BACKGROUND:For more than 30 years, there has been close cooperation between Japanese and German scientists with regard to information systems in health care. Collaboration has been formalized by an agreement between the respective scientific associations. Following this agreement, two joint workshops took place to explore the similarities and differences of electronic health record systems (EHRS) against the background of the two national healthcare systems that share many commonalities. OBJECTIVES:To establish a framework and requirements for the quality of EHRS that may also serve as a basis for comparing different EHRS. METHODS:Donabedian's three dimensions of quality of medical care were adapted to the outcome, process, and structural quality of EHRS and their management. These quality dimensions were proposed before the first workshop of EHRS experts and enriched during the discussions. RESULTS:The Quality Requirements Framework of EHRS (QRF-EHRS) was defined and complemented by requirements for high quality EHRS. The framework integrates three quality dimensions (outcome, process, and structural quality), three layers of information systems (processes and data, applications, and physical tools) and three dimensions of information management (strategic, tactical, and operational information management). CONCLUSIONS:Describing and comparing the quality of EHRS is in fact a multidimensional problem as given by the QRF-EHRS framework. This framework will be utilized to compare Japanese and German EHRS, notably those that were presented at the second workshop.

Summary Background: For more than 30 years, there has been close cooperation between Japanese and German scientists with regard to information systems in health care. Collaboration has been formalized by an agreement between the respective scientific associations. Following this agreement, two joint workshops took place to explore the similarities and differences of electronic health record systems (EHRS) against the background of the two national healthcare systems that share many commonalities. Objectives: To establish a framework and requirements for the quality of EHRS that may also serve as a basis for comparing different EHRS. Methods: Donabedian’s three dimensions of quality of medical care were adapted to the outcome, process, and structural quality of EHRS and their management. These quality dimensions were proposed before the first workshop of EHRS experts and enriched during the discussions. Results: The Quality Requirements Framework of EHRS (QRF-EHRS) was defined and complemented by requirements for high quality EHRS. The framework integrates three quality dimensions (outcome, process, and structural quality), three layers of information systems (processes and data, applications, and physical tools) and three dimensions of information management (strategic, tactical, and operational information management). Conclusions: Describing and comparing the quality of EHRS is in fact a multidimensional problem as given by the QRF-EHRS framework. This framework will be utilized to compare Japanese and German EHRS, notably those that were presented at the second workshop.

Patient registries are a useful tool to measure outcomes and compare the effectiveness of therapies in a specific patient population. High data quality and completeness are therefore advantageous for registry analysis. Data integration from multiple sources may increase completeness of the data. The pediatric renal transplantation registry CERTAIN identified Eurotransplant (ET) and the Collaborative Transplant Study (CTS) as possible partners for data exchange. Import and export interfaces with CTS and ET were implemented. All parties reached their projected goals and benefit from the exchange.

Standardized exchange of clinical information is a key factor in the provision of high quality health care systems. In this context, the openEHR specification facilitates the management of health data in electronic health records (EHRs), while the ISO/IEEE11073 (also referred to as X73PHD) family of standards provides a reference framework for medical device interoperability. Hospitals and health care providers using openEHR require flawless integration of data coming from external sources, such as X73PHD. Hence, a harmonization process is crucial for achieving a seamless, coherent use of those specifications in real scenarios. Such harmonization is the aim of this paper. Thus, the classes and attributes of a representative number of X73PHD specializations for medical devices-weight, temperature, blood pressure, pulse and heart rate, oximetry, and electrocardiograph-along with the X73PHD core document-ISO/IEEE11073-20601-have been analyzed and mapped to openEHR archetypes. The proposed methodology reuses the existing archetypes when possible and suggests new ones-or appropriate modifications-otherwise. As a result, this paper analyzes the inconsistencies found and the implications thereof in the coordinated use of these two standards. The procedure has also shown how existing standards are able to influence the archetype development process, enhancing the existing archetype corpus.

Structured collection of clinical facts is a common approach in clinical research. Especially in the analysis of rare diseases it is often necessary to aggregate study data from several sites in order to achieve a statistically significant cohort size. In this paper we describe a framework how to approach an integration of heterogeneous clinical data into a central register. This enables site-spanning queries for the occurrence of specific clinical facts and thus supports clinical research. The framework consists of three sequential steps, starting from a formal data harmonization process, to the data transformation methods and finally the integration into a proper data warehouse. We implemented reusable software templates that are based on our best practices in several projects in integrating heterogeneous clinical data. Our methods potentially increase the efficiency and quality for future data integration projects by reducing the implementation effort as well as the project management effort by usage of our approaches as a guideline.

Many healthcare providers digitize their paper-based patient records from routine care, destroying originals (replacing scanning). Current regulations are unclear as to which paper-based patient records may be destroyed after digitization if the respective patients participate in clinical trials. GCP-compliant destruction is possible if both sponsors and authorities recognize the digital copies as source documents. Recognition should be based on digitized paper-based patient records complying with the requirements for certified copies defined in ‘Note for Guidance – CPMP/ICH/135/95’. This paper describes principles by which digitized patient records can be recognized as GCP-compliant certified copies, allowing the paper-based originals to be destroyed. A prerequisite is written proof that the digitization process implemented is controlled and its outcome quality is permanently monitored.

Background The usage of patient data for research poses risks concerning the patients’ privacy and informational self-determination. Next-generation-sequencing technologies and various other methods gain data from biospecimen, both for translational research and personalized medicine. If these biospecimen are anonymized, individual research results from genomic research, which should be offered to patients in a clinically relevant timeframe, cannot be associated back to the individual. This raises an ethical concern and challenges the legitimacy of anonymized patient samples. In this paper we present a new approach which supports both data privacy and the possibility to give feedback to patients about their individual research results. Methods We examined previously published privacy concepts regarding a streamlined de-pseudonymization process and a patient-based pseudonym as applicable to research with genomic data and warehousing approaches. All concepts identified in the literature review were compared to each other and analyzed for their applicability to translational research projects. We evaluated how these concepts cope with challenges implicated by personalized medicine. Therefore, both person-centricity issues and a separation of pseudonymization and de-pseudonymization stood out as a central theme in our examination. This motivated us to enhance an existing pseudonymization method regarding a separation of duties. Results The existing concepts rely on external trusted third parties, making de-pseudonymization a multistage process involving additional interpersonal communication, which might cause critical delays in patient care. Therefore we propose an enhanced method with an asymmetric encryption scheme separating the duties of pseudonymization and de-pseudonymization. The pseudonymization service provider is unable to conclude the patient identifier from the pseudonym, but assigns this ability to an authorized third party (ombudsman) instead. To solve person-centricity issues, a collision-resistant function is incorporated into the method. These two facts combined enable us to address essential challenges in translational research. A productive software prototype was implemented to prove the functionality of the suggested translational, data privacy-preserving method. Eventually, we performed a threat analysis to evaluate potential hazards connected with this pseudonymization method. Conclusions The proposed method offers sustainable organizational simplification regarding an ethically indicated, but secure and controlled process of de-pseudonymizing patients. A pseudonym is patient-centered to allow correlating separate datasets from one patient. Therefore, this method bridges the gap between bench and bedside in translational research while preserving patient privacy. Assigned ombudsmen are able to de-pseudonymize a patient, if an individual research result is clinically relevant.

BACKGROUND:The results of pediatric renal transplantation have improved markedly in the last decade. However, a number of relevant clinical problems remain, such as organ damage caused by chronic rejection, long-term toxicity of immunosuppressive therapy, difficulty in developing tolerance-inducing protocols, secondary cardiovascular comorbidity, post-transplantation lymphoproliferative disease, suboptimal longitudinal growth, quality of life, adherence to immunosuppressive medication, and structured transition programs to adult care. These unmet clinical needs require intense collaborative and interdisciplinary clinical research. We recently founded the Cooperative European Paediatric Renal TransplAnt INitiative (CERTAIN; www.certain-registry.eu) as a research network and platform built on a novel, web-based registry.RESULTS:The registry's dataset provides essential information on generic kidney transplantation-related topics and also captures pediatric-specific topics, such as growth, physical and psychosocial development, and adherence. Due to its flexibility the system can be used as follows: (1) as a registry capturing a minimal or an extended dataset; (2) as a center and/or country-specific transplantation database; or (3) as a patient-specific electronic transplantation chart. The data can be exported directly from the CERTAIN web application into statistical software packages for scientific analyses. The rights regarding data ownership, evaluation, and publications are regulated in the registry's rules of procedure. Data quality is ensured by automatic software validation and a manual data review process. To avoid redundant data entry, CERTAIN has established interfaces for data change with Eurotransplant, the Collaborative Transplant Study (CTS), and the registry of the European Society of Pediatric Nephrology (ESPN) and European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) (ESPN/ERA-EDTA registry). CERTAIN fulfils all regulatory and ethical requirements of the European Union and Germany, in particular, regarding patients' data privacy and security.CONCLUSION:Using modern information technology, the recently established multinational CERTAIN Registry fills a gap in Europe for collaborative 5 research and quality assurance in the field of pediatric renal transplantation.

Clinical trials are of high importance for medical progress. But even though more and more clinical data is available in electronic patient records (EPRs) and more and more electronic data capture (EDC) systems are used in trials, there is still a gap which makes EPR / EDC interoperability difficult and hampers secondary use of medical routine data. The openEHR architecture for Electronic Health Records is based on a two level modeling approach which makes use of 'archetypes'. We want to analyze whether archetypes can help to bridge this gap by building an integrated EPR / EDC system based on openEHR archetypes. We used the 'openEHR Reference Framework and Application' (Opereffa) and existing archetypes for medical data. Furthermore, we developed dedicated archetypes to document study meta data. We developed a first prototype implementation of an archetype based integrated EPR / EDC system. Next steps will be the evaluation of an extended prototype in a real clinical trial scenario. Opereffa was a good starting point for our work. OpenEHR archetypes proved useful for secondary use of health data.

Purpose: This paper introduces the modelling of a prototype neonatology electronic patient record (EPR) using openEHR archetypes. The EPR is necessary to support the complex communication tasks of the innovative concept of 'Developmental, Family-Centred, Individual Care of Premature Infants and Newborns' established for the Department of Neonatology at Heidelberg University Hospital.Methods: The data to be documented was analysed and modelled using the five step openEHR data modelling approach (odma).Results: The analysis revealed a total of 1818 items, which could be arranged into 70 clinical concepts. The items and concepts were then mapped to 132 openEHR archetypes. Fifty-eight of these archetypes could be reused either directly or via specialisation. from the existing openEHR archetypes. A further 67 archetypes were newly developed. To combine and constrain archetypes for local settings 16 templates were developed.Conclusion: By using the five step openEHR data modelling approach, semantic interoperability, and a reduced need for repeated documentation of the same data can be realised. This is of major importance within the hospital as well as for trans-institutional data exchange. (C) 2009 Elsevier Ireland Ltd. All rights reserved.

Background: Acceptance by citizens seems to be crucial for the future success of an electronic health record (EHR) in Germany and Austria. We analyzed citizens' knowledge and expectations about the concept and contents of an EHR. We also addressed possible fears and barriers, and we investigated desired EHR functionalities relevant to citizens in the Austrian and German population.Methods: Standardized interviews of a convenience sample of 203 Austrian and 293 German citizens recruited in two metropolises.Results: Up to three-quarter of the interviewed citizens already collect and store medical documents at home, mostly in paper-based form. No respondents had already used an Internet-based personal health record. Between 80% and 90% of respondents were supportive of the idea of an electronic exchange of health-related data between health care providers as core functionality of an EHR. However, many respondents formulated concerns with regard to data protection and data security within an EHR. The EHR functionalities most supported by respondents included the electronic vaccination record, online information on doctors and hospitals, and the administration of appointments and reminders.Conclusion: The results indicate a generally positive attitude towards the EHR. However, the study shows that data protection is an issue for many citizens, and that despite strong media discussion, there are information deficits with regard to the national EHR initiatives. (C) 2009 Elsevier Ireland Ltd. All rights reserved.

Using openEHR archetypes to establish an electronic patient record promises rapid development and system interoperability by using or adopting existing archetypes. However, internationally accepted, high quality archetypes which enable a comprehensive semantic interoperability require adequate development and maintenance processes. Therefore, structures have to be created involving different health professions. In the following we present a model which facilitates and governs distributed but cooperative development and adoption of archetypes by different professionals including peer reviews. Our model consists of a hierarchical structure of professional committees and descriptions of the archetype development process considering these different committees.

OBJECTIVES:Electronic patient record (EPR) systems are increasingly used and have matured sufficiently so as to contribute to high quality care and efficient patient management. Our objective is to summarize current trends and major achievements in the field of EPR in the last year and to discuss their future prospects.RESULTS:Integrating health data from a variety of sources in a comprehensive EPR is a major prerequisite for e-health and e-research. Current research continues to elaborate architectures, technologies and security concepts. To achieve semantic interoperability standards are developed on different levels, including basic data types, messages, services, architectures, terminologies, ontologies, scope and presentation of EPR content. Standards development organisations have started to harmonize their work to arrive at a consensus standard for EPR systems. Integrating the health care enterprise as a whole will optimize efficient use of resources, logistics and scheduling.CONCLUSIONS:The past few years have seen a myriad of developments of EPR systems. However, it is still a long way, until EPR systems can flexibly fulfill all user requirements and an EHR will become broadly accepted. Semantic interoperability will be a key to successful EPR use, especially to avoid double data entries and to better integrate data recording within local workflows. The patient will become an empowered partner, not only by giving him access to his health data. All this will result in enormous quantities of data. Thus, time has come to determine how relevant data can be presented to the stakeholders adequately.

At the University Children's Hospital Heidelberg the concept of 'Developmental, Family-Centred, Individual Care of Premature Infants and Newborns' was introduced to support optimal growth of premature infants. This interdisciplinary concept requires cooperation of different specialists. A well operating communication is a precondition for such cooperation. As a patient's record is not only used for storing information but also for exchanging information, the question was if a complete electronic patient record (EPR), in contrast to the existing patient's record, could sensibly support this new concept of care. To answer this question the whole communication of the staff in the infants ward was analysed using different observation methods. These observations delivered several issues which showed that an EPR could improve communication and workflow. Therefore an EPR for the neonatology at the University Children's Hospital Heidelberg can now be designed on the basis of our communication concept.