Reasoning / Medical Context / Physicians Area of Competence

Medical Informatics Learning Objectives for Undergraduate Medical Education created by the project group "Medical Informatics Education in Medicine" (chairs: M. Dugas, J. Stausberg) of the German Association for Medical Informatics, Biometry and Epidemiology (GMDS) Nr. Subject Learning Objective The medical student 1 Medical Documentation and Information Processing 1.1 Goals of medical documentation and information processing is able to explain on the basis of clinical examples why medical documentation is necessary. Reasoning / Medical Context / Physicians Area of Competence Documentation belongs to the mandatory tasks of a physician. Essential objectives is/are: the description of disease as basis of further treatment continuity and quality of treatment communication patient safety legal purposes evidence of services performed management/ billing scientific purposes Competence Context Level of Competence Role of Competence A 2 2, 3, 4, Comments Record keeping should be efficient and enable reuse for other documentation tasks. Competence context: A: The learning objective is relevant to all physicians, but not solely attributable to medical informatics. However, medical informatics has a particular expertise in this area., B: The learning objective is relevant to all physicians and primary competence of medical informatics. C: The learning objective in the field of medical informatics is relevant to physicians with a specialization (additional course). Objectives of the competence context C are only shown as an example. Competence Level: 1: referenced knowledge, 2: applied factual and conceptual knowledge, 3: applied knowledge and practical experience Role of competence: 1=medical expert, 2=communicator, 3=collaborator, 4=manager, 5=health advocate, =professional, =scholar Methods of Information in Medicine 2013(3) Supplement p. 1/10

1.2 Type and structure of medical documentation knows the various types of medical documentation, their structure and application in particular regarding the basic documentation in hospitals and medical practices. 1.3 Legal basis knows the legal basis for medical documentation and its function. 1.4 Electronic documentation is able to explain the advantages and disadvantages of electronic medical records as opposed to paper records and the problems arising from media discontinuities. 1.5 Catalogue of features is able to describe the metadata of a medical documentation in a structured format. Physicians need to be aware of the different types of documentation in order to use them properly. Depending on the application context, different types of documentation are used, e.g. in routine care or in research contexts. Basic documentation provides a uniform and structured basis for all medical caregivers. It can be used for both patientspecific and patient independent tasks and analyses. Physicians must know the legal basis for medical documentation in order to use it in accordance with legal regulations. In particular the following questions must be understood: Who must keep records? What is to be recorded? How is it to be recorded? Who may access the records? How are they to be stored? Accessibility and reuse are important advantages of electronic records. If electronic and paper records are used simultaneously, clear organizational guidelines are necessary in order to avoid false documentation and malpractice due to changes in media format. Physicians must keep the standards of their records up to date. The choice of features depends on the actual medical situation and results in the respective databases. Structured records allow for the re use and evaluation of the data elements. B 2 1, 2, 3, 4, 5,, A 2 2, 3, 4, B 1 2, 3, 4, B 2 4,, Basic, special and study documentation; history, findings and procedure documentation; register, surveillance; patient specific or patient independent documentation Reversal of the burden of proof. Reporting obligations. Examples for German Acts and Codes from which documentation requirements originate: Social Act V, Transfusion Act, Radiation Protection Ordinance, Protection Infection Act, Professional Code of Conduct, and Medical Devices Act Flexibility, legibility, data quality, availability, and readability Clear and unique definition of data elements, thus avoiding redundancy as the source of errors. Differentiation of identification and descriptive items with appropriate data types. Database design. Methods of Information in Medicine 2013(3) Supplement p. 2/10

1. Data management is aware of procedures to ensure high data quality and is able to query a database. 2 Medical Classification Systems and Terminology 2.1 ICD 10 is able to encode diagnoses using ICD 10 GM for both in and outpatients. 2.2 OPS is able to code procedures using German OPS and explain coding principles. 2.3 DRG knows the DRG system and its application, the necessary information and tools as well as the correct coding and the related classification codes. High quality of medical data is a prerequisite for valid study evaluation and quality assurance for legal issues. Physicians frequently query databases. According to the German coding standards, the physician is responsible for the records as well as for the correct coding of diagnoses. According to the German coding standards, the physician is responsible for the records as well as for the correct coding of procedures. The DRG system is a legally binding classification to determine reimbursement in the inpatient context. In order to act economically, physicians need to know its basic functioning. B 2 4,, B 3 3, 4, B 3 3, 4, A 2 3, 4, Criteria of quality: Completeness, plausibility, validity. Avoiding duplication. Regulatory requirements for data management. ICD 10 is among other things used for: reimbursement purposes, quality assurance, and health services research. Structure of ICD 10, classes of not otherwise specified (NOS), differentiating principle and secondary diagnoses, dagger and asterisk system, German coding standards; and the role of DIMDI. Structure of OPS, classes for not otherwise specified, significant procedure, multiple procedures, bilateral procedures, procedures that only need to be coded once. Definition of the DRGs, finding a DRG (using a grouper tool), base amount for a case, MDC, CCL, case mix index, normal length of stay, maximum (rewarded) length of stay, role of InEK (Hospital Remuneration System). Methods of Information in Medicine 2013(3) Supplement p. 3/10

2.4 Further classifications and terminologies knows other medical classifications and terminologies, their construction and areas of application. 3 Information Systems in Health Services 3.1 Functions of a HIS knows the tasks and functions of a HIS and is able to explain them. 3.2 Components of a HIS is able to name and explain the most important components of a HIS (RIS/PACS, LIS, PDMS, surgical system, etc.). 3.3 Requirements of a HIS is able to formulate functional requirements of department specific systems and to provide feedback to existing systems. 3.4 Using a clinical information system (CIS) is able to order tests, to document results as well as to prescribe medications and to write physicians letters in the CIS. Physicians should know internationally accepted classifications and terminologies in order to use them correctly in research and quality control contexts. Physicians use a HIS in the inpatient care. B 2 2, 3, 4 Many departments use specialized IT systems that are crucial to their work. In order to record notes and results correctly, clinical staff needs to know the features of those systems and their role in the HIS. Physicians should be able to support the selection of new departmental systems based on medical and organizational requirements. They should also be able to develop parameterization and customization according to the local environment and working practices. They should be able to distinguish tasks they can handle on their own from those that need cooperation with an informatics specialist. All physicians must be able to perform the daily routine tasks using a CIS in the context of inpatient care. C 2, UMLS, SNOMED, LOINC, ICD O, ICF B 2 2, 3, 4 HIS as a socio technical system. Necessity to configure and manage a HIS. The role of analysis features in a HIS (DWH). B 2 4, Definition of requirements; operational, organizational regulatory requirements, and technical requirements. Knowledge of usage scenarios. B 3 2, 3, 4 Methods of Information in Medicine 2013(3) Supplement p. 4/10

3.5 CIS features knows CPOE procedures and is able to explain their advantages and disadvantages as well as requirements arising in that context. 3. Electronic Patient Record knows the purpose and functions/features of the various types of professional electronic patient records (doctor initiated, facilityspecific, inter facility) as well as the personal electronic health record (initiated by the patient). 3. Patient safety knows the risks and possible errors when using IT systems in the healthcare field. Knows as well countermeasures to minimize them. CPOE (computerized physician order entry) and CDSS (clinical decision support system) are increasingly used in hospitals and medical practices. Since CPOE and CDSS increase patient safety on the one hand, but also induce errors due to incorrect data entry on the other hand, physicians must know the principles and the potential benefits as well as their risks and requirements. Electronic patient records are heterogeneous and often incomplete due to the variety of institutions in the health sector as well as the variety of legal and technical issues. The unavailability of records can affect patient safety among other things. Physicians should therefore be aware of the possibilities and limitations of the various record types in order to avoid treatment errors. Physicians need to be aware of the limitations and possible errors (entry errors and malfunctions) in IT systems in order to prevent harm from the patients. B 2 1, 2, 3, 4, B 2 1, 2, 3, 4, B 2 1, 3, 4, CPOE: e.g. ordering a CT scan. CDSS: e.g. checking drug interactions when prescribing. Explanation of the following data sets: electronic patient record (EPR), electronic health record (EHR), personal health record (PHR). Requirements for archiving. Identification of readmissions by case number and patient id. Civil and criminal liability. Necessary training/briefing; systematic testing; considering software risks; reporting obligations. 3.8 Registries knows the requirements for information processing in registries and is able to explain the expression EDC (Electronic Data Capture). 3.9 Medical practice information system knows the tasks and functions of information systems in out patient care and the physician s responsibility in operating those systems; is able to explain these. It is necessary to use registries and to submit documentation to them (e.g. cancer registries) both in hospital and private practice. Registries are essential tools in healthcare research. Physicians routinely use information systems in the out patient setting. They need to be aware of their responsibility with regard to patient confidentiality, data security & data privacy. B 2 2, 4,, B 2 1, 2, 3, 4, Information systems in the health care field provide central data for research purposes. Registry studies; importance of data quality. Methods of Information in Medicine 2013(3) Supplement p. 5/10

4 E Health and Telemedicine 4.1 Electronic Health Card knows tasks and functions of electronic health cards and health professional cards, as well as the principles of telematics. 4.2 Interoperability knows the concept of interoperability and its importance, levels, and requirements and is able to explain those in a clinical setting. 4.3 Standards in health telematics is able to identify important standards in health telematics. 4.4 Telemedicine knows about usage scenarios for telemedical applications and is able to explain their operating environments. 4.5 Consumer health informatics knows that patients can play an active role in their personal health care using IT services, and he/she is able to explain such systems. Electronic health cards, health professional cards and telematics infrastructure are the foundations of networking in the health service. Physicians define the content of a clinical documentation. They must, therefore, be aware of the consequences of the electronic data exchange within a hospital and between various healthcare facilities. For that reason, adequate communication standards must be applied. Physicians are involved in the selection of IT systems for hospitals and practices and therefore need a basic understanding of those standards. They should know that electronic data exchange between different IT systems and medical devices can be problematic and that appropriate communication standards are needed. The importance of telemedical applications is increasing, due to among other things increasing specialization and shortage of specialists. Physicians should therefore be aware of potential telemedical applications and their framework in order to evaluate the benefits and shortcomings for patients. Physicians should be able to advise their patients on information services in the context of prevention, diagnostics, and therapy. B 2 4, B 2 4, Health telematics are concerned with (among other things) ensuring secure communication over networks as well as to guarantee syntactic and semantic interoperability across the relevant applications. B 1 4, xdt, CDA, DICOM, HL, IHE B 2 1,4 Teleradiology, telepathology, case conferences on the net, monitoring home care patients, Ambient Assisted Living (AAL) B 2 5 Health related internet research, IT based documentation by the patients themselves (development of the disease, quality of life), prevention. Methods of Information in Medicine 2013(3) Supplement p. /10

5 Data Privacy Protection and Data Security 5.1 Ethical and legal principles 5.2 Pseudonymization/ anonymization is able to name and apply the fundamental principles of data privacy protection. is able to interpret and classify pseudonymized and anonymized patient data. 5.3 Data security knows procedures to guarantee the secure transmission and storage of patient data and to distinguish those procedures from insecure ones. Access to Medical Knowledge.1 MEDLINE performs literature searches in MEDLINE (PubMed), uses the query syntax properly, and is able to qualify scientific sources..2 Controlled vocabularies is able to explain the importance of controlled vocabularies in medicine and uses the MeSH in searching the literature. Physicians, i.e. persons you can trust and who are in a sensitive position, should deal competently and prudently with any information given to them. Ethical and law abiding conduct requires the relevant expertise. Physicians should be able to judge whether patient records are sufficiently anonymized so that they can be processed outside of the clinical environment. Secure transmission and tamper proof storage of patient data is necessary during inter facility patient treatment. Physicians need access to current medical literature in order to retrieve the relevant information for patient treatment and research. Controlled vocabularies, especially the Medical Subject Headings (MeSH) are a vital tool for efficient medical literature searches. Therefore, physicians must be able to apply the MeSH. B 3 1, 3, 4,, B 2 4,, Medical confidentiality, the basic right to informational self determination, Federal and State data protection Acts, dealing with molecular genetic data. Definition of anonymization and pseudonymization; risk of re identification B 2 1, 4 Symmetrical/asymmetrical cryptography, virus protection software, digital signature, tamper proof storage/archiving of patient data. A 3 1, 5, B 3 1, 5, Boolean operators, quality assessment of the retrieved sources Using the MeSH in order to optimize recall and precision of a query.3 Recall and precision can explain the importance of recall and precision in database queries..4 Medical databases knows drug information systems and can work with them. Physicians have to apply quality criteria in order to evaluate their search results, thus those results, especially from large databases, can be assessed. Drug information systems are essential for patient care especially with regard to therapeutic safety. Methods of Information in Medicine 2013(3) Supplement p. /10 B 2 1, 5, A 2 2, 3, Contraindications, side effects, and interactions

.5 Guidelines knows quality and development stages of guidelines. Medical Signal and Image Processing.1 Biosignal processing is able to name biosignal procedures; and knows how to apply filtering techniques accordingly..2 Medical Imaging knows examples of medical imaging and can identify their characteristics..3 Image enhancement knows procedures for image enhancement and how to apply them..4 Image analysis is able to explain and apply the registration and segmentation of medical images..5 Visualization knows different visualization methods including their properties and specific features (artefacts). 8 Other Topics 8.1 Quality control and risk management is able to explain the fundamental concepts and methods of quality control and risk management. Physicians apply properly valid guidelines for patient care. Methods of Information in Medicine 2013(3) Supplement p. 8/10 A 2 1, 2, 3, Categories of evidence, recommendation level, and role of knowledge based systems to improve decisionmaking. Physicians work with various biosignals (e.g. ECG, EEG, and EMG) in patient diagnostics and treatment. They should, therefore, know the qualities of those biosignals in order to interpret them properly. B 2 1 see.1. A 2 1 Including x ray, and ultrasound images, microscopic and macroscopic images. DICOM Standard Physicians should be able to apply basic procedures such as windowing, brightness/contrast control, and simple filtering techniques in diagnostic imaging in order to avoid misdiagnoses. Physicians should be able to use medical imaging procedures in order to apply them correctly in patient diagnostics and treatment. Physicians who are specialized in fields using imaging procedures such as radiologists or cardiologists must be capable of correctly assessing and applying visualization techniques. Physicians should know the most important methods of quality control and risk management so that they can actively contribute to patient safety. B 3 1 Histogram spreading / equalization (bone and soft tissue window), edge and contrast enhancement. B 3 1 Data and model driven processes. Diagnostic support systems C 2 1 Data and model driven, direct and indirect visualization A 2 4, 5, Quality of structure/process/outcome; quality indicators, PDCA cycle, critical incident reporting system (CIRS)

8.2 Internet for physicians knows how to present hospitals and clinics on the internet as well as the framework for medical internet consultations. 8.3 Medical teaching and learning systems knows examples of medical teaching and learning systems and is experienced in their application. 8.4 MI in medical research is able to set forth the regulatory requirements and data standards for medical research. 8.5 Bioinformatics in medical research knows gene and protein databases as well as the appropriate search and query methods, and is able to explain them. Physicians have to respect professional and ethical rules. Physicians should be able to use simulators for training and post graduate education. Additionally they should know teaching and learning systems for patients in order to advise them properly. Scientifically active physicians should understand regulatory requirements and standards in order to apply them in the planning and implementation of studies. Physicians in basic research should be able to carry out appropriate searches. Due to improvements in personalized medicine, such databases are to be used in routine care as well. B 1 5, Media literacy. Quality rules for websites with health related content. C 2 5, C 2 4, 5,, C 2 5,, The central role of IT systems and methods of medical informatics in healthcare research. CDISC, SDTM, MedDRA. Declaration of Helsinki, Informed consent, GCP. Requirements for archiving research data. Methods of Information in Medicine 2013(3) Supplement p. 9/10

List of Abbreviations AAL Ambient Assisted Living BDSG German Federal Data Protection Law CDA Clinical Document Architecture CIRS Critical Incident Reporting System CIS Clinical Information System CCL Clinical Complexity Level DICOM Digital Imaging and Communications in Medicine DIMDI German Institute for Medical Documentation and Information DRG Diagnosis Related Groups DWH Data Warehouse EDC Electronic Data Capture EHR Electronic Health Record EPR Electronic Patient Record HIS Hospital Information System HL Health Level ICD International Classification of Diseases and Health Related Problems IS Information System LIS Laboratory Information System LOINC Logical Observation Identifiers Names and Codes MDC Major Diagnostic Category MeSH Medical Subject Headings MI Medical Informatics OPS German Operation and Procedure Classification PACS Picture Archiving and Communication System PDMS Patient Data Management System (Intensive Care Medicine) PHR Personal Health Record RIS Radiology Information System SNOMED Systematized Nomenclature of Medicine UMLS Unified Medical Language System xdt Data Exchange Formats for Medical Practices Methods of Information in Medicine 2013(3) Supplement p. 10/10