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The management and maintenance of paper-based patient record archives involve high running costs. Therefore, many health care providers choose to digitize their paper records subsequently destroying the originals. By now, this is an established procedure for patient records from routine care. However, at present it is unclear under which circumstances the patient records of patients taking part in clinical trials can be destroyed after digitization. Paper-based original records may only be destroyed if their digital copies are recognized as source documents by both sponsors and authorities. The authors believe that this recognition should be possible, as long as the scanned paper-based records fulfill the requirements for certified copies according to the Note for Guidance CPMP/ICH/135/95 (ICH-GCP). This requires that, based on the applied rules, it can be proven at any time that the existing digitization process is clearly regulated, and the resulting quality is regularly controlled and sufficiently high. The objective of this key issues paper is to present the manner in which the existing regulatory guidelines can be implemented to allow the digitized patient records being recognized as source documents. An English version of this article will be published in “Clinical Investigation” (Future Science) [1]. [ABSTRACT FROM AUTHOR]

IEC 80001-1 is an international standard and offers recommendations for a risk management process for medical information technology networks (MITs). MITs are defined as IT networks incorporating at least one medical device. The goal is to build and maintain reliable and secure MITs for hospitals of all kids. To achieve it, the standard suggests applying risk management and defines the roles involved as well as their responsibilities. A central role is the medical IT-network risk manager, assigned by the top management of organizations. He communicates with and mediates between clinical, medical device and IT divisions and compiles risk relevant facts usually distributed among them. All identified risks are analyzed, evaluated and documented in the risk management file along with counter measures and a final assessment of acceptability. We acknowledge that implementing the suggested process will create an overhead cost in documentation and - partly by extension - in personnel. However we believe that the investment at the start of projects is worthwhile, because it helps to prevent or solve problems in later stages. Especially consecutive projects can profit from the investment, reducing required effort and costs. Furthermore, a reliable and secure MIT forms the basis for frictionless routine operations and innovations for connected medical devices. Hence the investment is justified. Applying risk management to the whole cooperation all at once is unrealistic. Focusing on parts of the network, which are crucial to a new project is more recommendable. With a smaller scope, risk management remains feasible and can later be expanded to other parts of the network. IEC 80001-1 demands communication among involved employees from different specialties and divisions. This offers a chance for cooperation to find better decisions and solutions regarding an organization's medical IT network. [ABSTRACT FROM AUTHOR]

This project aimed at the implementation of an information model and a corresponding HL7 FHIR® data model for the transmission of tumor data between cancer registries and the Institute for Quality Assurance and Transparency in Healthcare (IQTIG). The project is based on a concept study from IQTIG focusing on a future quality assurance measure of the treatment of patients with localized prostate cancer. In this study quality aspects have been developed, whichmeans that different topics of interest have been adressed, but no specific quality indicators were developed. Based on the quality aspects possible data fields have been extracted which might be necessary for future quality indicators. Upon those information entities an informationmodel was designed. Based on the information model a data model in HL7 FHIR® has been developed and validated against a validation engine provided by the online platform Simplifier. This work shows the difference between an informationmodel and a data model. The information model is crucial for establishing a common understanding between all stakeholders supporting interoperability. The data model is important for the underlying technology, but does not necessarily explain the overall process. Hence, information and data model complement each other. The theroretical work presented in this paper will be the basis for further projects. A following project will use the data model to transfer tumor data between the clinical cancer registry of Lower Saxony and the IQTIG. [ABSTRACT FROM AUTHOR]

In the last ten years, a national IT infrastructure with an electronic health record (ELGA) has been established in Austria. In 2016, e-medication was successfully put into operation as an ELGA service. This paper summarizes the most important steps in the development of the project and presents essential results and lessons learned. The main challenges were the overlapping planning, testing, usability of the software products, and the coordination of the rollout. [ABSTRACT FROM AUTHOR]

The governance of large-scale scientific research projects often attracts little attention. Organisational obstacles resulting from the chosen structure are accepted, although methods for analysing the governance of organisations have long existed. This paper uses these methods to identify these obstacles and to draw conclusions for the design of future large-scale research projects. The governance of the NAKO health study, in which the roles of the sponsor and the recipient of funding are mixed, serves as an example. We performed a governance analysis according to Benz et al. which revealed a serious disturbance of the (political) competition. This and other adverse effects additionally identified could be of possible significance also to other large-scale research projects. [ABSTRACT FROM AUTHOR]

Background: Improper information transmission can lead to compromised patient safety and quality of life when patients are transferred from one setting to another. Electronic instruments may improve this situation, however, they are rarely used. Objective: The aim of this study therefore was to investigate the technical and organizational feasibility, usability, usefulness and completeness of an electronic instrument that is based on the German HL7 CDA standard for eNursing Summaries. Materials and methods: To this end, a test health telematics infrastructure, which included the German electronic health card, was established and nursing summary application was developed that allowed summary documents to be communicated between a hospital and a nursing home. The users were asked to evaluate the usability of the nursing summary application as well as to compare the usefulness and completeness of electronically and paper transmitted information. Results: This study demonstrated the feasibility of implementing an electronic nursing summary application that was based on the German HL7 CDA standard eNursing Summary and that was integrated in a test health telematics infrastructure. It could also be shown that the users rated this application as usable and that electronically supported patient transfers were superior to paper based ones. The use of the German electronic health card was regarded as a barrier by the users. Discussion: This study emphasizes the feasibility, relevance and barriers of electronically supported transfers of patients with nursing needs. Nurses working in hospitals and long-term care can integrate an application based on the HL7 CDA Standard ePfgebericht into their working processes and get better and more complete information. To ensure continuity of care in a sustainable manner in the future, the German HL7 CDA based eNursing Summary standard should become part of the German telematics infrastructure. [ABSTRACT FROM AUTHOR]

The certificate “epidemiology” provides an opportunity for epidemiologists in Germany to have their postgraduate further education in epidemiology certified by the scientific societies. The original certificate guidelines from 1992 have now been revised to reflect changes and current development. This paper documents the revision process and the current version of the guidelines. [ABSTRACT FROM AUTHOR]

Virtual patients have long been established as part of medical training. With their help, students can develop their therapeutic and diagnostic skills under conditions that are as realistic as possible, without any risk for a patient. While model or dummy simulations represent a standard in dentistry for the training of manual skills, computer-based, interactive simulations of virtual patient cases in this field are rarely described. Some of these systems have been designed for a limited purpose and do not permit a flexible and reusable design of virtual patients, or only permit it with restrictions. The MedBiquitous standard offers solutions for this purpose. This has proven itself in the medical field as a basis for virtual patient simulations. It offers an expandable structure for the data of virtual patients and describes fundamental algorithms of associated simulation software. In this paper, virtual patient player simulation software for interactive emergency training in dentistry is developed on the basis of the MedBiquitous model. As an example, a first virtual patient was created. MedEmergency Player enables action-focussed simulation without rigidly predefined linear or branched treatment pathways, unlike existing systems and the previous use of the MedBiquitous standard. The user directly experiences and examines the reactions as with a real patient [ABSTRACT FROM AUTHOR]

According to the German E-Health-Law it will be mandatory to hand out a national medication plan (BMP) in printed form to all patients that have a prescription of three or more drugs to take at the same time starting 1st April, 2017. Part of this printout is a datamatrix code that encodes all medication information using the XML-based UKF (German: Ultrakurzformat) in order to include a means for a standardized electronic transfer of the data. Generated by the general practitioner, the medication plan also needs to be updated through medical specialists, clinical doctors or pharmacists. This paper documents, based on usage scenarios for the BMP, the long way from theory to practical use and points to organizational and technical hurdles that need to be overcome as part of the digitalization. Along with the implications for the process dimension, a technical infrastructure is introduced and different challenges in working with the UKF are identified and discussed [ABSTRACT FROM AUTHOR]

Information technology in health care has a clear potential to improve quality and efficiency of health care, especially in the area of medication processes. On the other side, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. The objective of this paper is to summarize definitions and observations on IT usage in pharmacotherapy, and to derive recommendations and future research priorities for decision makers and domain experts. The recommendations address, among others, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions and the need for their continuous evaluation. [ABSTRACT FROM AUTHOR]

Information technology in health care has a clear potential to improve quality and efficiency of health care, especially in the area of medication processes. On the other side, existing studies show possible adverse effects on patient safety when IT for medication-related processes is developed, introduced or used inappropriately. The objective of this paper is to summarize definitions and observations on IT usage in pharmacotherapy, and to derive recommendations and future research priorities for decision makers and domain experts. The recommendations address, among others, a stepwise and comprehensive strategy for IT usage in medication processes, the integration of contextual information for alert generation, the involvement of patients, the semantic integration of information resources, usability and adaptability of IT solutions and the need for their continuous evaluation. [ABSTRACT FROM AUTHOR]

Due to the high popularity of mobile devices barriers for mobile learning are becoming less. Place-and time-independent access to information is part of everyday life. The number of mobile applications is steadily growing. Currently there are more than 500,000 mobile applications, so-called apps, available for the Apple iPhone/iPad which can be downloaded in the Apple iTunes Store. More than ten percent of these apps are mobile learning applications. Before starting development of a mobile app we need to analyze all requirements accurately. This is due to the fact that there is a multiplicity of different operating systems with different functionalities. This paper shows general properties of so-called native, hybrid, and web applications and advantages and disadvantages in development and use of the finished application. In addition, current software, which supports the development of a mobile application is explained. Finally the differences of the various development options are shown based on concrete mobile applications. [ABSTRACT FROM AUTHOR]