Philosophiae Doctor - PhD / A phenomenological philosophy underlies this research study which attempts to understand clinicians’ perception and understanding of an electronic patient record (EPR) system currently operational at a hospital in the Western Cape Province in South Africa (SA). Healthcare is a human right, thus patient records contain critical data and mostly paper-based in many SA hospitals. Clinicians are the EPR primary users and their attitude in its use is important for its success. This study explores, identifies and determines clinicians’ cognitive attributes towards EPR with a technology use framework developed. An initial quantitative approach was applied but unsuccessful due to low sample size. A pilot study was then conducted using 11 respondents. Purposive sampling was first initiated then snowball introduced later to improve the sample size qualitatively. Interviews were administered to 15 clinicians and tape recorded. Narrative content analysis was used as the preferred analysis technique because of the advantage of gaining direct information from study participants, unobtrusive and a nonreactive way to study the phenomenon of interest. Research findings tested 12 propositions and found high impact relationships between attitude (ATT) and each listed theme namely: perceived usefulness (PU), perceived ease of use (PEOU), complexity (COM), facilitating condition (FC), use behaviour (USE). Use behaviour had high impact relationships with storage (STO) and retrieval (RET). There were moderate impact relationships between PU and USE; PEOU and PU; RA and ATT; job fit (JF) and ATT; USE and share (SHA). The implication here is that any EPR system to be implemented should be tested using this framework to ascertain its usefulness and fit with a hospital's objectives and users expectations. By so doing, anticipated problems can be mitigated against and resolved before implementation. The study contributes to the information system (IS) body of knowledge through the technology use framework. The framework is for adoption by hospital management and its use by clinicians where EPR is operational. Traditional IS frameworks can be adopted for hospitals about to implement EPR because of the relevance of the "intent to use" theme.

This paper deals with medical data extraction from electronic patient record (EPR) system. Most of the medical data are stored in patient record systems, and data that are much valuable for medical research. If a researcher wants to extract medical information today, it has to be done manually because the data are stored in unstructured textual format in a system created by hospital staff. There is no way of extracting data in structure way. This paper is going to introduce an information extraction application for EPR system that allows the researcher to set up a study with inclusion and parameters for extraction for retrospective surveys in a webuser-interface environment. Inclusion is what the researcher would like to study (a defined category or criteria) and parameters specify the characteristics of inclusion the criteria. Result of this application provides an extracted clinical data that is used for retrospective surveys, downloadable to an MS-Excel file.

Wenn ein Chirurg heutzutage während der Operation Informationen aus der Patientenakte benötigt, ist er gezwungen, sich entweder unsteril zu machen oder Personal anzuweisen, ihm die entspre-chenden Informationen zugänglich zu machen. Aus technischer Sicht ist ein System zur intraoperati-ven Bedienung und Darstellung sehr einfach zu realisieren. Grundlage dafür ist eine elektronische Patientenakte (EPA), welche beispielsweise softwaregenerierten oder eingescannten Dokumenten verwaltet. Die vorliegende Arbeit widmet sich den folgenden Fragen: Wird ein solches System im Operationssaal sinnvoll genutzt? Welche Methoden zur sterilen Bedienung kommen infrage? Wie muss die grafische Darstellung auf den Operationssaal abgestimmt werden? Kann durch das Imple-mentieren aktueller Kommunikationsstandards auf alle verfügbaren Patientendaten zugegriffen werden? Dazu wurden in einer ambulanten HNO-Klinik zwei Pilotstudien durchgeführt. In der ersten Studie wurde das erste auf dem Markt befindliche kommerzielle Produkt „MI-Report“ der Firma Karl Storz evaluiert, welches per Gestenerkennung bedient wird. Für die zweite Studie wurde ein EPA-System entwickelt (Doc-O-R), welches eine Vorauswahl der angezeigten Dokumente in Abhängigkeit des Eingriffs traf und mit einem Fußschalter bedient werden konnte. Pro System wurden ca. 50 Eingriffe dokumentiert. Dabei wurde jedes angesehene Dokument und der Nutzungsgrund protokolliert. Die Systeme wurden durchschnittlich mehr als einmal pro Eingriff genutzt. Die automatische Vorauswahl der Dokumente zur Reduzierung der Interaktionen zeigte sehr gute Ergebnisse. Da das behandelte Thema noch in den Anfängen steckt, wird in der Arbeit am Ende auf die Vielzahl von Möglichkeiten eingegangen, welche bezüglich neuartiger Darstellungsmethoden, Bedienvorrich-tungen und aktueller Standardisierungsaktivitäten noch realisiert werden können. Dadurch werden zukünftig auch die Abläufe in der Chirurgie beeinflusst werden.:1 Einführung 13 1.1 Problemstellung 14 1.2 Stand der Wissenschaft und Technik 14 1.2.1 Überblick 15 1.2.2 Digitalisierung des Operationssaals 16 1.2.3 Verbreitung Elektronischer Datenverarbeitungssysteme im Krankenhaus 16 1.2.4 Definitionen zum Begriff der elektronischen Patientenakte 17 1.2.5 Aufbau eines EPA-Systems 20 1.2.6 Sterile Bedienkonzepte 20 1.2.7 Darstellung 27 1.2.8 Standardisierung 33 2 Aufgabenstellung 39 3 Materialien und Methoden 41 3.1 Klinik 41 3.1.1 Technischer Stand 41 3.1.2 Abläufe im IRDC 41 3.2 Protokollierung 43 3.3 Verwendete Dokumente 44 3.3.1 KIS-Übersicht 44 3.3.2 Audiogramm 45 3.3.3 Tympanogramm 46 3.3.4 Blutwerte 47 3.3.5 OP-Bericht 48 3.3.6 Rhinomanometrie 50 3.3.7 Computertomographie 50 3.3.8 Bilder vorangegangener Untersuchungen und Operationen 51 3.3.9 Radiologische Gutachten 52 3.3.10 Anamnese 53 3.3.11 Überweisung 54 3.3.12 Stimmbefund 55 3.4 Statistische Auswertung 55 3.4.1 Abhängigkeit des betrachteten Dokuments von der Art des Eingriffs 55 3.4.2 Bewertung des Algorithmus zur automatischen Vorauswahl der Dokumente 56 3.5 Vorbereitung 57 3.6 Studie „MI-Report“ 57 3.6.1 Anzeige 58 3.6.2 Sensor und Bedienung 59 3.6.3 Personen 59 3.6.4 Vorbereitung 60 3.6.5 Protokollierung 60 3.7 Studie „Doc-O-R“ 62 3.7.1 Klinik 63 3.7.2 Vorbereitung 64 3.7.3 Protokollierung 64 3.7.4 Metadaten 65 3.7.5 Softwareentwicklung 65 4 Ergebnisse 69 4.1.1 Statistische Auswertung 71 4.2 Studie „MI-Report“ 71 4.2.1 Aktivierung 72 4.2.2 Nutzung 72 4.3 Studie „Doc-O-R“ 75 4.3.1 Datenlage 75 4.3.2 Algorithmus 75 4.3.3 Nutzung 77 4.3.4 Phasen 78 4.3.5 Operateure 79 4.3.6 Revisionen 79 5 Diskussion 81 5.1 Nutzung 81 5.2 Schwächen des Studienaufbaus 82 5.3 Statistische Auswertung 83 5.4 Darstellung 83 5.5 Standards 83 5.5.1 Technische Faktoren 84 5.5.2 Emotionale Faktoren 84 5.5.3 Strategische Faktoren 84 5.5.4 Ökonomische Faktoren 85 5.5.5 Rechtliche Faktoren 85 5.5.6 Machtpolitische Faktoren 85 5.6 Studie „MI-Report“ 85 5.6.1 Grafische Oberfläche 85 5.6.2 Aktivierung 86 5.6.3 Nutzung 86 5.6.4 Schwächen des Studienaufbaus 87 5.7 Studie „Doc-O-R“ 88 5.7.1 Schwächen der Studie 88 5.7.2 Algorithmus 88 5.7.3 Darstellung 88 5.7.4 Bedienung 89 5.7.5 Phasen 89 5.7.6 Nutzung 89 5.7.7 Revisionen 90 6 Schlussfolgerung 91 6.1 Bedienung 91 6.2 Standardisierung 92 6.3 Darstellung 93 6.4 Nutzungsverhalten 94 7 Ausblick 97 7.1 Bedienung 98 7.2 Standardisierung 100 7.3 Darstellung 102 7.4 Nutzungsverhalten 104 8 Zusammenfassung der Arbeit 105 9 Abbildungsverzeichnis 109 10 Quellenangaben 112 Anhang A Anatomische und physiologische Grundlagen 119 Anhang B Ambulante Eingriffe in der HNO-Chirurgie 121 Anhang C Schematischer Aufbau des Operationstraktes 123

Os recentes avanços nas tecnologias de comunicação e computação viabilizaram o pronto acesso às informações do prontuário eletrônico do paciente (PEP). O potencial de difusão de informações clínicas resultante suscita preocupações acerca da priva-cidade do paciente e da confidencialidade de seus dados. As normas presentes na legislação dispõem que o conteúdo do prontuário deve ser sigiloso, não cabendo o acesso a ele sem a prévia autorização do paciente, salvo quando necessário para be-neficiá-lo. Este trabalho propõe o MACA, um modelo de autorização contextual para o controle de acesso baseado em papéis (CABP) que contempla requisitos de limita-ção de acesso ao PEP em ambientes abertos e distribuídos. O CABP regula o acesso dos usuários ao PEP com base nas funções (papéis) que eles exercem numa organi-zação. Uma autorização contextual usa informações ambientais disponíveis durante o acesso para decidir se um usuário tem o direito e a necessidade de acessar um re-curso do PEP. Isso confere ao MACA flexibilidade e poder expressivo para estabele-cer políticas de acesso ao PEP e políticas administrativas para o CABP que se adap-tam à diversidade ambiental e cultural das organizações de saúde. O MACA ainda permite que os componentes do PEP utilizem o CABP de forma transparente para o usuário final, tornando-o mais fácil de usar quando comparado a outros modelos de CABP. A arquitetura onde a implementação do MACA foi integrada adota o serviço de diretórios LDAP (Lightweight Directory Access Protocol), a linguagem de pro-gramação Java e os padrões CORBA Security Service e Resource Access Decision Fa-cility. Com esses padrões abertos e distribuídos, os componentes heterogêneos do PEP podem solicitar serviços de autenticação de usuário e de autorização de acesso de modo unificado e coerente a partir de múltiplas plataformas. A implementação do MACA ainda tem a vantagem de ser um software livre, de basear-se em componen-tes de software sem custos de licenciamento e de apresentar bom desempenho para as demandas de acesso estimadas. Por fim, a utilização rotineira do MACA no con-trole de acesso ao PEP do InCor-HC.FMUSP, por cerca de 2000 usuários, evidenciam a exeqüibilidade do modelo, da sua implementação e da sua aplicação prática em casos reais. / The recent advances in computing and communication technologies allowed ready access to the electronic patient record (EPR) information. High availability of clinical information raises concerns about patients privacy and data confidentiality of their data. The legal regulation mandates the confidentiality of EPR contents. Everyone has to be authorized by the patients to access their EPR, except when this access is necessary to provide care on their behalf. This work proposes MACA, a contextual authorization model for the role-based access control (RBAC) that considers the ac-cess restrictions requirements for the EPR in open and distributed environments. RBAC regulates user’s access to EPR based on organizational functions (roles). Con-textual authorizations use environmental information available at access time, like user/patient relationship, in order to decide whether a user is allowed to access an EPR resource. This gives flexibility and expressive power to MACA, allowing one to establish access policies for the EPR and administrative policies for the RBAC that considers the environmental and cultural diversity of healthcare organizations. MACA also allows EPR components to use RBAC transparently, making it more user friendly when compared with other RBAC models. The implementation of MACA architecture uses the LDAP (Lightweight Directory Access Protocol) directory server, the Java programming language and the standards CORBA Security Service and Re-source Access Decision Facility. Thus, heterogeneous EPR components can request user authentication and access authorization services in a unified and coherent way across multiple platforms. MACA implementation complies with free software pol-icy. It is based on software components without licensing costs and it offers good performance for the estimated access demand. Finally, the daily use of MACA to control the access of about 2000 users to the EPR at InCor-HC.FMUSP shows the feasibility of the model, of its implementation and the effectiveness of its practical application on real cases.

Os recentes avanços nas tecnologias de comunicação e computação viabilizaram o pronto acesso às informações do prontuário eletrônico do paciente (PEP). O potencial de difusão de informações clínicas resultante suscita preocupações acerca da priva-cidade do paciente e da confidencialidade de seus dados. As normas presentes na legislação dispõem que o conteúdo do prontuário deve ser sigiloso, não cabendo o acesso a ele sem a prévia autorização do paciente, salvo quando necessário para be-neficiá-lo. Este trabalho propõe o MACA, um modelo de autorização contextual para o controle de acesso baseado em papéis (CABP) que contempla requisitos de limita-ção de acesso ao PEP em ambientes abertos e distribuídos. O CABP regula o acesso dos usuários ao PEP com base nas funções (papéis) que eles exercem numa organi-zação. Uma autorização contextual usa informações ambientais disponíveis durante o acesso para decidir se um usuário tem o direito e a necessidade de acessar um re-curso do PEP. Isso confere ao MACA flexibilidade e poder expressivo para estabele-cer políticas de acesso ao PEP e políticas administrativas para o CABP que se adap-tam à diversidade ambiental e cultural das organizações de saúde. O MACA ainda permite que os componentes do PEP utilizem o CABP de forma transparente para o usuário final, tornando-o mais fácil de usar quando comparado a outros modelos de CABP. A arquitetura onde a implementação do MACA foi integrada adota o serviço de diretórios LDAP (Lightweight Directory Access Protocol), a linguagem de pro-gramação Java e os padrões CORBA Security Service e Resource Access Decision Fa-cility. Com esses padrões abertos e distribuídos, os componentes heterogêneos do PEP podem solicitar serviços de autenticação de usuário e de autorização de acesso de modo unificado e coerente a partir de múltiplas plataformas. A implementação do MACA ainda tem a vantagem de ser um software livre, de basear-se em componen-tes de software sem custos de licenciamento e de apresentar bom desempenho para as demandas de acesso estimadas. Por fim, a utilização rotineira do MACA no con-trole de acesso ao PEP do InCor-HC.FMUSP, por cerca de 2000 usuários, evidenciam a exeqüibilidade do modelo, da sua implementação e da sua aplicação prática em casos reais. / The recent advances in computing and communication technologies allowed ready access to the electronic patient record (EPR) information. High availability of clinical information raises concerns about patients privacy and data confidentiality of their data. The legal regulation mandates the confidentiality of EPR contents. Everyone has to be authorized by the patients to access their EPR, except when this access is necessary to provide care on their behalf. This work proposes MACA, a contextual authorization model for the role-based access control (RBAC) that considers the ac-cess restrictions requirements for the EPR in open and distributed environments. RBAC regulates user’s access to EPR based on organizational functions (roles). Con-textual authorizations use environmental information available at access time, like user/patient relationship, in order to decide whether a user is allowed to access an EPR resource. This gives flexibility and expressive power to MACA, allowing one to establish access policies for the EPR and administrative policies for the RBAC that considers the environmental and cultural diversity of healthcare organizations. MACA also allows EPR components to use RBAC transparently, making it more user friendly when compared with other RBAC models. The implementation of MACA architecture uses the LDAP (Lightweight Directory Access Protocol) directory server, the Java programming language and the standards CORBA Security Service and Re-source Access Decision Facility. Thus, heterogeneous EPR components can request user authentication and access authorization services in a unified and coherent way across multiple platforms. MACA implementation complies with free software pol-icy. It is based on software components without licensing costs and it offers good performance for the estimated access demand. Finally, the daily use of MACA to control the access of about 2000 users to the EPR at InCor-HC.FMUSP shows the feasibility of the model, of its implementation and the effectiveness of its practical application on real cases.