Clinical foundations and information architecture for the implementation of a federated health record service

Clinical care increasingly requires healthcare professionals to access patient record information that may be distributed across multiple sites, held in a variety of paper and electronic formats, and represented as mixtures of narrative, structured, coded and multi-media entries. A longitudinal person-centred electronic health record (EHR) is a much-anticipated solution to this problem, but its realisation is proving to be a long and complex journey. This Thesis explores the history and evolution of clinical information systems, and establishes a set of clinical and ethico-legal requirements for a generic EHR server. A federation approach (FHR) to harmonising distributed heterogeneous electronic clinical databases is advocated as the basis for meeting these requirements. A set of information models and middleware services, needed to implement a Federated Health Record server, are then described, thereby supporting access by clinical applications to a distributed set of feeder systems holding patient record information. The overall information architecture thus defined provides a generic means of combining such feeder system data to create a virtual electronic health record. Active collaboration in a wide range of clinical contexts, across the whole of Europe, has been central to the evolution of the approach taken. A federated health record server based on this architecture has been implemented by the author and colleagues and deployed in a live clinical environment in the Department of Cardiovascular Medicine at the Whittington Hospital in North London. This implementation experience has fed back into the conceptual development of the approach and has provided "proof-of-concept" verification of its completeness and practical utility. This research has benefited from collaboration with a wide range of healthcare sites, informatics organisations and industry across Europe though several EU Health Telematics projects: GEHR, Synapses, EHCR-SupA, SynEx, Medicate and 6WINIT. The information models published here have been placed in the public domain and have substantially contributed to two generations of CEN health informatics standards, including CEN TC/251 ENV 13606

Scaling up the Big Health Data Ecosystem: Engaging all Stakeholders!

There is now an urgent need to scale up our collective capability to learn insights from health data, to improve patient care pathways and health services, to ensure that public health measures and strategies are underpinned by real time evidence, and to accelerate research such as the development of drugs, vaccines and AI algorithms. Europe is investing within and across countries in research infrastructures to enable this scaling up, most frequently through federated architectures. The latest development is the plan from the European Commission to create a European Health Data Space. However, any architecture to combine data or to run distributed queries is critically dependent upon the data being held or mapped to a standardised form (structurally and semantically). Standards exist to achieve this, although more stakeholder engagement is needed in defining practical clinical models and value sets, but the real adoption of interoperability is disappointing and needs further incentivisation and investment. Data quality is another concern that can only be improved if there is awareness that this is important, a willingness to invest and a recognition that many stakeholders need to become motivated to improve quality. Scaling up the uses of data also means involving new actors such as industry. Societal trust is a vital prerequisite for enabling novel uses of data. Transparency is a critical success factor for trust. Data access governance rules must be developed through open public consultation. The bodies who make access decisions must publish information about the data accesses they have permitted. For the public to be on board they have to understand much more than most people do about the nature of health data, how it can be used for the benefit of society and what safeguards protect them when the data are used

"There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned

Biomedical Terminologies and Ontologies: Enabling Biomedical Semantic Interoperability and Standards in Europe

In the management of biomedical data, vocabularies such as ontologies and terminologies (O/Ts) are used for (i) domain knowledge representation and (ii) interoperability. The knowledge representation role supports the automated reasoning on, and analysis of, data annotated with O/Ts. At an interoperability level, the use of a communal vocabulary standard for a particular domain is essential for large data repositories and information management systems to communicate consistently with one other. Consequently, the interoperability benefit of selecting a particular O/T as a standard for data exchange purposes is often seen by the end-user as a function of the number of applications using that vocabulary (and, by extension, the size of the user base). Furthermore, the adoption of an O/T as an interoperability standard requires confidence in its stability and guaranteed continuity as a resource

Data quality in European primary care research databases. Report of a workshop held in London September 2013

Primary care research databases provide a significant resource for health services and epidemiological research. However since data are recorded primarily for clinical care their suitability for research may vary widely according to the research application or recording practices of individual general practitioners. A methodological approach for characterising data quality is required. We describe a one-day workshop entitled “Towards a common protocol for measuring and monitoring data quality in European primary care research databases”. Researchers, database experts and clinicians were invited to give their perspectives on data quality and to exchange ideas on what data quality metrics should be made available to researchers. We report the main outcomes of this workshop, including a summary of the presentations and discussions and suggested way forward

An electronic healthcare record server implemented in PostgreSQL

This paper describes the implementation of an Electronic Healthcare Record server inside a PostgreSQL relational database without dependency on any further middleware infrastructure. The five-part international standard for communicating healthcare records (ISO EN 13606) is used as the information basis for the design of the server. We describe some of the features that this standard demands that are provided by the server, and other areas where assumptions about the durability of communications or the presence of middleware lead to a poor fit. Finally, we discuss the use of the server in two real-world scenarios including a commercial application

A review of the empirical evidence of the value of structuring and coding of clinical information within electronic health records for direct patient care.

Background: The case has historically been presented that structured and/or coded electronichealth records (EHRs) benefit direct patient care, but the evidence base for this is not well documented. Methods: We searched for evidence of direct patient care value from the use of structured and/or coded information within EHRs. We interrogated nine international databases from 1990 to 2011. Value was defined using the Institute of Medicine’s six areas for improvement for healthcare systems: effectiveness, safety, patient-centredness, timeliness, efficiency and equitability. We included studies satisfying the Cochrane Effective Practice and Organisation of Care (EPOC) group criteria. Results: Of 5016 potentially eligible papers, 13 studies satisfied our criteria: 10 focused on effectiveness, with eight demonstrating potential for improved proxy and actual clinical outcomes if a structured and/or coded EHR was combined with alerting or advisory systems in a focused clinical domain. Three studies demonstrated improvement in safety outcomes. No studies were found reporting value in relation to patient-centredness, timeliness, efficiency or equitability. Conclusions: We conclude that, to date, there has been patchy effort to investigate empirically the value from structuring and coding EHRs for direct patient care. Future investments in structuring and coding of EHRs should be informed by robust evidence as to the clinical scenarios in which patient care benefits may be realised

The European Institute for Innovation through Health Data

The European Institute for Innovation through Health Data (i~HD, www.i-hd.eu) has been formed as one of the key sustainable entities arising from the Electronic Health Records for Clinical Research (IMI-JU-115189) and SemanticHealthNet (FP7-288408) projects, in collaboration with several other European projects and initiatives supported by the European Commission. i~HD is a European not-for-profit body, registered in Belgium through Royal Assent. i~HD has been established to tackle areas of challenge in the successful scaling up of innovations that critically rely on high-quality and interoperable health data. It will specifically address obstacles and opportunities to using health data by collating, developing, and promoting best practices in information governance and in semantic interoperability. It will help to sustain and propagate the results of health information and communication technology (ICT) research that enables better use of health data, assessing and optimizing their novel value wherever possible. i~HD has been formed after wide consultation and engagement of many stakeholders to develop methods, solutions, and services that can help to maximize the value obtained by all stakeholders from health data. It will support innovations in health maintenance, health care delivery, and knowledge discovery while ensuring compliance with all legal prerequisites, especially regarding the insurance of patient's privacy protection. It is bringing multiple stakeholder groups together so as to ensure that future solutions serve their collective needs and can be readily adopted affordably and at scale

National evaluation of the benefits and risks of greater structuring and coding of the electronic health record: exploratory qualitative investigation

Objective: We aimed to explore stakeholder views, attitudes, needs, and expectations regarding likely benefits and risks resulting from increased structuring and coding of clinical information within electronic health records (EHRs). Materials and methods: Qualitative investigation in primary and secondary care and research settings throughout the UK. Data were derived from interviews, expert discussion groups, observations, and relevant documents. Participants (n=70) included patients, healthcare professionals, health service commissioners, policy makers, managers, administrators, systems developers, researchers, and academics. Results: Four main themes arose from our data: variations in documentation practice; patient care benefits; secondary uses of information; and informing and involving patients. We observed a lack of guidelines, co-ordination, and dissemination of best practice relating to the design and use of information structures. While we identified immediate benefits for direct care and secondary analysis, many healthcare professionals did not see the relevance of structured and/or coded data to clinical practice. The potential for structured information to increase patient understanding of their diagnosis and treatment contrasted with concerns regarding the appropriateness of coded information for patients. Conclusions: The design and development of EHRs requires the capture of narrative information to reflect patient/clinician communication and computable data for administration and research purposes. Increased structuring and/or coding of EHRs therefore offers both benefits and risks. Documentation standards within clinical guidelines are likely to encourage comprehensive, accurate processing of data. As data structures may impact upon clinician/patient interactions, new models of documentation may be necessary if EHRs are to be read and authored by patients