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Healthsoftware: a new CEI Guide for software management in medical environment.
Giacomozzi, Claudia; Martelli, Francesco
The increasing spread of software components in the healthcare context renders explanatory guides relevant and mandatory to interpret laws and standards, and to support safe management of software products in healthcare. In a working group has been settled for the above purposes at Italian Electrotechnical Committee (CEI), made of experts from Italian National Institute of Health (ISS), representatives of industry, and representatives of the healthcare organizations. As a first outcome of the group activity, Guide CEI was published in February The Guide incorporates an innovative approach based on the proper contextualization of software products, either medical devices or not, to the specific healthcare scenario, and addresses the risk management of IT systems. The Guide provides operators and manufacturers with an interpretative support with many detailed examples to facilitate the proper contextualization and management of healthsoftware, in compliance with related European and international regulations and standards.
Use of Diabetes Data Management Software Reports by Health Care Providers, Patients With Diabetes, and Caregivers Improves Accuracy and Efficiency of Data Analysis and Interpretation Compared With Traditional Logbook Data
Hinnen, Deborah A.; Buskirk, Ann; Lyden, Maureen; Amstutz, Linda; Hunter, Tracy; Parkin, Christopher G.; Wagner, Robin
Background: We assessed users’ proficiency and efficiency in identifying and interpreting self-monitored blood glucose (SMBG), insulin, and carbohydrate intake data using data management software reports compared with standard logbooks. Method: This prospective, self-controlled, randomized study enrolled insulin-treated patients with diabetes (PWDs) (continuous subcutaneous insulin infusion [CSII] and multiple daily insulin injection [MDI] therapy), patient caregivers [CGVs]) and health care providers (HCPs) who were naïve to diabetes data management computer software. Six paired clinical cases (3 CSII, 3 MDI) and associated multiple-choice questions/answers were reviewed by diabetes specialists and presented to participants via a web portal in both software report (SR) and traditional logbook (TL) formats. Participant response time and accuracy were documented and assessed. Participants completed a preference questionnaire at study completion. Results: All participants (54 PWDs, 24 CGVs, 33 HCPs) completed the cases. Participants achieved greater accuracy (assessed by percentage of accurate answers) using the SR versus TL formats: PWDs, ()% versus ()%, P < ; CGVs, ()% versus ()%, P < ; HCPs, ()% versus ()%, P < Participants spent less time (minutes) with each case using the SR versus TL formats: PWDs, () versus (), P < ; CGVs, () versus (), P = ; HCPs, () versus (), P < The majority of participants preferred using the software reports versus logbook data. Conclusions: Use of the Accu-Chek Connect Online software reports enabled PWDs, CGVs, and HCPs, naïve to diabetes data management software, to identify and utilize key diabetes information with significantly greater accuracy and efficiency compared with traditional logbook information. Use of SRs was preferred over logbooks. PMID
Software for the occupational health and safety integrated management system
This paper intends to present the design and the production of a software for the Occupational Health and Safety Integrated Management System with the view to a rapid drawing up of the system documents in the field of occupational health and safety.
Electronic Health Record for Intensive Care based on Usual Windows Based Software.
Reper, Arnaud; Reper, Pascal
In Intensive Care Units, the amount of data to be processed for patients care, the turn over of the patients, the necessity for reliability and for review processes indicate the use of Patient Data Management Systems (PDMS) and electronic health records (EHR). To respond to the needs of an Intensive Care Unit and not to be locked with proprietary software, we developed an EHR based on usual software and components. The software was designed as a client-server architecture running on the Windows operating system and powered by the access data base system. The client software was developed using Visual Basic interface library. The application offers to the users the following functions: medical notes captures, observations and treatments, nursing charts with administration of medications, scoring systems for classification, and possibilities to encode medical activities for billing processes. Since his deployment in September , the EHR was used to care more than five thousands patients with the expected software reliability and facilitated data management and review processes. Communications with other medical software were not developed from the start, and are realized by the use of basic functionalities communication engine. Further upgrade of the system will include multi-platform support, use of typed language with static analysis, and configurable interface. The developed system based on usual software components was able to respond to the medical needs of the local ICU environment. The use of Windows for development allowed us to customize the software to the preexisting organization and contributed to the acceptability of the whole system.
[Application of password manager software in health care].
When using multiple IT systems, handling of passwords in a secure manner means a potential source of problem. The most frequent issues are choosing the appropriate length and complexity, and then remembering the strong passwords. Password manager software provides a good solution for this problem, while greatly increasing the security of sensitive medical data. This article introduces a password manager software and provides basic information of the application. It also discusses how to select a really secure password manager software and suggests a practical application to efficient, safe and comfortable use for health care. Orv. Hetil., , (52),
Software architecture and engineering for patient records: current and future.
Weng, Chunhua; Levine, Betty A; Mun, Seong K
During the "The National Forum on the Future of the Defense Health Information System," a track focusing on "Systems Architecture and Software Engineering" included eight presenters. These presenters identified three key areas of interest in this field, which include the need for open enterprise architecture and a federated database design, net centrality based on service-oriented architecture, and the need for focus on software usability and reusability. The eight panelists provided recommendations related to the suitability of service-oriented architecture and the enabling technologies of grid computing and Web for building health services research centers and federated data warehouses to facilitate large-scale collaborative health care and research. Finally, they discussed the need to leverage industry best practices for software engineering to facilitate rapid software development, testing, and deployment.
Personal stories within virtual environments: embodiments of a model for cancer patient information software.
Greene, D D; Heeter, C
Two new cancer patient information CD-ROMs extend the personal stories within virtual environments model of cancer patient information developed for Breast Cancer Lighthouse. Cancer Pain Retreat and Cancer Prevention Park: Games for Life are intended to inform and inspire users in an emotionally calming and intimately informative manner. The software offers users an experience--of visiting a virtual place and meeting and talking with patients and health care professionals.
Lifelong personal health data and application software via virtual machines in the cloud.
Van Gorp, Pieter; Comuzzi, Marco
Personal Health Records (PHRs) should remain the lifelong property of patients, who should be able to show them conveniently and securely to selected caregivers and institutions. In this paper, we present MyPHRMachines, a cloud-based PHR system taking a radically new architectural solution to health record portability. In MyPHRMachines, health-related data and the application software to view and/or analyze it are separately deployed in the PHR system. After uploading their medical data to MyPHRMachines, patients can access them again from remote virtual machines that contain the right software to visualize and analyze them without any need for conversion. Patients can share their remote virtual machine session with selected caregivers, who will need only a Web browser to access the pre-loaded fragments of their lifelong PHR. We discuss a prototype of MyPHRMachines applied to two use cases, i.e., radiology image sharing and personalized medicine.
Improving the quality of care of patients with rheumatic disease using patient-centric electronic redesign software.
Newman, Eric D; Lerch, Virginia; Billet, Jon; Berger, Andrea; Kirchner, H Lester
Electronic health records (EHRs) are not optimized for chronic disease management. To improve the quality of care for patients with rheumatic disease, we developed electronic data capture, aggregation, display, and documentation software. The software integrated and reassembled information from the patient (via a touchscreen questionnaire), nurse, physician, and EHR into a series of actionable views. Core functions included trends over time, rheumatology-related demographics, and documentation for patient and provider. Quality measures collected included patient-reported outcomes, disease activity, and function. The software was tested and implemented in 3 rheumatology departments, and integrated into routine care delivery. Post-implementation evaluation measured adoption, efficiency, productivity, and patient perception. Over 2 years, 6, patients completed 19, touchscreen questionnaires. The software was adopted for use by 86% of patients and rheumatologists. Chart review and documentation time trended downward, and productivity increased by 26%. Patient satisfaction, activation, and adherence remained unchanged, although pre-implementation values were high. A strong correlation was seen between use of the software and disease control (weighted Pearson's correlation coefficient , P = ), and a relative increase in patients with low disease activity of 3% per quarter was noted. We describe innovative software that aggregates, stores, and displays information vital to improving the quality of care for patients with chronic rheumatic disease. The software was well-adopted by patients and providers. Post-implementation, significant improvements in quality of care, efficiency of care, and productivity were demonstrated. Copyright © by the American College of Rheumatology.
Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.
Ronquillo, Jay G; Zuckerman, Diana M
Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from through primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of software devices ( million units) were subject to recalls, with 12 of these devices (, units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review
Measuring health care process quality with software quality measures.
Yildiz, Ozkan; Demirörs, Onur
Existing quality models focus on some specific diseases, clinics or clinical areas. Although they contain structure, process, or output type measures, there is no model which measures quality of health care processes comprehensively. In addition, due to the not measured overall process quality, hospitals cannot compare quality of processes internally and externally. To bring a solution to above problems, a new model is developed from software quality measures. We have adopted the ISO/IEC software quality standard for health care processes. Then, JCIAS (Joint Commission International Accreditation Standards for Hospitals) measurable elements were added to model scope for unifying functional requirements. Assessment (diagnosing) process measurement results are provided in this paper. After the application, it was concluded that the model determines weak and strong aspects of the processes, gives a more detailed picture for the process quality, and provides quantifiable information to hospitals to compare their processes with multiple organizations.
ERIC Educational Resources Information Center
Journal of Chemical Education,
Presented are reviews of two computer software packages for Apple II computers; "Organic Spectroscopy," and "Videodisc Display Program" for use with "The Periodic Table Videodisc." A sample spectrograph from "Organic Spectroscopy" is included. (CW)
Software for Dosage Individualization of Voriconazole for Immunocompromised Patients
VanGuilder, Michael; Donnelly, J. Peter; Blijlevens, Nicole M. A.; Brüggemann, Roger J. M.; Jelliffe, Roger W.; Neely, Michael N.
The efficacy of voriconazole is potentially compromised by considerable pharmacokinetic variability. There are increasing insights into voriconazole concentrations that are safe and effective for treatment of invasive fungal infections. Therapeutic drug monitoring is increasingly advocated. Software to aid in the individualization of dosing would be an extremely useful clinical tool. We developed software to enable the individualization of voriconazole dosing to attain predefined serum concentration targets. The process of individualized voriconazole therapy was based on concepts of Bayesian stochastic adaptive control. Multiple-model dosage design with feedback control was used to calculate dosages that achieved desired concentration targets with maximum precision. The performance of the software program was assessed using the data from 10 recipients of an allogeneic hematopoietic stem cell transplant (HSCT) receiving intravenous (i.v.) voriconazole. The program was able to model the plasma concentrations with a high level of precision, despite the wide range of concentration trajectories and interindividual pharmacokinetic variability. The voriconazole concentrations predicted after the last dosages were largely concordant with those actually measured. Simulations provided an illustration of the way in which the software can be used to adjust dosages of patients falling outside desired concentration targets. This software appears to be an extremely useful tool to further optimize voriconazole therapy and aid in therapeutic drug monitoring. Further prospective studies are now required to define the utility of the controller in daily clinical practice. PMID
Phynx: an open source software solution supporting data management and web-based patient-level data review for drug safety studies in the general practice research database and other health care databases.
Egbring, Marco; Kullak-Ublick, Gerd A; Russmann, Stefan
To develop a software solution that supports management and clinical review of patient data from electronic medical records databases or claims databases for pharmacoepidemiological drug safety studies. We used open source software to build a data management system and an internet application with a Flex client on a Java application server with a MySQL database backend. The application is hosted on Amazon Elastic Compute Cloud. This solution named Phynx supports data management, Web-based display of electronic patient information, and interactive review of patient-level information in the individual clinical context. This system was applied to a dataset from the UK General Practice Research Database (GPRD). Our solution can be setup and customized with limited programming resources, and there is almost no extra cost for software. Access times are short, the displayed information is structured in chronological order and visually attractive, and selected information such as drug exposure can be blinded. External experts can review patient profiles and save evaluations and comments via a common Web browser. Phynx provides a flexible and economical solution for patient-level review of electronic medical information from databases considering the individual clinical context. It can therefore make an important contribution to an efficient validation of outcome assessment in drug safety database studies.
Software Tools to Support the Assessment of System Health
NASA Technical Reports Server (NTRS)
Melcher, Kevin J.
This presentation provides an overview of three software tools that were developed by the NASA Glenn Research Center to support the assessment of system health: the Propulsion Diagnostic Method Evaluation Strategy (ProDIMES), the Systematic Sensor Selection Strategy (S4), and the Extended Testability Analysis (ETA) tool. Originally developed to support specific NASA projects in aeronautics and space, these software tools are currently available to U.S. citizens through the NASA Glenn Software Catalog. The ProDiMES software tool was developed to support a uniform comparison of propulsion gas path diagnostic methods. Methods published in the open literature are typically applied to dissimilar platforms with different levels of complexity. They often address different diagnostic problems and use inconsistent metrics for evaluating performance. As a result, it is difficult to perform a one ]to ]one comparison of the various diagnostic methods. ProDIMES solves this problem by serving as a theme problem to aid in propulsion gas path diagnostic technology development and evaluation. The overall goal is to provide a tool that will serve as an industry standard, and will truly facilitate the development and evaluation of significant Engine Health Management (EHM) capabilities. ProDiMES has been developed under a collaborative project of The Technical Cooperation Program (TTCP) based on feedback provided by individuals within the aircraft engine health management community. The S4 software tool provides a framework that supports the optimal selection of sensors for health management assessments. S4 is structured to accommodate user ]defined applications, diagnostic systems, search techniques, and system requirements/constraints. One or more sensor suites that maximize this performance while meeting other user ]defined system requirements that are presumed to exist. S4 provides a systematic approach for evaluating combinations of sensors to determine the set or sets of
Development and implementation of a 'Mental Health Finder' software tool within an electronic medical record system.
Swan, D; Hannigan, A; Higgins, S; McDonnell, R; Meagher, D; Cullen, W
In Ireland, as in many other healthcare systems, mental health service provision is being reconfigured with a move toward more care in the community, and particularly primary care. Recording and surveillance systems for mental health information and activities in primary care are needed for service planning and quality improvement. We describe the development and initial implementation of a software tool ('mental health finder') within a widely used primary care electronic medical record system (EMR) in Ireland to enable large-scale data collection on the epidemiology and management of mental health and substance use problems among patients attending general practice. In collaboration with the Irish Primary Care Research Network (IPCRN), we developed the 'Mental Health Finder' as a software plug-in to a commonly used primary care EMR system to facilitate data collection on mental health diagnoses and pharmacological treatments among patients. The finder searches for and identifies patients based on diagnostic coding and/or prescribed medicines. It was initially implemented among a convenience sample of six GP practices. Prevalence of mental health and substance use problems across the six practices, as identified by the finder, was % (range %). % of identified patients were female; % were private patients. One-third (%) of identified patients were prescribed more than one class of psychotropic medication. Of the patients identified by the finder, % were identifiable via prescribing data, % via diagnostic coding. The finder is a feasible and promising methodology for large-scale data collection on mental health problems in primary care.
Médicarte software developed for the Quebec microprocessor health card project.
Lavoie, G; Tremblay, L; Durant, P; Papillon, M J; Bérubé, J; Fortin, J P
The Quebec Patient Smart Card Project is a Provincial Government initiative under the responsibility of the Rgie de l'assurance-maladie du Québec (Quebec Health Insurance Board). Development, implementation, and assessment duties were assigned to a team from Université Laval, which in turn joined a group from the Direction de la santé publique du Bas-St-Laurent in Rimouski, where the experiment is taking place. The pilot project seeks to evaluate the use and acceptance of a microprocessor card as a way to improve the exchange of clinical information between card users and various health professionals. The card can be best described as a résumé containing information pertinent to an individual's health history. It is not a complete medical file; rather, it is a summary to be used as a starting point for a discussion between health professionals and patients. The target population is composed of persons 60 years and over, pregnant women, infants under 18 months, and the residents of a small town located in the target area, St-Fabien, regardless of age. The health professionals involved are general practitioners, specialists, pharmacists, nurses, and ambulance personnel. Participation in the project is on a voluntary basis. Each health care provider participating in the project has a personal identification number (PIN) and must use both an access card and a user card to access information. This prevents unauthorized access to a patient's card and allows the staff to sign and date information entered onto the patient card. To test the microprocessor card, we developed software based on a problem-oriented approach integrating diagnosis, investigations, treatments, and referrals. This software is not an expert system that constrains the clinician to a particular decisional algorithm. Instead, the software supports the physician in decision making. The software was developed with a graphical interface (Windows ) to maximize its user friendliness. A version of the
Reusable Software Usability Specifications for mHealth Applications.
Cruz Zapata, Belén; Fernández-Alemán, José Luis; Toval, Ambrosio; Idri, Ali
One of the key factors for the adoption of mobile technologies, and in particular of mobile health applications, is usability. A usable application will be easier to use and understand by users, and will improve user's interaction with it. This paper proposes a software requirements catalog for usable mobile health applications, which can be used for the development of new applications, or the evaluation of existing ones. The catalog is based on the main identified sources in literature on usability and mobile health applications. Our catalog was organized according to the ISO/IEC/IEEE standard and follows the SIREN methodology to create reusable catalogs. The applicability of the catalog was verified by the creation of an audit method, which was used to perform the evaluation of a real app, S Health, application created by Samsung Electronics Co. The usability requirements catalog, along with the audit method, identified several usability flaws on the evaluated app, which scored 83%. Some flaws were detected in the app related to the navigation pattern. Some more issues related to the startup experience, empty screens or writing style were also found. The way a user navigates through an application improves or deteriorates user's experience with the application. We proposed a reusable usability catalog and an audit method. This proposal was used to evaluate a mobile health application. An audit report was created with the usability issues identified on the evaluated application.
A Software Framework for Remote Patient Monitoring by Using Multi-Agent Systems Support.
Fernandes, Chrystinne Oliveira; Lucena, Carlos José Pereira De
Although there have been significant advances in network, hardware, and software technologies, the health care environment has not taken advantage of these developments to solve many of its inherent problems. Research activities in these 3 areas make it possible to apply advanced technologies to address many of these issues such as real-time monitoring of a large number of patients, particularly where a timely response is critical. The objective of this research was to design and develop innovative technological solutions to offer a more proactive and reliable medical care environment. The short-term and primary goal was to construct IoT4Health, a flexible software framework to generate a range of Internet of things (IoT) applications, containing components such as multi-agent systems that are designed to perform Remote Patient Monitoring (RPM) activities autonomously. An investigation into its full potential to conduct such patient monitoring activities in a more proactive way is an expected future step. A framework methodology was selected to evaluate whether the RPM domain had the potential to generate customized applications that could achieve the stated goal of being responsive and flexible within the RPM domain. As a proof of concept of the software framework's flexibility, 3 applications were developed with different implementations for each framework hot spot to demonstrate potential. Agents4Health was selected to illustrate the instantiation process and IoT4Health's operation. To develop more concrete indicators of the responsiveness of the simulated care environment, an experiment was conducted while Agents4Health was operating, to measure the number of delays incurred in monitoring the tasks performed by agents. IoT4Health's construction can be highlighted as our contribution to the development of eHealth solutions. As a software framework, IoT4Health offers extensibility points for the generation of applications. Applications can extend the framework in
Health care professional workstation: software system construction using DSSA scenario-based engineering process.
Hufnagel, S; Harbison, K; Silva, J; Mettala, E
This paper describes a new method for the evolutionary determination of user requirements and system specifications called scenario-based engineering process (SEP). Health care professional workstations are critical components of large scale health care system architectures. We suggest that domain-specific software architectures (DSSAs) be used to specify standard interfaces and protocols for reusable software components throughout those architectures, including workstations. We encourage the use of engineering principles and abstraction mechanisms. Engineering principles are flexible guidelines, adaptable to particular situations. Abstraction mechanisms are simplifications for management of complexity. We recommend object-oriented design principles, graphical structural specifications, and formal components' behavioral specifications. We give an ambulatory care scenario and associated models to demonstrate SEP. The scenario uses health care terminology and gives patients' and health care providers' system views. Our goal is to have a threefold benefit. (i) Scenario view abstractions provide consistent interdisciplinary communications. (ii) Hierarchical object-oriented structures provide useful abstractions for reuse, understandability, and long term evolution. (iii) SEP and health care DSSA integration into computer aided software engineering (CASE) environments. These environments should support rapid construction and certification of individualized systems, from reuse libraries.