The wealth of data generated in the clinical research and healthcare domain are still underused due to their high volume and heterogeneity which constitute them isolated islands of knowledge with high complexity of interlinking and potential mining. Meanwhile, the enormous funds dedicated in clinical research and healthcare by the industry and governments still do not meet their goals, leaving millions of patients years behind the development of effective treatment, which could save or improve their lives. This paper presents the PONTE platform, a set of tools and services aiming at interlinking and mining the big data in the clinical research and healthcare domain for the efficient, scientifically-valid design of clinical trials and the effective and fast subject recruitment. The use of the platform with real world scenarios by highly experienced clinical experts is also presented, as well as the evaluation results.

Eligibility Criteria (EC) comprise an important part of a clinical study, being determinant of its cost, duration and overall success. Their formal, computer-processable description can significantly improve clinical trial design and conduction by enabling their intelligent processing, replicability and linkability with other data. For EC representation purposes, related standards were investigated, along with published literature. Moreover, a considerable number of clinicaltrials.gov studies was analyzed in collaboration with clinical experts for the determination and classification of parameters of clinical research importance. The outcome of this process was the EC Representation; a CDISC-compliant schema for organizing criteria along with a patient-centric model for their formal expression, properly linked with international classifications and codifications. Its evaluation against 200 randomly selected EC indicated that it can adequately serve its purpose, while it can be also combined with existing tools and components developed for both EC specification and especially application to Electronic Health Records.

The European Patient Summary (PS) guideline specifies a minimal dataset of essential and important information for unplanned or emergency care initially defined in the epSOS project with aim to improve patients' safety and quality of Care. The eHealth Network of European Union (EU) Member State (MS) representatives established under Article 14 of the EU directive 2011/24 on patient rights to cross-border healthcare adopted PS guideline in November 2013 and since then the guideline has been part of MS strategic eHealth implementation plans, standardization efforts, and concrete regional, national, European and international projects. This paper reviews implementation efforts for the implementation of an operational patient summary service in Greece drawing on challenges and lessons learned for sustainable standards-based large scale eHealth deployment in Europe and abroad, as well as the reuse of best practices from international standards and integration profiles.

The adoption of ICT technologies in healthcare for recording patients’ health events and progression in Electronic Health Records (EHRs) and Clinical Information Systems (CLIS) has led to a rapidly increasing volume of data which is, in general, distributed in autonomous heterogeneous databases. The secondary use of such data (commonly anonymised for privacy reasons) for purposes other than healthcare (such as patient selection for clinical trials) comprises an emerging trend. However, this trend encapsulates a great challenge; semantic interlinking of two different, yet highly related, domains (in terms of semantics) i.e., clinical research and healthcare. This paper aims at presenting an analysis of the heterogeneity issues met in this effort and describing the semantically-enabled multi-step process followed within the PONTE project for achieving the interlinking of these two domains for the provision of the size of the eligible patients for participation in a trial at the cooperating sites.

A 3D finite element model of the human middle ear was developed for the investigation of the modeling parameters' effect on the frequency response. In this study, we incorporated realistic reconstructed geometries from microCT imaging data. The geometric representation of the stapedial annular ligament provided additional damping and the Rayleigh parameter β was adjusted to lower values in comparison to previous computational studies. The maximum displacement of the stapes footplate, equal to 0.168 μm, was observed at a frequency of 1050 Hz. The computational results were validated with experimental measurements. Good agreement is observed between our results and the experimental data and other finite element studies.

Great investments are made by both private and public funds and a wealth of research findings is published, the research and development pipeline phases quite low productivity and tremendous delays. In this paper, we present a novel authoring tool which has been designed and developed for facilitating study design. Its underlying models are based on a thorough analysis of existing clinical trial protocols (CTPs) and eligibility criteria (EC) published in clinicaltrials.gov by domain experts. Moreover, its integration with intelligent decision support services and mechanisms linking the study design process with healthcare patient data as well as its direct access to literature designate it as a powerful tool offering great support to researchers during clinical trial design.

Clinical trials often fail to demonstrate beneficial effects and might overestimate the unwanted effects, with their results having low external validity. They focus on single interventions, whereas the clinical practice environment comprises various features that affect the efficacy, feasibility, duration and costs of a clinical trial. In this chapter we discuss PONTE, a platform which effectively guides medical researchers through clinical trial protocol design and offers intelligent services that address clinical needs, such as effective inclusion/exclusion criteria specification, intelligent search through a wide range of databases, clinical findings and background knowledge, and automated estimation of eligible patient population at cooperating healthcare entities. To the best of our knowledge, and to date, the PONTE platform is the first paradigm of an automated system that can effectively guide clinical trials protocol design, by linking data with drug, target and disease knowledge databases, clinical care and clinical research information systems, and guiding the users automatically though the whole pipeline of the clinical trial protocol design.

The pharmaceutical industry is facing tremendous challenges stemming from the low success rates in their research efforts along with the increasing expenses per drug candidate and the urging need for safer and effective therapies to reach the patients faster. In fact, the average cost per drug candidate exceeds 1 billion Euros and the time to market is still more than 10 years. One of the most important, yet still rather technologically and methodologically poorly supported, steps in clinical research lies in the generation and validation of the hypothesis; i.e. the research question the validity of which a set of clinical trials will aim at proving. Given the intensive searching and knowledge extraction required at this step of the clinical research lifecycle combined with the wealth and constant increase of the available information in literature, the complexity of this process is extremely high and leaves room for a variety of scientific errors and bottlenecks. This paper describes a novel methodology and a set of mechanisms developed within the PONTE project for facilitating the hypothesis generation and validation process.

Electronic Health Records (EHRs) contain a rapidly increasing volume of data which is, in general, distributed in autonomous heterogeneous databases. An emerging trend is the secondary use of such data (in most cases anonymized for privacy reasons), for purposes other than healthcare, such as for generating accurate disorder epidemiology datasets, real world treatment progress assessment and patient selection for clinical trials among others. The structure and purpose of the EHRs pose significant limitations in the richness and the complexity of the questions to be posed. In fact, the latter case introduces a greater challenge; it requires that two different domains (in terms of semantics) need to be interlinked - clinical research and healthcare. This paper aims at presenting a novel SPARQL query rewriting mechanism as part of an ontology-based approach for interlinking clinical research with healthcare EHRs for supporting automatic selection of patients who satisfy the eligibility criteria of clinical trials.

Breast cancer diagnosis requires specific expertise from the Medical Doctors. Furthermore, prognosis, monitoring and early detection of malignant findings can be successfully realized through synergies between physicians, researchers and general population in concert with the health policy program of each country. Information technology and computational intelligence play a crucial role in the production of digital repositories and cancer registries as well as in the development of systems to support diagnosis. In this paper we present the concept and the architecture of an approved grant under the National Strategic Reference Framework 2007-2013 (NSRF), called e-Prolipsis. Through this project, we will design and implement a web based risk estimation platform and a Central Breast Cancer Registry (CBCR) that will co-operate to provide medical doctors and patients with services such as multiplicity in diagnostic opinions, synergy, computational risk estimation, access to statistical/epidemiological data for trend estimation. Such a system, will serve as a reference tool and will help the clinician, the radiologist, the rural doctor or trainee doctor in the final assessment on the existence or likelihood of breast cancer. The system will assist in the successful diagnosis of breast cancer, giving each patient access to a large pool of doctors and at the same time, the data stored in the CBCR will be used for statistical analysis, providing useful results for improving both the cancer detection application and for making a national policy for combating breast cancer. This system will be accessible through a Web Portal, with different access levels for patients, doctors and general public and different web services available to each user group, eliminating the geographical distances that would be imposed otherwise.

During the last years, need for increased funding for national health services offered to citizens is rising Ill. The reasons are (i) decreased ratio of working population/pensioners, as well as (ii) increase of life expectancy. Thus, high priority should be given to safeguarding the reliable administration of the financial resources devoted to this purpose.This paper describes the application of a "clever" system which can be used by social security bodies (SSBs) and healthcare providers for:a) Electronic data entry of prescriptions written by doctors to patients,b) Check of prescriptions against predefined rules entered in the system for errors or possible fraud, reporting all suspicious cases.In addition, an integrated system for administering prescriptions was implemented, that offers the ability to query, view and print data in the format required by the user.The application was designed and implemented using Microsoft Access 2002 relational database system environment. For testing the application, data by the Greek Social Security Body of people working in Healthcare (namely T.S.A.Y.) were used; all personal information was removed.

Public healthcare is a basic service provided by governments to citizens which is increasingly coming under pressure as the European population ages and the ratio of working to elderly persons falls. A way to make public spending on healthcare more efficient is to ensure that the money is spent on legitimate causes. This paper presents the work of the iWebCare project where a flexible, on-line, fraud detection, Web services platform was designed and developed. It aims to help those in the healthcare business, minimize the loss of funds to fraud. The platform is able to detect erroneous or suspicious records in submitted health care data sets, ensuring homogeneity and consistency and promoting awareness and harmonization of fraud detection practices across health care systems in the EU. Critical objectives included, the development of an ontology of health care data associated with semantic rules, implementation and initial population of an ontology and rules repository, development of a fraud detection engine and implementation of a data mining module. The potential impact of this work can be substantial. More money on healthcare mean better healthcare. Living conditions and the trust of citizens in public healthcare will be improved.

The implementation of digital watermarking technology in healthcare applications is still in its infancy; however, the benefits of exploring this technology towards secure and efficient health data management are steadily propagated and realized by the research community. The paper presents the architecture of a watermarking Software Development Kit (SDK), which provides multiple watermarking functionality and can be customized according to the targeted medical application, in order to address security of sensitive data, origin and data authentication, image archiving and retrieval. Two use cases of the proposed watermarking SDK are presented, the one involving access to the watermarking engine through a user interface, and the other referring to the case that the engine is embedded into the image acquisition device. The nature of the embeddable information that is applicable in each use case is also described.

Implementing telemedical solutions has become a trend amongst the various research teams at an international level. Yet, contemporary information access and distribution technologies raise critical issues that urgently need to be addressed, especially those related to security. The paper suggests the use of watermarking in telemedical applications in order to enhance security of the transmitted sensitive medical data, familiarizes the users with a telemedical system and a watermarking module that have already been developed, and proposes an architecture that will enable the integration of the two systems, taking into account a variety of use cases and application scenarios

The advantages of the introduction of information and communication technologies (ICT) in the complex healthcare sector are already well known and well stated in the past. It is common knowledge that in order to install any type of information system in healthcare, six main groups of issues have to be dealt with: organizational and cultural matters related to healthcare, technological gap between healthcare professionals and information science experts, legal requirements on the confidentiality of personal data, of patient related data and on data privacy, industrial and market position of healthcare informatics and interoperability complexity, lack of vision and leadership of the health care managers and health authorities and user acceptability and usability of the proposed information systems. In order to meet these issues stated above, a special focus group (Z3) performed an assessment of the situation of healthcare informatics in Greece and of the main key points that would lead to success. In that sense it is now common knowledge that Greece is lagging information and communication technology progress in healthcare because almost none of the above mentioned issues were dealt with. This assessment is the result of the interaction of more than 150 decision makers, medical informaticians, healthcare practitioners and other individual involved in healthcare. As a conclusion, this focus group resulted in 4 major propositions that will lead to healthcare informatics introduction with better success chances: focus on terminologies and standards, focus on interoperability and information systems sustainability, focus on clear goals and system metrics that can create a healthcare performance management cockpit, and focus on people and what they have to say, by creating a e-health forum. These conclusions were taken into consideration by the Greek government and are incorporated the IASYS project, the national healthcare informatics framework for the next ten years.

watermarking is a technology with many different application domains; nevertheless, its potential in providing value-added services towards secure and efficient health data management only recently started to be realized. The paper illustrates the perspectives of digital watermarking in the healthcare sector and presents a number of user-friendly graphical user interfaces needed to implement a multiple watermarking tool; this tool is aimed to be integrated in health information management systems, in order to enhance security of sensitive information and facilitate medical data management. The Graphical User Interface (GUI) allows the physician to define a Region Of Interest (ROI) in the image, which can either be totally ignored by the watermarking process or just accommodate the minimum payload (a reference watermark) needed to enable ROI integrity control. In the rest of the image, apart from the reference watermark, three other types of watermarks may also be embedded, providing origin identification, enhanced security of sensitive personal data, and efficient image indexing and data retrieval. The paper presents a number of graphical user interfaces that enable the watermark embedding and extraction modules with the required functionality, and describes the options that become available, towards secure and efficient medical data management.