HELEN, a modular framework for representing and implementing clinical practice guidelines.

OBJECTIVES: In order to implement clinical practice guidelines for the Department of Neonatology of the Heidelberg University Medical Center we developed a modular framework consisting of tools for authoring, browsing and executing encoded clinical practice guidelines (CPGs). METHODS: Based upon a comprehensive analysis of literature, we set up requirements for guideline representation systems. Additionally, we analyzed further aspects such as the critical appraisal and known bridges and barriers for implementing CPGs. Thereafter we went through an evolutionary spiral model to develop a comprehensive ontology. Within this model each cycle focuses on a certain topic of management and implementation of CPGs. RESULTS: In order to bring the resulting ontology into practice we developed a framework consisting of a tool for authoring, a server for web-based browsing, and an engine for the execution of certain elements of CPGs. Based upon this framework we encoded and implemented several CPGs in varying medical domains. CONCLUSIONS: This paper shall present a practical framework for both authors and implementers of CPGs. We have shown the fruitful combination of different knowledge representations such as narrative text and algorithm for implementing CPGs. Finally, we introduced a possible approach for the explicit adaptation of CPGs in order to provide institution-specific recommendations and to support sharing with other medical institutions.

Data security and protection in cross-institutional electronic patient records.

This paper aims at identifying the specific legal requirements concerning data security and data protection of patient health data that apply to a cross-institutional electronic patient record (EPR) and describes possible solutions for meeting these requirements. In Germany, the legal framework for such records provide that disclosure of patient health information to physicians of third-party institutions is only allowed in case that it is necessary for the joint treatment of the patient, i.e. in case of a "treatment connection". As a first step, the functionality of a remote-access architecture was proven allowing a one-way connection between the EPR systems of two health institutions in Germany, which jointly treat tumor patients. Besides, a signature system model for ensuring the integrity and authenticity of medical documents was developed and implemented in the existing information system architecture of the University Medical Center of Heidelberg. Especially in Germany, the legal framework for cross-institutional EPRs is very complex and has a considerable influence on the development and implementation of cross-institutional EPRs. However, its introduction is thought to be valuable, since a cross-institutional EPR will improve communication within shared care processes, and thus improve the quality of patient care.

Networking in shared care--first steps towards a shared electronic patient record for cancer patients.

OBJECTIVES: This paper aims at identifying the data protection and security requirements for a cross-institutional EPR. Three possible models and the first steps towards a cross-institutional EPR for the Thoraxklinik Heidelberg and the Department of Clinical Radiology of the University Medical Center of Heidelberg shall be discussed. METHODS: A comprehensive analysis of literature and legal documents supplied information for determining the data protection and security requirements. By means of information system analysis, the technical preconditions in both institutions as well as three possible models towards a cross-institutional EPR were identified. RESULTS: According to the German penal code it is only allowed to reveal patient information to external physicians in cases of so-called "treatment connection". An extension of the written consent, signed by the patient, verifying the patient agreement that his/her patient data will be stored in a cross-institutional EPR is needed. Among the three models that we identified, the model that constitutes of a virtual EPR with distributed data capture in both institutions was favored. By means of SecuRemote software a secure connection between the Thoraxklinik Heidelberg and the Department of Clinical Radiology was established, allowing the physicians to view the complete cross-institutional health information of a jointly treated patient during the weekly consultation on radiotherapy. CONCLUSIONS: Many requirements listed in this paper are requirements for electronic patient records in general. Besides these general requirements there are specific requirements for a cross-institutional EPR. The legal situation in Germany complicates the development and implementation of a cross-institutional EPR. However, we think that the efforts are reasonable, because a cross-institutional EPR will be able to improve the communication between health institutions, medical disciplines and persons involved in shared care processes. It provides them with more complete health information about the jointly treated patients. A cross-institutional EPR is, therefore, expected to improve the quality of patient care.

Electronic signature for medical documents--integration and evaluation of a public key infrastructure in hospitals.

OBJECTIVES: Our objectives were to determine the user-oriented and legal requirements for a Public Key Infrastructure (PKI) for electronic signatures for medical documents, and to translate these requirements into a general model for a signature system. A prototype of this model was then implemented and evaluated in clinical routine use. METHODS: Analyses of documents, processes, interviews, observations, and of the available literature supplied the foundations for the development of the signature system model. Eight participants of the Department of Dermatology of the Heidelberg University Medical Center evaluated the implemented prototype from December 2000 to January 2001, during the course of an intervention study. By means of questionnaires, interviews, observations and database analyses, the usefulness and user acceptance of the electronic signature and its integration into electronic discharge letters were established. RESULTS: Since the major part of medical documents generated in a hospital are signature-relevant, they will require electronic signatures in the future. A PKI must meet the multitude of responsibilities and security needs required in a hospital. Also, the signature functionality must be integrated directly into the workflow surrounding document creation. A developed signature model, fulfilling user-oriented and legal requirements, was implemented using hard and software components that conform to the German Signature Law. It was integrated into the existing hospital information system of the Heidelberg University Medical Center. At the end of the intervention study, the average acceptance scores achieved were mean = 3.90; SD = 0.42 on a scale of 1 (very negative attitude) to 5 (very positive attitude) for the electronic signature procedure. Acceptance of the integration into computer-supported discharge letter writing reached mean = 3.91; SD = 0.47. On average, the discharge letters were completed 7.18 days earlier. CONCLUSION: The electronic signature is indispensable for the further development of electronic patient records. Application-independent hard and software components, in accordance with the signature law, must be integrated into electronic patient records, and provided to certification services using standardized interfaces. Signature-oriented workflow and document management components are essential for user acceptance in routine clinical use.

Integration of clinical practice guidelines into a distributed regional electronic patient record for tumour-patients using XML: a means for standardization of the treatment processes.

With the rising efforts to guarantee a high quality treatment in medicine and to reduce the costs in the health care system, Clinical Practice Guidelines (CPG) have developed into a very important reference in medicine. CPGs are especially useful for the standardization of multi-professional treatment processes like the care for patients with malignant diseases. The Tumour-Centre Heidelberg/Mannheim (Germany) leads a project to build up a regional, virtual distributed Electronic Patient Record (EPR) for patients with malignant diseases in the Rhein-Neckar-Area. Aims of the first stages of the project are the introduction of the distributed EPR to two co-operating pilot-clinics. In this context we intend to provide access for medical professionals not only to the data of the jointly treated patients, but also to relevant existing CPGs and other medical knowledge sources like Medline and Cochrane-Library. Knowledge and Patient data should be interlinked to offer patient-specific views on the CPG-information. As all professions have different information needs, this views should be presented individualized according to the demands of the users. We analysed three relevant CPGs and defined a meta-structure that will be refined to a common meta-structure for CPGs in Oncology. CPGs as well as structured patient-documents will be implemented in the Extensible Markup Language (XML), as this platform-independent technology seems to suit our needs for data exchange and presentation purposes best. The implementation process will be accompanied tightly with evaluations to gain experience for further expansions of the EPR. The vision of the project is, that by integrating CPGs in a shared distributed EPR, the way towards standardized treatment processes in a local, but multi-professional setting, and the efforts to guarantee a high quality treatment in Oncology can sufficiently be supported.

Using the eXtensible Markup Language (XML) in a regional electronic patient record for patients with malignant diseases.

Communication between different institutions which are responsible for the treatment of the same patient is of outstanding significance, especially in the field of tumor diseases. Regional electronic patient records could support the co-operation of different institutions by providing ac-cess to all necessary information whether it belongs to the own institution or to a partner. The Department of Medical Informatics, University of Heidelberg is performing a project in co-operation with the Thoraxclinic-Heidelberg and the Department of Clinical Radiology, University of Heidelberg with the goal: to define an architectural concept for interlinking the electronic patient record of the two clinical institutions to build a common virtual electronic patient record and carry out an exemplary implementation, to examine composition, structure and content of medical documents for tumor patients with the aim of defining an XML-based markup language allowing summarizing overviews and suitable granularities, and to integrate clinical practice guidelines and other external knowledge with the electronic patient record using XML-technologies to support the physician in the daily decision process. This paper will show, how a regional electronic patient record could be built on an architectural level and describe elementary steps towards a on content-oriented structuring of medical records.