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Objective: Quality assurance (QA) in clinical trials is essential to ensure treatment is safely and effectively delivered. As QA requirements have increased in complexity in parallel with evolution of radiation therapy (RT) delivery, a need to facilitate digital data exchange emerged. Our objective is to present the platform developed for the integration and standardization of QART activities across all EORTC trials involving RT., Methods: The following essential requirements were identified: secure and easy access without on-site software installation; integration within the existing EORTC clinical remote data capture system; and the ability to both customize the platform to specific studies and adapt to future needs. After retrospective testing within several clinical trials, the platform was introduced in phases to participating sites and QART study reviewers., Results: The resulting QA platform, integrating RT analysis software installed at EORTC Headquarters, permits timely, secure, and fully digital central DICOM-RT based data review. Participating sites submit data through a standard secure upload webpage. Supplemental information is submitted in parallel through web-based forms. An internal quality check by the QART office verifies data consistency, formatting, and anonymization. QART reviewers have remote access through a terminal server. Reviewers evaluate submissions for protocol compliance through an online evaluation matrix. Comments are collected by the coordinating centre and institutions are informed of the results., Conclusions: This web-based central review platform facilitates rapid, extensive, and prospective QART review. This reduces the risk that trial outcomes are compromised through inadequate radiotherapy and facilitates correlation of results with clinical outcomes., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

Background: The European Centres of Reference Network for Cystic Fibrosis (ECORN-CF) established an Internet forum which provides the opportunity for CF patients and other interested people to ask experts questions about CF in their mother language. The objectives of this study were to: 1) develop a detailed quality assessment tool to analyze quality of expert answers, 2) evaluate the intra- and inter-rater agreement of this tool, and 3) explore changes in the quality of expert answers over the time frame of the project., Methods: The quality assessment tool was developed by an expert panel. Five experts within the ECORN-CF project used the quality assessment tool to analyze the quality of 108 expert answers published on ECORN-CF from six language zones. 25 expert answers were scored at two time points, one year apart. Quality of answers was also assessed at an early and later period of the project. Individual rater scores and group mean scores were analyzed for each expert answer., Results: A scoring system and training manual were developed analyzing two quality categories of answers: content and formal quality. For content quality, the grades based on group mean scores for all raters showed substantial agreement between two time points, however this was not the case for the grades based on individual rater scores. For formal quality the grades based on group mean scores showed only slight agreement between two time points and there was also poor agreement between time points for the individual grades. The inter-rater agreement for content quality was fair (mean kappa value 0.232 ± 0.036, p < 0.001) while only slight agreement was observed for the grades of the formal quality (mean kappa value 0.105 ± 0.024, p < 0.001). The quality of expert answers was rated high (four language zones) or satisfactory (two language zones) and did not change over time., Conclusions: The quality assessment tool described in this study was feasible and reliable when content quality was assessed by a group of raters. Within ECORN-CF, the tool will help ensure that CF patients all over Europe have equal possibility of access to high quality expert advice on their illness., (© 2012 d’Alquen et al; licensee BioMed Central Ltd.)

Background: EURO-TELEPATH is a European COST Action IC0604. It started in 2007 and will end in November 2011. Its main objectives are evaluating and validating the common technological framework and communication standards required to access, transmit, and manage digital medical records by pathologists and other medical specialties in a networked environment., Business Modelling: Working Group 1, "Business Modelling in Pathology," has designed main pathology processes - Frozen Study, Formalin Fixed Specimen Study, Telepathology, Cytology, and Autopsy - using Business Process Modelling Notation (BPMN)., Informatics Standards in Pathology: Working Group 2 has been dedicated to promoting the application of informatics standards in pathology, collaborating with Integrating Healthcare Enterprise (IHE), Digital Imaging and Communications in Medicine (DICOM), Health Level Seven (HL7), and other standardization bodies., Conclusions: Health terminology standardization research has become a topic of great interest. Future research work should focus on standardizing automatic image analysis and tissue microarrays imaging.

The COST Action IC0604 "Telepathology Network in Europe" (EURO-TELEPATH) is a European COST Action that has been running from 2007 to 2011. COST Actions are funded by the COST (European Cooperation in the field of Scientific and Technical Research) Agency, supported by the Seventh Framework Programme for Research and Technological Development (FP7), of the European Union. EURO-TELEPATH's main objectives were evaluating and validating the common technological framework and communication standards required to access, transmit and manage digital medical records by pathologists and other medical professionals in a networked environment. The project was organized in four working groups. orking Group 1 "Business modeling in pathology" has designed main pathology processes - Frozen Study, Formalin Fixed Specimen Study, Telepathology, Cytology, and Autopsy -using Business Process Modeling Notation (BPMN). orking Group 2 "Informatics standards in pathology" has been dedicated to promoting the development and application of informatics standards in pathology, collaborating with Integrating the Healthcare Enterprise (IHE), Digital Imaging and Communications in Medicine (DICOM), Health Level Seven (HL7), and other standardization bodies. Working Group 3 "Images: Analysis, Processing, Retrieval and Management" worked on the use of virtual or digital slides that are fostering the use of image processing and analysis in pathology not only for research purposes, but also in daily practice. Working Group 4 "Technology and Automation in Pathology" was focused on studying the adequacy of current existing technical solutions, including, e.g., the quality of images obtained by slide scanners, or the efficiency of image analysis applications. Major outcome of this action are the collaboration with international health informatics standardization bodies to foster the development of standards for digital pathology, offering a new approach for workflow analysis, based in business process modeling. Health terminology standardization research has become a topic of high interest. Future research work should focus on standardization of automatic image analysis and tissue microarrays imaging.

With the increased use of electric and electronic equipment in our offices, our daily exposure to electromagnetic fields has become increasingly complex due to the great variety of the frequency content of the fields. Today focus has shifted from monitors as the dominating sources of electromagnetic fields to other electronic equipment, cabling, nearby substations, power lines and stray currents in buildings. In the last 5 years wireless communication has become common in our offices. These devices use radio frequency waves to communicate and are therefore sources of radio frequency fields in our offices. To a certain degree, they all add to the complicated issue of the extensive field frequencies found in offices. The exposure of office workers is generally considered to be low and not in conflict with the existing guidelines, but if a precaution approach is applied there are a number of measures that can be taken to reduce the electromagnetic fields in offices in order to obtain a good electrical environment.

Objectives: This paper seeks to provide an overview of the initiatives that are proceeding internationally to develop standards for the exchange of electronic health record (EHR) information between EHR systems., Methods: The paper reviews the clinical and ethico-legal requirements and research background on the representation and communication of EHR data, which primarily originates from Europe through a series of EU funded Health Telematics projects over the past thirteen years. The major concepts that underpin the information models and knowledge models are summarised. These provide the requirements and the best evidential basis from which HER communications standards should be developed., Results: The main focus of EHR communications standardisation is presently occurring at a European level, through the Committee for European Normalisation (CEN). The major constructs of the CEN 13606 model are outlined. Complementary activity is taking place in ISO and in HL7, and some of these efforts are also summarised., Conclusion: There is a strong prospect that a generic EHR interoperability standard can be agreed at a European (and hopefully international) level. Parts of the challenge of EHR interoperability cannot yet be standardised, because good solutions to the preservation of clinical meaning across heterogeneous systems remain to be explored. Further research and empirical projects are therefore also needed.

Challenges regarding standardization in e-Health are analyzed, and solutions for ensuring their practical implementation are proposed. Emphasis is put on new mechanisms for enhancing the collaboration between the industry and standardization bodies.

Objectives: This review article aims to highlight the importance of standards for effective communication and provides an overview of international standardization activities., Methods: This article is based on the experience of the author of European standardization in CEN, which he leads, and the global work of ISO, where he is leading the security working group, and an overview of the work of DICOM, IEEE and HL7, partly using their web presentations., Results: Health communication is highly dependent of the general development of information technology with standards coming from ISO/IEC JTCI, ITU and several other organizations e.g. IETF, the World Wide Web consortium and Open group. A number of standardization initiatives have been in progress for more than ten years with the aim to facilitate different aspects of the exchange of health information. Electronic record architecture, Message structures, Concept representation, Device communication including imaging and Security are the main areas., Conclusions: Important results have been achieved, and in some fields and parts of the world, standards are widely used today. Unfortunately, we are still facing the fact that most healthcare information systems cannot exchange information with all systems for which this would be desired. Either the existing standards are not sufficiently implemented, or the required standards and necessary national implementation guidelines do not yet exist. This causes unacceptable risks to patients, inefficient use of healthcare resources, and sub-optimal development of medical knowledge. Fortunately, the different bodies are now largely co-operating to achieve global consensus.

This paper describes the information models that have been used to implement a federated health record server and to deploy it in a live clinical setting. The authors, working at the Centre for Health Informatics and Multiprofessional Education (University College London), have built up over a decade of experience within Europe on the requirements and information models that are needed to underpin comprehensive multi-professional electronic health records. This work has involved collaboration with a wide range of health care and informatics organisations and partners in the healthcare computing industry across Europe though the EU Health Telematics projects GEHR, Synapses, EHCR-SupA, SynEx and Medicate. The resulting architecture models have fed into recent European standardisation work in this area, such as CEN TC/251 ENV 13606. UCL has implemented a federated health record server based on these models which is now running in the Department of Cardiovascular Medicine at the Whittington Hospital in North London. The information models described in this paper reflect a refinement based on this implementation experience.

This article explains the basic concept of electronic signatures, raises the question of encryption standards ("asymmetrische Kryptographie") and analyzes the legal requirements for a safe IT-infrastructure. The "Gesetz über die elektronische Signatur" focuses on trust centers (certification-service-providers) identifying their customers, generating private and public keys and being responsible for the "online-identity" of their customers. In addition, the German Government has proposed a "Formanpassungsgesetz" in order to implement the EC-Directive on a Community framework for electronic signatures; according to the directive Member States have to ensure that "qualified" electronic signatures satisfy the legal requirements of a signature in relation to data in electronic form in the same manner as a hand-written signature satisfies those requirements in relation to paper based data and are admissible as evidence in legal proceedings.

In the face of the multiplication and the development of international surveillance networks for communicable diseases, many questions on the transmission of personal data and information arise. The confidential nature of shared data and their disclosure internationally within and outside the network are therefore potential sources for conflicts. To resolve these problems, Enter-net developed its 'Collaboration Principles' intended to apply to all the participants of the network and to all others potentially involved. These principles propose solutions to questions related to the access to databases created within the framework of the network, to the quality and confidentiality of circulating data, to the individual responsibility in the identification of an incriminated product in case of an outbreak, and even to the transmission of information outside the network. These principles, which are to be regularly reviewed, are primarily aimed at optimising early detection and management of foodborne outbreaks, and at taking the necessary measures for public health. Considering the nature of the problems, however, some of these principles are also of relevance to other surveillance networks.

This article describes our experiences in implementation of the European standard for the architecture of healthcare information systems. The standard was a great help, but this article focuses more on some problems we have encountered.

Based on the work of the ISHTAR, the TRUSTHEALTH1, the EUROMED-ETS and the MEDSEC project funded by the European Commission, the synergetic results of these different projects in providing a security infrastructure for the test environment of an oncological network will be demonstrated. The ISHTAR project investigated security issues in Health Care Establishments (HCE). It provides guidance for threat and risk analysis, and defines a schema for specification and implementation of appropriate security services and mechanisms to respond to the HCE security requirements of both communication and application security concepts. The TRUSTHEALTH1 project dealt with specification and test implementation of basic security services and mechanisms based on Health Professional Cards (HPC) and Trusted Third Party (TTP) services. Within the EUROMED-ETS project, the security solution has been extended to the Internet environment and WWW tools, successfully creating an Internet-based international TTP structure between the universities of Athens, Calabria, and Magdeburg. Finally, in the MEDSEC project the specification and implementation of a generic EDI security solution has been delivered to provide secure communication between applications and sites. In the ongoing TRUSTHEALTH2 project, the results of all these projects will be implemented in a real environment of cancer care.

Security is a key issue in healthcare information systems, since most aspects of security become of considerable or even critical importance when handling healthcare information. In addition, the intense need for information exchange has revealed interoperability of systems and applications as another key issue. Standardization can play an important role towards both these issues. In this paper, relevant standardization activities are briefly presented, and existing and emerging healthcare information security standards are identified and critically analysed. The analysis is based on a framework which has been developed for this reason. Therefore, the identification of gaps and inconsistencies in current standardization, the description of the conflicts of standards with legislation, and the analysis of implications of these standards to user organizations, are the main results of this paper.

Motivation for the creation of electronic data interchange (message) standards is discussed. The ISO Open Systems Interface model is described. Clinical information models, message syntax and structure, and the need for a standardized coded vocabulary are explained. The HIPAA legislation and subsequent HHS transaction recommendations are reviewed. The history and mission statements of six of the most popular message development organizations (MDOs) are summarized, and the data exchange standards developed by these organizations are listed. The organizations described include Health Level Seven (HL7), American Standards for Testing and Materials (ASTM) E31, Digital Image Communication in Medicine (DICOM), European Committee for Standardization (Comité Européen de Normalisation), Technical Committee for Health Informatics (CEN/TC 251), the National Council for Prescription Drug Programs (NCPDP), and Accredited Standards Committee X12 Insurance Subcommittee (X12N). The locations of Internet web sites for the six organizations are provided as resources for further information.

Different approaches to middleware, supporting systems integration in healthcare, are described and evaluated, regarding concepts, architectural framework, and relevance for healthcare enterprises. This evaluation includes CORBA, DHE, and HL7. CORBA, promoted in the healthcare area through the efforts of CORBAmed, is a strictly object-oriented approach, whereas DHE is based on process-related concepts. The earlier HL7 approach, without any modelling and with proprietary communication management, is changing to a harmonised information interchange concept in healthcare, taking into account also other protocols and medical domains with orientation to an electronic patient record. The opening also includes the separation of message definition and message exchange format, enabling the migration of different EDI standards. HL7 will also support the integration of standardised platforms as 'networking mediator applications'. Finally, some recommendations for future developments are given.

Communication standards are to facilitate the exchange of structured data and information between healthcare systems with different architectural concepts. Several national and international standard development organizations (SDO) are developing and maintaining standards, sometimes even for the same application. There is an increasing demand for a closer cooperation between SDO's and for a better harmonization of different standards going on. The current status of the most important standard application in healthcare is discussed and some further considerations for improving the harmonization process will be given.

Present health care information and communication system sufficiently respect neither the interests of the professional users (physicians, nurses, etc.) nor those of the usees (patients) concerning informational self-determination, integrity, and non-repudiation. The EU-AIM-SEISMED project has attacked this challenge. There is consensus that legal regulations and organisational measures around health care IT-systems have to be revisited and harmonised. However, the increasing processing capacities of IT-systems demand that the legitimate security interests of users and usees are enforced in advance--not only after the fact. This cannot be achieved against -----stems but only by the help of IT-systems. Since cryptographic mechanisms are an essential tool to this end SEISMED provides guidelines and technical recommendations on cryptographic mechanisms.

CEN committee TC 251 Medical Informatics, has set up a project team charged with producing a European pre-standard ENV on Healthcare Information Framework (HIF). The HIF is based on abstraction from a specific information system architecture to a reference architecture and further to a conceptual architectural framework based on serving open, distributed and heterogeneous healthcare enterprises. To specify the suitable healthcare information system architecture modelling of the healthcare enterprise is required. As there is no one method serving all needs, the HIF gives guidance on what aspects to look at in selecting a suitable modelling method. It is expected that the work will be completed by early 1995.

The paper links the previous and proposed activities of IMIA WG4 with the developments of IMIA WG10. The fading systems boundaries, increasing and integrated functionality together with the increasing use of information within HIS to care for patients raises the questions of whether HIS should be treated as 'safety critical' systems or medical devices and tested appropriately. These considerations immediately lead to the need to establish appropriate security standards for HIS.

This paper focuses on the current and future standardisation activities in CEN TC251 (European Standardisation Committee, Technical Committee on Medical Informatics). The progress of the Committee's standards development is summarized per working group. The main challenges of the next years are enumerated: coordination across working groups and project teams, quality management, and international harmonisation (especially with the USA).

The DICOM Standard for network communication has been approved by ACR and NEMA in October 1993. The ACC has joined the effort in 1992 and drives the extension of DICOM for Media Interchange with a focus on defining a digital recording standard for communication between catheterisation laboratories. This is a necessary foundation towards cinefilm replacement. DICOM networking is being adopted as a European Standard called MEDICOM and the increasing interest of the ESC is likely to result in the adoption of DICOM Media Storage and interchange as an extension of MEDICOM in 1995. This represents a major breakthrough in the communication of medical images in electronic form. DICOM has been designed to offer an integrated approach to the increasing use of high speed computer networks in health care as well as larger and higher throughput storage media. This article focuses on the network communication as well as introduces the extension of DICOM for Media interchange which has been approved early 1995.

Progress in pathology is related to application of new biological techniques and impact of electronic devices affecting transfer of information and images. The increase of specification of all kinds of disease classification induces a specific need for data exchange and expert consultation. The momentary technical situation in communication lines connected with medical fields, especially pathology is characterized by parallel operation of two basically different communication systems, namely a) systems based upon computerized data exchange (E-mail, etc.), and b) systems working at public access, i.e. telephone lines and their successors (digitized network, satellite system). Practical use in telecommunication in pathology has been gathered nearly exclusively by use of the second (public) system, and includes intraoperative classification of histological images (frozen sections), expert consultations, panel discussions, quantitative measurements, and access to image data bank systems. The use of remote control microscopes has been reported to work without major errors from Norway and Switzerland. In Norway, images and diagnostic informations are transferred by use of broad band networks (satellite communication), whereas in Switzerland the digitized network ISDN is used. The experiences show clearly that remote control microscopes are practicable and reliable tools for daily diagnostic work of pathologists, and that the quality of the transferred images is sufficient to allow sophisticated diagnoses. Expert consultations are routinely performed by use of the common telephone network in lung pathology, and can not be underestimated in their impact on the daily work. Accuracy of diagnosis, quality of staining and tissue handling, and reliability of diagnosis are automatically improved besides the positive legal aspects.

CAMARC-II intends to establish a European network of clinical and research centres, interconnected with the manufacturers of the relevant instrumentation and with 'end-users' like insurance companies, which will allow a standardised approach to the Functional Assessment (FA) of the motor (dis)ability of the motor impaired and/or the elderly. The objectives of the project are: to build-up a Europe-wide network to practice Movement Analysis; to define agreed clinical and experimental protocols; to integrate existing and new instrumentation; to define suitable User Interfaces driving the clinician in the tests; to define a comprehensive Knowledge Base (KB) of the MA experience: to build-up suitable databases (DB) of MA data accessible through the Network; to assess criteria for the definition of normative data for a conventional age-related classification of normality, impairment and disability for the motor behaviour. A number of achievements are mentioned in the paper.

For several years now, users have been waiting for standards allowing medical images to be exchanged, managed, stored and manipulated. Standards are prerequisites for the development of PACS and IMACS systems. It is because of the lack of standards that PACS have not yet widely been implemented. The ACR-NEMA committee (American College of Radiology--National Electronical Manufactures Association) are developing an image communication standard: DICOM 3.0. This should allow interconnection of different imaging modalities and other PACS nodes. Part of the DICOM 3.0 work will be demonstrated at RSNA 93 with involvement of Europe. In the European Standardization Committee (CEN), the technical committee responsible for the standardization activities in Medical Informatics (CEN TC 251), has agreed upon the directions and the scopes to be followed in this field. They are described in the directory of the European standardization requirements for health care informatics and programme for the development of standard adopted on 28 February 1991 by CEN TC 251. Top-down objectives describe the common framework and items like terminology, security, while the more bottom-up oriented items describe fields like medical imaging and multi-media. Since CEN TC 251 started working, an important coordination took place between Europe and the US and Japan, resulting in a common future approach. CEN TC 251 is setting the scene for a more technologically independent standard on a mid term basis. This standard will first have to be proto-typed before it can be published, because it must be possible to implement the standard, too much complexity will not be accepted by the industry. The European imaging standardization work based on the ISO/IPI standard, will be briefly explained; as well as the general framework model and object oriented model; the interworking aspects, and the relation to ISO standards. One should realize be realised that a standard is needed, which is not too ambitious. Because DICOM 3.0 will be ready soon, Europe has decided to support these activities and will concentrate on the next step to be taken.

This paper gives a summary of the work done by CEN TC 251 PT 004. The project team objective has been to investigate syntaxes of existing interchange formats (IFs) to be used in healthcare. A set of evaluation criteria have been developed based on functional requirements from two healthcare domains. 5 IFs; ASN.1, ASTM E1238, EDIFACT, Euclides and ODA have been evaluated. ASN.1 scores highest in the evaluation. However mapping from General Message Models (GMDs) to IF dependent message models (IFMDs) shows that all the IFs can be used. The project team recommends a strategy for development of GMDs, IFs and IFMDs.

The development of standard healthcare messages requires a full understanding of user needs, an appropriate organisation structure for developing consensus and a suitable methodology. This paper presents the current state of development in the European Standardisation Organisation's Working Group on Healthcare Messages and Communications (CEN TC251 WG3).

This article describes the actual user requirements of the health care sector in connection with telematics. The importance of standardization is stressed. The paper further gives an overview of the current standing of the activities of CEN TC 251 (European Standardization Committee, Technical Committee on Health Care Informatics).

Information at every nurse researcher's fingertips. That is the goal of an information system for nursing services in Europe. Not only would it be able to provide fast information for analyzing and developing nursing but it also aspires to end the costly duplication of research work regionally and worldwide. Below, a report on how a European network can be developed to become a potential hub for a global nursing system.