Diplomprüfung Schwerpunkt Medizinische Informatik

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1 Diplomprüfung Schwerpunkt Medizinische Informatik Holger Schmuhl 12. September 2005 Inhaltsverzeichnis I Strategic Information Management in Hospitals 9 1 Introduction 9 2 Basic Concepts 9 3 How Do Hospital Information Systems Look Like? Hospital Functions Modelling HIS Functional Modelling Technical Modelling Organisational Modelling Data Modelling Business Process Modelling Enterprise Modelling Reference Models A Metamodel for Modelling HIS: 3 LGM Domain Layer {Fachliche Ebene} Logical Tool Layer {Logische Werkzeugebene} Physical Tool Layer {Physische Werkzeugebene} Relationships Between Layers Information Processing Tools in Hospitals Typical Application Components Typical Physical Application Components Healthcare Professional Workstations Electronic Patient Record Systems Architectures of Hospital Information Systems Architectural Styles at the Logical Tool Layer Architectural Styles at the Physical Tool Layer Integrity and Integration within Hospital Information Systems Formal Integrity Content Integrity: Medical Data Dictionaries Integration Methods and Tools for System Integration in Distributed Systems Federated Database System Middleware Methods and Tools for Integrating Hospital Information Systems

2 3.8.1 Data Integration for the DB n Architectural Style Through Message Exchange (Communication Servers and Communication Standards) Access and Presentation Integration on the Basis of Distributed Object Systems (CORBAmed) Contextual Integration with CCOW Integration of HIS into Health Information Systems What are Good HIS? Quality of Structures Quality of Data Quality of Information Processing Tools Quality of Component Integration Quality of Processes Outcome Quality Balance as a Challenge for Information Management How to strategically Manage Hospital Information Systems Strategic, Tactical and Operational Information Management Information Management in Hospitals Strategic Information Management Tactical Information Management Operational Information Management Typical Organisational Structures for Strategic Information Management Strategic Planning of Hospital Information Systems Long-Term HIS Planning Short-Term HIS Planning Strategic Alignment Portfolio Management Purpose of Strategic Information Management Plans Structure of Strategic Information Management Plans Strategic Monitoring of HIS Strategic Directing of HIS II Taktisches Informationsmanagement 31 6 Einführung 31 7 Projektplanung 32 8 Projektbegleitung 34 9 Systemanalyse Systembewertung Systemauswahl Systembereitstellung Systemeinführung Projektabschluss 40 III Medizinische Dokumentation 41 2

3 15 Worum geht es bei der medizinischen Dokumentation? Medizinische Dokumentation: Muss das sein? Welche Ziele verfolgt die medizinische Dokumentation? Ziele im Bereich der Patientenversorgung Ziele im administrativen und rechtlichen Bereich Ziele im Bereich des Qualitätsmanagements Ziele im Bereich der Ausbildung Ziele im Bereich klinisch-wissenschaftlicher Forschung Multiple Verwendbarkeit von Patientendaten Medizinische Dokumentation: Ein Kinderspiel? Grundbegriffe zu medizinischen Dokumentations- und Ordnungssystemen Vom Merkmal zur Dokumentation Objekte und Merkmale Definitionen, Bezeichnungen und Terminologie Daten, Informationen und Wissen Eigenschaften medizinischer Dokumentationssysteme Medizinische Ordnungssysteme Wozu Ordnungssysteme? Begriffssysteme und Ordnungssysteme Klassifikationen Nomenklaturen Mischformen von Klassifikationen und Nomenklaturen Wichtige medizinische Ordnungssysteme Internationale Klassifikation der Krankheiten (ICD) Die 10. Revision (ICD-10) Erweiterungen der ICD Prozedurenklassifikationen Internationale Klassifikation der Prozeduren in der Medizin (ICPM) Bsp. zu ICPM: Operationenschlüssel nach 301 SGB V (OPS-301) ICD-10-PCS Prozedurenklassifikation Systematisierte Nomenklaturen der Medizin (SNOMED) SNOMED II SNOMED Reference Terminology (SNOMED RT) SNOMED Clinical Terms (SNOMED CT) Das TNM-System Diagnosen- und therapieorientierte Fallgruppensysteme Grundlegendes Case-Mix-Index (CMI) Anwendung von DRGs Typische medizinische Dokumentationen Krankenakte Krankenaktenarchive Klinische Basisdokumentation Befunddokumentation Klinische Tumordokumentation Dokumentation zur Qualitätssicherung Klinische und epidemiologische Register Dokumentation bei klinischen Studien Dokumentation in Versorgungsnetzwerken

4 19 Nutzen und Gebrauch medizinischer Dokumentationssysteme Kasuistische Nutzung Patientenübergreifendes Berichtswesen Klinisch-wissenschaftliche Studien Gütekriterien für das Wiederfinden von Information Planung medizinischer Dokumentations- und Ordnungssysteme Planung medizinischer Ordnungssysteme Allgemeine Grundsätze Grundsätze zur Ordnung qualitativer Daten Grundsätze zur Ordnung quantitativer Daten Planung medizinischer Dokumentationssysteme Prolektive Auswertungen und prospektive Studien Dokumentation bei klinischen Studien Relevante Gesetze und Verordnungen 66 IV Einführung in die Gesundheitsökonomie ( Einführung ) Relevanz der Gesundheitsökonomie Besonderheiten der Gesundheitsökonomie Einführung in das ökonomische Denken Grundlagen der (Kranken-)Versicherung Voraussetzungen einer Versicherung Grundprinzipien der Versicherung Maßnahmen zur Wahrung der versicherungstechnischen Äquivalenz seitens des Versicherers Zentrale Phänomene auf Versicherungsmärkten Die private Krankenversicherung in Deutschland (PKV) PKV-Unternehmen in Deutschland (Stand Ende 2003) Prämien in der PKV Komponenten der Prämienberechnung Wettbewerbsprobleme der PKV Probleme der Altersrückstellung Verhältnis der PKV zu Leistungsanbietern Gesetzliche Krankenversicherung Grundprinzipien Leistungen Versicherungspflicht Versicherte in der GKV Finanzierung der GKV Umlageverfahren Vergleich des Kapitaldeckungs- und des Umlageverfahrens Beiträge Verhältnis der GKV zu Leistungsanbietern Wettbewerb in der GKV Ziele des Wettbewerbs in der GKV Mittel des Wettbewerbs in der GKV freie Kassenwahl

5 Risikostrukturausgleich Wettbewerbsparameter Kritik Problembereiche der GKV Demografische Entwicklung Technischer Fortschritt Arbeitslosigkeit ( Reformoption: Bürgerversicherung (SPD) ) Auswirkungen der Bürgerversicherung ( Reformoption: Kopfprämienmodell (CDU/CSU) ) Auswirkungen des Kopfprämienmodells ( Vergleich der Reformoptionen ) Steuerung der Nachfrage nach Gesundheitsleistungen durch Selbstbeteiligung Funktionen von Selbstbeteiligungen Formen der Selbstbeteiligung in der Krankenversicherung Prozentuale Selbstbeteiligung Gebühr Indemnitätsregelung (Festzuschuss) Selbstbehalt: Erkrankungskosten < Selbstbehalt Selbstbehalt: Erkrankungskosten > Selbstbehalt Erwünschte und unerwünschte Effekte von Selbstbeteiligung in einer sozialen KV Vergütung der Anbieter von Gesundheitsleistungen Grundsätzliche Probleme der Honorierung von Gesundheitsdienstleistungen Charakteristika eines Vergütungssystems Alternativen der Definition der Mengenkomponente (Vergütungsformen) Verfahren zur Bestimmung der Bewertungs- bzw. Preiskomponente (Vergütungstarif) Alternative Vergütungsverfahren für Leistungserbringer Vergütung der ambulant tätigen Vertragsärzte der GKV in Deutschland Arzt als Gatekeeper der Versorgung Vergütung von Krankenhausleistungen auf der Grundlage von DRGs Prospektive Vergütungssysteme Diagnosis Related Groups (DRGs) Schema der DRG-Zuordnung Das DRG-basierte Prospective Payment System (PPS) von Medicare in den USA DRG in Deutschland - G-DRG Refinement-Ansatz Struktur der G-DRGs Angebotsinduzierte Nachfrage (Supplier-Induced Demand) Ausgangsbedingungen Definition von angebotsinduzierter Nachfrage Begünstigende Faktoren für angebotsinduzierte Nachfrage Ursprüngliche Beobachtungen, die zur Hypothese der angebotsinduzierten Nachfrage führten Kritik an der Hypothese der angebotsinduzierten Nachfrage aus Sicht der Vertreter des traditionellen Wettbewerbmodells Hinweise auf angebotsinduzierte Nachfrage, die mit dem traditionellen Wettbewerbsmodell schwer zu erklären sind Probleme und Kritik im Zusammenhang mit der Analyse von angebotsinduzierter Nachfrage Maßnahmen gegen angebotsinduzierte Nachfrage

6 31 Kleinräumige Variationen in der Nutzung gesundheitlicher Versorgung (Small Area Variations) Hintergrund Faktoren der Variation der Nutzung Praxisstil-Hypothese Unsicherheit als Ursache unterschiedlicher Praxisstile Wohlfahrtsverlust durch kleinräumige Variationen Gesundheitssysteme im internationalen Vergleich Idealtypen der Organisation von Gesundheitssystemen Idealtypus marktliches Gesundheitssystem Idealtypus Sozialversicherungssystem Idealtypus staatlicher Gesundheitsdienst Ländervergleich Deutschland, USA, Großbritannien Die Health Care Systems in Transition (HiT) Länderprofile des European Observatory ( Integrierte Versorgung nach 140a-d SGB V ) Hintergrund Inhalt Typen der integrierten Versorgung Kalkulation der Vergütung in integrierten Versorgungssystem Ökonomische Evaluation von Gesundheitsleistungen Hintergrund, Zielsetzung, Studientypen und Grundprinzipien der ökonomischen Evaluation Hintergrund Wege zur Effizienz Ziele der ökonomischen Evaluation Typologie der ökonomischen Evaluation Typen der Evaluation von Gesundheitsleistungen Prinzip der vollständigen ökonomischen Evaluation Kosten-Effektivitäts-Ebene Inkrementeller Vergleich Inkrementelle Kosten-Effektivitäts-Relation Typologie ökonomischer Evaluationsstudien Perspektiven ökonomischer Evaluationen Argumente für die gesamtgesellschaftliche Perspektive Messung von Kosten in der ökonomischen Evaluation Definition von Kosten Kategorien von Kosten Schritte der Messung direkter Kosten Verfahren zur Ermittlung von Schattenpreisen Indirekte Kosten Produktivitätsrelevante Krankheitsfolgen Humankapitalansatz Friktionskostenansatz Diskontierung Krankheitskostenstudien Datenquellen Methodische Ansätze Messung von Effekten in der ökonomischen Evaluation Übersicht über die Messung von Effekten Beispiel für Kosten-Effektivitäts-Analyse Qualitätsgewichtete Lebensjahre (QALYs)

7 Gesundheitsbezogene Lebensqualität Dimensionen der Lebensqualität Hierarchie der Nutzwertmessung mit QALYs Messung der Lebensqualität Krankheitsspezifische vs. generische Maße Profilmaße vs. Indexmaße EuroQol EQ-5D Präferenzbasierte Bewertung von gesundheitsbezogener Lebensqualität Beispiel für Kosten-Nutzwert-Analyse Methoden zur monetären Bewertung gesundheitlicher Effekte Entscheidungsunterstützung durch ökonomische Evaluation QALYs, Entscheidungsverfahren und -regeln Entscheidungen, die durch ökonomische Evaluation beeinflusst werden können V Fallstudien zur Gesundheitsökonomie und Gesundheitspolitik Gesundheitsökonomische Aspekte des Screenings Definition von Screening Welche Bedingungen sollten für ein Screening erfüllt sein? Sensitivität und Spezifität Schlussfolgerungen ( Das Oregon-Experiment ) Ausgangslage Budgetvergabe auf der Grundlage von Kosteneffektivität Kritik am methodischen Vorgehen Kosten-Effektivitäts-Relationen wurden fehlerhaft berechnet Keine Berücksichtigung von unterschiedlichen Patienteneigenschaften Starke Diskrepanz zwischen den aus Nutzwerteinschätzungen und den aus Rationierungsentscheidungen abgeleiteten Präferenzen Utilitaristisch-paternalistischer Ansatz der zentralen Budgetallokation hat nur schwache wohlfahrtstheoretische Grundlage Demografischer Wandel und Gesundheitssystem Maße der Bevölkerungsdynamik Faktoren des demografischen Wandels in Deutschland Maße für die sozialpolitische Belastung durch den demografischen Wandel Abhängigkeit der Inanspruchnahme der Gesundheitsversorgung von der Nähe zum Tod Managed Care in den USA Definition und Zielsetzung von Managed Care Formen von Managed-Care-Organisationen Einfluss auf Leistungserbringer Instrumente von Managed Care Primärarztstruktur Ökonomische Anreize Direkte Eingriffe in das Versorgungsgeschehen Externe Managed-Care-Mechanismen: Wettbewerb und externe Qualitätsicherung Auswirkungen auf Kosten der Versorgung Umsetzung von Managed-Care-Instrumenten im deutschen GKV-System (SGB V) Fazit

8 40 Disease Management Definition von Disease Management Charakteristika von Disease Management Merkmale der für Disease Management geeigneten Krankheiten Disease Management vs. Case Management Elemente eines Geschäftsplans für Disease Management Disease Management Programme (DMP) in Deutschland Anforderungen an DMP Vorteile und Chancen von DMP Nachteile oder Risiken von DMP Gewinne und technischer Fortschritt auf dem Pharmamarkt Charakteristika, Ziele und Ergebnisse der klinischen Prüfung in den Phasen I bis IV Entwicklung eines neuen Medikaments Investition in ein neues pharmazeutisches Produkt Der Patentschutz auf ein neu entwickeltes Produkt: ein wesentlicher Erlösfaktor

9 Teil I Strategic Information Management in Hospitals [HAWB04, WW04] 1 Introduction hospital information system: information processing and information storing subsystem of a hospital holistic{ganzheitlich} view of patient and hospital: complete picture of care of the patient, independent of where in the hospital the patient has been or will be treated Information processing is... quality factor cost factor productivity factor ICT has become economically important decisive {entscheidend} for the quality of health care. Integrated processing of information is important, because: all groups of people and all areas of a hospital depend on its quality amount of information processing in hospitals is considerable healthcare professionals frequently work with the same data Systematic processing of information contributes to high-quality patient care reduces costs Information processing in hospitals is complex. Therefore... is needed: systematic management and operation of hospital information systems health information specialists responsible for the management and operation of hospital information systems 2 Basic Concepts Data: representation of information, or knowledge in a formalised manner {Art}, suitable for communicating, interpreting, or processing. Information: specific knowledge about entities such as facts, events, things, persons, processes, ideas, or concepts. Knowledge: general information about concepts in a certain domain. System: set of people, things, and/or events that forms an entity, together with their relationships. Systems can be divided into subsystems and can be represented by using models. 9

10 Model: Models are a description of what the modeller thinks to be relevant to a system. Models... usually form a simplified representation of reality should be adapted to a specific question or task should be appropriate to provide answers for these question or tasks Information System: part of an enterprise that processes and stores data, information, and knowledge (socio-technical subsystem). Components: enterprise function describes what acting human or machines have to do in a certain enterprise to contribute to its mission and goals. (denoted usually by nouns or gerunds) activity is an instantiation of an enterprise function working on an individual entity. business processes describe the (chronological and logical) sequence of activities together with the conditions under which they are invoked, to achieve a certain enterprise goal. Hospital Information System: socio-technical subsystem of a hospital that comprises all information processing functions and the human or technical actors in their information processing role. Typical components of HIS are... the hospital functions supported the business processes that take place the application components that support the hospital functions physical data processing components that realize the application components The subsystem of the HIS where computer based tools are used is called the computersupported part of the HIS. The architecture of an information system describes its fundamental organisation, represented by its components, their relationships to each other and to the environment, and by the principles guiding its design and evolution. The goal of an HIS is to adequately enable the execution of hospital functions for patient care taking economic, legal, and other requirements into account When a HIS makes available the right information and the right knowledge at the right time in the right place for the right people in the right form so that these people can make the right decisions, this is called information and knowledge logistics. Health Information Systems {Informationssystem des Gesundheitswesen}: trans-institutional information systems 10

11 3 How Do Hospital Information Systems Look Like? 3.1 Hospital Functions Typical main hospital functions are patient admission with appointment scheduling, patient identification, administrative admission {Administrative Aufnahme}, clinical admission, and information planning and organisation of patient treatment with presentation of information and knowledge, decision making and patient information, and care planning order entry and communication of findings with preparation of an order, taking samples or scheduling appointments and procedures, transmission of the order, and reporting of findings execution of diagnostic or therapeutic procedures clinical documentation performed by physicians and nurses administrative documentation and billing patient discharge and referral to other institutions These hospital functions are typically supported by functions such as handling of patient records with creation and dispatch of documents, management of documentation for special areas or special purposes and of clinical registers, coding of diagnoses and procedures, and analysis, archiving, and management of patient records work organisation and resource planning with scheduling and resource allocation, materials and pharmaceuticals management, management and maintenance of equipment, support in the general organisation of work, office communication support, and basic information processing support hospital administration with quality management, controlling and budgeting, cost-performance accounting, financial accounting, human resources management, and general statistical analysis Those hospital functions describe what a hospital system should support. It is not important at this point how they are supported - by paper-based or by computer-based information processing tools. 3.2 Modelling HIS Metamodel: language for describing models of a certain class. A metamodel usually describes the modelling framework, which consists of modelling syntax and semantics the representation of the object (sometimes) modelling rules Functional Modelling A functional metamodel represents the functions of a hospital (what is to be done). Elements are the functions which are supported by the application components of the HIS. Relationships represent the information exchange between them. Typical questions answered by the modelling: Which hospital functions are supported by which HIS components? 11

12 Which specific hospital functions are part of which global hospital functions? Which hospital functions share the same data? Does the functional model correspond to a reference? Typical representations: (hierarchical) lists of functions Technical Modelling Technical metamodels are used to build models that describe the information processing tools. Elements represent typically physical data processing components and application components. Relationships represent data transmission between physical data processing components or communication between application components. Typical questions answered by the modelling: Which information processing tools are used? Which application components communicate with each other? What are the data transmission connections between the physical data processing components? What does the network technology look like? What technical solutions are used to guarantee the security and reliability of information processing tools? Typical representations: lists graphs Organisational Modelling Organisational metamodels are used to build models that describe the organisation of a unit or area. (e.g. organisational structure of a hospital, in context of HIS: organisation of information management) Elements represent usually units or roles in a certain organisational relationship. Typical questions answered by the modelling: Which organisational units exist in a hospital? Which institutions are responsible for information management? Who is responsible for information management of a given area or unit? Typical representations: lists of organisational units graphs 12

13 3.2.4 Data Modelling Data metamodels are used to create models that describe the data processed and stored in a hospital information system. Elements typically represent entity types and their relationships. Typical questions answered by the modelling: What data are processed and stored in the information system? How are data elements related? Typical representations: graphs (e.g. UML) Business Process Modelling Business process metamodels are used to create models that focus on a dynamic view of information processing. Elements used are activities and their chronological and logical order. Often other elements are added, such as the role or unit that performs an activity, or the information processing tools that are used. Possible perspectives: Functional perspective: What activities are being performed, and which data flows are needed to link these activities? Behavioural perspective: When are activities being performed, and how are they performed? Do they use mechanisms such as loops and triggers? Organisational perspective: Where and by whom are activities being performed? Informational perspective: Which entity types or entities (documents, data, products) are being produced or manipulated? Typical questions answered by the modelling: Which activities are executed with regard to a given hospital function? Who is responsible and which tools are used in a given activity? What are the weak points of the given process and how can they be improved? Typical representations: Simple process chains Event driven process chains Activity diagrams Petri nets Enterprise Modelling Enterprise modelling comprises all modelling aspects. Beyond this, enterprise modelling considers the dependencies of these models and, therefore, offers a more holistic view. Typical questions to be answered with enterprise modelling are: Which hospital functions are supported by which information processing tools? Are the information processing tools sufficient to support the hospital functions? 13

14 Is the communication among the application components sufficient to fulfil the information needs? Which aims of the enterprise will be affected by a certain application component? In which area of the hospital are specific data on specific objects used? Enterprise modelling frameworks help classify and organise these models and facilitate understanding their dependencies and the difficulties that may arise if certain aspects of enterprise modelling are not considered. Frameworks are often presented as matrices where the rows reflect distinctive views on the enterprise and the columns describe different concepts related to the enterprise. Depending on the modelling goals, a model may be created for each cell of the matrix. A well-known enterprise modelling framework is the Zachman framework for information systems architectures Reference Models present a kind of model pattern for a certain class of aspects these model patterns can help to derive more specific models through modifications, limitations, or add-ons (generic reference models) can be used to directly compare models concerning their completeness (non-generic reference models) general model can be defined as a reference model for a certain class of aspects Business reference models describe models of processes, data, and organisation of a certain class of organisations Software reference models serve to derive models for different variants of a software product Procedure reference models focus on how to do certain things, for example, how to introduce an information system component 3.3 A Metamodel for Modelling HIS: 3 LGM [WBW03, WHBW04] 14

15 3.3.1 Domain Layer {Fachliche Ebene} The domain layer describes a hospital independent of its implementation as a set of enterprise functions. Functions (represented by rectangles) need information of a certain type about physical or virtual entities of the hospital. These types are represented as entity types (represented by ovals). The access of a function to an entity can be using information (expressed by attribute access type; represented by an arrow from an entity type to a function) updating information (expressed by attribute access type; represented by an arrow from a function to an entity type) Note: Metamodel of domain layer just considers the static view of a hospital no associations between functions that represent processes (this would be part of a dynamic view) Logical Tool Layer {Logische Werkzeugebene} At the logical tool layer, application components are the centre of interest. Application components support enterprise functions. Computer-based application components are controlled by application programs, which are adapted software products; paper-based application components are controlled by conventional working plans that describe how people use paper-based data processing components. Application components are responsible for the storage and for the communication of data about entities of a certain type. Therefore, we also have to describe how entity types are logically stored, and how application components have to communicate to ensure the access of the enterprise functions to entity types as described at the domain layer. Computer-based application components may have a local database system to store data, and paper-based application components may file their documents in a document collection. Communication interfaces (represented by small ovals) ensure the communication among application components (component interfaces), but also between an application component and a user (user interfaces). For communication among application components, communication links can be defined (represented by arrows, direction represents the direction of communication) Physical Tool Layer {Physische Werkzeugebene} The physical tool layer is a set of physical data processing components. Types: human actors (e.g. person delivering mail) paper-based physical tools (e.g. printed forms, telephones... ) computer systems (e.g. servers, pcs, switches... ) They are physically connected via so-called data transmission connections. The constellation of these networks leads to physical networks, which are based on network protocols Relationships Between Layers A variety of dependencies, called interlayer relationships, exist among components of different layers. domain layer logical tool layer relationships: functions application components (represented by a so-called application component configuration). It states that hospital functions in a specific organisational unit may be supported by several application components together by a single application component 15

16 by combinations of both Questions leading to application component configuration for a specific function: Which application components are jointly necessary to support a function completely? Which possible alternatives are there to support a function? Application component configurations can give hints about redundancies within HIS weaknesses in the domain layer at the logical tool layer, entity types can be stored in a database system or in a document collection, and entity types can be communicated over communication links. logical tool layer physical tool layer (represented by a so-called data processing component configuration). It states that an application component may be installed on several data processing components together on a single data processing component through combinations of both Questions leading to data processing component configuration Which physical data processing components are jointly necessary to support an application component completely? Which possible alternatives are there to support an application component? 3.4 Information Processing Tools in Hospitals Typical Application Components Application Components for Patient Administration functionality for patient admission, discharge, and transfer (ADT), basic dataset documentation, and billing component which is responsible for uniquely identify the patient and referring case(s) must be able to provide up-to-date administrative patient data for all other application components all other application must be able to transmit relevant administrative patient data to the patient administration component usually called patient management system (PMS) link between clinical application components and the general administrative application components Application Components on Wards functionality for medical documentation, nursing documentation, order entry and result reporting, ward management, and knowledge access medical documentation systems should support specific documentation tasks (e.g. patient history, care planning, progress notes, report writing) in different medical fields. These components normally offer predefined forms for unstructured, semi-structured or structured data entry, as well as reporting and analysis functionality. Due to growing importance of the coding of diagnoses and procedures, those components must support the easy search of suitable classes and codes in catalogues of already-coded terms. 16

17 nursing documentation systems must be oriented towards the so called nursing process (nursing patient history, nursing care planing, execution of nursing tasks, and evaluation of results). They should support the definition and use of predefined nursing care plans. order entry systems comprise order entry of diagnostic or therapeutic procedures, appointment scheduling, printing of labels, as well as the communication and presentation of findings or reports. (additional order entry components can offer service catalogues, which present the available service types of the different service units. Close connected medical and nursing documentation. ward management application components usually support the assignment of patients to beds and rooms. knowledge servers offer access to medical and nursing knowledge to healthcare professionals Application components that comprise functionality for medical documentation, nursing documentation, order entry and result reporting, and ward management are sometimes also called clinical information systems. Application Components in Outpatient Units Outpatient care means patient care during one or several short visits in outpatient departments in a hospital. In most cases, those visits are related to previous or future inpatient stays in the same hospital. functionality to be offered: appointment scheduling, printing of receipts or other documents, medical documentation, work organisation support, billing, and other management functions (functions are similar to functions needed in practitioners offices software products for practitioners offices are used, which offer less connectivity to other clinical application components) Application Components in Diagnostic Service Units: Radiological Units tools that generate images are called modalities radiological information system (RIS) comprise functions for departmental management, including report writing, image storing, and communication. in case of analog pictures, application components for image storing and communication (archive management systems) support the archiving of analog pictures and their retrieval and lending. digital pictures are stored in picture archiving and communication systems (PACS). The application components must allow the storage, management and presentation of large amounts of data and their quick communication from storage media to the attached workstations for diagnosing specialists/ordering department Application Components in Diagnostic Service Units: Laboratory Units laboratory information systems (LIS) must be able to support the management of the whole procedure of analysis (... ) Application Components in Therapeutic Service Units: Intensive Care Units patient data management systems (PDMS) are specialised to automatically monitor, store, and clearly present a vast amount of patient-related clinical data. permanent availability of application components and their data is of highest importance 17

18 Application Components in Therapeutic Service Units: Operation Rooms operation planning systems allow assigning of operation date and time, though an operation plan can be created (operation planning) operation documentation systems offers functionality to document all details of the operation procedure and to finally create a report or/and to export the data to other systems operation management systems combine both functionalities Application Components for Hospital Administration one major goal is the documentation and billing of all accountable services support functions such as financial accounting, controlling and budgeting, cost-performance accounting, equipment inventory, and material management in general a close connection to nearly every application component is needed to obtain e.g. billing data and legally required diagnoses and procedure codes Application Components for Integration of Application Components see later Typical Physical Application Components characterisation by different properties: their location their mobility the installed application components infrastructure of a hospital can be described by the overall number of main data processing components (or the average per ward). It can comprise primarily paper-based data processing components, primarily computer-based data processing components, or a mixture of both Healthcare Professional Workstations Health care professional workstations{klinischer Arbeitsplatz} (HCPW) are very specific information processing tools (extensive functionality!) consist of a (mobile or stationary) personal computer, connected to the hospital s computer network, together with the application components installed. typical functionality offered: admission, discharge, transfer of patients (ADT) access to the electronic patient record order entry of examinations, drugs, meals, materials access to medical knowledge and Internet access text processing and statistical functionality 18

19 3.4.4 Electronic Patient Record Systems in general, a patient record is composed of all data and documents generated or received during the care of a patient at a healthcare institution. EPR is thus a complete or partial patient record stored on an electronic storage medium advantages: data can be accessed more quickly data is available at different places at the same time cannot get lost need less archiving space documents and data can be selected and presented in different forms (different views of data) deliberate exchange of information, and the efficiency of documentation as a whole disadvantages: strong dependence on complex technology strong dependence on the staff s ability to handle it quite expensive and only economical if it leads to the complete replacement of paperbased record archives hampered{behindert, erschwert} by organisational and legal problems EPR requires long-term systematic management and stepwise introduction process essential to be protected from unauthorised access (data access is too easy and may thus violate data protection) healthcare professional card to authorise 3.5 Architectures of Hospital Information Systems Architectural Styles at the Logical Tool Layer DB 1 : A HIS comprised only of one application component containing a database system (all patient-related data is stored in exactly one database system) precondition for the DB 1 architectural style is, that all different computer-based application components work only with the database system of the central application component. common when by the hospital self-developed application components are used or when all software products are from the same vendor standards (standardised interfaces) are needed, when software products from different vendors are connected in a DB 1 architectural style HISA (standardisation of the contents of the database systems / database schema standard is just at the beginning, no broader support yet) DB n : A HIS in which nearly every application component has its own database system, especially in modern HISs, in which commercial software components of many different software vendors are used patient-related data is stored redundantly in DB systems of different application components no way to guarantee data consistency, may lead to redundant data entry and inconsistent data useful to state that e.g. administrative patient data may be created and changed only by the patient management system 19

20 all application components should be connected to exchange patient-related data bidirectional connections between components cause an nearly exponential growth of the number of interfaces, when new components are added (so called spaghetti architectural style) message queue manager (communication server), to which all components are connected, reduces the number of needed interfaces, as only one interface per new component is needed (so called star architectural style) Architectural Styles at the Physical Tool Layer independently of the architectural style at the logical tool layer mainframe-based architecture: one or multiple mainframe systems to which various terminals (without own data processing facilities or local memories) are attached; old architecture, which is now discussed again in form of network computing (NC) client-server architecture: various servers are interconnected by a network. These servers can be e.g. application file servers or database servers, those two types can even be combined on one (physical) server. A variety of workstations (with own memory and data processing units) are connected to these server, which utilise the offered services. 3.6 Integrity and Integration within Hospital Information Systems Integrity: in the broadest sense correctness of data Formal Integrity Formal integrity comprises object identity and referential identity Object identity: is expected to be guaranteed by every DB. It means that an object has an existence that is independant of its value. Thus two objects may look the same (have the same value), but be different. Concerning DBs, the representation of every entity must be uniquely identifiable. Object identity can only be guaranteed when every patient receives a unique number, the patient identification number (PIN), which should have no internal meaning. (the same with case identifier etc.) Referential integrity: correct assignment of entities, e.g. of cases to a certain patient, or results from cases. Object identity is needed for referential integrity. Without object identity there is no referential integrity, and without referential integrity it cannot be ensured that results can be traced back to the correct patient. Transaction Management to Ensure Formal Integrity in the DB n Architectural Style Transaction management is required to ensure the formal integrity of a database. 2-phase commit protocol was developed for transaction management in DB n. Initial phase: protocol checks if transaction can be carried out by all affected databases; Second phase: changes are carried out. Preconditions: DB systems must be tightly coupled by synchronous communication, database schemata of all involved DB systems must be known ( Problem: in general the DB schema of commercial application components is not known). For every redundantly stored entity type, an application component is determined whose DB system serves as the master database system for this entity type. Thus, data about entities of this type can only be inserted, deleted, or changed in this master database system. 20

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