality, in which adequate resource management and signal processing play a key role in overall system performance. In this work, a context aware Intensive Care Unit is implemented and analyzed to provide scalable signal acquisition capabilities, as well as to provide tracking and access control. Wireless channel analysis is performed by means of hybrid optimized 3D Ray Launching deterministic simulation to assess potential interference impact as well as to provide required coverage/capacity thresholds for employed transceivers. Wireless system operation within the ICU scenario, considering conventional transceiver operation, is feasible in terms of quality of service for the complete scenario. Extensive measurements of overall interference levels have also been carried out, enabling subsequent adequate coverage/capacity estimations, for a set of Zigbee based nodes. Real system operation has been tested, with ad-hoc designed Zigbee wireless motes, employing lightweight communication protocols to minimize energy and bandwidth usage. An ICU information gathering application and software architecture for Visitor Access Control has been implemented, providing monitoring of the Boxes external doors and the identification of visitors via a RFID system. The results enable a solution to provide ICU access control and tracking capabilities previously not exploited, providing a step forward in the implementation of a Smart Health framework., Competing Interests: The authors declare no conflict of interest.

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., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

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., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

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.

New use cases to extend the interoperability standard ISO/IEEE11073 (X73) were found during the development of recent specializations. These use cases expose the need of remote command and control extensions to allow managers to configure agents through the standard. This paper presents a proposal for an extension of remote control and configuration service able to standardize a general procedure within the newest branch of this standard called X73 for Personal Health Devices (X73PHD). In order to develop a service for remote control, several approaches have been studied and discussed in the Personal Health Device Working Group (PHD-WG). The final solution is defined following the PHD-WG guidelines and integrated with the Optimized Exchange Protocol (X73-20601) and device specializations (X73-104xx). Previous works such as the classic command and control and the extended services packages from X73-10201 and X73-20301, respectively, have also been taken into account.

This paper investigates the application of the enterprise information system (EIS) paradigm to standardized cardiovascular condition monitoring. There are many specifications in cardiology, particularly in the ECG standardization arena. The existence of ECG formats, however, does not guarantee the implementation of homogeneous, standardized solutions for ECG management. In fact, hospital management services need to cope with various ECG formats and, moreover, several different visualization applications. This heterogeneity hampers the normalization of integrated, standardized healthcare information systems, hence the need for finding an appropriate combination of ECG formats and a suitable EIS-based software architecture that enables standardized exchange and homogeneous management of ECG formats. Determining such a combination is one objective of this paper. The second aim is to design and develop the integrated healthcare information system that satisfies the requirements posed by the previous determination. The ECG formats selected include ISO/IEEE11073, Standard Communications Protocol for Computer-Assisted Electrocardiography, and an ECG ontology. The EIS-enabling techniques and technologies selected include web services, simple object access protocol, extensible markup language, or business process execution language. Such a selection ensures the standardized exchange of ECGs within, or across, healthcare information systems while providing modularity and accessibility.

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.

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.

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.

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.

The new paradigm of e-Health demands open sensors and middleware components that permit transparent integration and end-to-end interoperability of new personal health devices. The use of standards seems to be the internationally adopted way to solve these problems. This paper presents the implementation of an end-to-end standards-based e-Health solution. This includes ISO/IEEE11073 standard for the interoperability of the medical devices in the patient environment and EN13606 standard for the interoperable exchange of the Electronic Healthcare Record. The design strictly fulfills all the technical features of the most recent versions of both standards. The implemented prototype has been tested in a laboratory environment to demonstrate its feasibility for its further transfer to the healthcare system.

Recent advances in biomedical engineering and continuous technological innovations in last decade are promoting new challenges, especially in e-Health environments. In this context, the medical devices interoperability is one of the interest fields wherein these improvements require a standard-based design in order to achieve homogeneous solutions. Furthermore, the spreading of wearable devices, oriented to the paradigm of patient environment and supported by wireless technologies as Bluetooth or ZigBee, is bringing new medical use cases based on Ambient Assisted Living, home monitoring of elderly, heart failure, chronic, under palliative care or patients who have undergone surgery, urgencies and emergencies, or even fitness auto-control and health follow-up. In this paper, several implementation experiences based on ISO/IEEE11073 standard are detailed. These evolved e-Health services can improve the quality of the patient's care, increase the user's interaction, and assure these e-Health applications to be fully compatible with global telemedicine systems.

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.

Interoperability among medical devices and compute engines in the personal environment of the patient, and with healthcare information systems in the remote monitoring and management process is a key need that requires developments supported on standard-based design. Even though there have been some international initiatives to combine different standards, the vision of an entire end-to-end standard-based system is the next challenge. This paper presents the implementation guidelines of a ubiquitous platform for Personal Health (p-Health). It is standard-based using the two main medical norms in this context: ISO/IEEE11073 in the patient environment for medical device interoperability, and EN13606 to allow the interoperable communication of the Electronic Healthcare Record of the patient. Furthermore, the proposal of a new protocol for End-to-End Standard Harmonization (E2ESHP) is presented in order to make possible the end-to-end standard integration. The platform has been designed to comply with the last ISO/IEEE11073 and EN13606 available versions, and tested in a laboratory environment as a proof-of-concept to illustrate its feasibility as an end-to-end standard-based solution.

In this paper a new wireless decision-support system for haemodialysis patients using heart rate variability (HRV) is presented. The telemedicine system provides connectivity to three participant sites: the general practitioner or nurse at the point of care in the dialysis unit, the remote information and processing server and the cardiologist. At the clinical point of care, the nurse acquires the electrocardiogram (ECG) by using a tailored mobile telecardiology system as well as other relevant physiological information during the clinical procedure, and sends it to the information server. The received information is stored in a secure file server, linked to the patient database and the ECG signal is automatically analyzed by using advanced signal processing tools in the processing server, where a complete clinical results report is generated. The cardiologist can then be linked by means of a web browser to the information server to analyze these results for further clinical diagnosis support. The system has been applied to study HRV in patients undergoing haemodialysis. The clinical report consisted of trends for time- and frequency-domain HRV indexes and other supplementary information automatically calculated, which show the response of the electrical activity of the heart to the dialysis process and that can be helpful for the follow-up of these patients. The telecardiology framework has been successfully evaluated both by the patients and the hospital personnel showing a high compliance with the system. The design and implementation of the telecardiology system have followed the most recent advances in web technologies, biomedical information and storage standards and signal processing techniques. The presented system can be used as a telemedicine tool for clinical diagnosis support and could also be used in other clinical settings.

We propose a telemedicine framework for remote and manufacturer independent pacemaker (PM) follow-up. The main goal is to provide the caregiver at the point-of-care with an efficient screening method to identify possible malfunction of the pacing system in collaboration with the specialist at the PM clinic. The concept was evaluated in a clinical trial on 44 patients (mean age 76 years). A total of 62 electrocardiogram (ECG) recordings were transmitted using a mobile PM follow-up unit. Using the automatic classification algorithm, 32 PMs were classified as 'OK' and eight PMs were classified as 'not OK'. In four cases a prediction regarding the working status of the PM was not possible. The signal processing classification was confirmed by expert classification (manual review of the ECG). The results indicate that the proposed PM follow-up concept has the potential to work as an efficient screening method and may spare a significant number of patients the burden of having to travel to specialized PM clinics.