Research Doctorate - Doctor of Philosophy (PhD) / It is difficult to decide when to replace (major components of) information systems (IS) used in large organisations. Obstacles include not only the cost and the technical complexities but also the fact that the workplace is dependent on the current IS and the users have familiarity with their functionalities. The problems become more complicated with increasing need for IS interconnectivity within and between organisations. Formal guidelines to assist in making replacement decisions are not commonly used. This thesis aims to develop a model of key factors involved in the IS replacement decision and to investigate the role of interoperability in this decision. It concentrates on the healthcare domain in NSW, Australia, which represents a complex distributed multilevel organisation, which has identified interoperability as a problem and has started initiatives to improve it. Research in IS and software engineering has shed light on many of the issues associated with the replacement decision. For example, studies in technology acceptance have explained why organisations delay in moving to new technologies, and modelled the effect of increasing popularity of such technologies. IS success models have explored the factors that contribute to success and failure of deployed systems, providing checklists to assess the appropriateness of current systems from the point of view of the users and other organisational stakeholders. Research into the value of user feedback has helped managers to align user expectations with workplace IS. In terms of software function, metrics have been developed to measure a range of factors including performance, usability, efficiency and reliability that help determine how well the systems are performing from a technical perspective. Additional research has identified important points to consider when comparing custom made systems versus buying off-the-shelf systems, such as skill availability and after sale support. Maturity models and life cycle analyses consider the effect of age on IS, and Lehman’s laws of software evolution highlight the need for maintenance if an IS is to survive. Improvements in interoperability at the information level have been achieved through domain specific standards for data integrity, and modular approaches for partial changes in IS. In particular, the healthcare domain has developed a number of standardised terminological systems such as SNOMED, LOINC, ICD and messaging standards such as HL7. Template high level data models have also been trialled as a way to ensure new IS remain compatible with existing systems. While this literature partially covers and contributes to the understanding of when and how to replace IS and/or components, to our knowledge there has been no attempt to provide an integrated model identifying factors to be considered in the replacement decision. The thesis adopts a multi method approach to build a model of IS replacement and to explore aspects of interoperability. Preliminary factors and their potential interactions were first identified from the literature. In depth interviews were conducted with 10 experts and 2 IS users to investigate the validity and importance of the factors and interactions and to elicit further potential items. The analysis of the transcripts guided review of further literature and contemporary data, which led to the development of a final model and insights into the role of interoperability. A member check was used to validate both the model and the researcher’s conclusions on interoperability. The final model is centred about the change request, that is, any request made by or on behalf of an executive officer in order to maintain or replace part or all of an IS. The change request is informed by user feedback but our research distinguishes the two factors because the change request factor filters and manages requests for change from multiple sources. Other factors that have an important direct or indirect effect on generating change requests include: the extent of system specialisation, that is, how the system is tailored to satisfy organisational requirements; popularity, the degree to which an IS or a component is liked or supported by its user community; the prevalence and severity of errors and failures in the systems; the usability and performance of the systems; and the adequacy of support, including training, documentation, and so on. The dependent factors are maintenance and replacement, determined through the change requests. The validation through member checking showed that IS practitioners found our model useful in explaining the replacement process. The model provided an interpretation of the change requests. By exposing and clustering reasons behind the change requests, the complexity of deciding whether to maintain or replace system components can be reduced. Individual factors can be addressed more specifically. Formal guidelines on whether to maintain or replace components or entire IS can be drawn up using this understanding. The factors and their interactions as explained in the model could be the basis of a decision tree, which would be customised for organisational jargon and priorities. The requirement for interoperability is an aspect of system specialisation. An important finding from the research was that one of the most significant reasons to change a system is when problems are encountered in exchanging data and information. Conversely, as long as systems can exchange data, there is less pressure to replace them. Organisations benefit more from systems that provide more support for interoperability. Findings on interoperability in the health domain were that existing messaging standards (mostly HL7) used in the information exchange between subsystems including legacy databases are useful and are used. Also, ambiguities are diminished with vocabularies (mostly SNOMED, LOINC and ICD are used in NSW health domain). However, a methodology known as Interoperability Framework supported by government funding bodies for comparing data models has not been adopted and is not given any significant credit by the users. Likewise, a government proposal to use an overarching high level data model has not been adopted, in part because it is too complex. To guide use of such a data model requires a methodology for comparing data models: an example of such a methodology is developed in this thesis. The thesis research found that replacement decisions in the healthcare domain are affected by the existing quasi-monopoly of large vendors which tend to use proprietary standards that limit interoperability. The research concludes that interoperability should be achieved by increased use of vendor-independent messaging and terminological standards. In order to get the co-operation of individual health institutions within the domain, initial investments should be concentrated on simple and easy to adopt standards. A primary limitation of this thesis is the extent of testing of the findings. Data from a broader range of organisations, in different sectors and different countries, is needed to validate the model and to guide development of decision making tools that are based on it. Particularly valuable would be case studies of IS replacement decision making and the process which executives use in determining change requests. The priorities of the factors and their attributes as well as the strengths of the relationships in the model need to be tested empirically using tailored survey instruments. Another interesting research avenue which was only touched on in the thesis was the effect of policies and legislation on interoperability and on replacement decisions.

Submitted by Marcos Samuel (msamjunior@gmail.com) on 2017-02-09T11:47:40Z No. of bitstreams: 1 DISSERTACAO Marcio vFinal V5.pdf: 1960502 bytes, checksum: 48e28ffa2855fe34bf05e15d83f75664 (MD5) / Approved for entry into archive by Vanessa Reis (vanessa.jamile@ufba.br) on 2017-02-09T14:38:45Z (GMT) No. of bitstreams: 1 DISSERTACAO Marcio vFinal V5.pdf: 1960502 bytes, checksum: 48e28ffa2855fe34bf05e15d83f75664 (MD5) / Made available in DSpace on 2017-02-09T14:38:45Z (GMT). No. of bitstreams: 1 DISSERTACAO Marcio vFinal V5.pdf: 1960502 bytes, checksum: 48e28ffa2855fe34bf05e15d83f75664 (MD5) / Hospitais e clínicas ao redor do mundo têm se beneficiado do uso da Tecnologia da Informação para atender pacientes com diversas enfermidades. Dentre os softwares e hardwares disponíveis, destacam-se, por sua importância na avaliação da condição clínica dos pacientes, os equipamentos de monitoramento de sinais vitais, tais como frequência cardíaca, temperatura, pressão arterial e saturação de oxigênio. Apesar da relevância destes dispositivos, observa-se uma lacuna no que diz respeito à sua interoperabilidade com diferentes sistemas. Normalmente, quando há funções de compartilhamento, são utilizados padrões ou protocolos de comunicação proprietários que dificultam o desenvolvimento de uma solução integrada. Entretanto, alguns padrões de interoperabilidade para área médica têm sido adotados com o objetivo de compatibilizar a utilização desses aparelhos em sistemas integrados. Dentre estes, destaca-se o Health Level Seven (HL7) que define um formato comum para transmissão, recepção e armazenamento de informações clínicas, independentemente do protocolo de comunicação adotado pelo fornecedor. Desta forma, o HL7 vem sendo utilizado no desenvolvimento de sistemas médicos centralizados que capturam e armazenam dados provenientes de equipamentos heterogêneos de monitoramento de sinais vitais. Contudo, quando se trata de armazenar dados de diversos pacientes por longos períodos (meses ou anos registrados minuto a minuto, por exemplo), este padrão revela-se inadequado. Padrões como o HL7 têm sido largamente utilizados em soluções que envolvem o armazenamento em bancos de dados tradicionais, apesar destes serem menos eficientes em armazenar e disponibilizar, em tempo real, grandes volumes de dados, diferentemente dos historiadores de dados industriais ou Process Information Management System (PIMS). O que essencialmente diferencia um PIMS de um banco de dados tradicional é a sua capacidade de armazenar grandes volumes de dados consumindo pouco espaço em disco, devido ao uso de filtros de compressão e exceção antes do efetivo armazenamento. Entretanto, para que dados no padrão HL7 sejam inseridos em um PIMS, é necessário convertê-los para um padrão de comunicação adequado. O Plant Information (PI) é um PIMS que opera no padrão OLE for Process Control (OPC) e tem sido largamente utilizado com sucesso na indústria de manufatura para resolver a interoperabilidade entre os diversos equipamentos e sistemas. Neste sentido, o presente trabalho propõe resolver este mesmo problema em sistemas da área médica ao desenvolver um servidor HL7-OPC que habilita o PI a capturar e armazenar longas séries históricas de sinais vitais. Consequentemente, além do tradicional monitoramento das condições de saúde, em tempo real ou histórico, os dados podem ser analisados por algoritmos de reconhecimento de padrões para, dentre outras finalidades, determinar com antecipação a probabilidade de ocorrências médicas em pacientes sob monitorização. Foi realizado um estudo detalhado dos padrões de comunicação utilizados na indústria e na área médica, seguido de uma análise da arquitetura do padrão OPC e da arquitetura geral dos PIMS, especialmente quanto a algoritmos de compressão e exceção. Com base nos elementos levantados, foi possível desenvolver o Servidor HL7-OPC proposto neste trabalho. A solução foi submetida à uma sequência de cenários de testes que comprovaram o seu pleno funcionamento e desempenho.

[EN] Healthcare domain produces and consumes big quantities of people's health data. Although data exchange is the norm rather than the exception, being able to access to all patient data is still far from achieved. Current developments such as personal health records will introduce even more data and complexity to the Electronic Health Records (EHR). Achieving semantic interoperability is one of the biggest challenges to overcome in order to benefit from all the information contained in the distributed EHR. This requires that the semantics of the information can be understood by all involved parties. It has been stablished that three layers are needed to achieve semantic interoperability: Reference models, clinical models (archetypes), and clinical terminologies. As seen in the literature, information models (reference models and clinical models) are lacking methodologies and tools to improve EHR systems and to develop new systems that can be semantically interoperable. The purpose of this thesis is to provide methodologies and tools for advancing the use of archetypes in three different scenarios: - Archetype definition over specifications with no dual model architecture native support. Any EHR architecture that directly or indirectly has the notion of detailed clinical models (such as HL7 CDA templates) can be potentially used as a reference model for archetype definition. This allows transforming single-model architectures (which contain only a reference model) into dual-model architectures (reference model with archetypes). A set of methodologies and tools has been developed to support the definition of archetypes from multiple reference models. - Data transformation. A complete methodology and tools are proposed to deal with the transformation of legacy data into XML documents compliant with the archetype and the underlying reference model. If the reference model is a standard then the transformation is a standardization process. The methodologies and tools allow both the transformation of legacy data and the transformation of data between different EHR standards. - Automatic generation of implementation guides and reference materials from archetypes. A methodology for the automatic generation of a set of reference materials is provided. These materials are useful for the development and use of EHR systems. These reference materials include data validators, example instances, implementation guides, human-readable formal rules, sample forms, mindmaps, etc. These reference materials can be combined and organized in different ways to adapt to different types of users (clinical or information technology staff). This way, users can include the detailed clinical model in their organization workflow and cooperate in the model definition. These methodologies and tools put clinical models as a key part of the system. The set of presented methodologies and tools ease the achievement of semantic interoperability by providing means for the semantic description, normalization, and validation of existing and new systems. / [ES] El sector sanitario produce y consume una gran cantidad de datos sobre la salud de las personas. La necesidad de intercambiar esta información es una norma más que una excepción, aunque este objetivo está lejos de ser alcanzado. Actualmente estamos viviendo avances como la medicina personalizada que incrementarán aún más el tamaño y complejidad de la Historia Clínica Electrónica (HCE). La consecución de altos grados de interoperabilidad semántica es uno de los principales retos para aprovechar al máximo toda la información contenida en las HCEs. Esto a su vez requiere una representación fiel de la información de tal forma que asegure la consistencia de su significado entre todos los agentes involucrados. Actualmente está reconocido que para la representación del significado clínico necesitamos tres tipos de artefactos: modelos de referencia, modelos clínicos (arquetipos) y terminologías. En el caso concreto de los modelos de información (modelos de referencia y modelos clínicos) se observa en la literatura una falta de metodologías y herramientas que faciliten su uso tanto para la mejora de sistemas de HCE ya existentes como en el desarrollo de nuevos sistemas con altos niveles de interoperabilidad semántica. Esta tesis tiene como propósito proporcionar metodologías y herramientas para el uso avanzado de arquetipos en tres escenarios diferentes: - Definición de arquetipos sobre especificaciones sin soporte nativo al modelo dual. Cualquier arquitectura de HCE que posea directa o indirectamente la noción de modelos clínicos detallados (por ejemplo, las plantillas en HL7 CDA) puede ser potencialmente usada como modelo de referencia para la definición de arquetipos. Con esto se consigue transformar arquitecturas de HCE de modelo único (solo con modelo de referencia) en arquitecturas de doble modelo (modelo de referencia + arquetipos). Se han desarrollado metodologías y herramientas que faciliten a los editores de arquetipos el soporte a múltiples modelos de referencia. - Transformación de datos. Se propone una metodología y herramientas para la transformación de datos ya existentes a documentos XML conformes con los arquetipos y el modelo de referencia subyacente. Si el modelo de referencia es un estándar entonces la transformación será un proceso de estandarización de datos. La metodología y herramientas permiten tanto la transformación de datos no estandarizados como la transformación de datos entre diferentes estándares. - Generación automática de guías de implementación y artefactos procesables a partir de arquetipos. Se aporta una metodología para la generación automática de un conjunto de materiales de referencia de utilidad en el desarrollo y uso de sistemas de HCE, concretamente validadores de datos, instancias de ejemplo, guías de implementación , reglas formales legibles por humanos, formularios de ejemplo, mindmaps, etc. Estos materiales pueden ser combinados y organizados de diferentes modos para facilitar que los diferentes tipos de usuarios (clínicos, técnicos) puedan incluir los modelos clínicos detallados en el flujo de trabajo de su sistema y colaborar en su definición. Estas metodologías y herramientas ponen los modelos clínicos como una parte clave en el sistema. El conjunto de las metodologías y herramientas presentadas facilitan la consecución de la interoperabilidad semántica al proveer medios para la descripción semántica, normalización y validación tanto de sistemas nuevos como ya existentes. / [CAT] El sector sanitari produeix i consumeix una gran quantitat de dades sobre la salut de les persones. La necessitat d'intercanviar aquesta informació és una norma més que una excepció, encara que aquest objectiu està lluny de ser aconseguit. Actualment estem vivint avanços com la medicina personalitzada que incrementaran encara més la grandària i complexitat de la Història Clínica Electrònica (HCE). La consecució d'alts graus d'interoperabilitat semàntica és un dels principals reptes per a aprofitar al màxim tota la informació continguda en les HCEs. Açò, per la seua banda, requereix una representació fidel de la informació de tal forma que assegure la consistència del seu significat entre tots els agents involucrats. Actualment està reconegut que per a la representació del significat clínic necessitem tres tipus d'artefactes: models de referència, models clínics (arquetips) i terminologies. En el cas concret dels models d'informació (models de referència i models clínics) s'observa en la literatura una mancança de metodologies i eines que en faciliten l'ús tant per a la millora de sistemes de HCE ja existents com per al desenvolupament de nous sistemes amb alts nivells d'interoperabilitat semàntica. Aquesta tesi té com a propòsit proporcionar metodologies i eines per a l'ús avançat d'arquetips en tres escenaris diferents: - Definició d'arquetips sobre especificacions sense suport natiu al model dual. Qualsevol arquitectura de HCE que posseïsca directa o indirectament la noció de models clínics detallats (per exemple, les plantilles en HL7 CDA) pot ser potencialment usada com a model de referència per a la definició d'arquetips. Amb açò s'aconsegueix transformar arquitectures de HCE de model únic (solament amb model de referència) en arquitectures de doble model (model de referència + arquetips). S'han desenvolupat metodologies i eines que faciliten als editors d'arquetips el suport a múltiples models de referència. - Transformació de dades. Es proposa una metodologia i eines per a la transformació de dades ja existents a documents XML conformes amb els arquetips i el model de referència subjacent. Si el model de referència és un estàndard llavors la transformació serà un procés d'estandardització de dades. La metodologia i eines permeten tant la transformació de dades no estandarditzades com la transformació de dades entre diferents estàndards. - Generació automàtica de guies d'implementació i artefactes processables a partir d'arquetips. S'hi inclou una metodologia per a la generació automàtica d'un conjunt de materials de referència d'utilitat en el desenvolupament i ús de sistemes de HCE, concretament validadors de dades, instàncies d'exemple, guies d'implementació, regles formals llegibles per humans, formularis d'exemple, mapes mentals, etc. Aquests materials poden ser combinats i organitzats de diferents maneres per a facilitar que els diferents tipus d'usuaris (clínics, tècnics) puguen incloure els models clínics detallats en el flux de treball del seu sistema i col·laborar en la seua definició. Aquestes metodologies i eines posen els models clínics com una part clau del sistemes. El conjunt de les metodologies i eines presentades faciliten la consecució de la interoperabilitat semàntica en proveir mitjans per a la seua descripció semàntica, normalització i validació tant de sistemes nous com ja existents. / Boscá Tomás, D. (2016). DETAILED CLINICAL MODELS AND THEIR RELATION WITH ELECTRONIC HEALTH RECORDS [Tesis doctoral no publicada]. Universitat Politècnica de València. https://doi.org/10.4995/Thesis/10251/62174 / TESIS

Indiana University-Purdue University Indianapolis (IUPUI) / Precision medicine refers to the delivering of customized treatment to patients based on their individual characteristics, and aims to reduce adverse events, improve diagnostic methods, and enhance the efficacy of therapies. Among efforts to achieve the goals of precision medicine, researchers have used observational data for developing predictive modeling to best predict health outcomes according to patients’ variables. Although numerous predictive models have been reported in the literature, not all models present high prediction power, and as the result, not all models may reach clinical settings to help healthcare professionals make clinical decisions at the point-of-care. The lack of generalizability stems from the fact that no comprehensive medical data repository exists that has the information of all patients in the target population. Even if the patients’ records were available from other sources, the datasets may need further processing prior to data analysis due to differences in the structure of databases and the coding systems used to record concepts. This project intends to fill the gap by introducing an interoperable solution that receives patient electronic health records via Health Level Seven (HL7) messaging standard from other data sources, transforms the records to observational medical outcomes partnership (OMOP) common data model (CDM) for population health research, and applies predictive models on patient data to make predictions about health outcomes. This project comprises of three studies. The first study introduces CCD-TOOMOP parser, and evaluates OMOP CDM to accommodate patient data transferred by HL7 consolidated continuity of care documents (CCDs). The second study explores how to adopt predictive model markup language (PMML) for standardizing dissemination of OMOP-based predictive models. Finally, the third study introduces Personalized Health Risk Scoring Tool (PHRST), a pilot, interoperable OMOP-based model scoring tool that processes the embedded models and generates risk scores in a real-time manner. The final product addresses objectives of precision medicine, and has the potentials to not only be employed at the point-of-care to deliver individualized treatment to patients, but also can contribute to health outcome research by easing collecting clinical outcomes across diverse medical centers independent of system specifications.

Οι σύγχρονες τάσεις στο χώρο των υπηρεσιών Υγείας απαιτούν αναβάθμιση των προσφερόμενων υπηρεσιών με ταυτόχρονο εξορθολογισμό του κόστους των. Τη λύση αυτή είναι σε θέση να δώσουν συστήματα μηχανοργάνωσης των Μονάδων παροχής υπηρεσιών υγείας. Ένα ολοκληρωμένο πληροφοριακό σύστημα υγείας (ΟΠΣΥ) είναι το πληροφοριακό σύστημα εκείνο που συμβάλει στην ενοποίηση, συστηματική παρακολούθηση, διαχείριση και έλεγχο των δεδομένων (οικονομικά, επιχειρησιακά, οργανωτικά καθώς και ιατρικά δεδομένα) ενός νοσοκομείου ή, γενικά μιας μονάδας υγείας, με σκοπό την αναβάθμιση της ποιότητας των υπηρεσιών την αναδιοργάνωση των εσωτερικών διεργασιών και την εξυπηρέτηση του πολίτη. Είναι δε σημαντικός ο ρόλος του όσον αφορά τη διάχυση και αξιοποίηση της ιατρικής πληροφορίας για ερευνητικούς και στατιστικούς σκοπούς αλλά και όσον αφορά με τη χρήση νέων τεχνολογιών πληροφορικής κι επικοινωνιών από τους ιατρούς, νοσηλευτές και διοικητικό και λοιπό προσωπικό ενός νοσοκομείου. Στόχος της μεταπτυχιακής διπλωματικής αυτής εργασίας είναι η παρουσίαση των θεμάτων διαλειτουργικότητας και ανταλλαγής δεδομένων μεταξύ Πληροφοριακών Συστημάτων στο χώρο της Υγείας, ένα αντικείμενο που αποτελεί σημαντικό παράγοντα επιτυχίας και αξιοποίησης των Πληροφοριακών Υποδομών αυτών από τους επαγγελματίες Υγείας. Στις εισαγωγικές ενότητες αναλύεται η σημερινή κατάσταση στο χώρο της πληροφορικής υγείας και παρουσιάζονται τα χαρακτηριστικά των σύγχρονων ΟΠΣΥ, χρησιμοποιώντας μάλιστα ως παράδειγμα ένα εμπορικό προϊόν (το λογισμικό medico//s). Στη συνέχεια παρουσιάζονται οι κωδικοποιήσεις που χρησιμοποιούνται στα συστήματα αυτά, με ιδιαίτερη μνεία στην ελληνική μετάφραση της κωδικοποίησης ICD-10 απο το Υπουργείο Υγείας. Επίσης γίνεται ειδική αναφορά και αναλυτική παρουσίαση με παραδείγματα στο διεθνές πρωτόκολλο επικοινωνίας HL7. Στα επόμενα κεφάλαια παρουσιάζεται το πρότυπο XDS-MS, ένα πρότυπο ιατρικών εγγράφων που υπηρετεί τους σκοπούς της διαλειτουργικότητας. Αναλύονται τα περιεχόμενα του εγγράφου αλλά και η δομή της όλης υλοποίησης ώστε το έγγραφο να μπορεί να διαμοιράζεται μεταξύ των επαγγελματιών υγείας. Για τις ανάγκες της εργασίας αυτής παρουσιάζεται το πρότυπο για τις συνόψεις νοσηλείας σύμφωνα με την αρχιτεκτονική ιατρικών εγγράφων (CDA) του HL7, τόσο όπως έχει τυποποιηθεί για την υποστήριξης Αγγλόφωνων νοσοκομείων/κειμένων αλλά και όπως είναι δυνατόν να προσαρμοστεί στις ανάγκες των Ελληνικών μονάδων Υγείας και της Ελληνικής γλώσσας. Στο πλαίσιο της παρούσας εργασίας, συγκεντρώθηκαν και παρατίθενται επίσης πρότυπα ιατρικών εγγράφων απο ελληνικά νοσοκομεία που χρησιμοποιούν ΟΠΣΥ. Επίσης, προτείνονται μελλοντικές επεκτάσεις και βελτιώσεις στο ερευνητικό αντικείμενο αυτό όπως αυτές προκύπτουν από την διεθνή βιβλιογραφία. Τέλος στο Παράρτημα της εργασίας παρουσιάζονται αναλυτικά οι κώδικες των εγγράφων CDA. / With advances in technology, the health care system requires an amelioration of services offered, as well as cost control. The solution is given by Integrated Health Information Systems (IHIS), a discipline at the intersection of information science, computer science, and health care that deals with the resources, devices, and methods required to optimize the acquisition, storage, retrieval, and use of information in health and biomedicine. Health informatics tools include not only computers but also clinical guidelines, formal medical terminologies, and information and communication systems. It is applied to the areas of nursing, clinical care, pharmacy, etc. The Cross-Enterprise Sharing of Medical Summary (XDS-MS) Integration Profile, a profile based on the HL7 Clinical Document Architecture (CDA) standard, defines the appropriate standards for document transmission and a minimum set of "record entries" that should be forwarded or made available to subsequent care provider(s) during specific transfer of care scenarios. In addition, this integration profile needs to define the utilization requirements/options for the receiving entity in order to ensure that the "care context" of the sending entity is appropriately maintained following the information transfer. So in this thesis there is an analysis of IHIS, with the paradigm of the medico//s software, as well as a presentation of coding systems in Heath Care Informatics. There are mentioned several systems, among which is found the HL7 one, analyzed by specific examples, and also the ICH-10. As for the latter there is a presentation of its greek translation as by the greek Ministry of Health. In the following chapters there is the description of the XDS-MS profile, both in its (english) version and the greek “translation”. In addition, there is a collection of medical documents by greek hospitals that use IHIS.

Submitted by Automação e Estatística (sst@bczm.ufrn.br) on 2018-04-11T20:06:38Z No. of bitstreams: 1 JoaoMarcosTeixeiraLacerda_TESE.pdf: 2501621 bytes, checksum: 99185146bcff087f88f53cf6f0e68bc8 (MD5) / Approved for entry into archive by Arlan Eloi Leite Silva (eloihistoriador@yahoo.com.br) on 2018-04-16T21:47:10Z (GMT) No. of bitstreams: 1 JoaoMarcosTeixeiraLacerda_TESE.pdf: 2501621 bytes, checksum: 99185146bcff087f88f53cf6f0e68bc8 (MD5) / Made available in DSpace on 2018-04-16T21:47:10Z (GMT). No. of bitstreams: 1 JoaoMarcosTeixeiraLacerda_TESE.pdf: 2501621 bytes, checksum: 99185146bcff087f88f53cf6f0e68bc8 (MD5) Previous issue date: 2017-06-16 / A comunicação de sistemas de informação com dispositivos biomédicos tornou-se complexa, não só devido à existência de vários protocolos de comunicação proprietários, mas também à maneira imutável de incorporar esse software a esses dispositivos. Nesse sentido, esta tese propõe uma arquitetura orientada a serviço para acessar dispositivos biomédicos como uma forma de abstrair os mecanismos de escrita e leitura de dados desses dispositivos, contribuindo assim, para que o foco da equipe de desenvolvimento de software biomédico se destine a seus requisitos funcionais, ou seja, regras de negócio relevantes para o domínio do problema. A arquitetura deste trabalho consiste em seis componentes principais: um Web Service para transporte e conversão dos dados do dispositivo, protocolos de comunicação para acessar os dispositivos, processadores de dados, um repositório de dispositivos para armazenar dados e informações transmitidas, um componente para tratamento de erros e por fim, um componente para configuração da arquitetura. Para o desenvolvimento de SOA-BD, foram utilizadas tecnologias como a linguagem XML e a linguagem de programação Java. Além disso, foram utilizados Padrões de Projeto como projeto de software. Para a validação deste trabalho, os dados foram coletados de monitores de sinais vitais em um centro de terapia intensiva utilizando o padrão médico HL7. Os testes obtiveram uma diferença de cerca de 1 segundo em termos de tempo de resposta com o uso da arquitetura. Para fins conclusivos, foi constatado que a SOA-BD obteve resultados importantes, como a redução da complexidade do protocolo de acesso, a oportunidade de tratar os pacientes em longas distâncias, permitindo um desenvolvimento mais fácil de aplicações de monitoramento e interoperabilidade com dispositivos biomédicos de diversos fabricantes. / The communication of information systems with biomedical devices has become complex not only due to the existence of several private communication protocols, but also to the immutable way that software is embedded into these devices. In this sense, this thesis proposes a service-oriented architecture to access biomedical devices to abstract the mechanisms of writing and reading data from these devices, thus contributing to enable the focus of the development team of biomedical software to be intended for its functional requirements, i.e. business rules relevant to the problem domain. The SOA-BD architecture consists of six main components: A Web Service for transport and conversion of the device data, Communication Protocols to access the devices, Data Parsers to process data, a Device Repository to store data and transmitted information, Error handling, for error handling of these information and Setup, for configuration of the architecture. For the development of SOA-BD, technologies such as the XML language and the Java programming language were used. In addition, Design Patterns were used as software design. For the validation of this work, data has been collected from vital sign monitors in an Intensive Care Unit using the HL7 standard. The tests obtained a difference of about only 1 second in terms of response time with the use of SOA-BD. For conclusive purposes, SOA-BD achieves important results such as the reduction on the access protocol complexity, the opportunity for treating patients over long distances, allowing easier development of monitoring applications and interoperability with biomedical devices from diverse manufacturers.

The Swedish National Archives are in charge of the management of Common Specifications (CS). CS are genericmetadata specifications that provides structure and markup when transferring digital information betweeninformation systems and to electronic archives. As of now there is no CS for electronic healthcare records (EHR).Organizations around Sweden have developed their own specifications for transferring healthcare information. Inaddition to that, there are comprehensive international EHR metadata standards established. The Swedish NationalArchives have commissioned a study of EHR metadata specifications and standards to aid in the development of theCS.A Delphi study was conducted, including respondents from major archiving organizations in Sweden, to identifynecessary metadata categories when exchanging EHRs. The data was analyzed considering the international EHRmetadata standards HL7 CDA2 and CEN/ISO EN13606, as well as digital preservation metadata categories. Theresults were a set of metadata categories necessary to include in a CS. In addition, a subset of suggested mandatorymetadata categories is proposed and a list of implications for practice. Clinical codes, auditing, and separatingmetadata related to different contexts are a sample size of the implications.The results were evaluated in an interview with the Swedish National Archives, as well as Sydarkivera. Three criteriafor evaluating the results were proposed, being that the results had to consider a common terminology as well as bebased on a metadata standard and Swedish metadata specifications for EHRs. The interview revealed that the resultssatisfied these criterions, except for requiring a study on one additional user environment of EHRs.

The delivery of quality healthcare to all citizens at reasonable costs is an important challenge. With the increase in the aging population, the costs of managing chronic diseases increase. Today, healthcare services tend to shift from recovery to prevention. Remote healthcare monitoring is crucial for prevention and monitoring of chronic diseases since they require continuous and long-term monitoring. The advances in networking, mobile communications and medical device technologies offer a great potential to realize remote healthcare monitoring. However, seamless integration of multi-modal medical devices to the existing healthcare information systems is necessary for the automated use of medical device observations in related applications. The thesis addresses the automatic acquisition and use of multi-modal medical device observations in healthcare information systems. The interoperability of medical devices with healthcare information systems requires both physical connectivity and application level interoperability. Therefore, the thesis concentrates on both the medical device domain and the interoperability efforts on the existing healthcare information systems. It provides an interoperability solution based on ISO/IEEE 11073 and HL7 standards. This work is also realized the automatic acquisition and use of multi-modal medical device observations in an intelligent healthcare monitoring and decision support system which is developed as a part of the IST-027074 SAPHIRE project funded by the European Commission.

This thesis is concerned with electronic prescription of drugs in the Czech republic. The objective is to find a proper standard for electronic medical data exchange and use it for building a new data communication interface for the e-prescription system. This work attends to the evolution and actual situation of the national e-prescription system. The system is based on one central storage for e-prescriptions, however, currently it isn't being used. On basis of valid legislation, electronic prescription and drug dispense processes are analyzed. Furthermore, present central storage data interface is explored. Considering advantages, that are bound to utilization of electronic data exchange standards, main objective of this thesis is given, to design a new interface for transmission of e-prescriptions and drug dispense notifications. New interface shall adhere to standards. Czech standard DASTA and europian norm EN13606 were examined. After all, set of specifications HL7 (Health Level Seven) has been chosen, which suits the requirements best. Data interface design, with HL7 standards, is based on exchange of documents. Documents (prescription, dispense notification) are expressed in the Clinical Document Architecture (CDA) format, and exchanged between applications by means of the Medical Records domain messages. The structure of wrappers, forming a message, results from common HL7 Specification Infrastructure. Presented design has been inspired by Finnish solution eResepti. The design tries to transform present interface of central storage to format, which is defined by selected HL7 specifications. It can be used in both local and central e-prescription systems. It may also support the development of systems for electronic health(care) records exchange.

This thesis deals with the information support of laboratory requisitions in medical facilities in the Czech Republic. Its aim is to analyze the usage status of electronic request systems and their integration into hospital systems in practice of Czech medical equipment. Further, on the basis of the survey, the thesis draws conclusions about the overall state and an assumed development of such systems. The analysis was conducted by means of questionnaire survey in a randomly chosen sample of health facilities in the CR. The study results can serve both to the actual respondents who participated in the study for comparison with the competition and to IS / ICT companies for the eventual development of application software systems to support the analyzed area. The work is divided into a theoretical and a practical part. The theoretical part is based on the available research, literature and electronic sources concerning information technology in health care. The practical part deals with the research study - a questionnaire survey, analysis, and interpretation of results.