Ebook: Collaborative Patient Centred eHealth

Evolution in Hardware

Twenty-five years agoin 1983the first MIC congress was organizedin collaboration between the Dutch VMBI, founded in 1971, and the Belgian MIM, founded in 1974. This collaboration proved to be a golden choice. But who of the participants of the current MIC ever used 5- or 7-hole paper tapes or punched cards, 5¼ or 3½ inch diskettes, DEC-tapes or digital magnetic tapes? Who still remembers the time that the speed of computers was measured in thousands of instructions per second, that computers had magnetic core memory, and that removable magnetic disks had a storage capacity of a mere hundred thousand bytes? Besides, who can still read his old digital files, produced by a mainframe or minicomputer of those early years? Perhaps, the most impressive observation is that Moore's Law (that the number of transistors on integrated circuits doubles every two years) has proven to be valid for half a century, until today.

Evolution in Software

Indeed, incredibly many changes took place regarding computer hardware. But this is not less the case with respect to the software. Are there still any MIC-participants who ever programmed in Assembler, Fortran, Cobol, ALGOL? Are there still systems operational in MUMPS or Basic? Anyway, the writers of this foreword, who stood at the cradle of both associations, VMBI and MIM, have experienced all this – although they can hardly remember these developments, because of the extremely high speed by which they occurred.

Evolution in Manware

The expectations in the ‘ancient times’ of VMBI, MIM and MIC were tremendous but nobody was able to predict the advent of the PC (cf. MITS' Altair 8080 in 1974), of the world-wide web in 1991, and the public start of the Internet in 1992; and who at that time had ever heard of computer viruses and computer crime? Who was concerned about computer security, data confidentiality and privacy protection? Nobody expected the incredibly fast proliferation and processing speed of computers and their application for actually all aspects of society, including health care. Who could have predicted, that not the hardware or the software, but that manware, the human factor, would be the crucial factor for successful applications in the medical domain? Anyway, this remark pertains to all applications in society. If there is anything special that we have discovered during the last 25 years, it is that computers can only be successfully applied when processing systems can be formalized and when to be automated processes are repeatable and procedures can be standardized.

Evolution in Disciplines

All this applies in particular to health care, where the human factor is perhaps the most prominent of all computer applications in whole society. Our processing methods have become more and more abstract, and are less and less dependent on concrete hardware and software. In the beginning, Medical Informatics was foremost an art, an applied technology.

In the early eighties, books written by Marsden S. Blois, François Grémy and others introduced the term of Medical Information Science (instead of Medical Informatics), hereby emphasizing the differences in information processing in medicine.

Gradually, R&D departments were founded in universities to develop advanced training and education programs. Medical Informatics evolved from a domain of co mputer applications to a multidisciplinary field, where medical students, MSc and PhD students were trained and progressively adopted the methods used in this field. As it became clear that specific methods were lacking for medical informatics applications we decided to borrow and adapt some from adjacent scientific disciplines such as physics, statistics and informatics. Therefore, it also became evident that Medical Informatics is not a fundamental scientific area on its own, but an applied field. It is at most an ancillary science, only existing for the benefit of health care. It is not an independent, ‘stand-alone’ domain, such as astronomy, geology or biology. As medicine itself is a combination of many different disciplines, medical informatics bears the same characteristics. For every different application in medicine and health care, multidisciplinary teams are composed to solve specific problems. Likewise, different people, disciplines and skills are required for computer interpretation of medical signals or images than for the construction of electronic health records or for the development of modern hospital networks providing seamless access to patient data, or again for R&D pertaining to the development of systems for intensive care units. Home care and remote patient monitoring even involve participation of patients in the management of their condition, hence their influence and input in the design of such systems cannot be underestimated.

Evolution in Types of Processes

In Medical Informatics three types of processes play a central role: (1) organizational (2) patient-related and (3) decision making-related. The first type deals with settings, such as a hospital care setting or a primary care setting; the second is related to health and disease (i.e. to patients); the third type of process aims at assisting in decision making and therapy and evolves in the brains of healthcare professionals. Hence, in all domains data, information, and knowledge play a key role. As these three processes evolve, dealing with individuals – patients, doctors, and nurses – because of that human factor there are obviously limitations imposed by formalization and standardization.

This is why medical informatics R&D most often bears a multidisciplinary character. This is caused by the fact that (1) medical informatics deals in essence with the entire and very complex domains of medicine and health care (2) R&D is conducted by individuals originating from multiple and distinct scientific disciplines (3) R&D should not only incorporate knowledge from the natural sciences but should also be based on ‘soft’ knowledge stemming from the behavioral sciences and medical experience, and should also take into account ethical aspects.

Evolution in Patient Involvement

Nobody could have predicted the enormous impact of the PC and the Internet on modern society, including health care. The patients are also increasingly using the computer and are browsing the Internet to find answers related to their health condition. Since the moment that PubMed was made accessible to patients, the number of consultations by patients has grown by a factor of 10. Patients and their relatives or friends are increasingly interested to obtain information from MEDLINE or other resources on specific diseases and health related matters. This is also why the reliability of such information is crucial. For this reason, about 15 years ago HON (Health on the Net), founded by Jean-Raoul Scherrer in cooperation with the EC, developed the HON Code of Conduct for medical websites. Websites which comply with the HON Code of Conduct are allowed to use the HON logo as a sign of the higher reliability of the information they present.

Evolution of Biomedical Informatics

In parallel to medical research medical informatics is evolving constantly. It is only about fifteen years ago that basic medical research was primarily concerned with problems in physiology, anatomy, embryology, or immunology; fundamental research in biomedicine was generally done on the level of organs and organisms. Nowadays, the challenges are of a different nature where many research projects are primarily conducted at the level of biomolecules and cells. This is partly the effect of the unravelling of the genome and the proteome. Genomics (the study of the genome and the genes) and proteomics (the study of the proteins produced by the cell on the basis of information encoded in the genes) have also a profound effect on modern clinical research and population-based research. Therefore, a new branch of informatics in medicine emerged under the name of bioinformatics (or biomedical informatics). Despite these rapid and important changes it will still take a considerable amount of time before the newly gained insights in biomolecular and bioinformatics research can be translated into clinical and medical practice, i.e., into new diagnostic and therapeutic techniques.

Evolution in eHealth R&D

In the last 15 years, the European Commission has supported major research, development and deployment programs which also facilitated international cooperation. Over the years the nomenclature used to designate our field also evolved from medical informatics, to medical telematics, to ICT in health and now to eHealth. Today's research priorities focus on personalized systems, on modeling and simulation (VPH), on accelerating the convergence of biomaterial development (nanotechnology and microsystems) and on blurring the boundaries between the fields of research and care. Deployment initiatives address cross-border communication (e.g. of health record summaries and e-prescriptions) and on interoperability between eHealth systems in general. In this rapidly evolving (and rather technical) environment one significant challenge remains: more consistency and continuity to support in a substantial way the longer term views such as semantics research (following Basic Formal Ontology principles), international standardization, and eHealth systems' quality labeling and certification. Without these, interoperability will continue to be an illusion.

Evolution in Expectations and Future Needs

In the past, there have been some unrealistic expectations regarding the possible contributions of medical informatics to health care such as the predictions in the 1970s on the expected impact of medical decision-support systems and expert systems on health care. However such contributions appeared to be very modest, to say the least. The same applies to the overly optimistic expectations regarding the introduction of electronic health records. Although the technology is widely available all these developments appear to be far more complex than expected. Many effects related to (1) the human factor and (2) obstacles which we regard as informational in nature, were underestimated and still continue to slow down our efforts.

The need for an improved understanding of the nature of medical knowledge to better serve health remains to be emphasized.

Medicine and health care offer us wonderful opportunities (but assign us also a heavy and unique responsibility) to better understand and describe the human nature in all the interrelated levels influencing health. Let us therefore join forces (biomedical, ICT staff and clinicians) to address this challenge!

Rotterdam, Jan H. van Bemmel

Gent, Georges J.E. De Moor

August 2008

Two level object modelling has been introduced in recent health care IT standards, such as Health Level 7 version 3, CEN/ISO 13606 and OpenEHR. Generic functions of electronic health records and electronic messages can be developed in such a way that they become independent of the clinical data, but allow its data management. Clinical data are elicited from clinicians and modelled in the form of clinical statements or archetypes. Such clinical statements or archetypes can be standardized and inserted into the technology upon choice of clinicians. This allows flexibility in development using collections of standardized models. Detailed clinical models (DCM) thus make clinical data explicit, allowing its use in multiple standards and multiple technologies. This paper presents an overview of work for DCM including a workshop in Brisbane in 2007 and project proposals for HL7, CEN and ISO joint standardization work.

Today's healthcare systems are facing huge challenges related to the aging of population, availability of resources, development and availability of new technology and individual empowerment. A Microsoft Healthcare belief is that people are the key to success, whether success is measured by healthy patients or a healthy bottom line, that knowledge is a strong enabler of transformation of healthcare delivery, that IT is an agent of change and last, but equally important, Health IT needs to be available to many, not just some. The article will provide some arguments about heath IT contribution and Microsoft vision regarding the future of delivery of health care.

In recent years international policies have aimed to stimulate the use of information and communication technologies (ICT) in the field of health care. Belgium has also been affected by these developments and, for example, health electronic regional networks (“HNs”) are established. Thanks to a qualitative case study we have explored the implementation of such innovations (HN) to better understand how health professionals collaborate through the HN and how the HN affect their relationships. Within the HNs studied a common good unites the actors: the continuity of care for a better quality of care. However behind this objective of continuity of care other individual motivations emerge. Some controversies need also to be resolved in order to achieve cooperative relationships. HNs have notably to take national developments into account. These developments raise the question of the control of medical knowledge and medical practice. Professional issues, and not only practical changes, are involved in these innovations.

The LISA application, developed by the University Hospitals Leuven, permits referring physicians to consult the electronic medical records of their patients over the internet in a highly secure way. We decided to completely change the way we secured the application, discard the existing web application and build a completely new application, based on the in-house developed hospital information system, used in the University Hospitals Leuven. The result is a fat Java client, running on a Windows Terminal Server, secured by a commercial SSL-VPN solution.

Home health care (HHC) organizations as well as hospitals encounter information-tracking problems regarding their patients. When a patient is admitted to the hospital, it is not always possible/easy to find out if this person already had HHC and if so, by which organization it was provided. HHC organizations also not always know to which hospital a person is admitted. At discharge, although discharge documents exist, HHC organizations not always receive the necessary information. However, sharing information between the different care-partners involved is important, among others for the continuity of care. Hospitals will gain better insight in the provided home care before admission, and HHC organizations will get a more complete and direct insight in the course of care at the hospital. In doing so, they are better prepared to provide the necessary care for the patient admitted to the hospital or returning at home. Discussion with the partners involved in the IBBT-Trans-eCare project resulted in tracking the current problems, defining goals and presenting a solution to meet the defined problems.

Cross-border activities in health care in the European single market are increasing. Many of these cross-border developments are related to e-Health. E-Health describes the application of information and communication technologies across the whole range of functions that affect the health care sector. E-health attracts a growing interest on the European level that highlights the sharp need of appropriate regulatory framework able to ensure its promotion in the European Union. Some Directives constitute a step in this direction. Both the Data Protection Directive, the E-Commerce Directive, the Medical Device Directive and the Directive on Distance Contracting are some of the most important European legal achievements related to e-Health. Although the directives are not adopted especially for e-health applications, they are indirectly very important for e-Health. Firstly, the Data Protection Directive applies to personal data which form part of a filing system and contains several important principles that have to be complied with by e-Health actors processing personal data concerning health. Secondly, the E-commerce Directive applies to services provided at a distance by electronic means. Many e-Health applications fall within this scope. Thirdly, the Medical Devices Directive is of importance for the e-Health sector, especially with regard to e.g. the medical software that is used in many e-health applications. Finally, the Directive on Distance Contracting applies to contracts for goods or services which make use of one or more means of distance communication; E-Health business may involve the conclusion of contracts.

Despite these Directives more developments are needed at the European level in order to make sure that e-Health will play an even more important role in health care systems than is the case today. The new e-Health applications like electronic health records, e-health platforms, health grids and the further use of genetic data and tissue involve new legal challenges. Several member states are introducing electronic health records or e-Health platforms. The use of electronic health records that contain data of several health actors poses new risks with some legal consequences. Recently, grids are being used in some ambitious medical and healthcare applications. In order to be truly effective such grid applications must draw together huge amounts of data from disparately located computers – which implies data sharing across jurisdictions and the sharing of responsibilities by a range of different data controllers. E-Health will also enhance the further use of human tissue and genetic data. More and clear guidelines on the reimbursement criteria for telemedicine and on liability would also be very useful. Guidance at the European level can be given as to the criteria that (tele-) health sessions will have to comply with for reimbursement purposes, since it is still unclear when e-Health sessions will be reimbursed. It is clear that the existing European legal framework is not finished yet and that more specific European rules are needed.

We often restrict the analysis of eHealth services to a concept of privacy. In this article, we'll demonstrate that other legislation can apply to those services as Directive 2000/31/EC on Ecommerce. By creating telematic networks or infrastructure, eHealth services are offering information services. But what are the consequences with such concept? What are the duties and rights for the actors of the network(s)? We'll try to answer to some questions, even if it won't be exhaustive.

The paper proposes a data protection framework for trans-European medical research projects, which is based on a technical security infrastructure as well as on organizational measures and contractual obligations. It mainly relies on pseudonymization, an internal Data Protection Authority and on a Trusted Third Party. The outcome is an environment that combines both good research conditions and an extensive protection of patients' privacy.

During the past decade the healthcare industry has evolved from paper-based storage of clinical data into the digital era. Electronic healthcare records play a crucial role to meet the growing need for integrated data-storage and data communication. In this context a new law was issued in Belgium on December 7th, 2005, which requires physiotherapists (but also nurses and speech therapists) to keep an electronic version of the registry. This (electronic) registry contains all physiotherapeutic acts, starting from January 1, 2007. Up until that day, a paper version of the registry had to be created every month.

This article describes the development of an electronic version of the registry that not only meets all legal constraints, but also enables to verify the traceability and inalterability of the generated documents, by means of SHA-256 codes. One of the major concerns of the process was that the rationale behind the electronic registry would conform well to the common practice of the physiotherapist. Therefore we opted for a periodic recording of a standardized “image” of the controllable data, in the patient database of the software-system, into the XML registry messages. The proposed XSLT schema can also form a basis for the development of tools that can be used by the controlling authorities. Hopefully the electronic registry for physiotherapists will be a first step towards the future development of a fully integrated electronic physiotherapy record.

By means of a certification procedure for the software systems, we succeeded in developing a user friendly system that enables end-users that use a quality labeled software package, to automatically produce all the legally necessary documents concerning the registry. Moreover, we hope that this development will be an incentive for non-users to start working in an electronic way.

If Electronic Health Record (EHR) systems are to provide an effective contribution to healthcare across Europe, a set of benchmarks need to be set to ensure the quality of such systems. This article describes the results of the EU funded QRec- project and emphasizes the need for validation of clinical archetypes to support the semantic interoperability between EHR systems and other interacting eHealth applications.

In this paper, we describe the design, creation and testing of a new Web-Based Electronic Health Record for Out-of-Hours (OOH) use with special emphasis on coding matters. The context is the Belgian health system, in which a patients' health record keeper is a specific GP, to whom the OOH reports, generated by any colleague who meets this patient during week-end or night shifts should converge. The system enables structured and secured acquisition of the records, intermediate storage and transmission to the GP's who keep the respective records.

In the first part of the paper, the design and implementation of this web-based application are highlighted in view of the SOEP registration methodology and explaining how coding was implemented, so that the users apply it seamlessly.

Currently, the web-based OOH health record has been deployed and is en effective use by GP's of the Domus Medica association.

In the second part, a first evaluation is made, based on feedback by a group of pilot users, this evaluation shows good acceptance by field users.

Data currently available in primary care Electronic Patient Records (EPR) can potentially be used to study quality of care. In this paper we investigate to which extend these data can reflect GPs' “thoughts” that are an important issue when considering GPs' practice and quality improvement cycle. Within the Resoprim project, we mainly used the consolidated data of three software systems, 26 practices, 1 554 hypertensive patients and 1 977 contacts. Extracted data from the EPR were: some diagnoses, some drugs, referral events, marital status, some parameters (smoking status, height, weight, blood pressure). As “gold standard” of GPs' thoughts we used an electronic questionnaire at the end of each contact. Measures of missing and incoherent values were used to assess our “gold standard”. Sensitivity, positive predictive values, correctness and global completeness were used to measure the quality of the automatic extracted data (our proxy). For the “gold standard”, the global percentage of missing values is 1.88% and of incoherent values is 3.92%. For most of the practices, the PPV or the correctness of automatic extracted drugs and automatic extracted parameters is high (>95%). The PPV of automatic extracted diagnoses is variable (42.1% to 94.9%). The sensitivity of automatic extracted diagnoses and drugs is lower than 67%. For most of the practices the sensitivity of automatic extracted parameters (excl. smoking status) is higher than 95%. The global completeness of height and weight is lower than 76%. Referrals are badly recorded or extracted. Currently in Belgium, without additional investigations, databases built on data extracted from EPRs can hardly be considered as good proxies of what is thought or known by the GPs. To use them as proxies, we should at least develop tools such as electronic questionnaires to calibrate them. As priority, we suggest an improvement of the extraction procedure design, of the current software interfaces and of the quality control of the extraction modules in order to improve respectively the extracted drugs sensitivity, the global completeness of extracted parameters and the PPV of extracted diagnoses. Training GPs could also be helpful.

The ISO TC215 WG4 pseudonymisation task group has produced in 2008 a first version of a technical specification for the application of pseudonymisation in Healthcare Informatics 0. This paper investigates the principles set out in the technical specification as well as its implications in eHealth. The technical specification starts out with a conceptual model and evolves from a theoretical model to a real life model by adding assumptions on the observability of personal data.

We made the decision in our hospital to radically eliminate the paper archive by bulk scanning over a million medical records. This reorganization goes together with installation of new workflows for injecting information that is still captured on paper as automatically as feasible into the electronic medical record. In this article we describe our organizational and technical approach and we highlight principles which our experience suggests to be useful.

This article describes the implementation of an Electronic Nursing Record (ENR) in Maasland Hospital (Orbis Medical and Healthcare group) in Sittard, the Netherlands. Through analysis of documents, structured interviews and participatory observation, a study was made of the plans prior to the introduction of the ENR, how the process proceeded, which enhancing and constraining factors influenced the process and how the nursing staff experienced the introduction of the ENR. The implementation of the system took place in 2006 and 2007. The selection and design of the system was carried out first, followed by a pilot phase. After thorough review and adjustment, the introduction of the ENR in the other wards of the hospital followed according to plan. The implementation process was carried out by several nurses in different roles (project management, project group members, key-users and teachers). The introduction of the system had two objectives: saving time by promoting efficiency and quality improvement by the introduction of standardization in documentation and the use of nursing care plans. The study indicates, however, that no time-efficiency was achieved by using the ENR so far. This had an adverse effect on the acceptance of the system by the nurses. The nurses were positive about the set-up of the implementation process, especially the contribution of the project group, the key-users on the ward and the resources which were made available (the staffing, external expertise and training).

Background and objectives: In Intensive Care Units, the amount of data to be processed for patients care, the turn over of the patients, the necessity for reliability and for review processes indicate the use of Patient Data Management Systems (PDMS) and electronic health records (EHR). To respond to the needs of an Intensive Care Unit and not to be locked with proprietary software, we developed a PDMS and EHR based on open source software and components.Methods: The software was designed as a client–server architecture running on the Linux operating system and powered by the PostgreSQL data base system. The client software was developed in C using GTK interface library. The application offers to the users the following functions: medical notes captures, observations and treatments, nursing charts with administration of medications, scoring systems for classification, and possibilities to encode medical activities for billing processes. Results: Since his deployment in February 2004, the PDMS was used to care more than three thousands patients with the expected software reliability and facilitated data management and review processes. Communications with other medical software were not developed from the start, and are realized by the use of the Mirth HL7 communication engine. Further upgrade of the system will include multi-platform support, use of typed language with static analysis, and configurable interface. Conclusion: The developed system based on open source software components was able to respond to the medical needs of the local ICU environment. The use of OSS for development allowed us to customize the software to the preexisting organization and contributed to the acceptability of the whole system.